(35 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical fixation and biocompatibility, with no mention of AI/ML technologies or data processing.
No
The device is described as a fixation device for prosthetic material and tissue approximation, not as a device used to treat a disease or condition. While it assists in surgical procedures, its primary function is mechanical fixation rather than therapeutic intervention.
No
Explanation: The device is used for fixation of prosthetic material and approximation of tissue, indicating a therapeutic or surgical function rather than diagnostic.
No
The device description clearly states it is a physical device consisting of a handle, shaft, and wire, used to deliver physical constructs (Q-Rings). It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of prosthetic material and approximation of tissue" during surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The device is a surgical tool that delivers physical implants (Q-Rings) into the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool used on the human body.
N/A
Intended Use / 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.
Product codes
GDW
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Salute Stapler and Staples
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
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 Crossroad | ||
| 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 |
| (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.
1
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.
2
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.
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 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
4
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