TBI STAND

K972709 · Mick Radio-Nuclear Instruments, Inc. · IYE · Oct 16, 1997 · Radiology

Device Facts

• Record ID: K972709
• Device Name: TBI STAND
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: IYE · Radiology
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

TBI Stand is a mechanical support device for patients undergoing total body radiation therapy. It provides a vertical, standing platform to facilitate whole-body irradiation via medical electron accelerators. The device features adjustable components for head, shoulder, and arm positioning, along with hand grips and a film cassette holder. It includes an optional scatter screen to enhance surface dose during photon treatments. The device is used in a clinical radiation therapy setting, operated by medical staff to ensure patient stability and reproducible positioning during treatment. It benefits patients by providing a stable, adjustable structure for consistent radiation delivery.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Constructed from stainless steel, Delrin, acrylic, wood, and Formica. Mechanical support device; floor-standing unit. Features include adjustable head, shoulder, and arm supports, hand grips, film cassette holder, lung shield supports, and optional scatter screen. No energy source or software components.

Indications for Use

Indicated for patients requiring total body radiation therapy in a vertical (standing) position. Used for support and repositioning during high-energy photon or electron irradiation. Optional scatter screen used to increase surface dose during photon treatment.

Regulatory Classification

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.

Predicate Devices

• MED-TEC Radio Therpay Treatment Chair (K951947)

Submission Summary (Full Text)

{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,<br>90 IYE (per 21 CFR section 892.5050) |
| Manufacturer's Name: | Mick Radio-Nuclear Instruments, Inc. |
| Address: | 1470 OutlookmAvenue<br>P.O. Box 99<br>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,<br>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<br>Chair<br>K951947 | Mick Radio-Nuclear<br>Total Body<br>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<br>(Scatter Screen) | No | Yes |
| Construction: | Wood, Plastic and<br>Carbon Fiber | Stainless Steel, Delrin,<br>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:

K972709

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 [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/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