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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Salute II Disposable Fixation Device:

Crucially, the provided document is a 510(k) Summary and FDA clearance letter, not a detailed study report. Therefore, it focuses on demonstrating equivalence to a predicate device rather than presenting a comprehensive study with specific acceptance criteria, statistical power calculations, or detailed performance metrics. As a result, many of the requested items cannot be fully extracted or are explicitly stated as "Not Applicable" or "Not Provided."

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria or a direct comparison to specific reported device performance values in the way one might expect from a detailed clinical or performance study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device through:

Same intended use: The Salute II Disposable Fixation Device has the same intended use as the predicate device (fixation of prosthetic material and approximation of tissue in surgical procedures).
Similar technological characteristics: Both devices place stainless steel wire into tissue/prosthetics to fixate prosthetics/approximate tissue using a handle and shaft to deliver 316L stainless steel Q-shaped constructs.
Equivalent performance: Bench testing demonstrated the proposed product "delivers the same shape and comparably sized Q-rings, which provides equivalent fixation."

Therefore, the "acceptance criteria" here are less about numerical thresholds for sensitivity/specificity and more about establishing functional and safety equivalence to a legally marketed predicate device.

Table of Implicit Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Intended Use Equivalence: Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.	Met: The Salute II has the same stated Intended Use as the predicate device (Salute Stapler and Staples).
Technological Equivalence - Q-Ring Placement: Designed to place stainless steel wire into tissue/prosthetics to fixate prosthetics/approximate tissue, delivering permanently implanted, 316L stainless steel Q-shaped constructs (Q-rings) via a handle and shaft.	Met: The Salute II performs this function with the same Q-ring material and design principle.
Functional Equivalence - Q-Ring Characteristics: Delivers Q-rings of the same shape and comparable size as the predicate device.	Met: "Based on bench testing, the Proposed Product delivers the same shape and comparably sized Q-rings..."
Functional Equivalence - Fixation Performance: Provides equivalent fixation to the predicate device.	Met: "...which provides equivalent fixation."
Safety - Biocompatibility: The device materials (especially the permanently implanted components and those in contact with tissue) must be biocompatible.	Met (Prospective): "In addition, biocompatibility will be completed and passed before the Proposed Product is launched." (This indicates completion post-submission but pre-launch, and is a standard requirement for such devices).
Safety - New Features: New features (distal tip rotation, end of construct indication, handle lock-out) must not introduce new safety concerns and should function as intended. (This is implied as part of the overall safety assessment for predicate equivalence).	Met (Implied): New features were added as "user conveniences" based on market and user feedback, and the overall determination is safe and effective.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not provided. The performance data is based on "bench testing" which implies mechanical or functional tests in a laboratory setting, not human subject data.
- Data Provenance: Bench testing data, conducted by Davol, Inc. (submitter). Location of testing not specified, but typically conducted in-house by the manufacturer. Prospective, as it was conducted for the purpose of this submission. Since it's bench testing, country of origin related to patient data is not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this relies on bench testing of physical characteristics (shape, size, fixation strength), expert review of patient data ground truth is not relevant. The "ground truth" for bench testing would be objective measurements and engineering specifications.
Adjudication method for the test set:
- Not applicable. No human interpretation of complex medical data requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device for surgical fixation, not an AI/imaging diagnostic device. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual surgical fixation device, not an algorithm.
The type of ground truth used:
- For bench testing: Engineering measurements, physical specifications, and comparative performance against the predicate device in terms of Q-ring shape, size, and fixation equivalence.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI algorithm requiring a training set. If "training set" refers to design iterations or prototypes, that information is not provided.
How the ground truth for the training set was established:
- Not applicable. Same as above.

Summary

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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.100 Sockanossett CrossroadCranston, 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(Onux Medical, Inc.)

Device Description: D.

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.