(15 days)
Not Found
No
The description focuses on mechanical movement and control via a teach pad or GUI, with no mention of AI/ML terms or capabilities.
No.
The device's intended use is to support and aid in positioning a patient during radiation therapy, not to treat or diagnose a disease or condition itself.
No
The device aids in patient positioning during radiation therapy, which is a treatment procedure, not a diagnostic one. It manipulates the patient's position rather than gathering information about their condition.
No
The device description clearly outlines physical components including platforms, linear elements, a controller unit, a teach pad, and a PC with a GUI, indicating it is a hardware device with software control.
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.
- Device Description: The description details a mechanical system for moving and positioning a patient. It does not involve analyzing biological samples or providing diagnostic information.
- 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.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a patient positioning system used in a therapeutic setting (radiation therapy).
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
90 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 teach pad. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Med-Tec Inc.'s "Med-Tec 6 Degree Axis Couch", Elekta Instrument Inc.'s "Elekta Oncology Systems Precise™ Treatment Table"
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The bird is composed of three thick, curved lines. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Intelligence Medizintechnik GmbH % Mr. Stefan Preiss 510(k) TPR Project Manager TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite # 104 NEW BRIGHTON MN 55112
Re: K041448
Trade/Device Name: HexPod™ RT Couch Top Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI Dated: May 28, 2004 Received: June 1, 2004
OCT
5 2004
. Dear Mr. Preiss:
This letter corrects our substantially equivalent letter of June 16, 2004 regarding the HexPod™ RT Couch Top and the incorrect regulation number, name and product code.
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 (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 (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
1
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 continue 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 (240) 276-0120. 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 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/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
2
HexaPOD™ RT CouchTop
Product documentalion
Medical Intelligence Medizintechnik GmbH
Image /page/2/Picture/3 description: The image shows a logo with the words "Medical Intelligence" to the right of a symbol. The symbol is a circle with a dollar sign inside of it. The dollar sign has a snake wrapped around it.
FDA 510k submission
Ko41449
JUN 16 2004
510(k) SUMMARY
Applicant:
| 2. | Address: | Feyerabendstrasse 13 – 15
86830 Schwabmünchen
Germany |
|----|-------------------|-------------------------------------------------------------|
| 3. | Contact Person: | Christian Hieronimi
Tel. +49 (0) 8232 9692-0 |
| 4. | Preparation Date: | February 10, 2004 |
| 5. | Device Submitted: | HexaPOD™ RT Couch Top |
-
Proprietary Name: HexaPOD™ RT CouchTop
-
Common Name: Hexapod
-
Classification Name: Couch, Radiation Therapy, Powered Powered radiation therapy patient support assembly Product Code JAI
். Substantial Equivalence: The HexaPOD is substantially equivalent to the following legally marketed devices: Med-Tec Inc.'s "Med-Tec 6 Degree Axis Couch", and Elekta Instrument Inc.'s "Elekta Oncology Systems Precise™ Treatment Table". The characteristics of this device are similar to those of the predicate devices 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. 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 teach pad. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
Intended Use: 11. The intended use of the device is to support and aid in positioning a patient during radiation therapy.
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| HexaPOD™ RT CouchTop | Part H 02 | Image: Medical Intelligence logo |
|---|---|---|
| Product documentation | ||
| FDA 510k submission | K041448 | |
| 12. Biocompatibility: | The HexaPOD is not in contact with 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). |
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4
Indications for Use
1041448
510(k) Number (if known):
Device Name:
HexaPOD™ RT CouchTop
Indications For Use:
The intended use of the device is to support and aid in Intended Use: positioning a patient during radiation therapy.
Prescription Use _YES (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 R. Legron
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number .
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