KSEA SCB ACC CONTROL

K023704 · KARL STORZ Endoscopy-America, Inc. · FTA · Jan 30, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023704
• Device Name: KSEA SCB ACC CONTROL
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FTA · General, Plastic Surgery
• Decision Date: Jan 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The KSEA SCB ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.

Device Story

The Karl Storz SCB ACC Control is an interface device featuring a touch screen panel; it provides centralized remote control for various operating room equipment including overhead/surgical lights, cameras, video devices, telephones, air-conditioning, and teleconference systems. Operated by surgical staff in the operating room, the device acts as a control hub to manage environmental and surgical equipment settings. By consolidating control of disparate systems into a single interface, it streamlines OR workflow, allowing clinicians to adjust lighting, imaging, and communication parameters without leaving the sterile field or interacting with multiple individual controllers.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Interface device with touch screen panel for remote control of OR equipment. Operates as a centralized control system for surgical lights, cameras, video, and environmental systems.

Indications for Use

Indicated for use in the operating room to provide remote control of surgical lights, cameras, video equipment, telephones, HVAC, and teleconferencing 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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JAN 3 0 2003

K023704

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices 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>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Remote Control |
| | Trade Name: (optional)<br>Karl Storz SCP ACC Control |

Indication: The KSEA SCB ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.

Device Description: The Karl Storz SCB ACC Control is an interface device to provide remote control via a touch screen panel.

The Karl Storz SCB ACC Control is substantially equivalent to the Substantial Equivalence: predicate device since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB ACC 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. Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2003

Karl Storz Endoscopy-America, Inc. Susie S. Chen Director, Regulatory & Product Legal Affairs 600 Corporate Pointe, 5th Floor Culver City, California 90230-7600

Re: K023704

Trade/Device Name: KSEA SCB ACC Control Regulation Number: 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTA Dated: October 31, 2002 Received: November 4, 2002

Dear Ms. Chen:

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 such 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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Page 2 - Ms. Susie S. Chen

This letter will allow you to begin marketing your device as described in your Section 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Muriam C. Provost

(axCelia 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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K023704 510(k) Number (if known):

Device Name: SCB ACC Control

Indications for Use: The KSEA SCB ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21 CFR 801.109)
OR Over-The-Counter Use:

*Miriam C. Provost*
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K623704
(Optional Format 1-2-96)

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