(183 days)
The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC).
A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.
Stellar Series Surgical Lights with Hermes
The provided document is a 510(k) premarket notification letter from the FDA for a surgical lamp device (Skytron Stellar Series Surgical Lights with Hermes). This type of document is a regulatory approval and does not contain the detailed technical study information outlined in your request.
The letter confirms substantial equivalence to a predicate device, allowing the manufacturer to market the product. However, it does not include:
- A table of acceptance criteria and reported device performance: This document does not detail specific performance metrics or acceptance criteria for the surgical lights.
- Sample size for the test set or data provenance: There is no mention of a test set, sample sizes, or where data originated.
- Number/qualifications of experts for ground truth: Ground truth determination is not discussed as there's no mention of a study involving expert assessment.
- Adjudication method: Not applicable as no expert-based ground truth is discussed.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is not pertinent to a surgical lamp and is not mentioned. AI assistance is also not relevant to this device.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device (surgical light), not an algorithm.
- Type of ground truth used: Not applicable as there's no data analysis discussed in this letter.
- Sample size for the training set: Not applicable as no algorithm training is discussed.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence of a physical medical device. It does not contain the detailed study design, performance data, or AI-related metrics that your request is asking for.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
00 Corporate Boulevard ockville MD 20850
NOV 1 3 2002
Skytron, Division The KMW Group, Inc Larry Perez VP Technical Services P. O. Box 888615 Grand Rapids, Michigan 49588-8615
Re: K021585
Trade/Device Name: Stellar Series Surgical Lights with Hermes Regulation Number: 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: September 24, 2002 Received: September 25, 2002
Dear Mr. Perez:
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 - Mr. Larry Perez
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 t proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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,
Muriam C. Provost
(Celia 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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Page 1 of 1
510(k) Number (if known):
TM Stellar Series Surgical Lights with Hermes Device Name:
Indications For Use:
The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC).
A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.
Users of the Stellar Series Surgical Lights with Hermes ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists,
(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)
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Over-The-Counter Use__
Miriam C. Purret
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K033535
4.0
§ 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.