PADLOCK CLIP-12

K120814 · Aponos Medical Corp. · PKL · Sep 6, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120814
• Device Name: PADLOCK CLIP-12
• Applicant: Aponos Medical Corp.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Sep 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 - Bleeding Ulcers - Arteries <2mm - Polyps <1.5cm diameter - Diverticula in the Colon - Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Device Story

Padlock Clip™ is a single-use, radiopaque ligation clip designed for tissue approximation in the gastrointestinal tract. Constructed from superelastic Nitinol® (shape memory alloy), the clip is preloaded onto a flexible delivery system. During flexible endoscopy, the clinician deploys the clip to compress tissue for hemostasis or lesion management. The device functions by mechanically approximating tissue walls to facilitate healing or stop bleeding. It is intended for use by trained physicians in clinical settings. The device provides a mechanical solution for GI defects, offering a minimally invasive alternative to surgical intervention for specified perforations and bleeding sites.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and animal testing.

Technological Characteristics

Single-use, radiopaque ligation clip. Material: Nitinol® (superelastic shape memory alloy). Dimensions: 6 to 24mm opening sizes. Delivery: Flexible delivery system. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring endoscopic tissue compression in the GI tract for lesion marking, hemostasis (mucosal/submucosal defects, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), or closure of luminal perforations <20mm treatable conservatively.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OVESCO Endoscopy AG OTSCTM 'Over-The-Scope-Clipping System Set including the OTSCTM Reloader (K101428)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

CTO

John Fee VP of Quality and Regulatory Affairs Phone: [phone] Email: [e-mail]

#### 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

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#### 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 <2mm o
- Polyps <1.5cm diameter O
- Diverticula in the Colon o
- Closure of GI tract luminal perforations < 20mm that can be treated . conservatively.

#### Description of Device:

The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy (Nitinol®) for tissue approximation device with opening sizes of 6 to 24mm on a flexible delivery system.

#### Compliance with Special Controls:

Aponos Medical is unaware of any performance standard regarding this type of device that has been promulgated by FDA.

#### Performance Standards:

Aponos Medical has conducted appropriate testing and has determined that the Padlock Clip ligation clip is acceptable for its intended use.

Section 9 includes completed Standard Data Reports (Form FDA 3654) for these standards, as well as those relevant to sterilization, referenced in this submission.

#### Technological Characteristics Summary:

The Padlock Clip™ system set is substantially equivalent to the predicates, as they have similar technological characteristics. The results of animal and performance testing show no new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2015

Aponos Medical Corp. John Fee VP of Quality & Regulatory Affairs 16 Hillside Road Kingston, NH 03848

Re: K120814

Trade/Device Name: Aponos Medical, Padlock Clip™ Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): August 20, 2012 Received (Date on orig SE ltr): August 21, 2012

Dear John Fee,

This letter corrects our substantially equivalent letter of September 6, 2012.

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. 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

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Page 2 -

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Section 4: Indications for Use Statement

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
- Bleeding Ulcers o
- Arteries <2mm o
- 0 Polyps <1.5cm diameter
- o Diverticula in the Colon

Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Reproductive, Gastro-Renal, and<br>Urological Devices | |
| 510(k) Number | K120814 |