(15 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.
The provided document is a 510(k) Premarket Notification for a medical device called the HexaPOD™ RT Couch Top. It outlines the device's description, intended use, and its substantial equivalence to a predicate device.
However, 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, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because no such studies were required or performed for this specific device submission.
The 510(k) submission for the HexaPOD™ RT Couch Top focuses on demonstrating substantial equivalence to a previously legally marketed device (Medical Intelligence's "HexaPOD RT Couch Top") rather than proving novel performance against specific acceptance criteria through new clinical or performance studies. The modifications made were evolutionary hardware changes and implementing additional safety functions, which did not trigger a requirement for new performance data.
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medical
intelligence
PREMARKET NOTIFICATION
| 510(k) SUMMARY | K06 2639 | |
|---|---|---|
| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
| 2. | Address: | Feyerabendstrasse 13 - 1586830 SchwabmünchenGermany |
| 3. | Contact Person: | Christian HieronimiTel. +49 (0) 8232 9692-0 |
| 4. | Preparation Date: | February 15, 2006 |
| 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. |
| SEP 21 2006 | ||
| K062639 | ||
| 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:• Table top changed to iBEAM Couch Top• Table top extension• Geometric locations of actuators changed• Implementing additional safety functions |
| 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 a logo with a circle that has a vertical line through the center. To the right of the circle, the words "medical intelligence" are written in a serif font. The word "medical" is above the word "intelligence". The logo appears to be for a medical intelligence company.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 1 2006
Medical Intelligence Medizintechnik GmbH c/o Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K062639
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: August 21, 2006 Received: September 6, 2006
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 shows a circular logo with the text "1906-2006" at the top. In the center of the logo, the letters "FDA" are prominently displayed. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a row beneath the word "Centennial".
na and Promoting Public He
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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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
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):
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)
David L. Seymour
(Division Sign-Off) Division of Reproductive, Abde 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.