(90 days)
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.
The Karl Storz Media Control is a remote control unit.
The provided text is a 510(k) summary for the KSEA SCB Media Control device, which is a remote control unit. It does not contain information typically associated with studies proving acceptance criteria for AI/ML-driven medical devices.
Therefore, many of the requested fields cannot be extracted or are not applicable.
Here's a breakdown based on the available information:
1. Table of acceptance criteria and the reported device performance:
This device is a remote control unit, not an AI/ML diagnostic or measurement device. The 510(k) summary states, "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."
This implies that the "acceptance criteria" were met by demonstrating substantial equivalence to a legally marketed predicate device, rather than through specific performance metrics measured in a study. Therefore, there are no reported quantitative performance metrics in the document.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (KSEA SCB Media Control) | Basic features and general intended uses are similar to predicate. Minor differences have no effect on performance, function, or general intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a remote control unit, and the 510(k) summary does not describe a test set or data for performance evaluation in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth establishment is not relevant for this type of device according to the provided documentation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable.
8. The sample size for the training set:
Not applicable. This device does not involve a training set.
9. How the ground truth for the training set was established:
Not applicable.
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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, Inc600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | James A. Lee, Ph.D.Regulatory Affairs Specialist |
| Device Identification: | Common Name: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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Image /page/1/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 its wings spread, symbolizing the department's mission to protect the health of all Americans.
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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):
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: | ✓ |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices |
003510(k) Numb
§ 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.