StayFuse GT-IP has identical design features as the original StayFuse™, as such, GT-IP is a scalar version indicated for the IP joint of the great toe.

AI/ML Overview

This submission describes a medical device, the StayFuse GT-IP, which is a scalar version of an existing device (StayFuse K990804) designed for the IP joint of the great toe. The 510(k) summary highlights that the new device has identical design features to the original, differing only in physical size. Therefore, the provided documents do not contain information related to a clinical study or performance data of the GT-IP requiring acceptance criteria.

The core of this 510(k) submission is a claim of substantial equivalence to a previously cleared device (StayFuse K990804). Substantial equivalence means that the new device has the same intended use as the predicate device, and the same technological characteristics, or, if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness.

Because the StayFuse GT-IP is described as having "identical design features as the original StayFuse™," and the only difference is "physical size" for use in a specific joint, a clinical study demonstrating performance against acceptance criteria for the new device is typically not required. The FDA's substantial equivalence determination for this device is based on the comparison to the predicate device, not on new clinical performance data for the GT-IP itself.

Therefore, the following information cannot be extracted from the provided text as it pertains to a performance study that was not conducted for this specific 510(k) submission:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and data provenance
Number of experts used to establish ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
Standalone (algorithm only) performance study
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

Summary

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StayFuse GT-IP K 022726 510(k) Premarket Notification Summary

Demonstrating Substantial Equivalence to StayFuse™ K990804 August 12, 2002

Manufacturer Identification and Sponsor

Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855-1781 Telephone: 906-226-9909 906-226-4455 Fax:

Official Contact: Kathy Moran, Manager Regulatory Affairs Establishment Registration Number: 1833824

Device Identification

Proprietary Name: StayFuse GT-IP Common Name: StayFuse GT-IP Regulation Number: 888.3040, Class II Classification Number: 87HWC

Substantial Equivalence:

Proprietary Name and original 510(k): StayFuse™; K990804 Common Name: StayFuse™ Regulation Number: 888.3040, Class II Classification Numbers: 87HWC

Device Description

StayFuse GT-IP has identical design features as the original StayFuse™, as such, GT-IP is a scalar version indicated for the IP joint of the great toe.

Technological Comparison

Pioneer Surgical Technology's StayFuse GT-IP is substantially equivalent to the unmodified StayFuse™ device. There are no different technological characteristics between the new device and the cleared device except for physical size.

Indications for Use

StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.

Intended Use

StayFuse GT-IP is a screw device designed to stabilize and hold small bones in alignment during the healing process. StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 6 2002

Ms. Kathy Morgan

Manager of Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855

Re: K022726

Trade/Device Name: StayFuse GT-IP Regulation Number: 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulation Class: II Product Code: HWC Dated: August 12, 2002

Received: August 16, 2002

Dear Ms. Morgan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kathy Morgan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

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

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510(k) NUMBER (IF KNOWN) : K022726

DEVICE NAME: StayFuse GT-IP

INDICATIONS FOR USE :

StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ___ (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Stip Dwork

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.