(70 days)
Not Found
Not Found
No
The description focuses on a simple fiber optic light source and mechanical attachment, with no mention of AI/ML terms or functionalities.
No
The device is a surgical light for illumination, not a device intended to treat or manage a disease or condition.
No
The device is described as a "task light for surgical procedures" and provides "visible illumination of the surgical field or the patient." Its function is to illuminate, not to diagnose.
No
The device description explicitly details hardware components such as a fiber optic bundle, lighthead, and clips, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visible illumination of the surgical field or the patient during surgical procedures. This is a direct interaction with the patient's body for visualization during a medical procedure.
- Device Description: The device is described as a fiber optic surgical light designed for illumination.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical light, which is a medical device used in vivo (within the living body) to aid in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FST
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Used by surgeons and other medical care practitioners in a surgical setting.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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.
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.
1
1
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.
2
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
3
Indications for Use
510(k) Number (if known): K083710 ·
Device Name: Retractor Lite
Indications For Use:
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.
× 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