(266 days)
The Resolution 360 ULTRA Clip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:
-
Endoscopic marking
-
Hemostasis for:
-Mucosal/sub-mucosal defects <3cm
-Bleeding ulcers
-Arteries <2mm
-Polyps <1.5cm 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 bowel; and Anchoring to affix fully covered sophageal 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 360TM ULTRA 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™ ULTRA Clip delivery system is offered in a 235cm working length.
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 ULTRA 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 clip jaws will be available with a 17mm clip opening.
This document is a 510(k) summary for the Boston Scientific Resolution 360™ ULTRA Clip. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, I cannot provide information on acceptance criteria, reader improvement with AI assistance, or standalone algorithm performance for such a device.
However, I can extract information regarding the device acceptance criteria and the bench tests conducted to demonstrate the Resolution 360™ ULTRA Clip meets these criteria.
Here's the information based on the provided text, focusing on the device's physical and functional performance:
Accepted Criteria and Reported Device Performance
The document states that the proposed device was evaluated against predefined acceptance criteria, and the performance met these requirements. While the specific numerical acceptance criteria are not detailed in this summary, the document lists the bench tests performed to demonstrate compliance.
| Acceptance Criterion (Inferred from Test) | Reported Device Performance (Implied "Meets Requirements") |
|---|---|
| Clip Assembly Repeated Open/Close | Met pre-defined acceptance criteria |
| Clip Opening Gap | Met pre-defined acceptance criteria |
| Retention Force | Met pre-defined acceptance criteria |
| Clip Opening Force | Met pre-defined acceptance criteria |
| Clip Close Force | Met pre-defined acceptance criteria |
| Scope Compatibility/Usability | Met pre-defined acceptance criteria |
| Endoscope Damage - Clip Passibility | Met pre-defined acceptance criteria |
| Magnetic Resonance (MR) Conditional | Determined to be an MR Conditional device |
Study Details (Focusing on Device Performance, not AI)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting. The country of origin of the data is not specified, but the applicant is Boston Scientific Corporation, located in Marlborough, MA. The study is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as these are bench tests for a mechanical clip, not a diagnostic device requiring expert interpretation for ground truth. Performance is measured objectively.
4. Adjudication method for the test set:
- Not applicable for bench testing of a mechanical device. Performance is determined by direct measurement against 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:
- No, this was not done. This submission is for a medical device (hemostatic clip), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This submission is for a medical device (hemostatic clip), not an algorithm.
7. The type of ground truth used:
- The "ground truth" for these bench tests would be the pre-defined engineering specifications and performance targets for the device's mechanical and functional characteristics.
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning study, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set. The "ground truth" for the device's general design and functional requirements would be established through engineering design principles, industry standards (like ISO 10993, ISO 11135-1, ISO 10993-7), and regulatory guidance (like the FDA Guidance for Establishing Safety and Compatibility of Passive Implants in the MR Environment).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of each other, and the word "ADMINISTRATION" below them. The logo is clean and professional, and it is likely used on official FDA documents and websites.
September 1, 2020
Boston Scientific Corporation Elena Hennessey Fellow, Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K193424
Trade/Device Name: Resolution 360™ ULTRA Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: July 31, 2020 Received: August 3, 2020
Dear Elena Hennessey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K193424
Device Name Resolution 360 ULTRA Clip
Indications for Use (Describe)
The Resolution 360 ULTRA Clip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:
-
Endoscopic marking
-
Hemostasis for:
-Mucosal/sub-mucosal defects <3cm
-Bleeding ulcers
-Arteries <2mm
-Polyps <1.5cm 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 bowel; and Anchoring to affix fully covered sophageal 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)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K193424 Page 1 of 3
SECTION 5 510(K) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Elena Hennessey Fellow Regulatory Affairs Specialist Tel: 508-683-4347 Date Prepared: December 9, 2019
2. Proposed Device:
Trade Name: Resolution 360™ ULTRA Clip Common Name: Hemostatic Metal Clip for the GI Tract Regulation Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II
3. Predicate Device:
Primary Predicate Device:
Trade Name: Resolution 360™ Clip Common Name: Hemostatic Metal Clip for the GI Tract Regulation Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K151802
And
Secondary Predicate Device:
Trade Name: SureClip MAX Repositionable Hemostasis Clip Common Name: Hemostatic Metal Clip for the GI Tract Regulation Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K182556
{4}------------------------------------------------
And
Reference Device:
Trade Name: Resolution™ Hemostasis Clipping Device Common Name: Hemostatic Metal Clip for the GI Tract Regulation Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K122660 and K142973
4. Device Description:
The Resolution 360TM ULTRA 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™ ULTRA Clip delivery system is offered in a 235cm working length.
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 ULTRA 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 clip jaws will be available with a 17mm clip opening.
5. Indications for Use:
The Resolution 360 ULTRA 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
{5}------------------------------------------------
-
- As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively
6. Technological Characteristics:
The proposed Resolution™ 360 ULTRA Clip has different technological characteristic compared to the primary predict Resolution 360™ Clip (K151802). However, both the proposed and the proposed and primary predicate devices can pass through forward viewing endoscopes with a working channel equal to or greater than 2.8 mm to the target position. In addition, the materials of the components used to manufacture the deployed clip components of the proposed and primary predicate are identical.
The proposed Resolution 360 ULTRA Clip has identical indications for use as the primary predicate Resolution 360 Clip. The proposed device has the identical intended use and is placed using the identical methodology as the predicate devices. The proposed device will be available with a 17mm clip opening which is similar to the secondary predicate SureClip MAX Repositionable Hemostasis Clip (K182556) and functions in the same manner as the primary predicate Resolution 360 Clip (K151802). However, the proposed devices deployed clip length is slightly longer than that the predicate devices.
The materials of the proposed Resolution 360 ULTRA Clip are identical to the primary predicate device Resolution 360 Clip.
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",
The following bench tests were performed on the Resolution™ 360 ULTRA Clip: Clip Assembly Repeated Open/Close: Clip Opening Gap: Retention Force: Clip Opening Force: Clip Close Force; Scope Compatibility/Usability; and Endoscope Damage - Clip Passibility.
In addition, the proposed device was evaluated for Magnetic Resonance to support MR Conditionality for the proposed device. Magnetic Resonance (MR) testing along with scientifically based rationale for clinically relevant acceptance criteria consistent with the recommendations contained in the FDA Guidance for Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (issued December11, 2014) were completed. The results from the test data and scientific rationale have determined the Resolution 360™ ULTRA Clip to be an MR Conditional device.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Resolution 360 ULTRA Clip is substantially equivalent to the currently cleared Resolution 360 Clip (K151802) and SureClip MAX Repositionable Hemostasis Clip (K182556) as the performance of the proposed device meets the requirements of its pre-defined acceptance criteria and intended use.
§ 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.