AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT

K993522 · Aktina Medical Physics Corp. · JAI · Jan 10, 2000 · Radiology

Device Facts

• Record ID: K993522
• Device Name: AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
• Applicant: Aktina Medical Physics Corp.
• Product Code: JAI · Radiology
• Decision Date: Jan 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

Indications for Use

Tennis Racquet inserts are intended for use in Radiation Therapy to facilitate treatment of the patient when laying prone or supine on the treatment couch. Tennis Racquets provide a beam path that is considered attenuation free while supplying firm support for the patient.

Device Story

The Tennis Racquet Insert is a patient support accessory used in radiation therapy departments. It functions as a structural insert for treatment couches, providing a firm surface to support patients in prone or supine positions during external beam irradiation. The device is designed to provide an attenuation-free beam path, minimizing interference with the radiation delivery. It is operated by radiation therapy staff. The device does not contact the patient directly, as a sheet is placed between the patient's skin and the support surface. By providing stable positioning, it assists clinicians in accurate patient alignment for treatment delivery.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Patient support insert for radiation therapy treatment tables. Designed for attenuation-free beam path. Non-patient contacting (requires sheet). No new materials introduced.

Indications for Use

Indicated for patients undergoing external beam radiation therapy requiring support in prone or supine positions on a treatment couch.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Predicate Devices

• Siemens ZXT Therapy Treatment Table (K910971)

Submission Summary (Full Text)

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## JAN 1 0 2000

K993522
Page 1 of 2

### Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

October 1, 1999

#### 1. General Provisions

Trade Name: Tennis Racquet Insert Tennis Racquet Insert Common Name:

Applicant Name and Address:

AKTINA Medical Physics Corporation 360 North Route 9 W Congers, New York, 10920 Phone: [phone] FAX: [phone] Registration Number: 2436865

#### 2. Name of Predicate Devices

Siemens ZXT Therapy Treatment Table (K910971) 1

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

#### 3. Classification

This device is classified as a class II device according to 21 CFR 892.5770.

#### 4. Performance Standards

The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Tennis Racquet Inserts.

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Kittredge
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#### 5. Intended Use and Device Description

The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.

#### 6. Biocompatibility

The Tennis Racquet is not in contact with the patient at any time when in use as a sheet is to be placed between the patient's skin surface and the treatment support when in use. Additionally there are no new materials introduced in the manufacture of this device, therefore, no biocompatibility studies were undertaken for the device.

### 7. Summary of Substantial Equivalence

This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2000

Aktina Medical Physics Corporation

Re:

K993522 Tennis Racquet Insert Dated: October 14, 1999 Received: October 18, 1999 Regulatory class: II 21 CFR 892.5770/Procode: 90 JAI

Dear Ms. Zacharopoulos:

Joan Zacharopoulos

360 North Route 9W

Congers, NY 10920

Vice President

We have reviewed vour 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 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 Requlations, 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(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/dsma/dsmamain.html".

Sincerely yours,

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

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# Indications for Use

510(k) Number:

93522

Device Name: Tennis Racquet Insert

Indications for Use:

Tennis Racquet inserts are intended for use in Radiation Therapy to facilitate treatment of the patient when laying prone or supine on the treatment couch. Tennis Racquets provide a beam path that is considered attenuation free while supplying firm support for the patient.

| (Division Sign-Off) | | |
|--------------------------------------------------------|---------|-----------------------|
| Division of Reproductive, Abdominal, ENT | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
| 510(k) Number | K993522 | |
| Prescription Use:<br>(Per 21 CFR 801.109) | or | Over-The Counter Use: |