(128 days)
Not Found
None
No
The summary describes a mechanical device for positioning limbs during x-ray and does not mention any AI or ML components or functions.
No.
The device's stated function is to position and secure limbs for radiographic x-ray exposure, not to treat or diagnose a disease or condition. It is a positioning aid for imaging.
No
Explanation: The device is used for positioning and securing limbs for x-ray exposure and does not provide any diagnostic information itself.
No
The device description and intended use clearly describe a physical device (R-CLIP) used for positioning limbs during x-ray exposure. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The R-CLIP's intended use is to position and secure limbs for radiographic x-ray exposure. This is a physical positioning device used during an imaging procedure, not a device that analyzes biological samples.
The description clearly indicates its function is related to radiographic imaging, which is an in-vivo (within the living body) diagnostic method, not in-vitro.
N/A
Intended Use / Indications for Use
-
- The R-CLIP positions and secures limbs for radiographic x-ray exposure.
-
- 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 the limb during exposure.
-
- The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.
Product codes
90 IXA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic x-ray
Anatomical Site
limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical staff
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.
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 (301) 594-4613. 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/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
1
510(k) Number (if known): _ K 983918 Cassatte links adjolucent Device Name:
Indications For Use:
. ...
-
- The R-CLIP positions and secures limbs for radiographic x-ray exposure.
-
- 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.
-
- 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)