RESOLUTION II CLIP

• K Number: K102764
• Device Name: RESOLUTION II CLIP
• Manufacturer: Boston Scientific Corporation
• Date Cleared: 2010-12-22 ( 89 days)
• Product Code: PKL FIN
• Regulation Number: 876.4400

Intended Use

The Resolution II Clip is indicated for clip placement within the Gastrointestinal 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 - Anchoring to affix jejunal feeding tubes to the wall of the small bowel - As a supplementary method for closure of GI tract luminal perforations <20mm that can be treated conservatively

Device Description

The Resolution II Clip consists of a pre-loaded, radiopaque, single-use clip on a flexible delivery system. The Resolution II Clip is designed to be compatible with Gastroscopes with working channels ≥2.8, and/or Duodenoscopes and Colonoscopes with working channels ≥3.2mm. The Resolution II Clip jaws are engineered to open and close no more than five times, aiding in repositioning of the clip at the lesion site. Opening and closing capability may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution II Clip will be offered in 155cm and 235cm lengths. The deployed clip is constructed of stainless steel while the delivery system is constructed of stainless steel, polyethylene, and polyester materials.

Predicate Devices

K040148

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical clip and delivery system with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is used for hemostasis, which is the stopping of blood flow, addressing bleeding, and aiding in the closure of perforations, all of which are therapeutic interventions.

Diagnostic

No

The device is indicated for therapeutic purposes such as hemostasis, anchoring, and closure of perforations, and for endoscopic marking. It does not perform a diagnostic function by identifying or characterizing a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of stainless steel, polyethylene, and polyester, and describes a delivery system and clip, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
• Device Function: The Resolution II Clip is a device used within the gastrointestinal tract for mechanical purposes (marking, hemostasis, anchoring, closure). It is a therapeutic and procedural device, not a diagnostic one that analyzes samples.
• Intended Use: The stated intended uses are all related to physical interventions within the body.
• Device Description: The description details a physical clip and delivery system, not components for performing laboratory tests.
• Performance Studies: The performance studies focus on biocompatibility, mechanical properties, and endoscope compatibility, which are relevant for an implantable/interventional device, not an IVD.

Therefore, the Resolution II Clip is a medical device, but it falls under a different category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Resolution II Clip is indicated for clip placement within the Gastrointestinal Tract for the purpose ol:

• 1. Endoscopic Marking
• 2. Hemostasis for:
  • Mucosal/sub-mucosal defects

Regulation Number and Section

§ 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.

Summary

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K102764
Page 1 of 2

SECTION 6 510(k) SUMMARY

1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Elena Nieves Sr. Regulatory Affairs Specialist Date Prepared: August 30, 2010

2. Device

Trade Name: Resolution II Clip Common Name: Endoscopic Clipping Device Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: FIN and MND Classification: Class II

3. Predicate Devices

Boston Scientific Corporation, Resolution Hemostasis Clipping Device (K040148)

4. Device Description

The Resolution II Clip consists of a pre-loaded, radiopaque, single-use clip on u flexible delivery system.

The Resolution II Clip is designed to be compatible with Gastroscopes with working channels ≥2.8, and/or Duodenoscopes and Colonoscopes with working channels ≥3.2mm.

The Resolution II Clip jaws are engineered to open and close no more than five times, aiding in repositioning of the clip at the lesion site. Opening and closing capability may be linited by clinical circumstances and patient anatomy, among other factors.

The Resolution II Clip will be offered in 155cm and 235cm lengths. The deployed clip is constructed of stainless steel while the delivery system is constructed of stainless steel, polyethylene, and polyester materials.

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DEC 2 2 2010

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K102764
Page 2 of 2

5. Indication for Use:

The Resolution II Clip is indicated for clip placement within the Gastrointestinal Tract for the purpose ol:

• 1. Endoscopic Marking
• 2. Hemostasis for:
  • Mucosal/sub-mucosal defects