STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM

K991703 · Stryker Instruments · GCJ · May 27, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991703
• Device Name: STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
• Applicant: Stryker Instruments
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 27, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HERMES-Ready™ Total Performance System is intended for use in the cutting. drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics. dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include use of the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes. The Hermes aspect of this device allows the surgeon to remotely control the input parameters (panel selection options) through voice control technology, via a headset. Optional pendant control (wired remote), and conventional footswitch control are also available. The HERMES system allows voice and pendant control of the SE5 Shaver with buttons handpiece only.

Device Story

HERMES-Ready™ Total Performance System (TPS) is a surgical power tool system for bone/tissue manipulation. Input: surgeon voice commands via headset, wired pendant, or footswitch. Operation: system interprets voice/remote inputs to adjust device parameters (e.g., speed, mode) for the SE5 Small Joint Shaver and other handpieces. Output: mechanical power for cutting, drilling, reaming, or debriding. Used in OR by surgeons; voice control enables hands-free adjustment of surgical parameters, potentially increasing efficiency and reducing reliance on auxiliary staff for console adjustments. System integrates power control with surgical instrumentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical power system comprising handpieces (e.g., SE5 Shaver), control console, and remote interfaces. Energy source: electrical power. Control interfaces: voice recognition headset, wired pendant, and footswitch. Connectivity: wired integration between console, handpieces, and control peripherals. Sterilization: compatible with standard surgical instrument sterilization protocols.

Indications for Use

Indicated for surgical procedures requiring cutting, drilling, reaming, decorticating, and smoothing of bone and bone-related tissue, including orthopedic, dental, oral, maxillofacial, plastic, ENT, and neurological surgeries. Also indicated for placement of fixation devices (screws, wires, pins) and metal cutting. Endoscopic applications include wrist joint tissue morselization, debridement of synovitis, articular cartilage flaps, torn ligaments, and management of osseous lesions (eburnated surfaces, osteophytes).

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 1999

Ms. Nicole Petty Regulatory Affairs Representative Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K991703

Trade Name: The HERMES-Ready™ Total Performance System Regulatory Class: II Product Code: GCJ Dated: May 18, 1999 Received: May 19, 1999

Dear Ms. Petty:

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 requirement, 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. Nicole Petty

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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## Indications for Use Statement

×991703 510(k)

Number

The HERMES-Ready™ Total Performance System Device Name

Indications The HERMES-Ready™ Total Performance System is intended for use in the cutting. drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics. dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

> The endoscopic applications with TPS include use of the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

> The Hermes aspect of this device allows the surgeon to remotely control the input parameters (panel selection options) through voice control technology, via a headset. Optional pendant control (wired remote), and conventional footswitch control are also available. The HERMES system allows voice and pendant control of the SE5 Shaver with buttons handpiece only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division of General Restorative Devices | CG 9 | 7 D 510(k) Number -