(266 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
Yes.
The device is used for therapeutic purposes such as hemostasis, anchoring, and closure of luminal perforations, which directly address and treat medical conditions within the GI tract.
No
The device is indicated for therapeutic purposes such as hemostasis, anchoring, and closure, not for diagnosing conditions.
No
The device description clearly outlines physical components made of stainless steel, polyester, and Cobalt Chrome, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the GI tract) for mechanical purposes like marking, hemostasis, anchoring, and closure. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health status.
- Device Description: The device is a physical clip and delivery system designed for deployment inside the GI tract. This is consistent with a surgical or endoscopic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Resolution 360 ULTRA Clip is a therapeutic/interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
§ 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 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
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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
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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 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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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
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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