(48 days)
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement, teeth and other 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 or cutting of screws, metal, wires, pins, and other fixation devices.
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.
This document is a 510(k) summary for the Stryker Consolidated Operating Room Equipment (CORE) System. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. This type of information is typically found in performance testing sections of a 510(k) submission, which evaluates quantifiable metrics like accuracy, precision, or other performance characteristics of the device.
The provided document is limited to:
- Device identification: Trade Name, Common Name, Classification Names, Equivalent predicate devices, Device Description, Intended Use, Technological Comparison.
- Regulatory correspondence: A letter from the FDA confirming substantial equivalence and outlining general controls.
- Indications for Use Statement: Detailing the surgical procedures and materials the device is intended for.
Therefore, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The document focuses on demonstrating substantial equivalence to predicate devices, implying that its safety and effectiveness are established by comparison to existing, legally marketed devices with similar technological characteristics and intended uses, rather than through a new, standalone performance study with detailed acceptance criteria as one might see for novel AI/software devices.
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KO4O369
510(k) Summary
| Trade Name: | Stryker Consolidated Operating Room Equipment (CORE)System |
|---|---|
| Common Name: | Console |
| Classification Names: | Bone Cutting Instruments and Accessories. (per 21 CFR section872.4120)Ear, Nose and Throat Electric or Pneumatic Surgical Drill. (per21 CFR section 874.4250)Powered Simple Cranial Drill, Burrs, Trephines andtheirAccessories (per 21 CFR section 882.4310) |
| Equivalent to: | Stryker CORE Console (K032303), Stryker TPS Plus (K032117)Stryker TPS (Dental-K943540, ENT-K943569, Neuro-K943541), TPS Hermes (K991696), 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 thesystem. |
| Intended Use: | The Stryker Consolidated Operating Room Equipment (CORE)System is intended for use in the cutting, drilling, reaming,decorticating, and smoothing of bone, bone cement, teeth andother related tissue in a variety of surgical procedures, includingbut not limited to Dental, ENT, Neuro and Endoscopic. It is alsousable in the placement or cutting of screws, metal, wires, pins,and other fixation devices. |
| TechnologicalComparison: | Technological characteristics are the same as previously clearedfor the Stryker CORE Console (K032303), Stryker TPS Plus(K032117), Stryker TPS System (K943540, K943569, K943541,and K991696), Stryker Navigation System (K012380) andDyonics (K771218). |
| Submitted by: | Jean W. SheppardRegulatory AnalystStryker Instruments |
| Date Submitted: | February 5, 2004 |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes that resemble human figures or waves, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Stryker Instruments Mr. Jean W. Sheppard Regulatory Analyst Instruments DIV 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K040369
Trade/Device Name: The Stryker Consolidated Operating Room Equipment (CORE) System Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZJ Dated: February 5, 2004 Received: February 13, 2004
Dear Mr. 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.
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Page 2 - Mr. Sheppard
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.
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) 594-5613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
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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Indications for Use Statement
510(k) Number (K040369):
Device Name
The Stryker Consolidated Operating Room Equipment (CORE) System
Indications The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to Dental. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The Stryker Consolidated Operating Room Equipment (CORE) System (K032303) is also, intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The Stryker Consolidated Operating Room Equipment (CORE) System (K040300) is also, intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws. metal, wires, pins, and other fixation devices.
Prescription Use X (Per 21 CFR 801Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
§ 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.