(39 days)
CyberKnife® System Patient Support Subsystem, Elekta Precise Table
Not Found
No
The summary describes a computer-controlled robotic arm for patient positioning, but there is no mention of AI or ML in the intended use, device description, or any other section. The control appears to be based on pre-programmed movements rather than adaptive learning or intelligent decision-making.
No
The device is a treatment table designed to support and precisely position a patient during medical procedures, such as radiosurgery and radiotherapy. It does not provide any therapeutic effect itself.
No
The device description states its purpose is "for supporting and positioning a patient," which is a treatment or operational function, not a diagnostic one.
No
The device description explicitly states it is an "electric computer-controlled treatment table" mounted on a "robotic arm," indicating it is a hardware device with integrated software control.
Based on the provided information, the RoboCouch Patient Support System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support and position a patient during medical procedures (radiosurgery, radiotherapy, etc.). This is a physical support and positioning function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details an electric, computer-controlled treatment table mounted on a robotic arm for patient positioning. This aligns with a medical device used for treatment support, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The RoboCouch is clearly a device used in conjunction with medical procedures, but it does not perform a diagnostic test itself.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
90 JAI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CyberKnife® System Patient Support Subsystem, Elekta Precise Table
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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: (408) 716-4600 Fax: (408) 716-4601
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.
1
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.
2
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 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 (800) 638-2041 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
3
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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