(14 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 terms or capabilities.
No
The device supports and aids in the positioning of a patient during radiation therapy, but it does not directly provide the therapy itself.
No
The device description states its purpose is to aid in positioning a patient during radiation therapy and mentions accurate positioning within six degrees of freedom. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description explicitly states the HexaPOD evo consists of physical platforms, length-adjustable elements, a controller unit, and a hand control, all of which are hardware components. While it mentions a GUI on a PC, the core functionality relies on the powered mechanical system.
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 Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening of diseases.
The device is a patient positioning system used in a clinical setting for radiation therapy, which is a treatment modality.
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 evo consists of two platforms, which are connected by six 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 (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): 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.
Not Found
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
HexaPOD RT evo Couch Top – Special 510(k)
98 intelligence
PREMARKET NOTIFICATION
510(k) SUMMARY
| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
|---|---|---|
| 2. | Address: | Robert-Bosch-Straße 8 |
| 86830 Schwabmünchen | ||
| Germany | ||
| 3. | Contact Person: | Michael Wolff |
| Tel. +49 (0) 8232 9692-701 | ||
| 4. | Preparation Date: | July 24, 2007 |
| 5. | Device Submitted: | HexaPOD™ evo RT Couch Top |
| 6. | Proprietary Name: | HexaPOD™ evo 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. | ||
| 10. | Device Description: | The HexaPOD evo consists of two platforms, which are |
| connected by six 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. |
| Document #: | PMN 510(k) summary | Version 02 | vom/of 2007-08-14 | . The a The may 1 |
|---|---|---|---|---|
| and the production of the country | ||||
| Company of Children Comments of Children | and and and the comments of the comments of | 11.4.10.2019 | ||
| Company control of the be | ||||
| Corporal Talking Alabara | ||||
| Company of Children Company of |
UCI 25 2007
1
HexaPOD RT evo Couch Top – Special 510(k)
Image /page/1/Picture/1 description: The image contains a logo with the words "medical intelligence" written to the right of a circle with a vertical line through it. The words "medical" and "intelligence" are stacked on top of each other. The text and the logo are in a simple, sans-serif font.
-
Intended Use: The intended use of the device is to support and aid in positioning a patient during radiation therapy.
-
Summary of the Product The only modification made to the product are the Change: following evolutionary hardware changes:
- . Hardware redesign of the HexaPOD module to decrease total height of the couchtop
- Carbon fibre tabletop is connected directly to the o six actuators
- Different type of actuators ୍
- Active brakes o
- Actuator motor electronic moved to controller 0 box
- Hardware redesign of the HexaPOD module to . increase Safe Workload to 250 kg
- Different type of actuators
- Connection to table base is accomplished by 0 screws
- . The centre of coordinate system of the HexaPOD is shifted 100 mm longitudinally to the gantry: change in controller software.
- Mode of operation: continuous .
-
- Summary of the Product The HexaPOD is identical with the predicate device Similarities to Predicate concerning: Device
- . Intended use
- Behaviour of movement .
- Software interface to external control device .
-
- Biocompatibility: The HexaPOD evo 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.
-
- Performance Data: No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation).
| Document #: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMN 510(k) summary | | The A-40 40-4-4-4 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| "ht li ham a se | 1 : 2 : 3 : 3 : 1 : 1 : 2 | Version 02
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | vom/of 2007-08-14
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or perhaps a caduceus without the snake.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2007
Medical Intelligence Medizintechnik GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K072898
Trade/Device Name: HexaPOD™ evo RT Couch Top Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: October 9, 2007 Received: October 11, 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 (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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Page 2
Enclosure
4
Indications for Use
510(k) Number (if known):
HexaPOD™ evo RT Couch Top
Indications For Use:
Device Name:
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 CPRN, Office of Device Evaluation (ODE)
Helentemen
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number Page 1 of 2_________________________________________________________________________________________________________________________________________________________________