(87 days)
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.
The Karl Storz SCB ACC Control is an interface device to provide remote control via a touch screen panel.
The provided text is a 510(k) summary for the Karl Storz SCB ACC Control, which is a remote control interface device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the device itself.
Therefore, most of the requested information cannot be extracted from this document, as a typical performance study as requested for AI/ML devices or diagnostic tools is not present. The device described is a remote control for operating room equipment, and its safety and effectiveness are primarily supported by its functional equivalence to existing devices, not by a study with ground truth and expert consensus.
Here's what can be extracted based on the provided text, and where the information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria in the document for a performance study. The 510(k) summary focuses on substantial equivalence. | The device provides "remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room." It is stated to be "substantially equivalent to the predicate device since the basic features and intended uses are the same." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The document does not describe a performance study with a test set of data.
- Data Provenance: Not applicable.
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)
- Number of Experts: Not applicable. Ground truth establishment is not relevant for this device's regulatory submission as described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no test set or adjudication method described.
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 device is a remote control, not an AI/ML-driven diagnostic or assistive device that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Ground truth is not a concept applied in this 510(k) submission for this type of device.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
Summary:
The provided document is a 510(k) summary for a remote control device (KSEA SCB ACC Control). Its regulatory pathway is based on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting a performance study with acceptance criteria, ground truth, and expert evaluations typical of AI/ML or diagnostic devices. Therefore, most of the requested information regarding performance studies, sample sizes, expert involvement, and ground truth is not applicable to this submission. The "study" referenced in the prompt (if interpreted as the documentation within the 510(k)) primarily consists of a comparison to a predicate device, asserting that "minor differences...have no effect on the performance, function or general intended use of these devices."
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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 DriveCulver 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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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 (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
§ 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.