(76 days)
Not Found
Not Found
No
The description focuses on mechanical components and their function in delivering physical rings for fixation. There is no mention of data processing, algorithms, or learning capabilities.
No
The device is used for fixation of prosthetic material and approximation of tissue, which are surgical procedures, not therapeutic applications.
No
The device description clearly states its purpose is for "fixation of prosthetic material and approximation of tissue" using "Q-shaped rings," which is a surgical therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components such as a reusable handle, shaft, shaft tip, and a disposable implant cartridge made of stainless steel wire, indicating it is a hardware device.
Based on the provided information, the Salute® Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "fixation of prosthetic material and approximation of tissue" during surgical procedures. This is a surgical device used directly on the patient's body.
- Device Description: The device is described as a system for delivering "Q-shaped rings" made of stainless steel wire for fixation. This is a mechanical surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly manipulate or fix tissues within the body during surgery.
N/A
Intended Use / 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.
Product codes
GDW
Device Description
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:: serio numbers of the shaft/handle match.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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_________________________________________________________________________________________________________________________________________________________________
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