The Thompson Surgical Instruments, Inc. Retractor Lite intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor blade which it can attach to through the use of TECASONTM P XRO clips. The Retractor Lite is designed to provide visible illumination of the surgical field or the patient through a Xenon light source only. The Retractor Lite is designed to be used by surgeons and other medical care practitioners in a surgical setting.

Device Description

Thompson Surgical Instruments. Inc. Retractor Lite is a fiber optic surgical light designed to provide visible illumination of the surgical field or the patient. The Retractor Lite consists of a flexible "gooseneck" supported lighthead for easy positioning, a fiber optic bundle, and two molded clips made of TECASONTM P XRO used to attach the gooseneck portion of the light to a retractor blade. The Thompson surgical Retractor Lite is designed as a task light for surgical use.

AI/ML Overview

This is a 510(k) summary for a surgical light, not a medical AI device, and therefore does not contain the detailed study information typically found in submissions for AI/ML-driven devices. As such, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's why the requested information is not available in the provided text:

Device Type: The "Retractor Lite" is a fiber optic surgical light, a traditional medical device, not an AI/ML-driven device. 510(k) submissions for such devices typically focus on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than complex performance studies with acceptance criteria, ground truth, and expert evaluation as would be required for AI.
510(k) Summary Nature: A 510(k) summary is a brief overview, primarily concerned with establishing substantial equivalence to a legally marketed predicate device. It doesn't contain detailed study protocols, acceptance criteria, or performance metrics in the way an AI device submission (which might include clinical validation studies) would.

Information provided in the 510(k) summary:

Acceptance criteria and reported device performance: Not explicitly stated as detailed performance criteria (e.g., sensitivity, specificity, AUC) for an AI device. The submission relies on demonstrating substantial equivalence to predicate surgical lamps, implying that if it functions similarly, it meets the required performance for its intended use.
Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information: These are all concepts relevant to the evaluation of AI/ML models. Since this is a traditional medical device (a surgical light), these types of studies and associated data are not part of its 510(k) submission. The FDA clearance is based on the device's design, materials, and intended use being substantially equivalent to existing, legally marketed surgical lamps.

Summary

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K0837b

510(k) SUMMARY FEB 2 3 2009 Thompson Surgical Instruments, Inc. Retractor Lite

Applicant:

Stephanie A. Zalucha Thompson Surgical Instruments, Inc. 10170 E. Cherry Bend Road Traverse City, MI 49684 Tel: 231-922-5170 Fax: 231-922-0174

Registration #:

John

Trade Name:

Classification Name:

Common or Usual Name:

Date Summary Prepared:

Device Description:

Intended use:

1450428

July, 15 2008

Retractor Lite

Surgical Lamp

Light, Surgical, Fiber Optic

The Retractor Lite is designed to be a replacement or substitute for headlamps and it uses the same technology currently used in other headlamps and light sources. These other devices have similar performance characteristics which have been previously cleared by the FDA.

The Thompson Surgical Instruments, Inc. Retractor Lite intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor blade which it can attach to through the use of TECASON™ P XRO clips. The Retractor Lite is designed to provide visible illumination of the surgical field or the patient through a Xenon light source only. The Retractor Lite is designed to be used by surgeons and other medical care practitioners in a surgical setting.

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DEPARTMENT OF HEALTH & HUMAN SERVICES -

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus, a symbol associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2009

Thompson Surgical Instruments, Inc. % Ms. Stephanie A. Zalucha Product Manager 10170 East Cherry Bend Road Traverse City, Michigan 49684

Re: K083710

Trade/Device Name: Retractor Lite Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: February 12, 2009 Received: February 17, 2009

Dear Ms. Zalucha:

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. Stephanie A. Zalucha

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For Voto Dan Director
Mark N. Melkerson
Director
2/20/09

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K083710 ·

Device Name: Retractor Lite

Indications For Use:

× AND/OR Prescription Use CFR 801 Subpart D) (21 CFR 801 Subpart C) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Rodale form

(Division Sign-Off) (Division Sign-Ord) Restorative, Division of original Devices

Page 1 of

510(k) Number K083710

Regulation Number and Section

§ 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.