Laparoscopic Gastrointestinal Sizing Tool Classification Rules
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the laparoscopic gastrointestinal sizing tool into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the laparoscopic gastrointestinal sizing tool. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Compliance Requirements
- #1
Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following: (i) Trocar compatibility, which includes shaft bending force characterization; (ii) Joint strength tensile testing; (iii) Distal loop extension/retraction force characterization; (iv) Material selection analysis, which includes corrosion and visual inspection; and (v) Accuracy of the dimensional measurement.; Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device.; The patient-contacting components of the device must be demonstrated to be biocompatible.; Labeling of the device must include: (i) A statement regarding metal allergies if the device is made from metallic components; (ii) Specific instructions for proper device use including information regarding: (A) Inspection of device prior to use; (B) Surgical access techniques or methodologies; (C) Instructions for avoiding structural damage to vagus nerve bundle; (D) Trocar compatibility; (E) Sizing methodology; and (F) Minimum and maximum dimensional parameters that the device is capable of measuring; (iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and (iv) An expiration date.; This device is subject to premarket notification requirements under section 510(k) of the FD&C Act (21 U.S.C. § 360(k)).; Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.; FDA must grant or deny accessory classification requests not later than 85 days after receipt and, if granting, publish a notice in the Federal Register within 30 days of announcing the classification.; When a written request for accessory classification is included in a submission for marketing authorization, FDA must grant or deny the request along with the response to the PMA or 510(k). Upon granting, FDA will publish a notice in the Federal Register within 30 days of announcing the classification.
Market Impacts
Classification into class II with special controls reduces regulatory burden compared to class III, enhancing market access for laparoscopic gastrointestinal sizing tools by providing a clearer regulatory pathway; Premarket notification requirements under section 510(k) of FD&C Act apply to all laparoscopic gastrointestinal sizing tools entering the US market; Potential future exemption from premarket notification requirements under section 510(m) if FDA determines it's not necessary for safety and effectiveness assurance; Prescription-only device status restricts market access to healthcare professionals and facilities only, no direct consumer sales
Validated Company Impacts
Edwards Lifesciences Corp
Edwards Lifesciences operates in medical technologies but focuses primarily on cardiovascular devices such as heart valves and monitoring systems, not gastrointestinal or laparoscopic surgical tools. The company's business model involves compliance with medical device regulations generally, but this specific rule targets a niche device category outside their core product portfolio. The rule directly addresses multiple operational and regulatory risks identified by the company, including regulatory approvals (premarket notification requirements under 510(k)), manufacturing and quality problems (performance testing, biocompatibility, and sterility requirements), and clinical trials/procedures (labeling requirements for proper device use and surgical techniques). These alignments indicate significant regulatory impact on the company's core operations.
MERIT MEDICAL SYSTEMS INC
Merit Medical Systems primarily manufactures interventional cardiology and radiology devices, not laparoscopic gastrointestinal surgical tools. Their product portfolio focuses on vascular access, embolization, and drainage products, with no alignment to the specific laparoscopic gastrointestinal sizing tools regulated by this FDA classification rule. The rule directly addresses the company's FDA regulatory clearance risk by establishing a clear class II classification pathway with specific performance testing and labeling requirements, which reduces regulatory uncertainty. It also aligns with sterilization service provider dependency risk through requirements for sterility and reprocessing validation of patient-contacting components.
TELEFLEX INC
Teleflex Inc is a global medical device manufacturer that designs, develops, and supplies single-use medical devices to hospitals and healthcare providers, directly aligning with the FDA rule targeting manufacturers of laparoscopic gastrointestinal sizing tools. The company's core business model involves medical technology products for clinical procedures, making it clearly subject to the classification, performance testing, labeling, and premarket notification requirements specified in the rule. The rule's regulatory requirements for medical device classification and premarket notification align moderately with the company's identified 'Healthcare Laws and Regulations' risk, which mentions potential penalties and operational disruptions. However, the specific focus on laparoscopic gastrointestinal sizing tools is highly specialized and may not directly impact the company unless they manufacture such devices, making the overall risk alignment weak.