(84 days)
The Sure-Point™ HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.
Template for Seeding Device: Probe Stabilization Device. Applicator for Remote Controlled Afterloading Brachytherapy.
This FDA 510(k) summary for the "Sure-Point™ HDR Needle Template" (K031273) does not contain the information requested in your prompt regarding acceptance criteria and performance studies.
This document is a declaration of substantial equivalence to existing predicate devices. This means that the manufacturer is asserting their device is as safe and effective as devices already on the market, based on similar intended use, technological characteristics, and materials.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, ground truth information, or details about comparative effectiveness studies, because this information is not present in the provided text.
Here's what I can infer from the document:
- Device Type: This is a physical medical device (a template for brachytherapy needles), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC.
- Approval Basis: Substantial equivalence, not based on a new performance study demonstrating effectiveness against specific acceptance criteria.
- Study Data: No study data is mentioned, as is common for many 510(k) submissions of physical medical devices demonstrating substantial equivalence.
If you have a document describing a performance study for an AI/software device, I would be happy to analyze it according to your prompt.
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JUL 15 2003
Ko31273
XI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS. May 30, 1997. [Separate Page]
- Submitter: Grea Wiita. Amertek Medical. Inc., 2655 North Ocean Drive. Singer Island. Florida 33404.
II. Classification Names and numbers: Accessory to Ultrasound Probe. Stepping Device, Code ITX. Accessory to Remote Controlled Radionuclide Applicator System. Code JAQ
III. Common/Usual Name: Template for Seeding Device: Probe Stabilization Device. Applicator for Remote Controlled Afterloading Brachytherapy.
IV. Proprietary Names: Sure-Point™ HDR Needle Template
V. Establishment Registration Number: 1066424
- VI. Classification: Acc. to ultrasonic transducer. Class II. CFR 892.1570: Acc. to Remote controlled radionuclide applicator system. Class II. CFR 892.5700.
VII. Substantial Equivalence: Sure-Point™ HDR Needle Template is substantially equivalent to its predicate device, Sure-Point Brachytherapy Template cleared under K011581 and to HDR templates cleared by Nucletron in K003270, Mick Radio-Nuclear in K993400, and related devices.
The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
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These products have the same intended use, as the equivalent devices cleared for marketing by the 510(k) process under K003270 and K990990 by Nucletron. K993400 by Mick Radio-Nuclear Instruments, and K910862 by Best industries.
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The technological characteristics for this product are the same as those for the predicate devices and those currently on the market. Minor differences in structure would not be expected to provide different results.
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Descriptive information provided shows that the materials from which Amertek™ is made are substantially equivalent to those of similar products, used for identical purposes, currently on the market.
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The FDA "Decision-Making Process" chart was used and appears in Attachment V.
(End of Summary)
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Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter of the circle. In the center of the circle are three curved lines that are stacked on top of each other. The text around the perimeter of the circle is not easily legible.
JUL 15 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Greg Wiita President Amertek Medical Inc. 2655 North Ocean Drive SINGER ISLAND FL 33404 Re: K031273
Trade/Device Name: Amertek™ Brachytherapy Template Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ
Dated: April 16, 2003 Received: April 23, 2003
Dear Mr. Wiita:
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 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 the 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 Office of Compliance at (301) 594-4639. 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 may be obtained 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/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
Page 2
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VIII. Indications for Use: [Separate Page]
510(k) Number: NA Kø3i 27-3
Device Name: Amertek™ Brachytherapy Template
The use of sealed radioisotopes to treat turnors within the body has been documented and published since the turn of the century. Modem era radiation therapy has developed delivery systems using isotopes-of cesium, iridium, iodine and gold, for a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. The two common modalities are the Low dose rate and High dose rate afterloaders.
The Sure-Point™ HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use Over-The-Counter Use OR (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices
510(k) Number
202177
4
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.