(88 days)
The Alton PT Stabilizer and Stepper is designed to allow precision ultrasound probe alignment, precise prostate visualization and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. It is also used to allow precision ultrasound alignment and precise prostate visualization in cryotherapy treatments for prostate treatment.
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This document is a 510(k) summary for the ALTONTM PT Stepper and Stabilizing System, a medical device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing performance data from a specific study against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from the provided text.
Here is the information that can be extracted, along with explanations for what cannot be found:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary for this device focuses on demonstrating substantial equivalence by comparing its intended use, technological characteristics, and materials to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As no specific performance study is detailed, there is no mention of a test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. There is no mention of a ground truth established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. There is no mention of a test set or an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. This device is a mechanical stepping and stabilization system for ultrasound probes in brachytherapy and cryotherapy, not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This device is a mechanical instrument, not an algorithm, so a standalone performance study in the context of AI is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. As no performance study requiring ground truth is detailed, this information is absent.
8. The sample size for the training set
This information is not provided. Not applicable to this type of device and submission.
9. How the ground truth for the training set was established
This information is not provided. Not applicable to this type of device and submission.
Summary of Device and Substantial Equivalence Claim:
The document describes the ALTON™ PT Stepper and Stabilizing System. This device is intended to allow precision ultrasound probe alignment, precise prostate visualization, and radioactive seed implantation in brachytherapy treatments, as well as precision ultrasound alignment and prostate visualization in cryotherapy treatments.
The substantial equivalence claim is based on:
- Same intended use: The device has the same intended use as several predicate devices (e.g., K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-963302 (Tayman Medical), K-972672 and K000960 by Barzell-Whitmeore).
- Same technological characteristics: The technological characteristics are stated to be the same as the predicate devices.
- Substantially equivalent materials: The materials used for the Alton™ are reported to be substantially equivalent (nearly identical with some) to those of similar products already on the market.
Conclusion:
The provided text constitutes a 510(k) summary demonstrating substantial equivalence for a medical device. It does not contain information about a specific study designed to meet pre-defined acceptance criteria, as is common for novel devices or those requiring a PMA. Instead, it relies on a comparison to existing, legally marketed predicate devices to establish safety and effectiveness.
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KCZ4183
XII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS. May 30, 1997. [Separate Pages1
I.* Submitter: Greg Wiita, Alton LLC., 2655 North Ocean Dr., Suite 430, Singer Island FL 33404. Phone: 561-721-9595
- II. Classification Names and numbers: Acc. to Ultrasound Probe, Stepping Device, Code ITX
III. Common/Usual Name: Stepping and Stabilization Device
IV. Proprietary Names: Alton™ PT Stepper and Stabilizing System
V. Establishment Registration Number: in process
VI. Classification: Acc. to ultrasonic transducer, Class II. CFR 892.1570
VII. Substantial Equivalence: Alton™ is substantially equivalent to the classified device and those cleared for marketing by the 510(k) process under K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K-963302 (Tayman Medical) as well as K-972672 and K000960 by Barzell-Whitmeore
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 the classified device and those cleared for marketing by the 510(k) process under K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above.
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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.
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Descriptive information provided shows that the materials from which Alton™ is made are substantially equivalent to (nearly identical with some) 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 IV.
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K024183
We believe we have complied fully with guidance documents and usual practices in preparing premarket notifications. If additional information or explanation is needed, please call me at 561-721-0595 or fax me at 561-842-6660. You may also call or fax Dr. Neal Dunning at 301-229-2138. Your prompt consideration will be appreciated.
Sincerely yours,
Greg Wiita President
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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 caduceus symbol, which features a staff with a snake winding around it, overlaid with three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2003
Mr. Greg Wiita President Alton Design, LLC 2655 N. Ocean Drive, Suite 403 SINGER ISLAND FL 33404
Re: K024183
Trade/Device Name: ALTONTM PT Stepper Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 KXK and ITX Dated: November 20, 2002 Received: December 19, 2002
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 contract 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.1 Indications for Use: [Separate Page]
83 Ko2 41 510(k) Number: NA
Device Name: Alton™ PT
The Alton PT Stabilizer and Stepper is designed to allow precision ultrasound probe alignment, precise prostate visualization and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer.
It is also used to allow precision ultrasound alignment and precise prostate visualization in cryotherapy treatments for prostate treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
OR
Prescription Use (Per 21 CFR 801.109)
David A. Legmann
(Division Sic Division of Reprodu Antogical Devi - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
Over-The-Counter Use (Optional Format 1-2-96)
6
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.