SCB COMPUTER MOTION INTERFACE CONTROLLER

K030718 · Computer Motion, Inc. · GCJ · Jun 5, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030718
• Device Name: SCB COMPUTER MOTION INTERFACE CONTROLLER
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.

Device Story

The SCB Computer Motion Interface Controller (SCIC) acts as a hardware bridge between HERMES-Ready™ medical devices and the Karl Storz Storz Communication Bus (SCB). It provides 8 additional connection ports, allowing integration of various surgical devices into the SCB ecosystem. Used in the operating room, it enables centralized control of connected equipment via Computer Motion's voice-control system. The device facilitates communication between disparate surgical systems, allowing healthcare providers to manage multiple devices through a unified interface, potentially streamlining surgical workflows and improving operational efficiency during procedures.

Clinical Evidence

Bench testing only. The submission included hazard analyses and hardware/software validation procedures demonstrating safety and effectiveness. No clinical data was required or provided.

Technological Characteristics

Provides 8 additional device connection ports for integration with the Storz Communication Bus (SCB). Tested to IEC 601-1, IEC 601-1-1, IEC 601-2-18, UL 2601-1, and various EN/CISPR electromagnetic compatibility standards (EN55011, EN61000 series).

Indications for Use

Indicated for use with the Storz Communication Bus (SCB) to connect HERMES-Ready™ devices to the SCB in a clinical setting.

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

• HERMES® Port Expander

Submission Summary (Full Text)

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JUN - 5 2003

K030718

an 1 of V

# SCB Computer Motion Interface Controller 510(k) Summary

In accordance with 21 CFR section 807.92 Computer Motion, Inc. (CMI) is submitting the following 510(k) Summary:

# 1) Submitter Information

Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117

Contact: Cathy Stupak, Ph.D.

#### 2) Name of Device:

| Proprietary Name: | SCB Computer Motion Interface Controller |
|----------------------|------------------------------------------|
| Common Name: | n/a |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Regulation Number: | 876.1500 |
| Product Code: | GCJ |
| Class: | Class II. |

#### 3) Substantial Equivalence:

This submission establishes the substantial equivalence of the SCB Computer Motion Interface Controller to Computer Motion's HERMES® Port Expander

### 4) Description of the Device:

The SCB Computer Motion Interface Controller (SCIC) connects devices that are controlled by Computer Motion's voice-control system to the Storz Communication Bus (SCB) manufactured by Karl Storz.

| Test | Title |
|--------------|------------------------------------------------------------|
| IEC 601-1 | International Standard for Medical<br>Electrical Equipment |
| IEC 601-1-1 | International Standard for Medical<br>Electrical Equipment |
| IEC 601-2-18 | International Standard for Medical<br>Electrical Equipment |
| UL 2601-1 | Underwriters Laboratory |

The SCIC is tested to the following standards:

continued

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/ C 3 0 7 / EONFIDENTIAL Pg 2 of 2

| Test | Title |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| EN55011/A1 CISPR 11 | Conducted Emission |
| EN55011/A1 CISPR11 | Radiated Emission |
| EN61000-4-2 | Electrostatic Discharge |
| EN61000-4-3 and EN50140 | RF Immunity |
| EN61000-4-4 | EFT/Bursts Immunity |
| EN61000-4-5 | Surge Immunity |
| EN61000-4-6 | Conducted Immunity |
| EN60601-1 | International Standard for Medical<br>Electrical Equipment |
| EN60601-1-1 | General Requirements for Safety -<br>Collateral Standard |
| EN 60601-1-2 | Emissions and Immunity Test<br>Measurements |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Part 1,<br>General Requirements for Safety, General<br>Instructions Part 1 |
| VA-19795 | CMI Environmental Testing |

# 5) Intended Use

The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.

## 6) Technological Characteristics in Comparison to the Predicate

The predicate, the HERMES Port Expander, is an extension of the HERMES O.R. Control Center, providing 8 additional device connection ports for devices, whereas the SCIC is an extension of the Storz SCB, providing 8 additional device connection ports for devices.

#### 8) Device Testing

Hazard analyses and hardware/software validations procedures were provided in this submission.

#### 9) Conclusion drawn from the Device Testing

Data included in this submission demonstrate the safety and effectiveness of the SCB Computer Motion Interface Controller.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2003

Mr. Keith Lowrey Regulatory Affairs Manager Computer Motion, Inc. 130-B Cremona Drive GOLETA CA 93117

Re: K030718

Trade/Device Name: SCB Computer Motion Interface Controller Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 GCJ Dated: March 6, 2003 Received: March 7, 2003

Dear Mr. Lowrey:

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 fegistration, 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 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 (OS) 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

# INDICATION FOR USE STATEMENT

Ko30718 510(k) Number (if known): _

Device Name: SCB Computer Motion Interface Controller

The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.

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Concurrence of CRDH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use (Optional Format 1-2-96)

":

David A. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices h10(k) Number

000023