(23 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 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.
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 is a 510(k) premarket notification for the Stryker Consolidated Operating Room Equipment (CORE) System, specifically the console. It doesn't contain information about AI/ML models or clinical studies to establish performance metrics as would typically be found for AI-driven diagnostic devices. This submission is for a traditional medical device (a surgical console) and demonstrates substantial equivalence to previously cleared devices. Therefore, many of the requested categories related to AI/ML performance and studies are not applicable.
Here's an analysis of the provided text based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This is achieved by showing that the new device has similar intended use and technological characteristics, and does not raise new questions of safety or effectiveness. The document itself is the comparison table demonstrating this equivalence.
| Acceptance Criteria | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use: Device is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in various surgical procedures (including ENT), and placement/cutting of screws, metal, wires, pins, and other fixation devices. | Equivalent: The Stryker CORE ENT System Console's intended use is identical to previously cleared predicate devices (e.g., Stryker CORE Console K032303, Stryker TPS Plus K032117) for cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement, and other bone-related tissue, including placement or cutting of screws, metals, wires, pins, and other fixation devices. |
| Technological Characteristics: Similar outer profile, handpiece connectors, footswitch connectors, adjustable operating parameters, system status display, software (microprocessor), non-volatile memory, power sources, power output, wireless tag technology, window jog capability, enhanced serial interface, and auxiliary control as legally marketed predicate devices. | Equivalent: The "TABLE 1-COMPARISON" explicitly demonstrates that the Stryker CORE ENT System Console has identical or substantially similar technological characteristics across all listed elements (Outer Profile, Handpiece Connector, Footswitch Connector, Adjustable Operating Parameters, System Status Display, Software, Non-volatile Memory, Power Source, Power Output, Wireless Tag Technology, Window Jog Capability, Enhanced Serial Interface, Auxiliary Control) when compared to its predicate devices like the Stryker CORE Console (K032303) and Stryker TPS Plus (K032117). Variations are noted for some predicates (e.g., power output difference with TPS Dental, lack of wireless tag/window jog/serial interface on some TPS systems), but the subject device aligns with at least one or more predicates that possess these features. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness. | Implied: The FDA's letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This determination implicitly confirms that the FDA found no new questions of safety or effectiveness for the device. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" for this device is demonstrating substantial equivalence through a comparative analysis of its design and technical specifications against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" establishment from experts for a test set in a 510(k) submission for a non-AI surgical console. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process for performance evaluation in this 510(k) submission.
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. This is not an AI-assisted device, and no MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device (surgical console) and does not deploy an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As described above, the "ground truth" concept is not directly applicable in the context of this traditional medical device 510(k) submission. The basis for approval is the demonstrated substantial equivalence to established predicate devices whose safety and effectiveness have already been determined.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model or training set.
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MAR - 3 2004
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 and theirAccessories (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 and otherbone related tissue in a variety of surgical procedures, includingbut not limited to ENT. It is also usable in the placement orcutting 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: | February 19, 2004 |
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| ELEMENT OFCOMPARISON | SUBJECT DEVICE:Stryker CORE ENTSystem Console | CLAIMED SEDEVICE # 1: TPSPlus System | CLAIMED SEDEVICE #2:Stryker CORESystem Console | CLAIMED SEDEVICE #3:Stryker TPS DentalSystem | CLAIMED SEDEVICE #4: StrykerTPS HermesSystem | CLAIMED SEDEVICE #5: StrykerNavigation System |
|---|---|---|---|---|---|---|
| 510(k) | K040300 | K032117 | K0323003 | K943540 | K991696 | K012380 |
| Intended Use | Intended for use in thecutting, drilling, reaming,decorticating, andsmoothing of bone, bonecement and other bonerelated tissue in a varietyof surgical procedures,including but not limitedto ENT. It is also usablein the placement orcutting of screws, metal,wires, pins, and otherfixation devices. | Intended for use in thecutting, drilling, reaming,decorticating, andsmoothing of bone, teethand other bone relatedtissue in a variety ofsurgical procedures,including but not limitedto Dental, ENT, Neuroand Endoscopic. It isalso usable in theplacement or cutting ofscrews, wires, pins, andother fixation devices. Itcan also be used to cutmetal. | Intended for use in thecutting, drilling, reaming,decorticating, andsmoothing of bone, bonecement and teeth in avariety of surgicalprocedures, includingbut not limited to Neuroand Endoscopic. It isalso usable in theplacement or cutting ofscrews, metal, wires,pins, and other fixationdevices.The endoscopicapplications with COREinclude use with the SE5Small Joint Shaver in thewrist for any need formorselization of tissuewithin the joint. Cutters wbe used to debridesynovitis, articular cartilagflaps, or torn ligamentswhen surgeons deemresection appropriate.Burs are indicated formanagement of osseouslesions such as eburnatearticular surfaces orosteophytes. | Intended for use in thecutting, drilling, reaming,decorticating, andsmoothing of bone, teethand other bone relatedtissue in a variety ofsurgical procedures,including but not limitedto Dental. It is alsousable in the placementor cutting of screws,wires, pins, and otherfixation devices. | Intended for use in thecutting, drilling, reaming,decorticating, andsmoothing of bone, teethand other bone relatedtissue in a variety ofsurgical procedures,including but not limitedto Endoscopic. It is alsousable in the placementof cutting of screws,wires, pins, and otherfixation devices. It canalso be used to cutmetal.The endoscopicapplications with TPSinclude use with the SE5Small Joint Shaver in thewrist for any need formorselization of tissuewithin the joint. Cutterswill be used to debridesynovitis, articularcartilage flaps, or tornligaments whensurgeons deemresection appropriate.Burs are indicated formanagement of osseouslesions such aseburnated articularsurfaces or osteophytes. | Intended for use as aplanning andintraoperative guidancesystem to enable openor percutaneous imageguided surgery. Thesystem is indicated forany medical condition inwhich the use of imageguided surgery may beappropriate and wherereference to a rigidanatomical structuresuch as the skull orvertebra can beidentified relative tomedical images. |
| Outer Profile | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | N/A |
| HandpieceConnector | Three connectors allow for three handpiece cords to be connected with two handpieces capable of running simultaneously. | Three connectors allow for three handpiece cords to be connected. | Three connectors allow for three handpiece cords to be connected with two handpieces capable of running simultaneously. | Three connectors allow for three handpiece cords to be connected. | Three connectors allow for three handpiece cords to be connected. | N/A |
| FootswitchConnector | Two connectors allow for two footswitches to run simultaneously | Yes | Two connectors allow for two footswitches to run simultaneously | Yes | Yes | N/A |
| AdjustableOperatingParameters | User used the LCD screen to set the desired operating parameters | User used the LCD screen to set the desired operating parameters | User used the LCD screen to set the desired operating parameters. | User used the LCD screen to set the desired operating parameters. | User used the LCD screen to set the desired operating parameters. | Speed Control on Handpiece |
| System StatusDisplay | Displayed on LCD screen. | Displayed on LCD screen. | Displayed on LCD screen. | Displayed on LCD screen. | Displayed on LCD screen. | N/A |
| Software | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Microprocessor | N/A |
| Non-volatileMemory | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | N/A |
| Power Source | Electricity | 12Volt Supply | Electricity | 12Volt Supply | Electricity | 12Volt Battery PowerSupply |
| Power Output | 400 Watts | 400 Watts | 400 Watts | 200 Watts | 200 Watts | 170 Watts |
| Wireless TagTechnology | Accessories are recognized and identified on the console screen | N/A | Accessories are recognized and identified on the console screen | N/A | N/A | N/A |
| Window JogCapability | Window Jog allows the cutter to turn slowly which enables the user can stop the cutter in any position in the window. | Window Jog allows the cutter to turn slowly which enables the user can stop the cutter in any position in the window. | Window Jog allows the cutter to turn slowly which enables the user can stop the cutter in any position in the window. | N/A | N/A | N/A |
| Enhanced SerialInterface(IEEE1394Firewire) | Serial communicationschannel between theconsole and otherdevices allowing thetransfer of data andcontrol information | N/A | Serial communicationschannel between theconsole and otherdevices allowing thetransfer of data andcontrol information | N/A | N/A | Instrument's positioninformation passed tothe host system througha standard serial link |
| Auxiliary Control | Mechanism to providepower and control to andretrieve data fromhandpiece mountedsubsystems | N/A | Mechanism to providepower and control to andretrieve data fromhandpiece mountedsubsystems | N/A | N/A | Wireless software controland active LED's arebattery driven, butoptional wire suppliedpower available. |
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TABLE 1-COMPARISON
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, which is composed of three curved lines that suggest wings and a body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Stryker Instruments c/o Jean W. Sheppard Regulatory Analyst 4100 East Milham Ave. Kalamazoo, MI 49001
Rc: K040300
Trade/Device Name: The Stryker Consolidated Operating Room Equipment (CORE) System Regulation Number: 21 CFR 874.4250 Regulation Name: ENT electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: February 5, 2004 Received: February 9, 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.
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 - Jean W. Sheppard
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loter natification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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) 594-4613. 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,
Akeryl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
The Stryker Consolidated Operating Room Equipment (CORE) Device Name System
The Stryker Consolidated Operating Room Equipment (CORE)System is Indications ti yker Consondated operating, drilling, reaming, decorticating, and miching of bone, bone cement and other bone related tissue in a sinoounning of bono, come ares, including but not limited to ENT. It variety of surgical proceeded or cutting of screws, mctal, 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)
Kacey A. Baker
Dohthalmic Ear, d Threat Devi
510(k) Number K040300
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.