RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)

• K Number: K983918
• Device Name: RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
• Manufacturer: MASTEK, INC.
• Date Cleared: 1999-03-12 ( 128 days)
• Product Code: IXA
• Regulation Number: 892.1850
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

1. The R-CLIP positions and secures limbs for radiographic x-ray exposure.
2. The R-CLIP provides vertical and horizontal limb positioning relative to plane of radiographic view.
3. The R-CLIP avoids x-ray exposure to surgical staff by eliminating the need to hold the limb during exposure.
4. The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.

Device Description

Radiolucent Cassette LIMB Positioner (R-Clip)

AI/ML Overview

This is a 510(k) clearance letter for a device called "Radiolucent Cassette LIMB Positioner (R-Clip)". The letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the provided documents do not contain information about the device's acceptance criteria or any study that proves the device meets those criteria.

The documents are a regulatory clearance letter and a description of the device's intended use. They do not detail the technical performance or testing conducted to support the substantial equivalence claim.

Therefore, I cannot provide the requested information.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Marcos V. Masson, MD Mastek, Inc. 1200 Binz, Suite 1200 Houston, TX 77004

Re:

K983918 Radiolucent Cassette LIMB Positioner (R-Clip) Dated: January 13, 1999 Received: January 14, 1999 Regulatory class: II 21 CFR 892.1850/Procode: 90 IXA

Dear Dr. Masson:

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 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). 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 III (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 requirements, 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.

This letter will allow you to begin marketing your device as described in your 510(t) 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerety vours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 983918 Cassatte links adjolucent Device Name:

Indications For Use:

. ...

• 1. The R-CLIP positions and secures limbs for radiographic x-ray exposure.
• 2. The R-CLIP provides vertical and horizontal limb positioning relative to plane of The N-CLIf provides vertical mis note in a note of radiographic view.
• The R-CLIP avoids x-ray exposure to surgical staff by eliminating the need to hold 3. the limb during exposure.
• 4. The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thrid C. Lyson
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1850 Radiographic film cassette.

(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.