To be used in treatment where whole body radiation therapy is indicated. The shielding tray reduces the radiation exposure to those organs, such as lungs, which are desired to be shielded.

Device Description

The Dynamic Radiation Table, is a PC-controlled table which permits total body radiation and incorporates a series of moving tables or trays - one for the patient to lie on, protective organ shields tray and an attenuating tray. It incorporates a number of features such as x-ray trays for verification of radiation dose, number of safety features and limit switches.

AI/ML Overview

The provided text describes a medical device, the "Dynamic Shielding Radiation Table," and its comparison to a predicate device for the purpose of a 510(k) submission to the FDA. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is primarily a summary of safety and effectiveness, focusing on:

Device Description: What the device is and how it works.
Intended Use: The medical conditions and environment where the device is used.
Comparison to Predicate Devices: Highlighting similarities and differences with existing legally marketed devices (Siemens ZXT Treatment Table).
FDA Clearance Letter: Indicating that the device was found substantially equivalent to predicate devices.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided text.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Details about sample sizes, data provenance, number of experts, adjudication methods for a test set.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Details about standalone (algorithm-only) performance.
The type of ground truth used.
Sample size or ground truth establishment for a training set.
Any mention of performance studies or acceptance testing beyond a feature-by-feature comparison to predicate devices and general safety features.

Summary

{0}------------------------------------------------

AMERICAN BIOPHYSICS, INC. 10241 E. Thompson Rd. Indianapolis, IN 46239

K982446

Non-Confidential Summary of Safety and Effectiveness

page 1 of 3 July 14, 1998

Tel - (317) 862-1214 AMERICAN BIOPHYSICS, INC. 10241 E. Thompson Rd. Indianapolis, IN 46239 Official Contact: Iosenh Montebello, M.D. - President

Official Contact:	Joseph Montebello, M.D. - President
Proprietary or Trade Name:	Dynamic Shielding Radiation Table
Common/Usual Name:	Powered radiation therapy patient support assembly
Classification Name:	Powered Radiation Therapy Patient Support Assembly
Device:	Dynamic Shielding Radiation Table
Predicate Devices:	Siemens - ZXT Treatment Table - K910971

Device Description:

Guard is a thin-wall sleeve which when attached to a Filter / HME housing, is pulled over the breathing

Intended Use:
Indicated Use --	To be used in treatment where whole body radiation therapy is indicated.The shielding tray reduces the radiation exposure to those organs, such aslungs, which are desired to be shielded.
Environment of Use --	Hospital

Comparison to Predicate Devices: 1 1 2011 00

Attribute	Dynamic Shielding TableProposed device	Predicates(See specific listing)
Use
Intended for a patient to lie onduring radiation therapy	Yes	Siemens ZXTK910971
Intended to be used in a hospital	Yes	Siemens ZXT
Attribute	Dynamic ShieldingTableProposed device	Predicates(See specific listing)
Design
Patient lays on tableduring therapy treatment	Yes	Siemens ZXT
Motorized mechanism to move the tablein a longitudinal direction	Yes	Siemens ZXT
Ability to move in a verticalplane manually	Yes	Siemens ZXT
Digital indicators of movementon the operator panel	Yes	Siemens ZXT
PC based control of motor	Yes	Siemens ZXT
Safety features
Automatic termination of treatmentif table fails to move	Yes	Siemens ZXT
Automatic termination of treatmentif table speed varies more than 5%from programmed speed	Yes	Not available
Patient capacity	>500 lbs.	298 lbs.
Incorporate slots below the patientwhich permit verification of patientplacement, shielding, accuracy anddose measurements	Yes	Not done
Has Plexiglas housing for holdingbolusing materials in place	Yes	Current practice - laybolusing materialover and around patient
Dynamic shielding trayUtilizes custom lead shields	Yes	Current manualpractice
Shields are placed over patientand aligned by the clinician	Yes	Current practice
Maintenance of shields overpatients organ	Automatic	Performed manuallyby technician moving them
Tray moves via motorized systemtraveled coincident to the direction ofplacement of the patient table	Yes	Predicate is manual
Attenuating TrayStand which holds lead sheets usedto attenuate the beam	Yes	Not available
Attenuating TrayStand has a safety interconnectwhich assures that the attenuationstand is in place before the tableand beam are activated	Yes	Not available
Attribute	Dynamic ShieldingTableProposed device	Predicates(See specific listing)
Materials
Table is made of steel / aluminumrails	Yes	Siemens ZXT
Utilizes low voltage motor system	Yes	Siemens ZXT
Plexiglas housing for trays	Yes	Standard for currentpractice
Performance Standards / Specifications
None applicable under Section 514	Yes	Yes

{1}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness

page 2 of 3
July 14, 1998

ﺳﻴﻨﻬﺎ

{2}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness

page 3 of 3 July 14, 1998

Differences Between Other Legally Marketed Predicate Devices

The differences in the proposed device and a predicate, Siemens ZXT, are -

The proposed device is intended to be used to provide controlled motion of the patients during the radiation し. therapy treatment while standard radiation therapy couches are intended to provide stationary patient therapy to the designated area.
The proposed device range of motion in the longitudinal direction allows the whole patient body to be 2. swept through the beam of radiation from head to toe.
Shielding tray is motorized and controlled to move the shields coincident with the motion of the table over 3. the organs to be protected. This method reduces the potential of radiation exposure to the sensitive organs, e.g., lungs, which are intended to be protected.
Attenuating stand has a safety interlock to assure that it is in place before beam is activated. 4.
The Plexiglas housing on the table permits the patient have bolusing material place around them in a more ನೆ convenient fashion.

There are no other differences which would have a significant effect of the safety or effectiveness of the device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1998

American Biophysics, Inc. c/o Promedic, Inc. Paul E. Dryden 6329 W. Waterview Court McCordsville, IN 46055

Re:

K982446 Dynamic Shielding Radiation Table Dated: July 14, 1998 Received: July 15, 1998 Regulatory class: II 21 CFR 892.5770/Procode: 90 JAI

Dear Mr. Dryden:

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 (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 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 S10(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/cdch/dsmamain.html".

Sincerely yours,

Kilian Yin, Ph.D.

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

{4}------------------------------------------------

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number:	LA LA LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE	11 800o be assigned
----------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------

Device Name: Dynamic Shielding Radiation Table

Indicated for Use :

To be used in treatment where whole body radiation therapy is indicated. The shielding tray reduces the radiation exposure to those organs, such as lungs, which are desired to be shielded.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elmerl C. Segura

(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Device 510(k) Number

Prescription Use (Per CFR 801.109)

());

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.5770 Powered radiation therapy patient support assembly.

(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.