(87 days)
Not Found
No
The summary describes a mechanical device for patient positioning and does not mention any computational or analytical functions that would typically involve AI/ML.
No
The device is used to support and reposition a patient during radiation therapy, which is a therapeutic process. However, the device itself does not directly deliver the therapy or act mechanistically on the patient's condition. It's a support structure for a therapeutic procedure.
No
Explanation: The device is described as a support and repositioning stand for radiation therapy treatment, not for diagnosing medical conditions.
No
The device description clearly indicates a physical stand and an optional scatter screen, which are hardware components used to support and reposition a patient.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The TBI Stand is a physical support and positioning device used during radiation therapy treatment. It does not analyze biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states it's for "safely support and reposition a patient for radiation therapy treatment." This is a therapeutic support function, not a diagnostic one.
Therefore, the TBI Stand falls under the category of a medical device used in treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TBI Stand is used to safely support and reposition a patient for radiation therapy treatment in the vertical (standing) position when a physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physician utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.
Product codes
90 IYE
Device Description
The TBI Stand is used to safely support and reposition a patient for radiation therapy treatment in the vertical (standing) position when physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physicians utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
whole body
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)
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
Image /page/0/Picture/0 description: The image shows a close-up of a logo or design, primarily in black and white. The upper portion features bold, block-style lettering, with the letters appearing to be 'MRI'. Below the letters, there's a graphic representation of a sine wave, followed by a floral or star-like design on the right side.
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
Tab 10
73
1972709
OCT 16 1997
Premarket Notification [510(k)] Summary
July 12, 1997
| Trade Name: | TBI Stand |
|---|---|
| Common Name: | Total Body Irradiation Stand |
| Classification Name: | Medical charged partical radiation therapy system, |
| 90 IYE (per 21 CFR section 892.5050) | |
| Manufacturer's Name: | Mick Radio-Nuclear Instruments, Inc. |
| Address: | 1470 OutlookmAvenue |
| P.O. Box 99 | |
| Bronx, New York 10465 | |
| Corresponding Official: | Mr. Felix W. Mick |
| Title: | President |
| Telephone: | 718-597-3999 |
| Fax: | 718-824-8834 |
| Predicate: | MED-TEC Radio Therpay Treatment Chair, |
| Number: K951947 |
The TBI Stand is used to safely support and reposi-Device Description: tion a patient for radiation therapy treatment in the vertical (standing) position when physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physicians utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.
Support and permit repositioning of a vertical (standing) Intended Use: patient for total body radiation therapy.
See the attached "Predicate Comparison Technology Characteristics: Table" of the Mick TBI Stand and the MED-TEC Radio Therapy Treatment Chair.
1
Tab 10
Predicate Comparison Table
| Specifications | MED-TEC Treatment
Chair
K951947 | Mick Radio-Nuclear
Total Body
Irradiation Stand (TBI) |
|---------------------------------------|---------------------------------------|-------------------------------------------------------------|
| Vertical Patient Positioning | Yes, upper torso | Yes, whole body |
| Head Positioning | Yes | Yes |
| Shoulder Positioning | No | Yes |
| Arm Support | Yes | Yes |
| Hand Grips | Yes | Yes |
| Seat-Padded | Yes | Yes |
| AP/PA Treatment Positions | Yes | Yes |
| Transparent Back Support | Yes | Yes |
| Film Cassette Holder | No | Yes |
| Reproducible Settings | Yes | Yes |
| Lung Shiedl Supports | No | Yes |
| Radiation Spoiler
(Scatter Screen) | No | Yes |
| Construction: | Wood, Plastic and
Carbon Fiber | Stainless Steel, Delrin,
Acrylic, Wood, Formica |
| Weight: | 22 lbs | 100 lbs |
| Use Location | On treatment table | Rolls on floor |
2
Image /page/2/Picture/0 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)" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
16 1997
Felix W. Mick President Mick Radio-Nuclear Instruments, Inc. 1470 Outlook Avenue P.O. Box 99 Bronx, New York 10465
Re:
Total Body Irradiation Stand Dated: July 13, 1997 Received: July 21, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Mick:
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 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 II (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Fedgral 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 Radiation Control provisions, or other Federal laws or regulations.
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 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/dsmamain.html".
Sincerely yours,
h) Kiau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Tab 11
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: TBI Stand
Indications for Use:
The TBI Stand is used to safely support and reposition a patient for radiation therapy treatment in the vertical (standing) position when a physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physician utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gerrit A. Sygmon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number 1972709
OR
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use
75