(27 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
The device is indicated for purposes such as hemostasis for various conditions, anchoring to affix tubes and stents, and supplemental closure of luminal perforations, all of which are direct clinical interventions aimed at treating or mitigating health conditions within the gastrointestinal tract.
No
The device is indicated for therapeutic purposes such as hemostasis, anchoring, and closure, as well as endoscopic marking. None of its stated purposes involve diagnosing a condition.
No
The device description clearly states it is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device with physical components like a delivery system (handle assembly, delivery catheter) and a clip (stainless-steel capsule, clip arms, cobalt chrome yoke, styrene tension breaker). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this device is used within the gastrointestinal tract for therapeutic and marking purposes. It does not analyze samples taken from the body.
- The device description focuses on mechanical components and their function within the body. There is no mention of reagents, assays, or any other components typically associated with in vitro testing.
- The performance studies described are related to the device's physical properties and safety within an MR environment. These are not studies evaluating the accuracy or performance of a diagnostic test.
Therefore, the Resolution™ Clip, Resolution 360™ Clip, and Resolution 360™ ULTRA Clip are medical devices used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- · Mucosal/sub-mucosal defects
§ 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.
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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 the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
September 14, 2022
Boston Scientific Corporation Jia Huang Principal Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K222503
Trade/Device Name: Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: August 16, 2022 Received: August 18, 2022
Dear Jia Huang:
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/pm.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
1
CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K222503
Device Name Resolution™ Clip Resolution 360™ Clip Resolution 360™ ULTRA Clip
Indications for Use (Describe)
The proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- · Mucosal/sub-mucosal defects 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."
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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 (508) 683-4000 www.bostonscientific.com
510(k) Summary for Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Jia Huang Principal Regulatory Affairs Specialist Tel: 617-912-0826 Date Prepared: August 16, 2022
2. Proposed Device
Trade Name: Resolution™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II
Trade Name: Resolution 360™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II
Trade Name: Resolution 360™ ULTRA Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II
3. Predicate Devices
Trade Name: Resolution™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K142973
Trade Name: Resolution 360™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400
Image /page/3/Picture/13 description: The image shows the logo for Boston Scientific. The logo is in blue and features the words "Boston" on top of "Scientific". The font is a serif font, and the overall design is simple and professional.
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K222503 Page 2 of 4
Product Code: PKL Classification: Class II 510(k) Clearance Number: K151802
Trade Name: Resolution 360™ ULTRA Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K193424
4. Device Description
The Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are sterile devices 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 assembly and delivery catheter. The delivery system of Resolution 360™ Clip and Resolution 360™ ULTRA Clip will allow for the device to rotate at the distal end. The clip delivery system is offered in a 155cm and 235cm working length for Resolution Clip and Resolution 360 Clip but only 235 cm for Resolution 360 ULTRA Clip. 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 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 (only for Resolution 360 Clip and Resolution 360 ULTRA Clip) may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm.
5. Indications for Use
The proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects