(88 days)
The AKTINA Medical Physics Corporation Tilt Board is intended for use in Radiation Therapy as an aid in patient positioning for breast treatments.
Tilt Boards are also commonly known as Breast Boards and are intended for use in Radiation Therapy to facilitate patient positioning in irradiation of the breast.
The AKTINA Medical Physics Corporation Tilt Board is intended for use in Radiation Therapy as an aid in patient positioning for breast treatments.
This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices.
The provided text describes a 510(k) submission for a medical device called the "Tilt Board" (also known as a Breast Board). This submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
However, the provided document does not contain acceptance criteria for device performance or any study data proving the device meets specific performance criteria. The submission primarily focuses on:
- General Provisions: Trade name, applicant, predicate devices, classification, and performance standards (not established by FDA).
- Intended Use and Device Description: Used for patient positioning in radiation therapy for breast treatments.
- Biocompatibility: No studies undertaken as no patient contact and no new materials.
- Summary of Substantial Equivalence: States similarity in design, construction, materials, intended use, and performance to predicate devices, introducing no new safety or effectiveness issues.
- FDA Response Letter: Confirms substantial equivalence based on the provided information and allows marketing.
- Indications for Use: Reiterates the intended use.
Therefore, I cannot provide the requested information as it is not present in the given text.
The document is a regulatory submission for a Class II medical device, where the primary path to market is often through demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data against specific acceptance criteria. For devices like a "Tilt Board" which are positioning aids and not directly diagnostic or therapeutic in themselves, the "performance" often refers to basic functional safety (e.g., structural integrity, ease of use, stability) and alignment with the intended use of patient positioning, rather than a quantifiable clinical outcome requiring extensive studies with ground truth.
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JUL 30 1999
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
April 26, 1999
General Provisions 1.
Tilt Board Trade Name: Breast Board 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
Huestis Medical Flexi-board (K904005) and Med-Tec Corporation MT-200 Breast Boards (K935412). 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 As the Commissioner of the FDA has indicated, "...a determination of infringement litigation. 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 892.5050.
4. Performance Standards
The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Tilt Boards.
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5. Intended Use and Device Description
The AKTINA Medical Physics Corporation Tilt Board is intended for use in Radiation Therapy as an aid in patient positioning for breast treatments.
6. Biocompatibility
The Tilt Board 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, 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Rockville MD 20850
.
Food and Drug Administration 9200 Corporate Boulevard
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
JUL 30 1999
Joan Zacharopoulos Vice-President AKTINA Medical Physics Corporation 360 North Route 9W Congers. New York 10920
Re:
Tilt Board Dated: April 26, 1999 Received: May 3, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Zacharopoulos:
We have reviewed your 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 redassified 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 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 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,
Dan Setiz, M.D.
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
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Indications for Use
510(k) Number:
Device Name: Tilt Board
Indications for Use:
Tilt Boards are also commonly known as Breast Boards and are intended for use in Radiation Therapy to facilitate patient positioning in irradiation of the breast.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use:(Per 21 CFR 801.109) | ✓ | or | Over-The Counter Use: |
|---|---|---|---|
| ------------------------------------------- | --- | ---- | ----------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991546 |
|---|---|
| --------------- | --------- |
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.