(2 days)
Not Found
Not Found
No
The description focuses on mechanical movement and control via a hand control or GUI, with no mention of AI/ML for positioning or other functions.
No
The device is used to position a patient during radiation therapy, which is a therapeutic process, but the device itself does not administer therapy or directly treat the patient. It is a support and positioning aid.
No
The device description states its purpose is to "support and aid in positioning a patient during radiation therapy" and to "move the upper platform relative to the lower one." It focuses on physical manipulation and positioning, not on diagnosing medical conditions or generating diagnostic information.
No
The device description clearly outlines physical components like platforms, linear elements, a controller unit, and a hand control, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to support and aid in positioning a patient during radiation therapy." This is a therapeutic and positioning function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details a mechanical system for moving and positioning a patient. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Providing diagnostic information about a patient's health status.
The device is a patient positioning system used in a clinical setting for a therapeutic procedure (radiation therapy). This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the device is to support and aid in positioning a patient during radiation therapy.
Product codes
JAI
Device Description
The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
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
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation).
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K07/870
JUL 1 8 2007
HexaPOD RT Couch Top – Special 510(k)
edical
intelligence
| 10. | Device Description: | The HexaPOD consists of two platforms, which are
connected by six linear, rigid but length adjustable
elements which are powered. By appropriate
coordinative adjustment of these elements, the system
is able to move the upper platform relative to the lower
one. The movement can occur in all three dimensions
in space. Additionally the upper platform can rotate
around these three axes which results in a tilt or a
rotation of the upper platform relative to the lower one.
Finally an accurate positioning within all six degrees of
freedom (6DOF) can be provided. The HexaPOD
consists of a controller unit which is directed by a
cable connected hand control. Additionally it can be
directed via an external graphics user interface (GUI)
which is installed on a PC. |
|-----|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11. | Intended Use: | The intended use of the device is to support and aid in
positioning a patient during radiation therapy. |
| 12. | Summary of the Product
Change: | The only modification made to the product are the
following evolutionary hardware changes:
• Implementing additional safety functions
• Added enable switch board |
| 13. | Summary of the Product
Similarities to predicate
device | The HexaPOD is identical with the predicate device
concerning:
• Intended use
• Behaviour of movement
• Control software
• Electronic and electro-mechanical components |
| 12. | Biocompatibility: | The HexaPOD is not in direct contact with the patient.
At any time when in use 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 the
HexaPOD. Therefore, no biocompatibility studies were
undertaken for this device. |
| 13. | Performance Data: | No performance data is required for this Class II
device nor requested by the Food and Drug
Administration (Office of Device Evaluation). |
:
1
HexaPOD RT Couch Top – Special 510(k)
Image /page/1/Picture/1 description: The image shows the words "medical intelligence" stacked on top of each other. To the left of the words is a circle with a line going through the middle. The words are in a sans-serif font and are black in color. The image is simple and straightforward.
PREMARKET NOTIFICATION
510(k) SUMMARY
| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
|---|---|---|
| 2. | Address: | Robert-Bosch-Str. 8 |
| 86830 Schwabmünchen | ||
| Germany | ||
| 3. | Contact Person: | Christian Hieronimi |
| Tel. +49 (0) 8232 9692-0 | ||
| 4. | Preparation Date: | April 10, 2007 |
| 5. | Device Submitted: | HexaPOD™ RT Couch Top |
| 6. | Proprietary Name: | HexaPOD™ RT CouchTop |
| 7. | Common Name: | Hexapod |
| 8. | Classification Name: | Powered radiation therapy patient support assembly |
| Product Code JAI | ||
| 9. | Substantial Equivalence: | The HexaPOD is substantially equivalent to the |
| following legally marketed device: | ||
| Medical Intelligence's "HexaPOD RT Couch Top". | ||
| The characteristics of this device are similar to those | ||
| of the predicate device identified on the comparison | ||
| chart, which is provided with the premarket notification | ||
| submission. It is our opinion that the HexaPOD does | ||
| not have technological characteristics that raise | ||
| additional types of questions related to terms of safety | ||
| and effectiveness. |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white and appears to be a simple, graphic representation of the department.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
UL 1 8 2007
Medical Intelligence Medizintechnik GmbH c/o Mr. Stefan Preiss TÜV SÜD America, Inc. 1775 Old Highwav 8 NW. Ste. 104 NEW BRIGHTON MN 55112-1891
Re: K071870
Trade/Device Name: HexaPOD™ RT Couch Top Regulation Number: 21 CFR §892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: July 4, 2007 Received: July 6, 2007
Dear Mr. Preiss:
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/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal. The word "Centennial" is below the letters "FDA". Three stars are at the bottom of the seal.
3
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 | (Gast |
|---|---|
| 21 CFR 884.xxxx | (Obs |
| 21 CFR 892.xxxx | (Rad |
| Other |
roenterology/Renal/Urology) 240-276-0115 tetrics/Gynecology) 240-276-0115 iology); 240-276-0120 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
Enclosure
4
Indications for Use
510(k) Number (if known):
510(k) Number (if known): K062639 K071870
Device Name:
HexaPOD™ RT Couch Top
Indications For Use:
The intended use of the device is to support and aid in positioning a patient during radiation therapy.
Prescription Use _Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Heleneer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
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