(33 days)
Not Found
No
The summary describes a mechanical adapter for surgical light handles and makes no mention of AI or ML.
No
The device is a permanent replacement for a reusable surgical light handle, designed to allow the use of disposable covers and eliminate the need for cleaning and resterilizing the original handle. It does not exert any therapeutic effect on a patient.
No
The device is a light handle adapter, which is a permanent replacement for the original light handle on a surgical light. Its purpose is to facilitate the use of disposable light handle covers and eliminate the need for cleaning and resterilizing the original handle. This function is mechanical and related to surgical equipment utility, not to diagnosing medical conditions.
No
The device description clearly states it is a physical "Light Handle Adapter" designed to be permanently attached to a surgical light, indicating it is a hardware device.
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 a permanent replacement for surgical light handles to facilitate the use of disposable covers. This is a physical component used in a surgical setting.
- Device Description: The device is described as a permanent replacement handle for a surgical light.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples. This device is a physical accessory for a surgical light.
N/A
Intended Use / Indications for Use
The Light Handle Adapters are permanents to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the fight companies and other distributors.
The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.
Product codes
FTA
Device Description
The Light Handle Adapter is a permanent replacement for the light manufacture's OEM reusable handle and it is designed to be permanently attached to the surgical light.
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
No non-clinical tests were performed.
Clinical testing was not performed.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/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 abstract symbol that resembles a stylized human figure with outstretched arms, possibly representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2014
Litex Manufacturing Incorporated Mr. Mike Hoftman Advanced Medical Innovations 8741 Shirley Avenue Northridge, California 91324
Re: K142386
Trade/Device Name: Light Handle Adapters Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTA Dated: August 18, 2014 Received: August 27, 2014
Dear Mr. Hoftman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Binita S. Ashar -S 2014.09.29 15:15:54 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Light Handle Adapters
Indications for Use (Describe)
The Light Handle Adapters are permanents to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the fight companies and other distributors.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Exhibit #1
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
The assigned 510(k) number is:
1. Submitters Identification:
| Contact Person: | Noel Gharibian |
|---|---|
| Address: | Litex Manufacturing, Inc. |
| 1501 Sunshine Drive, | |
| Glendale, CA 91208 | |
| Tel: | 818-547-6777 |
| Fax: | 818-547-6777 |
| Date Prepared: | July 31, 2014 |
| 2. Name of the Device: | Light Handle Adapters |
| 3. Common Name: | Light, Surgical, Accessories |
| Regulation: | 878.4580 |
| Product Code: | FTA |
4. Predicate Device Information and Comparison:
| Device Description | Predicate Device | 510(k) Number | Comparison |
|---|---|---|---|
| Litex | |||
| Manufacturing, Inc. | |||
| Light Handle | |||
| Adapters | American Medical | ||
| MFG., Inc. Plastic | |||
| Disposable Surgical | |||
| Light Handle Cover & | |||
| Adapters. | K915068 | The subject device is | |
| basically identical to the | |||
| predicate device with | |||
| respect to technological | |||
| characteristics and | |||
| function of the adapters. |
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5. Device Description:
The Litex Manufacturing, Inc. Light Handle Adapter is a permanent replacement for the light manufacture's OEM reusable handle and it is designed to be permanently attached to the surgical light.
6. Intended and Indication for Use:
The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.
7. Discussion of Non-Clinical Tests Performed for the Determination of Substantial Equivalence are as follows:
No non-clinical tests were performed.
8. Discussion of Clinical Tests Performed:
Clinical testing was not performed.
9. Conclusions:
Based on the information provided in this submission we conclude that the Light Handle Adapters are substantially equivalent to the predicate and are safe and effective for its intended use.