(288 days)
The Stryker Auto Irrigation System is intended for use with the Maestro Pneumatic System for providing controlled, cooling irrigation during cutting, shaping, and removal of bone.
The Stryker Auto Irrigation System provides on-demand irrigation using a peristaltic pump. The system consists of an enclosure containing the pump, an attachable irrigation cassette and a sensor plug.
The provided document is a 510(k) summary for the Stryker Auto Irrigation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way modern AI/ML device submissions do.
Therefore, much of the requested information (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, ground truth establishment, or human-in-the-loop studies) is not available in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
The submission demonstrates substantial equivalence based on intended use and technological characteristics being similar to predicate devices. It does not present specific quantitative acceptance criteria or performance metrics for the device itself.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device (Anspach Irrigation Pump and Irrigation Pump II) | The Stryker Auto Irrigation System has the same intended use: "providing controlled, cooling irrigation during cutting, shaping and removal of bone." |
| Technological Characteristics: Same as predicate device | "This device and the predicate device have the same technological characteristics, the same operating principles and have similar performance characteristics." (Specific characteristics are not detailed, but imply similarity in pump mechanism, control, etc., without providing quantitative data). |
| Operating Principles: Same as predicate device | "This device and the predicate device have the same technological characteristics, the same operating principles and have similar performance characteristics." |
2. 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 submission does not include a specific "test set" in the context of an AI/ML device. The evaluation is based on a comparison to existing predicate devices, implying engineering design verification and validation, but not a clinical study or a data-driven performance study in the modern sense.
3. 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. Ground truth establishment is not relevant for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
5. 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
- Not applicable / Not provided. This is not an AI/ML device; it's an electromechanical surgical irrigation pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. Ground truth is not relevant for this type of device and submission. The "ground truth" for demonstrating substantial equivalence is the existing performance and safety profile of the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/ML device.
Study Proving Device Meets Acceptance Criteria:
The document states: "Based upon the comparison to the predicate devices, the Stryker Auto Irrigation System is substantially equivalent to a legally marketed device."
This means the "study" proving the device meets the "acceptance criteria" (which in this context is "substantial equivalence") is a comparison to predicate devices (K030576 Anspach Irrigation Pump and Irrigation Pump II). The comparison asserts that the Stryker Auto Irrigation System has:
- The same intended use.
- The same technological characteristics.
- The same operating principles.
- Similar performance characteristics.
The supporting evidence would typically be engineering design specifications, bench testing results, and perhaps biocompatibility testing (which are not detailed in this summary). There is no clinical trial data or performance study as we would see for a novel therapeutic or diagnostic device, especially not one involving AI/ML.
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stryker®
4100 E. Milham Avenue Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com
....
FEB - 2 2007
Instruments
| 510(k) Summary | |
|---|---|
| Device Sponsor: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
| Registration No .: | 1811755 |
| Trade Name: | Stryker Auto Irrigation System |
| Common Name: | Auto Irrigator |
| Classification Name: | Pump, Infusion (FRN) |
| Equivalent to: | K030576 Anspach Irrigation Pump and Irrigation Pump II |
| Device Description: | The Stryker Auto Irrigation System provides on-demand irrigation using aperistaltic pump. The system consists of an enclosure containing the pump,an attachable irrigation cassette and a sensor plug. |
| Indications for Use: | The Stryker Auto Irrigation System is intended for use with the MaestroPneumatic System for providing controlled, cooling irrigation during cutting,shaping and removal of bone. |
| Contraindications | • The Stryker Auto Irrigation System is contraindicated for use with anyfluids other than those specifically for surgical irrigation. |
| Substantial Equivalence(SE) Rational: | The Stryker Auto Irrigation System has the same intended use as theAnspach Irrigation Pump and Irrigation Pump II. This device and thepredicate device have the same technological characteristics, the sameoperating principles and have similar performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker AutoIrrigation System is substantially equivalent to a legally marketed device. |
| Submitted by: | Valerie FranckRegulatory Affairs Representative |
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Davis Runce --
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Signature
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Date submitted:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2007
Ms. Valerie Franck Regulatory Affairs Representative Stryker Stryker Instruments Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K061108
Trade/Device Name: Stryker Auto Irrigation System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 26, 2007 Received: January 30, 2007
Dear Ms. Franck:
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.
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Page 2 - Ms. Franck
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): _
Device Name: Stryker Auto Irrigation System
Indications for Use
The Stryker Auto Irrigation System is intended for use with the Maestro Pneumatic System for providing controlled, cooling irrigation during cutting, shaping, and removal of bone.
Contraindications
- · The Stryker Auto Irrigation System is contraindicated for use with any fluids other than those specifically for surgical irrigation.
Prescription Use _ X and/or Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cintron Bm
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Kpb Wps
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).