(84 days)
The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams.
The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams. This physical device is constructed of high-density materials that differentially attenuate the transmitted radiation beam.
The provided text describes a 510(k) premarket notification for a medical device and therefore does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.
This document is a regulatory submission for a Class II medical device (Radiation Therapy Wedges) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria. The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed device, not necessarily to present a de novo performance study with acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details of a study proving the device meets acceptance criteria.
- Sample size used for a test set or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Details on a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
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MAR 5 2002
KD/4081
Page 1 of 2
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
May 1, 2001
General Provisions 1.
Trade Name: Radiation Therapy Wedges Beam Modifier, Wedges 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
Mevatron KD-2, Siemens Medical Labs, Inc., K862339
Clinac 1800, Varian Associates, Inc., K832503 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 this product.
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K014081
Page 2 of 2
ડ. Intended Use and Device Description
The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams.
Biocompatibility 6.
This product raises no issues of biocompatibility.
7. Summary of Substantial Equivalence
This device is similar in design and 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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "U.S. Department of Health & Human Services - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 5 2002
Ms. Joan Zacharopoulos Vice President AKTINA Medical Physics Corp. 360 North Route 9W CONGERS NY 10920
Re: K014081
Received: December 11, 2001
Trade/Device Name: AKTINA Medical Physics Corporation Radiation Therapy Wedges Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: November 1, 2001
Dear Ms. Zacharopoulos:
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 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.
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.
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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 noutication. The I Dri Imaling of succion 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 II you desire specific acries at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on and 1-6639. Also, please note the regulation entitled, "Misbranding Other of Compilance as (2001) cation" (21 CFR Part 807.97). Other general information on by reserved to promazive nearchard from the Division of Small Manufacturers, your responsibilities 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/dsma/dsmamain.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:
Device Name:
Radiation Therapy Wedges
Indications for Use:
In radiation therapy, it is often desirable to modify the intensity or penetrating depth of a treatment beam so as to minimize radiation exposure to normal tissue. Many devices have and are used for this function including but not limited to partial beam blocks, tissue compensating filters, the most commonly, the wedge. This physical device is constructed of high-density materials that the most commonly, the weage. The payed block, differentially attenuate the transmitted radiation beam. When mabilities a weegs that is transmitted through the wedge will have a sloped intensity at The resulting radiation boan that is an un-attenuated beam, which is uniform and consistent in intensity across the beam at the patient's surface. These wedges are designed for use only as a intensity across are boaith photon beams in Radiation Therapy external beam treatments.
David A. Szymon
Abdominal.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Or
V
Over-The Counter Use:
(Per 21 CFR 801.109)
§ 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.