(82 days)
Not Found
Not Found
No
The summary describes a physical device (a belly board) used for anatomical displacement, with no mention of software, data processing, or AI/ML terms.
No
Explanation: The device is a belly board designed to displace the small bowel from a treatment area, which is a supportive function during medical treatment rather than a direct therapeutic intervention.
No
The device's intended use is to physically displace the small bowel during treatment, not to diagnose a condition.
No
The description clearly indicates a physical "belly board" with a "cutout," which is a hardware component. There is no mention of software.
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 physical cutout for displacing the small bowel during medical treatment. This is a physical manipulation of the body, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly describes a physical device used externally or in contact with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and related to patient positioning during treatment.
N/A
Intended Use / Indications for Use
The intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area. The belly board can be used by it's self or with MED-TEC's HipFix system. The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area.
Product codes
90 IYE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bowel
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 (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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICE
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an abstract bird or eagle with three curved lines forming its body and wings.
Public Health Service
Food and Drug Administra 9200 Cornorate Boulevard
DEC 23 2002
Mr. Donald F. Riibe Regulatory Affairs MED-TEC, Inc. 1401 8th St. SE P.O. Box 320 ORANGE CITY IA 51041 Re: K023293 Trade/Device Name: Bellyboard Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle . radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: September 18, 2002 Received: October 2, 2002
Dear Mr. Riibe:
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.
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); good manufacturing practice requirements as set 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.
1
Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Sincerely yours,
Henry C. Grigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
E-3.4 TTACHMENT
Page 1 of 1
510(k) Number (if known):
Device Name: __ Bellyboard
Indications For Use:
The intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area.
The belly board can be used by it's self or with MED-TEC's HipFix system.
The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symm
(Division Sion Andominal, 3 - 23 Der
Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter USE
(Optional Format 1-2-96)
Traditional 510(k)
DFR