(84 days)
Not Found
No
The summary describes a physical support device for radiation therapy and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No.
The device is described as an aid in supporting the patient during external beam irradiation, and it facilitates treatment by providing support and a clear beam path. It does not exert a therapeutic effect on the patient itself.
No
The device, a "Tennis Racquet Insert", is described as an aid for supporting patients during radiation therapy by providing a beam path and firm support. Its intended use is in treatment facilitation, not in diagnosis.
No
The device description clearly states it is a physical "Tennis Racquet Insert" used for patient support during radiation therapy, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "facilitate treatment of the patient when laying prone or supine on the treatment couch" in Radiation Therapy. This is a physical support device used during a medical procedure, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces its role as an "aid in supporting the patient during external beam irradiation."
- 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.)
- Providing diagnostic information
- Measuring analytes or biomarkers
The device is a physical accessory used in a radiation therapy setting to position and support the patient.
N/A
Intended Use / Indications for Use
The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.
Tennis Racquet inserts are intended for use in Radiation Therapy to facilitate treatment of the patient when laying prone or supine on the treatment couch. Tennis Racquets provide a beam path that is considered attenuation free while supplying firm support for the patient.
Product codes (comma separated list FDA assigned to the subject device)
90 JAI
Device Description
The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.
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
Radiation Therapy
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)
Not Found
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.
Siemens ZXT Therapy Treatment Table (K910971)
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
JAN 1 0 2000
K993522
Page 1 of 2
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
October 1, 1999
1. General Provisions
Trade Name: Tennis Racquet Insert Tennis Racquet Insert Common Name:
Applicant Name and Address:
AKTINA Medical Physics Corporation 360 North Route 9 W Congers, New York, 10920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865
2. Name of Predicate Devices
Siemens ZXT Therapy Treatment Table (K910971) 1
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
3. Classification
This device is classified as a class II device according to 21 CFR 892.5770.
4. Performance Standards
The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Tennis Racquet Inserts.
1
Kittredge
Page 7 of 7
5. Intended Use and Device Description
The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.
6. Biocompatibility
The Tennis Racquet is not in contact with the patient at any time when in use as 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 this device, therefore, no biocompatibility studies were undertaken for the device.
7. Summary of Substantial Equivalence
This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2000
Aktina Medical Physics Corporation
Re:
K993522 Tennis Racquet Insert Dated: October 14, 1999 Received: October 18, 1999 Regulatory class: II 21 CFR 892.5770/Procode: 90 JAI
Dear Ms. Zacharopoulos:
Joan Zacharopoulos
360 North Route 9W
Congers, NY 10920
Vice President
We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number:
93522
Device Name: Tennis Racquet Insert
Indications for Use:
Tennis Racquet inserts are intended for use in Radiation Therapy to facilitate treatment of the patient when laying prone or supine on the treatment couch. Tennis Racquets provide a beam path that is considered attenuation free while supplying firm support for the patient.
| (Division Sign-Off) | ||
|---|---|---|
| Division of Reproductive, Abdominal, ENT | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
| 510(k) Number | K993522 | |
| Prescription Use: | ||
| (Per 21 CFR 801.109) | or | Over-The Counter Use: |