(71 days)
Not Found
Not Found
No
The summary describes a system of surgical tools and accessories without mentioning any AI or ML capabilities.
No
The device is used for cutting, drilling, and smoothing bone, as well as placing or cutting various fixation devices. These functions are surgical tools rather than direct therapeutic actions to treat a disease or condition.
No
Explanation: The device is described as a surgical tool used for cutting, drilling, decorticating, and smoothing bone and other tissues, as well as manipulating fixation devices. Its intended use is purely operative, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as drills, reamers, saws, batteries, and chargers, indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical tool used for cutting, drilling, and manipulating bone and other tissues during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The components listed (drills, saws, batteries, etc.) are all instruments used for physical manipulation and cutting, not for analyzing biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used for treatment and manipulation within the body.
N/A
Intended Use / Indications for Use
The Stryker System 4000 Battery Powered Heavy Duty Handpieces and Accessories are intended for use in cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The Stryker System 4000 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
Product codes
KIJ
Device Description
The Stryker System 4000 is comprised of drills, a reamer, a rotary driver, saws, rechargeable batteries, battery chargers, a battery protector kit, sterilization cases and racks, and cutting accessories. The system is designed to meet the IEC 601.1 safety standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
bone and other bone related tissue
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
SEP - 4 1997
stryker®
4100 East Milham Avenue Kalamazoo, MI 49001 (616) 323-7700 (800) 253-3210
Device Name:
| Classification Name: | Surgical Instrument Motors and Accessories/Attachments
21 CFR 878.4820, Class I |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Battery Powered Surgical Instruments and Accessories |
| Proprietary Name: | Stryker System 4000 |
| Device Sponsor: | Stryker Corporation
Instruments Division
4100 E. Milham Avenue
Kalamazoo, MI 49001
Registration No: 1811755 |
| Regulatory Class: | Class I |
Summary of Safety and Effectiveness:
The Stryker System 4000 Battery Powered Heavy Duty Handpieces and Accessories are intended for use in cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The Stryker System 4000 is comprised of drills, a reamer, a rotary driver, saws, rechargeable batteries, battery chargers, a battery protector kit, sterilization cases and racks, and cutting accessories. The system is designed to meet the IEC 601.1 safety standards.
The Stryker System 4000 handpieces, batteries, battery charger, battery protector kit, and other system accessories are equivalent in intended use, safety, and effectiveness to existing powered instrument systems and accessories being marketed by companies such as 3M, Zimmer, and Sodem. The Stryker sterilization cases, rack, and cutting accessories are equivalent in intended use, safety, and effectiveness to existing products being marketed by Stryker Pre- The 1976 Medical Device Amendment.
The Stryker System 4000 Handpieces and Accessories do not raise any new safety and
1
effectiveness concerns when compared to similar devices already legally marketed. Therefore, the Stryker System 4000 Handpieces and Accessories are substantially equivalent to these existing devices mentioned above.
Melissa Harriger
Melissa Harriger Regulatory Affairs Representative Stryker Instruments
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "U.S. HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The image is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 1997
Ms. Melissa Harriger Regulatory Affairs Representative Stryker® Instruments ... ................................................................................................... 4100 East Milham Avenue Kalamazoo, Michigan 49001-6197
Re: K972367
Trade Name: Stryker System 4000 Heavy Duty Battery Powered Equipment Regulatory Class: I Product Code: KIJ Dated: June 24, 1997 Received: June 25, 1997
Dear Ms. Harriger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Melissa Harriger
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K972367 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Stryker System 4000 Heavy Duty Battery Power
Indications For Use:
The Stryker System 4000 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or 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 CDHR, Office of Device Evaluation (ODE)
OR
ign-Off) General Re-·············································································································································································· ちょった/ Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)