SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079

K051848 · Davol Inc., Sub. C. R. Bard, Inc. · GDW · Aug 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051848
• Device Name: SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
• Applicant: Davol Inc., Sub. C. R. Bard, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Salute II Disposable Fixation Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

Device Story

Salute II Disposable Fixation Device; manual surgical instrument for fixation of prosthetic material and tissue approximation. Device comprises handle and shaft; preloaded with 316L stainless steel wire. Delivers permanently implanted Q-shaped constructs (Q-Rings). Available in 18cm shaft (10 or 30 Q-Rings) or 38cm shaft (10, 30, or 60 Q-Rings; fits 5mm trocar). Features include distal tip rotation, end-of-construct indicator, and handle lock-out upon wire depletion. Used by surgeons in OR settings. Provides equivalent fixation to predicate; mechanical operation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing confirmed equivalent fixation and Q-ring geometry compared to predicate.

Technological Characteristics

Materials: 316L stainless steel wire. Form factor: Handle and shaft (18cm or 38cm). Operation: Manual mechanical delivery of Q-shaped constructs. Features: Distal tip rotation, end-of-construct indicator, handle lock-out. Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing laparoscopic, endoscopic, or open surgical procedures requiring fixation of prosthetic material or approximation of tissue.

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

• Salute Stapler and Staples (Onux Medical, Inc.)

Submission Summary (Full Text)

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K051848\$_{Kz}\$

# AUG 1 1 2005

### 510(k) Summary of Safety and Effectiveness: 7.0

#### Submitter Information: A.

| | Submitter's Name: | Davol, Inc. |
|----|------------------------|------------------------------------------------------------------------------------|
| | Address: | Subsidiary of C. R. Bard, Inc.<br>100 Sockanossett Crossroad<br>Cranston, RI 02920 |
| | Telephone: | 401-463-7000 Ext. 2386 |
| | Fax: | 401-463-3845 |
| | Contact Person: | Lucinda L. Fox |
| B. | Device Name: | Salute II Disposable Fixation Device |
| C. | Predicate Device Name: | Salute Stapler and Staples<br>(Onux Medical, Inc.) |

#### Device Description: D.

The Salute II Disposable Fixation Device consists of a handle, shaft/shaft tip and comes preloaded with 316L stainless steel wire. The device is used to deliver permanently implanted Q-shaped constructs (Q-Rings). Depending on user preference, the device is offered in an 18cm shaft preloaded with either 10 or 30 Q-Rings and a 38cm shaft (fits into a 5mm trocar) preloaded with either 10, 30, or 60 Q-Rings.

#### Intended Use: E.

The Salute II Disposable Fixation Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

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## Summary of Similarities and Differences in Technological F. Characteristics, Performance and Intended Use

The Proposed and Predicate Products are designed to place stainless steel wire into tissue/prosthetics to fixate prosthetics/approximate tissue. Both consist of a handle and shaft, which are used to deliver permanently implanted, 316L stainless steel Q-shaped constructs (Q-rings). The key differences between the Proposed and Predicate Products are: number of Q-rings delivered; disposable instead of reusable; preloaded with 316L stainless steel wire instead of a separate implant cartridge. In addition, the Proposed Product includes some features (distal tip rotation, end of construct indication, and handle lock-out when the wire is depleted) not available in the currently marketed Product. The new features were added as user conveniences based on market and user feedback.

#### Performance Data G.

Based on bench testing, the Proposed Product delivers the same shape and comparably sized Q-rings, which provides equivalent fixation. In addition, biocompatibility will be completed and passed before the Proposed Product is launched. Therefore, based on bench testing and biocompatibility, the Proposed Product will be safe and effective for its intended use.

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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 caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. The logo is black and white.

AUG 1 1 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lucinda L. Fox Manager, International Regulatory & Clinical Affairs Davol, Inc. 100 Sockanossett Crossroad Cranston, Rhode Island 02920

Re: K051848

R051640
Trade/Device Name: Salute® II Disposable Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: July 5, 2005 Received: July 7, 2005

Dear Ms. Fox:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 9 rQs) personalially equivalent (for the indications ferenced above and nave determined we a lies a levices marketed in interstate for use stated in the encrosule) to regally manst date of the Medical Device Amendments, or to commerce proc to May 20, 1776, the enaomatic with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the Feder devices mat have been reclassined in asse e approval of a premarket approval application (PMA). and Cosment Act (71ct) that do not require appen of the general controls provisions of the Act. The I ou may, mercere, market the as 1205, and include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to suell additional connoice is , Title 21, Parts 800 to 898. In addition, FDA may be found in the Obas neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DA s issuates or our device complies with other requirements of the Act that I Dr Has made a assoc regulations administered by other Federal agencies. You must of any I cacal statutes and regalanents, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements)01); good manufacturing practice requirements as set OF IT art 607); adomig (21 OFREE (21 CFR Part 820); and if applicable, the electronic forth in the quality by the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2- Ms. Lucinda L. Fox

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin marketing your antial equivalence of your device to a legally premarket notheation. The PDF mining of icention 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), please If you desire specific auriles ion your at [phone]. Also, please note the regulation entitled, Contact the Office of Compilance market notification" (21CFR Part 807.97). You may obtain Misolanding by telefone to premainters in the Act from the Division of Small other general informational 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 vours.

Kaubara Buchus
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K051848 |
|---------------------------|---------------------------------------|
| Device Name: | Salute II Disposable Fixation Device |

Indications For Use:

The Salute® II Disposable Fixation Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

Prescription Use
(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)

Saulana Buchund for melkerson
(Division Sign-Off) Page 1 of 1

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

510(k) Number K051848