LogoFDA 510(k) Search
K Number
K122660
Device Name
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Manufacturer
Boston Scientific Corporation
Date Cleared
2012-12-03

(94 days)

Product Code
PKLCLA
Regulation Number
876.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Resolution™ Hemostasis Clipping Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic Marking 2. Hemostasis for: - Mucosal/sub-mucosal defects < 3cm - Bleeding ulcers . - Arteries < 2cm . - Polyps < 1.5cm in diameter . - Diverticula in the colon . 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a supplemental closure method of luminal perforations <20mm that can be treated conservatively.
Device Description
The Resolution™ Hemostasis Clipping Device is a sterile, single-use, endoscopic clipping device consisting of two main components; the delivery system, and the clip. The delivery system is made up of a handle and delivery catheter. The delivery system is constructed using thermoplastic elastomers, stainless steel, polyethylone, and polyester materials. The Resolution™ Hemostasis Clipping Device delivery system is offered in 155cm and 235cm working lengths. The clip consists of a stainless steel capsule, and clip anns, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution clip jaws are engineered such that they can be opened and closed up to 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.
More Information

K040148

Not Found

No
The description focuses on the mechanical components and intended uses of a physical clipping device, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is used for hemostasis (stopping bleeding), which is a therapeutic intervention, and also for closure of luminal perforations.

No

The device is indicated for endoscopic clip placement for therapeutic purposes such as hemostasis, marking, anchoring, and closure, rather than for diagnosing conditions.

No

The device description clearly outlines physical components made of various materials (thermoplastic elastomers, stainless steel, polyethylene, polyester, Cobalt Chrome, styrene) and includes a delivery system and a clip, indicating it is a hardware device.

Based on the provided information, the Resolution™ Hemostasis Clipping Device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Resolution™ Hemostasis Clipping Device is a mechanical device used within the gastrointestinal tract for physical actions like marking, hemostasis (stopping bleeding), anchoring, and closing perforations. It does not analyze biological specimens in vitro.
  • Intended Use: The intended uses listed are all direct interventions within the body, not laboratory analysis of samples.

Therefore, this device falls under the category of a surgical or therapeutic device, not an IVD.

N/A

Intended Use / Indications for Use

The Resolution™ Hemostasis Clipping Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

  1. Endoscopic Marking
  2. 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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K122660 `Page 1/2

SECTION 5 510(k) SUMMARY

1. Submitter

DEC 03 2012

Boston Scientific Corporation . 100 Boston Scientific Way Marlborough. MA 01752 Telephone: 508-683-4454 Fax: 508-683-5939

Contact: Thomas Hirte Senior Manager Regulatory Affairs Date Propared: August 30, 2012

2. Device

Trade Name: Common Name: Classification Name: Regulation Number: Product Code: Classification:

Resolution™ Hemostasis Clipping Device Endoscopic Clipping Device Hemorrhoidal Ligator 876.4400 FHN and MND Class II

3. Predicate Devices

The Boston Scientific Corporation, Resolution™ Hemostasis Clipping Device (K040148).

4. Device Description

The Resolution™ Hemostasis Clipping Device is a sterile, single-use, endoscopic clipping device consisting of two main components; the delivery system, and the clip.

The delivery system is made up of a handle and delivery catheter. The delivery system is constructed using thermoplastic elastomers, stainless steel, polyethylone, and polyester materials. The Resolution™ Hemostasis Clipping Device delivery system is offered in 155cm and 235cm working lengths.

The clip consists of a stainless steel capsule, and clip anns, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution clip jaws are engineered such that they can be opened and closed up to 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.

0000014

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122660 Page 2/2

5. Indication for Use:

The Resolution™ Hemostasis Clipping Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

    1. Endoscopic Marking
    1. Hemostasis for:
    • Mucosal/sub-mucosal defects (・・・ 13