← Product Code [GDW](/productcode/GDW) · K050610 # SALUTE FIXATION SYSTEM (K050610) _Davol Inc., Sub. C. R. Bard, Inc. · GDW · May 25, 2005 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K050610 ## Device Facts - **Applicant:** Davol Inc., Sub. C. R. Bard, Inc. - **Product Code:** [GDW](/productcode/GDW.md) - **Decision Date:** May 25, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4750 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Salute Fixation System 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 Fixation System (SFS) delivers permanently implanted Q-shaped rings (Q-rings) to fixate prosthetic material or approximate tissue. System components: reusable handle, shaft (18cm or 38cm), and sterile disposable implant cartridge containing 316L stainless steel wire. Operation: surgeon loads cartridge into handle/shaft assembly; serial numbers must match for function; device forms Q-rings from wire as it is pulled from spool. Used in OR by surgeons. Output: Q-rings provide mechanical fixation. Benefits: secure attachment of prosthetics/tissue approximation. Differences from predicate: increased wire diameter (0.017" to 0.018"), deeper initial penetration depth, addition of 18cm shaft for open surgery, and higher capacity cartridges (30/50 Q-rings). ## Clinical Evidence Bench testing only. Testing demonstrated that Q-ring shape and dimensions are substantially equivalent to the predicate device. Biocompatibility testing for new PTFE material was required prior to release. ## Technological Characteristics Materials: 316L stainless steel wire, PTFE. Principle: Mechanical delivery of Q-shaped rings. Form factor: Reusable handle with 18cm or 38cm shaft; disposable implant cartridge. Connectivity: None. Sterilization: Not specified. Software: None. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ MAY 2 5 2005 K050610 page 1/2 Premarket Notification for the Salute® Fixation System (SFS) # 7.0 510(k) Summary of Safety and Effectiveness: #### A. Submitter Information: | Submitter's Name: | Davol, Inc. | | |------------------------|------------------------------------------------------------------------------------|-----------| | Address: | Subsidiary of C. R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920 | | | Telephone: | 401-463-7000 | Ext. 2386 | | Fax: | 401-463-3845 | | | Contact Person: | Lucinda L. Fox | | | Device Name: | Salute Fixation System | | | Predicate Device Name: | Salute Stapler and Staples
(Onux Medical, Inc.) | | #### Device Description: D. The Salute Fixation System consists of a reusable handle, shaft and shaft tip, as well as a sterile, disposable implant cartridge with wire survey ube and cover. The disposable implant cartridge comes prektades from 316L stainless steel wire. The device is used to deliver permanently maginn on Q-shaped rings (Q-ring). Depending on user preference, the handle may be used with an 18cm shaft or a 38cm shaft (fits into a 5mm trocal). Implant cartridges are offered with sufficient 316L stainless steel wire to form 10, 20, 30, or 50 Q-rings and are designed to work with either a 38cm shaft or an 18cm shaft. The handle and shaft are engraved with serial numbers, which must match in order for the device to function properly. The Instructions for Use (IFU) contain information to insure the implant cartridge is used with an appropriate shaft and to confir:: פּ serial numbers of the shaft/handle match. B. C. {1}------------------------------------------------ K050610 page 2/2 ### Premarket Notification for the Davol® X-Stream™ Laparoscopic Irrigation System #### E. Intended Use: The Salute Fixation System is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue. ### Summary of Similarities and Differences in Technological F. Characteristics, Performance and Intended Use The Proposed and Predicate devices are designed to place stainless steel sutures in tissue/prosthetics. Both Proposed and Predicate devices consist of a reusable handle and shaft, which are used to deliver permanently implanted, stainless steel Q-shaped rings from a disposable implant cartridge. The key differences between the Proposed and Predicate devices are: Initial wire penetration depth of the Q-ring as it is deployed, which required a change to the wire diameter from 0.017" to 0.018"; the addition of a 18cm shaft for use in open surgical procedures and addition of associated implant cartridges; and, the addition of implant cartridges with 30 and 50 Q-rings, which involved driving the wire as it was pulled off the spool. Although the Proposed's shaft tip was modified to deepen the wire's initial penetration into tissue/prosthetic, the overall diameter/configuration of the Q-ring was not changed. Increasing the depth of the wire's initial penetration merely enhances the Q-ring's ability to approximate tissue/ attach prosthetics. However, since the Proposed and Predicate Q-rings are comparable in terms of diameter and shape, their tissue/prosthatic fixation capabilities are the same. Although the Proposed contains new materials as a result of the "driven" wire and PTFE material change. Nove may be assessed using the same biocompatibility testing completed for the Predicate. #### G. Performance Data Biocompatibility will be completed and passed before the new PTF E material is released. Bench testing on the Proposed demonstrated the Qring shape and dimensions were substantially equivalent to the Predicate. Therefore, the Proposed device is safe and effective for its intended use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 5 2005 Ms. Lucinda L. Fox Manager, International Regulatory and Clinical Affairs Davol Incorporated 100 Sockanossett Crossroad Cranston, Rhode Island 02920 Re: K050610 Trade/Device Name: Salute® Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 8, 2005 Received: March 10, 2005 Dear Ms. Fox: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to togains and the Medical Device Amendments, or to commerce prof to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de necs that have been rouire approval of a premarket approval application (PMA). and Costictly recry to (71ct) that to not requent of the general controls provisions of the Act. The r ou may, mercrore, manel the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (ontrols. Existing major regulations affecting your device it may be subject to back addiness, 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 r icase be advised that I Dr o issually a that your device complies with other requirements of the Act that I Dri has intate and regulations administered by other Federal agencies. You must or any I catal statuted and registements, including, but not limited to: registration and listing (21 Compry with an the Her STequirements)01); good manufacturing practice requirements as set CI IN an the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ## 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 begin maxeting your marketing your device to a legally premarked notification. "The PDT Intentig of basistan 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 advice for your don't on the same and the regulation entitled, and contact the Office of Comphance at (210) =70 eart 807.97). You may obtain "Misbranding by reference to premarket nouffeasting on the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collschler risons of consected industry/support/index.html. Sincerely yours, Stupt Curds L. Michael G. Burrows, Ph.D. iriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number: Unknown K050610 Device Name: Salute® Fixation System Indications for Use: The Salute® Fixation System 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 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Stypt. Clurda ign-Off) (Division S Division of General, Restorative and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Page 1 of 1 --- **Source:** [https://fda-staging.innolitics.com/device/K050610](https://fda-staging.innolitics.com/device/K050610) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com