PRECISE CARBON FIBER TABLE TOP, MODEL 11-999

K032248 · Aktina Medical Physics Corp. · IYE · Sep 25, 2003 · Radiology

Device Facts

• Record ID: K032248
• Device Name: PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
• Applicant: Aktina Medical Physics Corp.
• Product Code: IYE · Radiology
• Decision Date: Sep 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

External beam radiation therapy is typically delivered from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants) to patients in the prone or supine position, lying on a patient support assembly (also known as the treatment couch). AKTINA Medical Physics Corporation has designed and manufactured a replacement table top of carbon fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

Device Story

Replacement carbon fiber table top for Elekta Precise Patient Support System; provides structural support for patients during external beam radiation therapy. Carbon fiber material offers high strength-to-weight ratio and radiolucency; enables wider range of beam angle orientations compared to non-radiolucent materials. Used in clinical radiation oncology settings; operated by radiation therapists/physicians. Device serves as passive patient support platform; facilitates accurate beam delivery by minimizing attenuation. Benefits include improved treatment planning flexibility and patient comfort due to lightweight design.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per FDA Blue Book Memorandum G95-1 (ISO 10993-1).

Technological Characteristics

Carbon fiber table top; radiolucent; compatible with Elekta Precise Patient Support System. Biocompatible per ISO 10993-1.

Indications for Use

Indicated for patients undergoing external beam radiation therapy (photon or electron beams) or radioactive source therapy, requiring support in prone or supine positions on a treatment couch.

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

• Elekta AB (K983678)
• AKTINA Medical Physics Corporation (K991546)

Submission Summary (Full Text)

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SEP 2 5 2003

Ko32248

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

June 30, 2003

#### 1. General Provisions

Trade Name: Precise Carbon Fiber Table Top Common Name: Patient Support Assembly

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

Elekta AB, K983678 and AKTINA Medical Physics Corporation, K991546 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 this product.

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# 5. Intended Use and Device Description

AKTINA Medical Phvsics Corporation has designed and manufactured a replacement table top of Carbon Fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber is provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

## 6. Biocompatibility

The Aktina Medical Corporation Precise Carbon Fiber Table Top has been shown to be biocompatible for its intended use based on the requirements of the FDA Blue Book Memorandum G95-1 (ISO 10993-1) and an evaluation of product testing and field experience for equivalent applications.

## 7. Summary of Substantial Equivalence

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

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of an eagle or other bird with three curved lines extending from its head, resembling feathers or wings. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2003

Mr. Tony Spaccarotella Direstor, QA/RA AKTINA Medical Corporation 360 North Route 9W CONGERS NY 10920

# Re: K032248

Trade/Device Name: Precise Carbon Fiber Table Top Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system

Regulatory Class: II Product Code: 90 IYE Dated: July 18, 2003 Received: July 25, 2003

Dear Mr. Spaccarotella:

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. Iisting 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.

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This letter will allow you to begin marketing your device as described in your Section 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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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# Indications for Use

510(k) Number: K032298

Device Name: Precise Carbon Fiber Table Top

Indications for Use:

External beam radiation therapy is typically delivered from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants) to patients in the prone or supine position, lying on a patient support assembly (also known as the treatment couch). AKTINA Medical Physics Corporation has designed and manufactured a replacement table top of carbon fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: V

or

Over-The Counter Use:

(Per 21 CFR 801.109)

David R. Lyman

(Division Sign-Of Division of Reprodi and Radiological D 510(k) Numbe