KSEA SCB MEDIA CONTROL

K020640 · KARL STORZ Endoscopy-America, Inc. · FTA · May 28, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020640
• Device Name: KSEA SCB MEDIA CONTROL
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FTA · General, Plastic Surgery
• Decision Date: May 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The KSEA SCB Media Control provides remote control for overhead and surgical lights, cameras, telephones, pagers, CD-players, audio volume output, and teleconference equipment in the operating room.

Device Story

The Karl Storz SCB Media Control is a remote control unit designed for use in the operating room. It functions as a centralized interface allowing surgical staff to manage various peripheral equipment, including overhead and surgical lights, cameras, communication devices (telephones, pagers), audio systems (CD-players, volume control), and teleconference equipment. By consolidating control of these disparate systems into a single unit, the device streamlines the operating room environment, enabling efficient adjustment of lighting, imaging, and communication settings during surgical procedures. The device is operated by clinical staff within the OR to facilitate equipment management without requiring manual adjustment of individual components, thereby supporting surgical workflow and potentially reducing distractions for the surgical team.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Remote control unit for operating room equipment. Connectivity involves integration with surgical lights, cameras, communication, and audio-visual systems via the Storz Communication Bus (SCB).

Indications for Use

Indicated for use in the operating room to provide remote control of surgical lights, cameras, communication devices (telephones, pagers), audio equipment (CD-players, volume output), and teleconference systems.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with This summaly of J10(x) safety and entownices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Lee, Ph.D.<br>Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Remote Control |

Trade Name: (optional) Karl Storz SCB Media Control

Indication: The KSEA SCB Media Control is a remote control unit for overhead and surgical lights, cameras, telephones, pagers, CD-players, audio volume output, and teleconference equipment in the operating room.

Device Description: The Karl Storz Media Control is a remote control unit.

Substantial Equivalence: The Karl Storz Media Control is substantially equivalent to the predicate device since the basic features and general intended uses are similar. The minor differences between the Karl Storz Media Control 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 these devices.

Signed:

James A. Lee, Ph.D. Regulatory Affairs Specialist

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## Public Health Service

## MAY 2 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James A. Lee, Ph.D. Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe, 5th Floor CULVER CITY CA 90230-7600

Re: K020640

Trade/Device Name: KSEA Storz Communication Bus (SCB) Media ControlTM Regulation Number: 21 CFR §878.4580 Regulation Name: Surgical lamp Product Code: 79 FTA Regulation Number: 21 CFR §876.1500 Regulatory Name: Endoscope and accessories Product Code: 78 FET Regulatory Class: II Dated: February 26, 2002 Received: February 27, 2002

Dear Dr. Lee:

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 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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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 C 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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510(k) Number (if known):

K020640

Device Name: SCB Media Control

Indications for Use: The KSEA SCB Media Control provides remote control for overhead and surgical lights, cameras, telephones, pagers, CD-players, audio volume output, and teleconference equipment in the operating room.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Prescription Use: | <div style="text-align: left;">✓</div> |
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| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |
| | (Optional Format 1-2-96) |
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| Division of Reproductive, Abdominal, and Radiological Devices | |

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