(28 days)
Not Found
Not Found
No
The description focuses on mechanical function and materials, with no mention of AI/ML terms or capabilities.
No
The device is described as an accessory to a surgical lamp, used to position the light for illumination during surgery. Its function is to facilitate the surgical procedure by providing light, not to treat any medical condition or affect the structure or function of the body.
No
The device is an accessory to a surgical lamp, used to position the light for illumination. It does not gather, process, or analyze any data from the patient to determine the presence or absence of a disease or condition.
No
The device description clearly states it is a physical light handle and adapter made of materials, intended to be used as accessories to a surgical lamp. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "accessories to a surgical lamp" for positioning the light during surgery. This is a surgical accessory, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical function of positioning a surgical light and preventing contamination. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Mentioning assays, reagents, or laboratory procedures
Therefore, the DeRoyal Disposable Rigid Light Handle and Adapter are surgical accessories and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DeRoyal Disposable Rigid Light Handle and Adapter are indicated for use as accessories to a surgical lamp. The adapter is to be used, when necessary, to attach the light handle to the surgical lamp. The light handle is to be used to position the light without contaminating the gloved hand.
Product codes
FTA
Device Description
The DeRoyal Disposable Rigid Light Handle and Adapter function in the same manner as predicate devices in that they are intended to be used as accessories to a surgical lamp which are used to position the light for illumination in various areas of the surgical field.
Device Design/ Materials UsedPhysical Properties: The DeRoyal Disposable Rigid Light Handle and Adapter are made of materials commonly used for their purposes. The light handle contains a protective shield at the base which is used to prevent the gloved hand from contaminated surfaces. The protective shield may be folded and attached to the light handle to reduce space needed for packaging and storage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
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
OCT 1 4 1999
DeRoyal Industries, Inc.
DeRoyal Disposable Rigid Light Handle and Adapter
510(k) Summary
Summary of the Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Based
SUBMITTER INFORMATION
DeRoyal Industries, Inc. NAME: ADDRESS: 200 DeBusk Lane Powell, TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION: (423) 362-6217 Lois Marsh September 15, 1999
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Disposable Rigid Light Handle and Adapter Surgical Light Handle and Adapter Light, Surgical, Accessories (79FTA)
PREDICATE OR LEGALLY MARKETED DEVICES
Charles Polo & Co. and Devon Industries
DEVICE DESRIPTION
The DeRoyal Disposable Rigid Light Handle and Adapter function in the same manner as predicate devices in that they are intended to be used as accessories to a surgical lamp which are used to position the light for illumination in various areas of the surgical field.
Device Design/ Materials UsedPhysical Properties: The DeRoyal Disposable Rigid Light Handle and Adapter are made of materials commonly used for their purposes. The light handle contains a protective shield at the base which is used to prevent the gloved hand from contaminated surfaces. The protective shield may be folded and attached to the light handle to reduce space needed for packaging and storage.
DEVICE INTENDED USE
The DeRoyal Right Handle and Adapter are intended to be used as accessories to a surgical lamp. The universal adapter is used to attach the light handle to the surgical lamp when necessary while the light handle is used to position the lamp to the desired area without contaminating the gloved hand.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLYMARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Material (Light Handle) | Plastic Polymers | Plastic Polymers |
| Protective Shield | Yes | Yes |
| Rigid | Yes | Yes |
| Universally Adaptable | Yes | Yes |
| Sterility | Sterile | Sterile |
| Disposable | Yes | Yes |
| Packaged | 1 or 2 per Pack | 1 or 2 per Pack |
| Material (Adapter) | Aluminum | Similar |
1
Image /page/1/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of three human figures, representing the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Ms. Lois Marsh Regulatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, Tennessee 37849
Re: K993089
Trade Name: DeRoyal Disposable Rigid Light Handle and Adapter Regulatory Class: II Product Code: FTA Dated: September 15, 1999 Received: September 16, 1999
Dear Ms. Marsh:
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 (QS) 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.
2
Page 2 - Ms. Lois Marsh
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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page of
510(k) Number (if known):
Device Name:
DeRoyal Disposable Rigid Light Handle and Adapter
Indications for Use:
The DeRoyal Disposable Rigid Light Handle and Adapter are indicated for use as accessories to a surgical lamp. The adapter is to be used, when necessary, to attach the light handle to the surgical lamp. The light handle is to be used to position the light without contaminating the gloved hand.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K993089
510(k) Number.
OR
Over-The-Counter Use
Prescription Use (Per 21 CFR §801.109) OR
Over-The-Counter Use