(30 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the intended use, device description, or other sections.
No
The device is used for cutting, drilling, and shaping bone and other tissues during surgical procedures, which are considered interventions rather than therapeutic treatments aimed at restoring health.
No
The device is described as being used for cutting, drilling, reaming, decorticating, and smoothing of bone, teeth, and other bone-related tissue, and for placing/cutting screws, wires, pins, and other fixation devices, as well as cutting metal. These are all therapeutic or surgical actions, not diagnostic ones.
No
The device description explicitly lists numerous hardware components (drills, shavers, motors, console, etc.) and the intended use involves physical manipulation of bone and tissue, indicating it is a hardware-based system.
Based on the provided information, the Stryker Total Performance (TPS) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function as a surgical tool for cutting, drilling, and manipulating bone and other tissues within the body during surgical procedures.
- Device Description: The components listed are all surgical instruments and accessories used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a patient's health, such as analyzing blood, urine, or tissue samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases, monitor health, or screen for conditions. The Stryker TPS System's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The Stryker Total Performance (TPS) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, teeth and other bone related tissue in a variety of surgical procedures, including but not limited to Dental, ENT, Neuro, and Endoscopic. It is also usable in the placement of cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
Product codes
DZI, ERL, HBE, EIA, HBC, HBE, HSZ, GEY
Device Description
The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943540, K943569, K943541, K991696, K012380, K771218
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Ko32117
AUG - 8 2003
,
510(k) Summary
| Trade Name: | Stryker Total Performance (TPS) System |
|---|---|
| Common Name: | Console |
| Classification Names: | Bone Cutting Instruments and Accessories. (per 21 CFR section |
| 872.4120) | |
| Ear, Nose and Throat Electric or Pneumatic Surgical Drill. (per | |
| 21 CFR section 874.4250) | |
| Powered Simple Cranial Drill, Burrs, Trephines and their | |
| Accessories (per 21 CFR section 882.4310) | |
| Equivalent to: | Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541), |
| TPS Hermes (991696), Stryker Navigation System (K012380) | |
| and Dyonics (K771218). | |
| Device Description: | The device description of the Stryker System includes drills, |
| shavers, shields, guards, motors, attachments, saws, wire drivers, | |
| collets, console, irrigation pump, cords, footswitch, handswitch, | |
| clips, tubing, cutting accessories, and sterilization cases. | |
| The scope of this modification is limited to the console of the | |
| system. | |
| Intended Use: | The Stryker Total Performance (TPS) System is intended for use |
| in the cutting, drilling, reaming, decorticating, and smoothing of | |
| bone, teeth and other bone related tissue in a variety of surgical | |
| procedures, including but not limited to Dental, ENT, Neuro, and | |
| Endoscopic. It is also usable in the placement of cutting of | |
| screws, wires, pins, and other fixation devices. It can also be | |
| used to cut metal. | |
| Technological | |
| Comparison: | Technological characteristics are the same as previously cleared |
| for the Stryker TPS System (K943540, K943569, K943541, and | |
| K991696), Stryker Navigation System (K012380) and Dyonics | |
| (K771218). | |
| Submitted by: | Jean W. Sheppard |
| Sr. Regulatory Affairs Representative | |
| Stryker Instruments | |
| Date Submitted: | July 8, 2003 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ms. Jean W. Sheppard Senior Regulatory Affairs Representative Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K032117 Trade/Device Name: Stryker Total Performance System Regulation Number: 21 CFR 872.4120, 874.4250, 882.4310, 882.6640 Regulation Name: Bone cutting instrument and accessories; Ear, nose, and throat electric pneumatic surgical drill Powered simple cranial drills, burrs, trephines, and their accessories Dental operative unit and accessories Regulatory Class: II Product Code: DZI, ERL, HBE, EIA, HBC, HBE, HSZ, GEY Dated: July 8, 2003 Received: July 9, 2003
Dear Ms. Sheppard:
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. Jean W. Sheppard
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), 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) you may obtain. 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,
Miriam C. Provost
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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Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________
Indications for Use Statement
| 510(k)
| Number | K032117 |
|---|---|
| Device Name | The Stryker Total Performance (TPS) System |
| Indications | The Stryker Total Performance (TPS) System is intended for use in |
| the cutting, drilling, reaming, decorticating, and smoothing of | |
| bone, teeth and other bone related tissue in a variety of surgical | |
| procedures, including but not limited to Dental, ENT Neuro and | |
| Endoscopic. It is also usable in the placement of cutting of screws, | |
| wires, pins, and other fixation devices. It can also be used to cut | |
| metal. |
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)
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032117