(82 days)
The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. It is intended to be used with ACMI, Storz, Wolf, or Olympus connector cables. The Lite Wand II is intended to be used by surgeons and medical care practitioners in a surgical setting.
Thompson Surgical Instruments, Inc. Lite Wand II is a fiber optic surgical light designed to provide visible illumination of the surgical field or the patient. The Lite Wand II consists of a Cam Joint fixture which attaches the device to a retractor system arm, a flexible "gooseneck" supported lighthead for easy positioning, and a fiber optic bundle. The Thompson surgical Lite Wand II is designed as a task light for surgical use.
The Lite Wand II 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 provided text is a 510(k) summary for the Lite Wand II, a surgical light. It describes the device, its intended use, and indicates that it has been found substantially equivalent to previously cleared devices. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data as typically required for evaluating AI/ML-based medical devices.
Therefore, I cannot provide the detailed information requested in the prompt. The 510(k) summary for the Lite Wand II is focused on its substantial equivalence to predicate devices, which is generally established through a comparison of technological characteristics and intended use, rather than extensive performance studies with specific quantitative acceptance criteria like those needed for AI/ML devices.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or details about the effect size of AI assistance.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used for performance evaluation.
- Sample size for the training set.
- How ground truth for the training set was established.
{0}------------------------------------------------
Traditional 510(k) Premarket Notification: Lite Wand II
510(k) SUMMARY Thompson Surgical Instruments, Inc. Lite Wand II
| Applicant: | Stephanic A. ZaluchaThompson Surgical Instruments Inc.10170 E. Cherry Bend RoadTraverse City, MI 49684Tel: 231-922-5170Fax: 231-922-0174 | JUN 25 2008 |
|---|---|---|
| Registration #: | 1450428 | |
| Date Summary Prepared: | January 16, 2008 | |
| Trade Name: | Lite Wand II | |
| Classification Name: | Surgical Lamp | |
| Common or Usual Name: | Light, Surgical, Fiber Optic | |
| Device Description: | Thompson Surgical Instruments, Inc. Lite Wand II is a fiber optic surgical lightdesigned to provide visible illumination of the surgical field or the patient. TheLite Wand II consists of a Cam Joint fixture which attaches the device to aretractor system arm, a flexible "gooseneck" supported lighthead for easypositioning, and a fiber optic bundle. The Thompson surgical Lite Wand II isdesigned as a task light for surgical use. | |
| The Lite Wand II is designed to be a replacement or substitute for headlampsand it uses the same technology currently used in other headlamps and lightsources. These other devices have similar performance characteristics whichhave been previously cleared by the FDA. | ||
| Intended use: | The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task lightfor surgical procedures. It is designed to be used in conjunction with a retractorsystem which it can attach to through the use of a Cam Joint. The Lite Wand IIis designed to provide visible illumination of the surgical field or the patientthrough a Halogen light source only. The Lite Wand II is designed to be usedby surgeons and other medical care practitioners in a surgical setting. |
Traditional 510(k) Premarket Notification: Lite Wand 11
This document contains information considered to be CONFIDENTIAL to Thumpson Surgical Instruments, Inc.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2008
Thompson Surgical Instruments, Inc. % Ms. Stephanie A. Zalucha Product Manager 10170 East Cherry Bend Road Traverse City, Michigan 49684
Rc: K080962
Trade/Device Name: Lite Wand II Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: May 22, 2008 Received: June 12, 2008
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 the reporting 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.
Mark M. Wilkerson
Mark N. Melkerson Director 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): K080962
Device Name: Lite Wand II
Indications For Use:
The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. It is intended to be used with ACMI, Storz, Wolf, or Olympus connector cables. The Lite Wand II is intended to be used by surgeons and medical care practitioners in a surgical setting.
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 807 Subpart C) |
|---|---|---|
| ✓ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative and Concurrence of CDRH, Office of Device Evaluation (ODE) and Neurological Devices
| 510(k) Number | 1208961 |
|---|---|
| --------------- | --------- |
§ 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.