(63 days)
The Synthes Light Guide is intended to transmit light to illuminate a surgical site during surgical procedures
The subject Synthes Light Guide uses a single 'fiberoptic' quartz fiber encased by medical grade stainless steel to externally illuminate a surgical site during surgical procedures. This light carrier is connected via standard adapters to currently marketed fiberoptic light cables which are sequentially connected to currently marketed Xenon or Halogen light sources. The materials and components of the Synthes Light Guide do not have patient contact or body fluid contact and therefore biocompatibility testing is not applicable. The device is approximately 310mm in length and 6mm in diameter. It is designed to be affixed via clamps to a ring retractor system which positions the device above the surgical site during a surgical procedure.
This document does not contain information on acceptance criteria or a study that proves the device meets acceptance criteria. It is a 510(k) summary and FDA clearance letter for a medical device called "Synthes Light Guide," which is a light source accessory used to illuminate surgical sites.
The document focuses on:
- Describing the device and its intended use.
- Comparing it to a predicate device to establish substantial equivalence.
- The FDA's decision to clear the device for market.
There is no mention of specific performance metrics, acceptance criteria, study designs, sample sizes, expert involvement, or any form of clinical or technical performance study data.
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DEC - 6 1995
- II. 510(k) Summary
| Submitted by: | Synthes (USA)1303 Goshen ParkwayWest Chester, PA 19380 |
|---|---|
| Contact Person: | Jonathan Gilbert |
| Date Prepared: | September 22, 1999 |
| Proprietary Name: | Synthes Light Guide |
| Common Name: | Light Source Accessory |
| Classification Name: | 21 CFR §878.4580 (surgical lamp) |
| Predicate Device: | K971057 - Cogent Light XLS Illuminator SystemCogent Light Technologies, Inc.26145 Technology DriveSanta Clarita, CA 91355-1137 |
Description of the Device:
The subject Synthes Light Guide uses a single 'fiberoptic' quartz fiber encased by medical grade stainless steel to externally illuminate a surgical site during surgical procedures. This light carrier is connected via standard adapters to currently marketed fiberoptic light cables which are sequentially connected to currently marketed Xenon or Halogen light sources. The materials and components of the Synthes Light Guide do not have patient contact or body fluid contact and therefore biocompatibility testing is not applicable. The device is approximately 310mm in length and 6mm in diameter. It is designed to be affixed via clamps to a ring retractor system which positions the device above the surgical site during a surgical procedure. An engineering drawing of the Synthes Light Guide is included as Tab 1.
The Cogent Light XLS Illuminator System consists of a light source control box, which houses a Xenon lamp, power supply and connects to a fiberoptic cable. This light guide carrier of the XLS Illuminator, a single fiberoptic cable (single quartz fiber) is used as part of their system for transmitting light to a surgical site.
| Comparison of Synthes Light Guide to Predicate Device | ||
|---|---|---|
| Synthes Light Guide | Cogent Light XLSIlluminator System fiberopticcable | |
| CHARACTERISTIC | ||
| Intended use: provideillumination during surgery | YES | YES |
| Lamp Type | None. Used inconjunction with Halogenor Xenon sources | Used in conjunction withXenon lamps |
| Lamp Rating | N/A | N/A |
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1999
Mr. Jonathan Gilbert Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301-1262
K993314 Re:
Trade Name: Synthes Light Guide Regulatory Class: II Product Code: FQP Dated: October 1, 1999 Received: October 4, 1999
Dear Mr Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 – Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stpt Rhodes
E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Abbreviated Premarket Notification Synthes Light Guide
INDICATIONS FOR USE STATEMENT VII.
510(k) Number:
(if known)
Device Name:
Synthes Light Guide
Indications For Use:
The Synthes Light Guide is intended to transmit light to illuminate a surgical site during surgical procedures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
1 OR Prescription Use (Per 21 CFR §801.109)
Over-The-Counter Use
Stypt Rhodes
(Division Sign-Off Division of Genera 510(k) Number _
storative Devices K993314
§ 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.