(48 days)
No
The summary describes a purely mechanical device for clipping within the GI tract. There is no mention of any software, algorithms, image processing, or data analysis that would suggest the use of AI/ML.
Yes
The device is indicated for purposes such as hemostasis for various defects, which directly addresses a medical condition (bleeding) and therefore has a therapeutic effect. It also serves as a supplemental closure method for luminal perforations and aids in anchoring medical devices, all of which are therapeutic interventions.
No
The device description and intended use indicate that the Resolution Hemostasis Clipping Device is used for therapeutic purposes such as hemostasis, marking, and anchoring, not for diagnosing conditions.
No
The device description clearly states it is a sterile, single-use, endoscopic clipping device consisting of physical components like a delivery system (handle, catheter) and a clip made of various materials (thermoplastic elastomers, stainless steel, polyethylene, polyester, Cobalt Chrome, styrene). This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Resolution Hemostasis Clipping Device is for clip placement within the gastrointestinal tract for various purposes like marking, hemostasis, anchoring, and closure of perforations. These are all in vivo procedures performed directly on the patient's body.
- Device Description: The device is a physical tool (a clipping device) used to manipulate tissue within the body. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body.
- Lack of IVD Characteristics: The description does not mention any components or processes typical of IVD devices, such as reagents, calibrators, controls, or analysis of biological samples.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic and procedural tool used within the body.
N/A
Intended Use / Indications for Use
The Resolution Hemostasis Clipping Device 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.
0
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. SUBMITTER:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939
Contact: Elena Nieves Principal, Regulatory Affairs Specialist Date Prepared: November 24, 2014
2. DEVICE:
| Name of Device: | Resolution™ Hemostasis Clipping Device |
|---|---|
| Common Name: | Hemostasis Clipping Device |
| Classification Name: | Hemorrhoidal Ligator |
| Regulation Number: | 876.4400 |
| Product Code: | FHN and MND |
| Classification: | Class II |
3. PREDICATE DEVICE:
Resolution™ Hemostasis Clipping Device Name of Device: 510(k) Number: K122660 Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: FHN and MND Classification: Class II
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, polyethylene, and polyester materials. The Resolution™ Hemostasis Clipping Device delivery system is offered in 155cm and 235cm working lengths.
1
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 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.
There are no associated accessories included with this device.
5. INDICATIONS FOR USE:
The Resolution™ Hemostasis Clipping Device is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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