(23 days)
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
This document is a 510(k) premarket notification for a medical device called "Rotatable Snares" from Boston Scientific Corporation. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness via clinical studies with acceptance criteria in the same way one would for a novel device or a PMA.
Therefore, the specific information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test sets (in the context of clinical data), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not typically found or required in a 510(k) submission for a device like this, especially when the changes are related to ergonomic improvements and not a fundamental change in the intended use or technology.
However, I can extract the information provided regarding performance data from the document:
1. A table of acceptance criteria and the reported device performance
The document states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." It then lists the tests performed. While specific numerical acceptance criteria and reported values are not provided in the summary, the conclusion is that the device met all specifications.
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Working Length | Met required specifications |
| Tortuous Path Functionality | Met required specifications |
| Rotation Capability | Met required specifications |
| Handle to Core Wire Tensile Strength | Met required specifications |
| Electrical Resistance | Met required specifications |
| Electrical Safety | Met required specifications |
| Snare Actuation | Met required specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes in-vitro testing, not clinical studies with patients. Therefore, the concept of sample size for a "test set" in the context of clinical data, country of origin, or retrospective/prospective data is not applicable here. The testing was performed on components, subassemblies, and/or full devices in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests performed are engineering/performance specification tests (e.g., electrical safety, tensile strength), not diagnostic or interpretative tasks requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements against predefined engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for an endoscopic snare, not an imaging or AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an endoscopic snare, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in-vitro testing, the "ground truth" would be the defined engineering specifications or performance standards for each test category (e.g., a specific tensile strength value, acceptable electrical resistance range, proper actuation of the snare).
8. The sample size for the training set
Not applicable. This document refers to in-vitro testing for an existing device with an ergonomic modification, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a machine learning context.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2016
Boston Scientific Corporation Michael Secondini Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K160637 Trade/Device Name: Rotatable Snares Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI, FGX Dated: March 4, 2016 Received: March 7, 2016
Dear Michael Secondini,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Rotatable Snares
Indications for Use (Describe)
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(K) Summary
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
| Contact: | Michael Secondini |
|---|---|
| Sr. Regulatory Affairs Specialist | |
| Email: | Michael.Secondini@bsci.com |
| Telephone: | (508) 683-6503 |
| Fax: | (508) 683-5939 |
Date Prepared: March 4, 2016
2. Device
| Trade Name: | Rotatable Snares |
|---|---|
| Common Name: | Rotatable Snares |
| Classification Name: | Snare, FlexibleSnare, Non-Electrical |
| Regulation Number: | 876.4300876.4730 |
| Product Code: | FDIFGX |
| Classification: | Class II |
3. Predicate Device
| Trade Name: | Rotatable Snares |
|---|---|
| Common Name: | Rotatable Snares |
| Manufacturer: | Boston Scientific Corporation |
| Clearance Numbers: | K131700 |
| Classification Name: | Snare, FlexibleSnare, Non-Electrical |
| Regulation Number: | 876.4300876.4730 |
| Product Code: | FDIFGX |
| Classification: | Class II |
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Special 510(k) Premarket Notification Rotatable Snares
4. Reference Device
Trade Name: Single Use Polypectomy Snares Captivator II, Single Use Polypectomy Snares Common Name: Polypectomy Snares Manufacturer: Boston Scientific Corporation K133987 Clearance Numbers: Classification Name: Snare, Flexible Snare, Non-Electrical 876.4300 Regulation Number: 876.4730 Product Code: FDI FGX Classification: Class II
5. Device Description
The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
6. Indications for Use
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
7. Technological Characteristics
This change is modifying the design of the Rotatable Snare to improve ergonomics of the device handle by moving the rotation actuator of the snare to the handle from its current position along the main sheath. The proposed Rotatable Snares are similar in materials, design, and manufacturing process to the predicate Rotatable Snares (K131700) and will use many of the same components as the reference Captivator II Snares (K133987). There are no new patient contacting materials used on the proposed snares.
8. Performance Data
In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for Working Length, Tortuous Path Functionality, Rotation Capability, Handle to Core
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Wire Tensile Strength, Electrical Resistance, Electrical Safety, and Snare Actuation. The results of all testing were passing.
9. Conclusion
Boston Scientific Corporation has demonstrated that the proposed Rotatable Snares are substantially equivalent to Boston Scientific Corporation's currently marketed Rotatable Snares (K131700).
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).