STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000

K100852 · Stryker Communications · OCS · May 6, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100852
• Device Name: STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
• Applicant: Stryker Communications
• Product Code: OCS · Gastroenterology, Urology
• Decision Date: May 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Stryker SwitchPoint Infinity® 3 Control System is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel.

Device Story

System acts as central hub for integration/control of surgical/ancillary equipment; audio/video/data routing; teleconferencing. Inputs: audio, video, data signals from various surgical/medical devices. Processing: matrix routing of signals to designated destinations (displays, recording, remote locations). Output: integrated control interface, visual status of connected devices, routed audio/video/data. Used in OR/clinical settings by medical personnel. Benefits: centralized management of OR equipment, improved communication/data flow within hospital campus and off-site.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Centralized control and matrix routing system for audio, video, and data. Provides user interface for device status and integration. Connectivity includes local and remote hospital campus/off-site communication. System architecture supports integration with ancillary surgical devices (e.g., Stryker SIDNE).

Indications for Use

Indicated for medical personnel requiring a central control and integration system for ancillary equipment, audio, video, and data routing, and teleconferencing in a clinical environment.

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.

Predicate Devices

• Stryker SwitchPoint Infinity Control System (K033132)
• Olympus EndoALPHA Integrated Endosurgery System (K051613)
• KSEA Storz Communication Bus (SCB) Media Control (K020640)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JUL 2 7 2015

Stryker Communications % TUV Rheinland of North America, Inc. Mr. Tamas Borsai Program Manager 12 Commerce Road Newton, CT 06470

Re: K100852

> Trade/Device Name: Stryker SwitchPoint Infinity® 3 Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCS Dated (Date on orig SE ltr): April 20, 2010 Received (Date on orig SE 1tr): April 22, 2010

Dear Mr. Borsai,

This letter corrects our substantially equivalent letter of May 6, 2010.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4: Indications for Use Statement

ommunications

510(k) Number (if known): K100852

## Device Name: Stryker SwitchPoint Infinity® 3 Control System

Stryker SwitchPoint Infinity® 3 Control Systern is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart 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)

Dild RP Anden for mkin
(Division Sign bm

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100852

Stryker Communications March 9, 2010

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C100852

510(k) Premarket Application

## Section 5: 510(k) Summary

MAY - 6 2010

The following information is provided as required by 21 CFR § 807.87 for Stryker SwitchPoint Infinity® 3 Control System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

| Device Proprietary Name: | Stryker SwitchPoint Infinity® 3 Control System |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Stryker SwitchPoint Infinity® 3 or SPI3 |
| Classification Name: | GCJ |
| Classification Number: | 21CFR § 876.1500 - Accessory to Laparoscope,<br>General and Plastic Surgery |
| Sponsor: | Stryker Communications<br>1410 Lakeside Parkway # 100<br>Flower Mound, Texas 75028<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Alma Relja, RAC |
| Date Prepared: | March 9, 2010 |

This submission describes the Stryker SwitchPoint Infinity® 3 Control System intended for use as a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as and teleconferencing for medical personnel. The system provides a user interface through which to centrally control and provide visual status of various compatible devices including surgical devices, such as through the Stryker SIDNE™ system, as well as other devices, such as audio/video equipment used by medical personnel. It also functions as a matrix router capable of dynamically routing an array of audio, video, or other data sources to an array of audio, video or other data destinations. The routing capability is used to integrate local audio/video sources and destinations within a room. The SPI3 system provides an interface to facilitate audio/video communications to other rooms within the hospital campus, as well as off-site.

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Equivalence for this device is based on similarities in intended uses, design and operational principles to the following substantially equivalent devices: Stryker SwitchPoint Infinity Control System (K033132), Olympus EndoALPHA Integrated Endosurgery System (K051613), and KSEA Storz Communication Bus (SCB) Media Control (K020640). The minor differences between the Stryker SwitchPoint Infinity® 3 Control System and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of the device. Therefore, based on the applicable testing and the equivalence information presented in this submission, Stryker Communications believes that the Stryker SwitchPoint Infinity® 3 Control System does not raise any new safety or efficacv issues.

Stryker Communications March 9, 2010