ROBOCOUCH PATIENT SUPPORT SYSTEM

K042146 · Accuray Incorporated · JAI · Sep 17, 2004 · Radiology

Device Facts

• Record ID: K042146
• Device Name: ROBOCOUCH PATIENT SUPPORT SYSTEM
• Applicant: Accuray Incorporated
• Product Code: JAI · Radiology
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

Intended Use

The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

Device Story

RoboCouch Patient Support System is an electric, computer-controlled treatment table designed for patient support and positioning during radiosurgery and radiotherapy. The device features a robotic arm providing 6 degrees of freedom for precise patient orientation. Operated by clinical staff in a treatment environment, the system facilitates accurate alignment required for radiation delivery. By enabling precise positioning, the device assists in the delivery of therapeutic radiation, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric, computer-controlled treatment table; 6 degrees of freedom robotic arm; powered radiation therapy patient support assembly; Class II device.

Indications for Use

Indicated for support and positioning of patients undergoing radiosurgery, radiotherapy, or other medical procedures requiring precise positioning.

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

• CyberKnife® System Patient Support Subsystem
• Elekta Precise Table

Submission Summary (Full Text)

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# 510(k) SUMMARY

K04246

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

## Name, Address, Phone and Fax number of the Applicant

Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: [phone] Fax: [phone]

Contact Person Anne Schlagenhaft

Date Prepared August 5, 2004

### Device Name

Trade Name: RoboCouch™ Patient Support System Classification Name: Powered radiation therapy patient support assembly

### Device Description

The RoboCouch Patient System is an electric computer-controlled treatment table for supporting and positioning a patient during radiosurgery, radiotherapy and other medical procedures requiring precise positioning. The RoboCouch is mounted on a robotic arm with 6 degrees of freedom.

### Intended Use

The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

## Substantial Equivalence

The RoboCouch is substantially equivalent to the CyberKnife® System Patient Support Subsystem and the Elekta Precise Table.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2004

Ms. Anne Schlagenhaft Sr. Regulatory Affairs Associate Accuray, Incorporated 1310 Chesapeake Terrace SUNNYVALE CA 94089

Re: K042146 Trade/Device Name: RoboCouch Patient Support Systems Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI

Dated: August 5, 2004 Received: August 9, 2004

Dear Ms. Schlagenhaft:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use as a real and in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 I ou may, therefore, marrs 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 (PMA), 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 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 r that FDA has made a determination that your device complies with other requirements of the Act that I 27 the Internance 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 William an the Prefer 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) I mis lotter will and in you ve organ finding of substantial equivalence of your device to a legally prematicated predicated." Twesults 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 If you dosite spoolins 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 Other or other 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 miorination on 300 responser Assistance at its toll-free number [phone] or Mandlaoturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

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

Enclosure

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# Indications for Use

510(k) Number (if known):

K04246

RoboCouch Patient Support System Device Name:

Indications For Use:

The RoboCouch Patient Support System is indicated for the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abo and Radiological Device 510(k) Number .

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