(71 days)
Not Found
Not Found
No
The summary describes a mechanical surgical stapler and staples with a coating. There is no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is used for fixation of prosthetic material and approximation of tissue, which is a surgical tool function, not a therapeutic action like healing or pain relief.
No
The provided text describes a surgical fixation system intended for tissue approximation and fixation of prosthetic material during surgical procedures. It is an instrument used for treatment or repair, not for identifying or determining the nature of a disease or condition.
No
The device description clearly states it is a "reusable surgical instrument with integral disposable cartridge for placing coated stainless steel constructs," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "fixation of prosthetic material and approximation of tissue" in surgical procedures. This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description details a surgical instrument and staples used for physical fixation. This aligns with a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The Salute Fixation System is indicated for use in a variety of laparocopic / endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.
Product codes
GDW
Device Description
A reusable surgical instrument with integral disposable cartridge for placing coated stainless steel constructs. This instrument may be used laparoscopically with 5mm trocars.
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
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Key Metrics
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
MAR 8 2002
510(k) Summary
2/19/02
Onux Medical, Inc. Contact Pers Trade or Proprietary Name: Common or Usual Name: Classification Name: Classification Number
Ruthann DePietre Endoscopic stupler and staple Endosconic and/or Accossory. Implantable Staple
Devices to Which Equivalence is Claimed
The ProTack™ laparoscopic stapler currently sold by Auto Suture (United States Surgical) and a variety of Ethicon staples (e.g. Proximate™ staples).
Description of Subject Device
A minor modification has been made to the Salute staples in that a coating has been added to the surface of the staples.
A reusable surgical instrument with integral disposable cartridge for placing coated stainless steel constructs. This instrument may be used laparoscopically with 5mm trocars.
Intended Use of Subject Device
The modification will not change the intended use of the device in any way from its original intended use.
The Salute Fixation System is indicated for use in a variety of laparoscopic / endoscopic or open surgical procedures for fixation of prosthctic material and approximation of tissue.
Comparison of Technical Aspects
The subject device modification is also incorporated in the ProTack™ laparoscopic staples and the Ethicon staples. The subject device and these equivalent devices use the same type of coating for the same purpose.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 MAR
Ms. Ruthann DePietro Vice President, Quality Assurance and Regulatory Affairs Onux Medical, Inc. 5 Merrill Drive Hampton, New Hampshire 03842
Re: K014286
Trade/Device Name: Salute Regulation Number: 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: December 21, 2001 Received: December 27, 2001
Dear Ms. DePietro:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 9 ro(x) premained 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 encrosule) to regally manatible for the Medical Device American beys commerce prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in asses approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that as not requestion the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 (800 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FFP inay be subject to such additional volulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that I Dr o lesaartes over device complies with other requirements of the Act that I Dr I had Intatutes and regulations administered by other Federal agencies. You must or any I oderal battle and step and the mot limited to: registration and listing (21 comply with an the 110 11 cm Part 801); good manufacturing practice requirements as set CFR in 6077, adoling (21 CFR Part 820); and if applicable, the electronic form in and quand of a movisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Ms. Ruthann DePietro
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manoling of substantial equivalence of your device to a legally prematicate device results in a classification 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 and If you desire specific advice for you invitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 0071. Additionally, for questions on the promotion and advertising of Compliance at (301) 591 1057. Thenker Compliance at (301) 594-4639. Also, please note the your do roo, proad over anding by reference to premarket notification" (21CFR Part 807.97). Tegulation chitted, "Misoranang of responsibilities under the Act may be obtained from the Outer general mionnation on Jour respectional 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 yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page L of __ of __ l
510(k) Number (if known):
Salute Device Name:
Indications For Use:
The Salute Fixation System is indicated for use in a variety of laparocopic / endoscopic I he Salute I Ixallon oyetem in articles of prosthetic material and approximation of tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Coucurence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pex 21 CFR 801.109)
OR
Over-The-Counter Use
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K614286
(Optional Format 1-2-96)