(2 days)
The intended use of the device is to support and aid in positioning a patient during radiation therapy.
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.
Here's a breakdown of the acceptance criteria and study information for the HexaPOD RT Couch Top device, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Support and aid in positioning a patient during radiation therapy. | The device is stated to be "identical with the predicate device concerning: • Intended use • Behaviour of movement • Control software • Electronic and electro-mechanical components" indicating it meets the intended use. |
| Safety Functions: Implement additional safety functions. | This was a specific modification made to the product. Performance data is not detailed, but the submission implies these functions were successfully implemented. |
| Enable Switch Board: Added enable switch board. | This was a specific modification made to the product. Performance data is not detailed, but the submission implies this was successfully added. |
| Biocompatibility: No direct patient contact, no new materials. | The device is explicitly stated to be "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." This implies the device meets the biocompatibility criteria by design and usage. |
| Basic Performance/Effectiveness: Similar to predicate device in behavior, control, and components. | The device is stated to be "identical with the predicate device concerning: • Intended use • Behaviour of movement • Control software • Electronic and electro-mechanical components." This forms the basis of its substantial equivalence. |
Important Note: The document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)." Therefore, detailed quantitative performance metrics or specific studies demonstrating device acceptance criteria are not provided in this document. The acceptance is based on demonstrating substantial equivalence to a predicate device, and the modifications being benign in terms of safety and effectiveness.
Study Information
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document states that "No performance data is required..." and therefore no specific test set data is presented. The submission relies on demonstrating substantial equivalence to a predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As no specific performance studies or test sets were mandated or performed for this submission, there's no mention of experts establishing ground truth for a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or independent performance study was conducted or presented.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a mechanical patient support system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies or AI assistance are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a mechanical patient support system, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Since no performance data or test sets were required or presented, no specific ground truth was established for the device itself in this submission. The "ground truth" for its acceptance is its demonstrated substantial equivalence to the predicate device, which implies the predicate device's performance characteristics are the standard.
-
The sample size for the training set
- Not Applicable. This device is a mechanical patient support system, not an AI or machine learning model that would require a training set.
-
How the ground truth for the training set was established
- Not Applicable. No training set was used.
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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 areconnected by six linear, rigid but length adjustableelements which are powered. By appropriatecoordinative adjustment of these elements, the systemis able to move the upper platform relative to the lowerone. The movement can occur in all three dimensionsin space. Additionally the upper platform can rotatearound these three axes which results in a tilt or arotation of the upper platform relative to the lower one.Finally an accurate positioning within all six degrees offreedom (6DOF) can be provided. The HexaPODconsists of a controller unit which is directed by acable connected hand control. Additionally it can bedirected 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 inpositioning a patient during radiation therapy. |
| 12. | Summary of the ProductChange: | The only modification made to the product are thefollowing evolutionary hardware changes:• Implementing additional safety functions• Added enable switch board |
| 13. | Summary of the ProductSimilarities to predicatedevice | The HexaPOD is identical with the predicate deviceconcerning:• 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 placedbetween the patient's skin surface and the treatmentsupport when in use. Additionally there are no newmaterials introduced in the manufacture of theHexaPOD. Therefore, no biocompatibility studies wereundertaken for this device. |
| 13. | Performance Data: | No performance data is required for this Class IIdevice nor requested by the Food and DrugAdministration (Office of Device Evaluation). |
:
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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. 886830 SchwabmünchenGermany |
| 3. | Contact Person: | Christian HieronimiTel. +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 assemblyProduct Code JAI |
| 9. | Substantial Equivalence: | The HexaPOD is substantially equivalent to thefollowing legally marketed device:Medical Intelligence's "HexaPOD RT Couch Top".The characteristics of this device are similar to thoseof the predicate device identified on the comparisonchart, which is provided with the premarket notificationsubmission. It is our opinion that the HexaPOD doesnot have technological characteristics that raiseadditional types of questions related to terms of safetyand effectiveness. |
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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.
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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
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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 __
Page 1 of 2
§ 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.