(87 days)
Not Found
Not Found
No
The summary describes a remote control interface device and does not mention any AI or ML capabilities.
No
The device is described as an interface for remote control of various operating room equipment, not for treating patients.
No
The device description clearly states "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." It is an interface device to provide remote control for various equipment, not to diagnose a condition or disease.
No
The device description explicitly states it is an "interface device to provide remote control via a touch screen panel," indicating it includes hardware (the touch screen panel) in addition to any software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides remote control for various equipment in the operating room. This is related to controlling the environment and tools used during a surgical procedure, not analyzing biological samples.
- Device Description: The description confirms it's an "interface device to provide remote control via a touch screen panel." This aligns with controlling equipment, not performing diagnostic tests on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely focused on controlling equipment within a surgical setting.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FTA
Device Description
The Karl Storz SCB ACC Control is an interface device to provide remote control via a touch screen panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4580 Surgical lamp.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows a logo with the word "EDITORZ" in large, bold, white letters against a black background. The letter "O" in "EDITORZ" is replaced by a solid black circle. Below "EDITORZ", there is smaller text that appears to read "EDITORZ.COM", also in white against the black background. The image has a grainy or speckled texture, giving it a distressed or vintage look.
JAN 3 0 2003
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.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Lee, Ph.D.
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Remote Control |
| | Trade Name: (optional)
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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
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.
2
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
003