ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25

K093845 · ETHICON, Inc. · GDW · Apr 7, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093845
• Device Name: ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
• Applicant: ETHICON, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Apr 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repair.

Device Story

The Ethicon SECURESTRAP™ is a 5mm laparoscopic, multi-fire, single-use fixation device. It is pre-loaded with 25 absorbable straps composed of a polydioxanone, L(-)-lactide, and glycolide blend. Used by surgeons in clinical settings for hernia repair, the device mechanically deploys straps to secure prosthetic mesh to soft tissue. The device functions as a manual surgical instrument; it does not involve electronic processing, software, or automated analysis. The benefit is the secure attachment of prosthetic material during surgical procedures, with the straps designed to be absorbed by the body over time.

Clinical Evidence

Bench and animal testing performed. Results demonstrate the device meets user specifications and functions as intended, supporting substantial equivalence to the predicate.

Technological Characteristics

5mm laparoscopic, multi-fire, single-use device. Straps composed of polydioxanone, L(-)-lactide, and glycolide blend dyed with D&C Violet No. 2. Materials evaluated per ISO 10993-1:2003. Mechanical actuation principle.

Indications for Use

Indicated for fixation of prosthetic material to soft tissues in minimally invasive and open 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

• AbsorbaTack™ Absorbable Fixation Device (K091900)

Submission Summary (Full Text)

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Traditional 510(k) — ETHICON

5 page 1/2

#### 510(K) SUMMARY 5

| Applicant: | Ethicon Inc.<br>P.O. Box 151<br>Route 22 West<br>Somerville, NJ 08876<br>USA<br>Phone: [phone]<br>Fax: [phone] | APR - 7 2010 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date:<br>Contact Person: | November 25, 2009<br>Joseph Kiceina | |
| Proprietary Device Name: | ETHICON SECURESTRAP™ 5mm Absorbable Strap<br>Fixation Device | |
| Common Device Name: | Implantable staple; 21CFR 878.4750 | |
| Classification: | GDW; Class II | |
| Predicate Devices: | AbsorbaTack™ Absorbable Fixation Device (K091900) | |
| Manufacturer: | Ethicon LLC<br>Guaynabo, Puerto Rico 00969<br>USA | |

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## 5.1 Substantially Equivalent To:

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is substantially equivalent to the Covidien AbsorbaTack™ Absorbable Fixation Device (K091900).

The ETHICON SECURESTRAPTM 5mm Absorbable Strap Fixation Device has the same intended use, and similar indications for use, technological characteristics, and principles of operation as its predicate device.

The minor technological differences between the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device and the AbsorbaTack™ Absorbable Fixation Device raise no new issues of safety or effectiveness as verified by performance data.

## 5.2 Description of the Device Subject to Premarket Notification:

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is a 5mm laparoscopic device for hernia repair. It is a multi-fire, single-use device pre-loaded with 25 absorbable straps. The straps are composed of a blend of polydioxanone and L(-)-lactide and glycolide dyed with D&C Violet No. 2.

### 5.3 Indications for Use:

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hemia repairs.

### 5.4 Performance Data:

An appropriate and complete performance testing program, including bench and animal, supports that the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device fulfills the device requirements as defined in used specifications, functions as intended, and is substantially equivalent to the predicate device.

#### 5.5 Overall Performance Conclusion:

An appropriate and complete performance testing program, including bench and animal testing was performed. Results support that the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device meets the device requirements as defined in user specifications, functions as intended, and is substantially equivalent to the predicate device. The materials that are used in the manufacturing of this device have been evaluated in accordance with ISO 10993-1:2003, Biological Evaluation of Medical Devices - Part 1 Evaluation and Testing and are equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR - 7 2010

Ethicon Inc. % Mr. Joseph Kiceina Manager, Regulatory Affairs · P.O. Box 151, Route 22 West Somerville, New Jersey 08876

Re: K093845

Trade/Device Name: Ethicon SECURESTRAP™ 5mm Absorbable Strap Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 31, 2010 Received: April 01, 2010

Dear Mr. Kiceina:

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 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

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Page 2 - Mr. Joseph Kiceina

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

For

N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4 INDICATIONS FOR USE STATEMENT

510(k) No (if known):

Device Name: ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device

#### Indications for Use:

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation-of-prosthetic-material-to-soft-tissues-in-various-minimally-invasive-and-open surgical procedures such as hernia repair.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Daniel Kane for MxM

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Division Blue-Off

(Division Slun-Of Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K093845