ENDOANCHOR AND OPENANCHOR

K013749 · Ethicon Endo-Surgery, Inc. · GDW · Feb 11, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013749
• Device Name: ENDOANCHOR AND OPENANCHOR
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair. The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.

Device Story

EndoANCHOR and OpenANCHOR are sterile, single-patient-use fixation instruments; deploy nitinol anchors into prosthetic material and soft tissue. EndoANCHOR: endoscopic or open surgical use; 3mm or 5mm diameter shaft; 301mm length; contains 20 nitinol anchors. OpenANCHOR: open surgical use; 3mm diameter shaft; 132mm length; contains 10 nitinol anchors. Anchors measure 5.9mm long by 6.7mm wide. Operated by surgeons in clinical settings. Device facilitates hernia repair by securing mesh and approximating tissue. Performance verified via bench and animal testing.

Clinical Evidence

Bench and animal testing only. No clinical data provided.

Technological Characteristics

Sterile, single-patient-use fixation instruments. Implants: nitinol anchors (5.9mm x 6.7mm). Shafts: 301mm (EndoANCHOR) or 132mm (OpenANCHOR) length; 3mm or 5mm diameter. Mechanical deployment mechanism. No software or electronic components.

Indications for Use

Indicated for fixation of prosthetic material to soft tissue and soft tissue approximation in minimally invasive and open general surgical procedures, including hernia repair.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Ethicon Endo-Surgery, Inc. ENDOPATH EMS (K913469)
• United States Surgical Corp. AutoSuture™ ProTack™ (K963999)

Submission Summary (Full Text)

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# EndoANCHOR and OpenANCHOR 510(k) Summary of Safety and Effectiveness

#### Company:

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati. OH 45242

FEB 1 1 2002

K013749

1/2

#### Contact:

Name: Doug Kentz Title: Regulatory Affairs Associate II

#### Date Prepared:

November 12, 2001

#### Name of Device:

Trade Name: EndoANCHOR and OpenANCHOR Fixation Devices Classification Name: Stapler, General & Plastic Surgery

#### Predicate Devices:

- Ethicon Endo-Surgery, Inc. ENDOPATH EMS cleared under K913469 on September . 30 1991.
- United States Surgical Corp. AutoSuture™ ProTack™ cleared under K963999 on . November 27, 1996.

#### Device Description:

The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments that deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications. The nitinol anchors are 5.9 mm long and 6.7 mm wide. The EndoANCHOR fixation device is designed for endoscopic surgical use with a trocar or for oven surgical use. Two sizes of the EndoANCHOR Fixation Device are offered: a 3 mm and 5 mm diameter shaft. Both instrument shafts are 301 mm long and contain 20 nitinol anchors. The OpenANCHOR Fixation Device is designed for open surgical use. The instrument has a 132mm long, 3 mm diameter shaft and contains 10 nitinol anchors.

#### Intended Use:

The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.

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## Technological Characteristics:

The EndoANCHOR and OpenANCHOR Fixation devices are similar to the predicate I ho Endor INON of the same intended use however these devices deploy an anchor shaped implant made of nitinol for fixation and approximation purposes.

### Performance Data

Preclinical testing was performed to ensure the device performs as intended when used I roomling to the instructions for use. Bench and animal testing demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Mr. Doug Kentz, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K013749

Trade/Device Name: EndoANCHOR and OpenANCHOR Fixation Devices Regulation Number: 878.4750, 876.1500 Regulation Name: Implantable staple Endoscope and accessories Regulatory Class: II

Product Code: GDW, GCJ Dated: November 12, 2001 Received: November 13, 2001

Dear Mr. Kentz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regary the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 accordance with the provisions of the Federal Food, Drug, de nees that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, clerelore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a saterial 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 I lease of devices and i Drimination that your device complies with other requirements of the Act than I Dr Haral statutes and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Doug Kentz, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in you've FDA finding of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you dosille specific advices and vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compliance at (201) 594-461 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information turers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Kol 3749

Device Name: EndoANCHOR and OpenANCHOR Fixation Devices

Indications for Use:

The EndoANCHOR Fixation Device is intended for fixation of prosthetic material I he EndoALVCHON Pradion between various minimally invasive and open general surgical procedures, such as hernia repair.

The OpenANCHOR Fixation Device is intended for fixation of prosthetic material t he Open in Croxia of soft tissue in various open general surgical procedures, such as hernia repair.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013749