(314 days)
The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which typically each have their own dedicated footswitch. The system includes a wireless footswitch and receiver. The SWUFS will be an accessory to and provide footswitch input control for the Stryker Total Performance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator.
The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which typically each have their own dedicated footswitch. The system includes a wireless footswitch and receiver. The SWUFS will be an accessory to and provide footswitch input control for the Stryker Total Performance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator.
This document is a 510(k) Summary of Safety and Effectiveness for the Stryker Wireless Universal Footswitch System (SWUFS). It focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel diagnostic AI device.
Therefore, many of the requested sections regarding acceptance criteria, study design, ground truth establishment, sample sizes for test/training sets, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission. The document primarily highlights adherence to voluntary safety standards and functional equivalence.
Here's an attempt to answer the questions based on the provided text, with clarifications where information is not available or relevant to a 510(k) for an accessory device:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of specific quantitative acceptance criteria and corresponding performance metrics in the way one would for a diagnostic accuracy study. Instead, it demonstrates compliance with recognized safety and electrical standards and functional equivalence to predicate devices. The "performance" is implicitly meeting these standards and functioning as intended.
| Acceptance Criteria Category (Derived from document) | Reported Device Performance (Derived from document) |
|---|---|
| Electrical Safety | Meets IEC 60601-1:1988, A1:1991, A2:1995 (General Requirements for Safety) |
| Meets IEC 60601-1-1:2000 (Safety Requirements for Medical Electrical Systems) | |
| Meets IEC 60601-1-2:2001 (Electromagnetic Compatibility ~ Requirements and Tests) | |
| Meets IEC 60601-2-2:1998 (Particular Requirements for the Safety of High Frequency Surgical Equipment) | |
| Functional Equivalence | Substantially equivalent in safety and efficacy to Stryker Sidne™ System (K022393), Stryker SERFAS System (K991960), and Stryker Total Performance System (K991703). |
| Intended Use | Utilizes a single footswitch to selectively control multiple compatible endoscopic and general surgery devices (Stryker Total Performance System, SERFAS consoles, Valleylab Electrosurgical Generator). |
| Safety Improvements | Elimination of numerous wires and multiple footswitches to improve safety and efficiency by centralizing controls, uncluttering the OR floor, and reducing set-up/clean-up time. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a non-diagnostic accessory device establishing substantial equivalence, not a clinical study on a "test set" of patient data. The evaluation focused on engineering compliance and functional testing, not data-driven performance metrics on patient samples.
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. Ground truth as typically defined in diagnostic AI studies (e.g., confirmed diagnosis, pathology) is not relevant for this type of device. The "ground truth" here is adherence to engineering standards and successful operation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" in the context of patient data that would require expert adjudication.
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. An MRMC study is relevant for diagnostic AI devices where human readers interpret medical images or data. The SWUFS is a hardware accessory (wireless footswitch) and does not involve AI or human "readers" interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The SWUFS is a hardware device; it does not have a "standalone algorithm" performance to evaluate. Its function is to facilitate human operators' control of other medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's regulatory clearance is compliance with recognized voluntary standards related to electrical safety, electromagnetic compatibility, and functional equivalence to existing legally marketed devices. Its performance is verified through engineering tests to ensure it meets these standards and accurately controls the intended surgical devices.
8. The sample size for the training set
Not applicable. The SWUFS is a hardware device; it does not involve machine learning or a "training set" of data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.
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5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2505 www.stryker.com
AUG - 9 2004
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Endoscopy
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name:
- . Endoscope and Accessories
- . Bone Cutting Instruments and Accessories
- Electrosurgical Cutting and Coagulation Device and Accessories. .
Common and Usual Name: Wireless Footswitch
Proprietary Name: Stryker Wireless Universal Footswitch System
This 510(k) summary of safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Stryker Wireless Universal Footswitch System (SWUFS) is substantially equivalent in safety and efficacy as the currently marketed Stryker Sidne™ System (K022393), Stryker SERFAS System (K991960), and Stryker Total Performance System (K991703).
The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which typically each have their own dedicated footswitch. The system includes a wireless footswitch and receiver. The SWUFS will be an accessory to and provide footswitch input control for the Stryker Total Performance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator. The elimination of numerous wires and multiple footswitches within the Operating Room will improve safety and efficiency by centralizing all footswitch controls, uncluttering the OR floor, and reducing set-up and clean-up time.
The Wireless Universal Footswitch System meets the necessary requirements of the following voluntary standards: IEC 60601-1:1988, A1:1991, A2:1995 Medical Electrical Equipment Part 1: General Requirements for Safety; IEC 60601-1-1:2000 Collateral Standard: Safety Requirements for Medical Electrical Systems; IEC 60601-1-2:2001 Collateral Standard: Electromagnetic Compatibility ~ Requirements and Tests; IEC 60601-2-2:1998 Particular Requirements for the Safety of High Frequency Surgical Equipment.
The technological differences between the Stryker Wireless Universal Footswitch System and the predicate Stryker Sidne™ System, Stryker SERFAS System, and Stryker Total Performance System do not raise new issues of safety and efficacy of the predicate devices. Therefore, the Stryker Wireless Universal Footswitch System is substantially equivalent to the currently marketed devices.
Michael Hilldoerfer Design Engineer Stryker Endoscopy
Date: June 14, 2004
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2004
Mr. Michael Hilldoerfer Design Engineer Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K033135 K035153
Trade/Device Name: Stryker Wireless Universal Footswitch System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS, GCJ, HRX, KOG Dated: July 2, 2004 Received: July 2, 2004
Dear Mr. Hilldoerfer:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premaince nealist in the indications
referenced above and have determined the device is substantially interests a referenced above and nave determined the assessed on the success marketed in interstate for use stated in the encrosule for legally manatinent date of the Medical Device Amendments, or to commerce prior to May 28, 1770, the enabilities of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMAN devices that have been recuire approval of a premarket approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premarket approval inns of the Ac and Cosment Act (Act) that do not require approvide on trols provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, inerelore, market the device, becycer of the general registration, listing of
general controls provisions of the Act include requirements for annual registration, l general controls of the rist not here not hoseline and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Comtrols) or class III (PMA), it If your device is classified (SCC above) filts existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation ED may be subject to such additional controller Links. Jan 200 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 89B be found in the Code of Pouchal City of Clevice in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substainments of the requirements of the Act
that FDA has made a determination that your device complies with on Your must that FDA has Inade a delemmation that Jour seee of by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21
comply with all the Act `s requirements, including, but not limited to: est comply with all the Act s requirements, mercesses on the requirements as set CFK Part 807), labeling (21 CFR Part 800); good manat 820); and if applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR Part 81 GFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Michael Hilldoerfer
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to obgin hakkemig your antial equivalence of your device to a legally premarket notification. The PDA midning of suckantal equice 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
s and the many of the comment of the same to the required on aniiled If you desire specific auvice for your act (301) 594-4659. Also, please note the regulation entitled, contact the Office of Complance at (39) 377-1471 (21CFR Part 807.97). You may obtain "Misoranding by relective to premained notificances in the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its told (demoment) html Manufacturers, International and Combailer Prosses of this main.html
Sincerely yours,
Miriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033135
Device Name Stryker Wireless Universal Footswitch System Indications For Use:
The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which wpically each have their own dedicated footswitch. The system includes a wireless ceiver. The SWUFS will be an accessory to and provide footswitch input control for the footswitch and Stryker Total Parformance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator.
Prescription) Jse X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE CO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K633135
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).