(50 days)
The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.
The disposable Light Guard Light Handle Cover is made from a plastic material and is a single use item used to cover the handle of a surgical light. This device fits over the handle of a surgical light to provide a sterile barrier between sterile personnel and the non-sterile light handle.
The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Light Guard Light Handle Cover) which focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information for the specific points you've listed (sample size, experts, adjudication, MRMC, standalone, ground truth, training set size).
The document states: "Xodus Medical Inc.'s Light Guard Light Handle Cover has the same physical characteristics, material and design as the predicate device. They are both designed to slide over a surgical light handle. Both the predicate device and Xodus Medical's device are used to provide a sterile barrier between the sterile personnel and the non-sterile light handle." This indicates that the regulatory approval was based on substantial equivalence, implying that the new device performs similarly to the already approved predicate device, rather than requiring a new clinical study to establish performance against specific acceptance criteria.
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K05332|
JAN | 9 2006
510(k) Summary
Xodus Medical, Inc. 510(k) Owner: Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: 724-337-5500 Fax: 724-337-0555 Contact: Craig Kaforcy (President)
Date Prepared: 10/26/05
Device Information
Trade/Device Name: Light Guard Common Name: Light Handle Cover Classification Name: Light, Surgical, Accessories Regulation Number: 21 CFR 878.4580 Product Code: FTA Regulatory Class: II
Predicate Device
Device Name: Qualtex Light Handle Cover Common Namc: Light Handle Cover 510 (k) Number: K911369 510 (k) Owner: Deroyal Industries, Inc. Classification Name: General & Plastic Surgery Regulation Number: 21 CFR 878.4800 Product Code: MDM Regulatory Class: I
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510(k) Summary
Device Description
The disposable Light Guard Light Handle Cover is made from a plastic material and is a single use item used to cover the handle of a surgical light. This device fits over the handle of a surgical light to provide a sterile barrier between sterile personnel and the non-sterile light handle.
Intended Use
The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.
Technological Characteristics Comparison
Xodus Medical Inc.'s Light Guard Light Handle Cover has the same physical characteristics, material and design as the predicate device. They are both designed to slide over a surgical light handle. Both the predicate device and Xodus Medical's device are used to provide a sterile barrier between the sterile personnel and the non-sterile light handle.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2006
Mr. Craig Kaforey President Xodus Medical, Inc. 702 Prominence Drive New Kensington, Pennsylvania 15068
Re: K053321
K025321
Trade/Device Name: Light Guard Light Handle and Light Handle Cover Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTA Dated: November 22, 2005 Received: November 30, 2005
Dear Mr. Kaforey:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications ferenced above and nave acterimined in the enclicate devices marketed in interstate for use stated in the encrosule) to regars actment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enaonance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Fede devices that have occh recalismed in assession of a premarket approval application (PMA). and Cosmetic Act (71ct) mat ac not requently subject to the general controls provisions of the Act. The r out thay, therefore, market the act include requirements for annual registration, listing of general controls provisions of the ree, 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 rr your device is classified (500 docrio, als. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may be Numa in the Overnments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a aond regulations administered by other Federal agencies. You must or any I odetar batates and submittenents, 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kaforey
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icticle witi anow you to begin managers .
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket nother 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 If you ucsire specific at not 101 Jour acc 101 ) 276-0115. Also, please note the regulation entitled, Colliact the Office of Comphalled at (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responsed Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
bae Budums
for
Mark N. Melkerson Acting Director 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): _ KO53321
Device Name: Light Guard Light Handle and Light Handle Cover
Indications for Use:
ﺴﻂ ﻋ ﺗ
The disposable Light Handle Cover is a single use sterile product. Its intended use is as The disposable Eight Handles. It is to be placed over the light handle prior to the a Cover 101 surgical procedure to provide the nurse or surgeon with a sterile protective start of a surgiour procedure to prolight during the procedure without compromising the cover to chable their to the re the use and come in contact with the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Raubere Friedmann-Fryer
Page 2.1
Division o al. Restorative. and New
510(k) Number K053321
§ 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.