(171 days)
Not Found
No
The summary describes a mechanical clip and delivery system, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes.
The device is used for hemostasis and treating lesions, which are therapeutic interventions.
No
The device is indicated for therapeutic purposes such as hemostasis, treating lesions, and closure of perforations, as well as for endoscopic marking of lesions, rather than for diagnosing conditions.
No
The device description clearly states it is a physical ligation clip made of a shape memory alloy with a flexible delivery system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Aponos Medical Padlock Clip™ is a mechanical device used within the gastrointestinal tract during flexible endoscopy. Its function is to physically compress tissue for purposes like hemostasis, marking lesions, or closing perforations.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with and manipulates tissue within the body.
Therefore, the Padlock Clip™ falls under the category of a surgical or endoscopic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Aponos Medical Padlock Clip™ is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs.
The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:
- Endoscopic marking of lesions. .
- Hemostasis for .
- Mucosal/Sub mucosal defects o
- o Bleeding Ulcers
- Arteries
§ 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
K120814
pg 1 of 2
SEP 6 2012
Section 3: 510(k) Summary (Per 21 CFR 807.92)
Establishment Information:
Aponos Medical Corp. is located at: Unit 7, RT 125 Kingston, NH 03848
The Company intends to register with FDA upon receipt of clearance of this 510(k) Notice, and prior to initiating distribution of any products. The manufacturing of the Padlock Clip™ device will be carried out by Aponos at their facility at the same location.
General Company Information:
17 Route 125, Bldg. A #7 Kingston, NH 03848 Phone: 603-347-8229 Fax: 978-945-6197
CTO
John Fee VP of Quality and Regulatory Affairs Phone: 603-702-0066 Email: tjfee@aol.com
Date Prepared
General Device Information:
Official Correspondent:
Product Name:
Common Name:
Classification Name:
Regulation Number:
Product Codes:
Predicate Device(s)
September 5, 2012
Aponos Medical Corp. Denis LaBombard
Padlock Clip™ (Padlock-G Clip)
Ligation clip
ligator, esophageal
21 CFR 876.440
MND and FHN. Class II device
OVESCO Endoscopy AG OTSCTM 'Over-The-Scope-Clipping System Set including the OTSCTM Reloader. 510k - K101428
1
510(k) Number - K120814
Device Name: Aponos Medical, Padlock Clip™
Indications for Use:
The Aponos Medical Padlock Clip™ is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs.
The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:
- Endoscopic marking of lesions. .
- Hemostasis for .
- Mucosal/Sub mucosal defects o
- o Bleeding Ulcers
- Arteries