(35 days)
The Resolution 360 Clip is indicated for placement in the Gastrointestinal tract for:
- Endoscopic Marking
- Hemostasis for:
• Mucosal/sub-mucosal defects < 3 cm
• Bleeding ulcers
• Arteries < 2 mm
• Polyps < 1.5 cm in diameter
• Diverticula in the colon
• Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection - Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
- As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively
The Resolution 360™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The Resolution 360™ Clip delivery system is offered in 155cm and 235cm working lengths. The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution™ 360 Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.
The provided text is a 510(k) summary for the Resolution 360 Clip, a medical device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria, study designs with sample sizes, expert qualifications, or adjudication methods for evaluating device performance against numerical thresholds.
The "Performance Data" section mentions that "bench tests were performed" and that "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." This is a qualitative statement about equivalence based on bench testing, not a detailed report of quantitative acceptance criteria and results.
Therefore, I cannot fulfill all parts of your request with the provided input. I will extract what information is present and explicitly state what is missing.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states that "bench tests were performed on the Resolution™ 360 Clip" and lists the types of tests (e.g., Clip Assembly Repeated Open/Close, Retention Force, Torque, Rotation, etc.). It then concludes, "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." However, it does not provide specific acceptance criteria (e.g., "Clip must withstand X cycles" or "Retention Force must be Y N") nor specific numerical performance results for these criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "bench tests" but does not specify sample sizes for these tests, nor the data provenance (e.g., country, retrospective/prospective).
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)
This information is not applicable/provided. The performance data discussed are bench tests of mechanical and material properties, not clinical studies requiring expert ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for clinical studies or evaluations where human judgment on image interpretation or clinical outcomes is involved. The "Performance Data" describes bench testing.
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
This information is not applicable/provided. The device is a "hemostatic metal clip" used for endoscopic procedures, not an AI-based diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. This question applies to AI algorithms. The Resolution 360 Clip is a mechanical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable. For the bench tests described, the "ground truth" would be the engineering specifications and established test methods, not clinical ground truths like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable/provided. "Training set" is relevant for machine learning/AI models. The device is a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, this question applies to AI models.
Summary of what is available in the document:
- Device Name: Resolution 360 Clip
- Intended Use: Placement in the Gastrointestinal tract for endoscopic marking, hemostasis, anchoring, and as a supplemental closure method for luminal perforations.
- Performance Testing Mentioned: Bench tests were performed covering aspects like: Clip Assembly Repeated Open/Close; Retention Force; Clip Approach; Torque; Rotation; Clip Opening and Close Force; Clip Deployment; Force; Scope Compatibility/Usability; Working Length; Endoscope Damage; Biopsy Valve Compatibility; Coil to Handle tensile; and Push/Pull wire to Handle Spool Slider tensile.
- Conclusion of Performance Testing: "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
- Predicate Device: Resolution™ Hemostasis Clipping Device (K142973)
- Technological Characteristics Comparison: The proposed device has identical intended use and methodology as the predicate but allows for 360° rotation of clip jaws via a control knob. Materials are identical to the predicate device.
- Regulatory Compliance: Meets requirements of ISO 10993, ISO 11135-1, and ISO 10993-7 for biological evaluation and sterilization.
The 510(k) summary provides a high-level overview for substantial equivalence determination but does not include the detailed technical report with specific acceptance criteria and performance data that would typically be found in the full submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
Boston Scientific Corporation Elena Nieves Principal, Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K151802 Trade/Device Name: Resolution 360 Clip Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated: June 30, 2015 Received: July 2, 2015
Dear Elena Nieves,
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.
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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|
| --------------------------------------------------------------------------------------------------- |
| 510(k) Number (if known) | K151802 |
|---|---|
| Device Name | Resolution 360 Clip |
Indications for Use (Describe)
The Resolution 360 Clip is indicated for placement in the Gastrointestinal tract for:
- Endoscopic Marking
- Hemostasis for:
• Mucosal/sub-mucosal defects < 3 cm
• Bleeding ulcers
• Arteries < 2 mm
• Polyps < 1.5 cm in diameter
• Diverticula in the colon
• Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection - Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
- As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively
| Type of Use (Select one or both, as applicable) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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SECTION 5 510(K) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Elena Nieves Principal Regulatory Affairs Specialist Tel: 508-683-4347 Fax: 508-683-5939 Date Prepared: August 3, 2015
2. Proposed Device:
Trade Name: Resolution 360™ Clip Device Common Name: Hemostatic Metal Clip for the GI Tract Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II
3. Predicate Device:
Trade Name: Resolution™ Hemostasis Clipping Device Device Common Name: Hemostatic Metal Clip for the GI Tract Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K142973
4. Device Description:
The Resolution 360™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip.
The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The Resolution 360™ Clip delivery system is offered in 155cm and 235cm working lengths.
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The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution™ 360 Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.
5. Indications for Use:
The Resolution 360 Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects < 3 cm ●
- . Bleeding ulcers
- Arteries < 2 mm ●
- Polyps < 1.5 cm in diameter ●
- Diverticula in the colon ●
- Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
-
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
-
- As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively
6. Technological Characteristics:
The proposed Resolution™ 360 Clip has similar technological characteristic as the predict Resolution™ Hemostasis Clipping Device (K142973).
The proposed device has the identical intended use and is placed using the identical methodology as the predicate device. However, the proposed device functions in a different manner by allowing for the user to rotate the clip jaws 360° via a control knob prior to deployment.
The materials of the proposed Resolution 360 Clip are identical to the predicate device.
7. Performance Data:
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products -Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals",
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The following bench tests were performed on the Resolution™ 360 Clip: Clip Assembly Repeated Open/Close; Retention Force; Clip Approach; Torque; Rotation; Clip Opening and Close Force; Clip Deployment; Force; Scope Compatibility/Usability; Working Length; Endoscope Damage; Biopsy Valve Compatibility; Coil to Handle tensile; and Push/Pull wire to Handle Spool Slider tensile.
The testing performed demonstrated that the proposed and predicate delivery systems are equivalent.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Resolution 360 Clip is substantially equivalent to the currently cleared Resolution Hemostatis Clipping Device (K142973).
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.