(46 days)
Not Found
No
The description focuses on mechanical and computer-controlled movements for patient positioning, with no mention of AI or ML terms or functionalities.
No
The device is a patient positioning table used for radiation therapy, which is a treatment modality, but the table itself does not deliver therapy or perform a therapeutic function on the patient. It is a support assembly.
No
The device is described as a patient positioning table used for radiation therapy and simulation, which are treatment-related activities, not diagnostic ones. Its function is to support and position patients, not to detect or diagnose diseases.
No
The device description clearly states it is a "powered radiation therapy patient support assembly" and describes physical components and motions, indicating it is a hardware device.
Based on the provided information, the Avanza patient positioning table is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "accurately and reproducibly position patients for radiation therapy and simulation." This is a physical positioning function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "powered radiation therapy patient support assembly" with various mechanical movements. This aligns with a physical positioning device used in a clinical setting, not a laboratory diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
Therefore, the Avanza patient positioning table is a medical device used in radiation therapy for patient support and positioning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Avanza patient positioning table is used as a universal patient support to accurately and reproducibly position patients for radiation therapy and simulation. The Avanza is used with THERATRON® Equinox™ units and is also adaptable to third party radiation therapy treatment devices.
Product codes (comma separated list FDA assigned to the subject device)
JAI
Device Description
The Avanza Patient Positioning Table is a powered radiation therapy patient support assembly that is substantially equivalent in functionality and performance as the previously cleared Precise Treatment Table.
The Avanza Patient Positioning Table is supported by a mechanism and features several functions including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions. The computer-controlled table can be activated by using the table mounted control panels or by using an optional hand control.
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
Not Found
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.
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
MAY 15 2006
5. 510(K) SUMMARY
| Date Summary Prepared | March 20, 2006 |
|---|---|
| Submitted by | MDS Nordion |
| 447 March Road | |
| Ottawa, Ontario K2K 1X8 | |
| Canada | |
| Tel. (613) 592-3400 | |
| Fax. (613) 592-2006 | |
| Contact Person | Mr. Ross Kachaniwsky |
| Director, Quality & Requlatory Affairs | |
| Device Name | Avanza |
| Common Name | Patient Positioning Table |
| Classification Name | Couch, Radiation Therapy, Powered |
| Legally Marketed Predicate Device | Precise Treatment Table (K983678) |
Description of Device
The Avanza Patient Positioning Table is a powered radiation therapy patient support assembly that is substantially equivalent in functionality and performance as the previously cleared Precise Treatment Table.
The Avanza Patient Positioning Table is supported by a mechanism and features several functions including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions. The computer-controlled table can be activated by using the table mounted control panels or by using an optional hand control.
Intended Use of Device
The Avanza patient positioning table is used as a universal patient support to accurately and reproducibly position patients for radiation therapy and simulation. The Avanza is used with THERATRON® Equioin™ units and is also adaptable to third party radiation therapy treatment devices.
1
Class Justic States DEPARTMENT OF HEALTH & HUMAN SER
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 15 2006
Mr. Ross Kachaniwsky Director, Quality Assurance MDS Nordion 447 March Road Ottawa, Ontario, K2K 1X8 CANADA
Re: K060870
Trade/Device Name: Avanza Patient Positioning Table Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: March 23, 2006 Received: March 30, 2006
Dear Mr. Kachaniwsky:
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, 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" arranged around the perimeter. In the center of the logo, the letters "FDA" are prominently displayed above the word "Centennial". Below "Centennial" are three stars arranged horizontally. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.
2
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.
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
海大学学生学 2019年
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for MDS Nordion. The logo features the text "MDS Nordion" in a bold, sans-serif font, with the word "MDS" slightly larger and positioned above "Nordion". Above the text is a curved line that arches over the letters "MDS". Below the company name is the tagline "Science Advancing Health" in a smaller, italicized font.
Avanza FDA 510(k) Submission
INDICATIONS FOR USE 4.
510(k) Number: K060870
Device Name:
Avanza Patient Positioning Table
Indications For Use:
The Avanza patient positioning table is used as a universal patient support to accurately and reproducibly position patients for radiation therapy and simulation. The Avanza is used with THERATRON® Equinox™ units and is also adaptable to third party radiation therapy treatment devices.
Prescription Use
(Part 21 CFR 801 Subpart D) √
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Divisi .. .. ... Division a Repressments on Presse and Rachaegic, i | Seeps
510(k) Numeer
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060870
Page 7