(71 days)
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.
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 provided document is a 510(k) premarket notification for the Stryker System 4000. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance data from a specific study with acceptance criteria.
Therefore, many of the requested fields cannot be directly populated from the given text. The document primarily makes claims of equivalency in intended use, safety, and effectiveness.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria or detailed performance metrics. Instead, it asserts substantial equivalence to existing devices. The key "acceptance criteria" for a 510(k) submission is typically that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: No new intended uses compared to predicate devices. | The Stryker System 4000 is intended for cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue, as well as placing/cutting screws, wires, pins, and other fixation devices, and cutting metal. This is stated to be equivalent to existing powered instrument systems. |
| Safety Equivalence: No new safety concerns compared to predicate devices. | The system is designed to meet IEC 601.1 safety standards. The document states it "does not raise any new safety... concerns when compared to similar devices already legally marketed." |
| Effectiveness Equivalence: No new effectiveness concerns compared to predicate devices. | The document states it "does not raise any new... effectiveness concerns when compared to similar devices already legally marketed." |
| Design Equivalency: Composition and design features are comparable. | The system comprises drills, reamer, rotary driver, saws, rechargeable batteries, chargers, battery protector kit, sterilization cases/racks, and cutting accessories, which are claimed to be equivalent to predicate devices from 3M, Zimmer, Sodem, and Stryker's pre-1976 products. |
Study Information (Based on 510(k) Nature)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided. This document is a 510(k) premarket notification. It does not describe a clinical study with a test set of data in the manner of an AI/ML device. The claim is based on substantial equivalence to predicate devices, potentially through design comparison, bench testing, and compliance with standards rather than clinical performance data from a "test set."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable / Not Provided. No "ground truth" for a test set is described or established in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No test set requiring adjudication is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a mechanical surgical instrument, not an AI/ML diagnostic device. An MRMC study is not relevant to this type of device and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This is a physical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. The concept of "ground truth" as typically used for AI/ML or diagnostic studies does not apply here. The "truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are comparable to legally marketed devices already established as safe and effective.
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The sample size for the training set:
- Not Applicable / Not Provided. This is not an AI/ML device; therefore, there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable / Not Provided. As there is no training set, this question is not relevant.
In summary: The provided text is a regulatory submission focused on establishing substantial equivalence for a physical surgical device. It explicitly states that the device does not raise new safety or effectiveness concerns compared to existing, legally marketed predicate devices (Stryker's own pre-1976 products, and products from 3M, Zimmer, and Sodem). The "study" here is essentially the comparison and justification provided within the 510(k) submission itself, supported by design specifications and compliance with standards like IEC 601.1. It does not involve a clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would.
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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/Attachments21 CFR 878.4820, Class I |
|---|---|
| Common/Usual Name: | Battery Powered Surgical Instruments and Accessories |
| Proprietary Name: | Stryker System 4000 |
| Device Sponsor: | Stryker CorporationInstruments Division4100 E. Milham AvenueKalamazoo, MI 49001Registration 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
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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.
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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)
§ 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.