(88 days)
K-972152, K-011581, K-864807, K-871413, K-913293, K-963302, K-972672, K000960
No
The summary describes a mechanical device for ultrasound probe alignment and visualization, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for precise probe alignment and visualization in brachytherapy and cryotherapy treatments, which are therapeutic procedures, but the device itself is a positioning/guidance tool, not a therapeutic device.
No
The device is described as an "ultrasound probe alignment" and "visualization" tool for brachytherapy and cryotherapy treatments, specifically for precise prostate visualization and radioactive seed implantation. While it uses ultrasound for visualization, its primary stated purpose is to guide therapeutic interventions (seed implantation, cryotherapy), not to diagnose a condition or disease. It aids in the treatment of cancer, rather than its detection or characterization.
No
The device description is not provided, but the intended use clearly describes a device designed for physical manipulation and alignment of an ultrasound probe and visualization for procedures like brachytherapy and cryotherapy. This strongly suggests a hardware component is involved in the physical alignment and stabilization, making it unlikely to be software-only.
Based on the provided information, the Alton PT Stabilizer and Stepper is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during a medical procedure (brachytherapy and cryotherapy) to assist with ultrasound probe alignment and visualization of the prostate. This is a procedural aid, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: While the description is "Not Found," the intended use clearly points to a physical device used for positioning and guidance during treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic results based on laboratory testing.
IVDs are typically used to test samples like blood, urine, tissue, etc., to diagnose diseases, monitor health, or screen for conditions. The Alton PT Stabilizer and Stepper's function is entirely focused on facilitating a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
90 KXK, ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate (or other)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
K-972152, K-011581, K-864807, K-871413, K-913293, K-963302, K-972672, K000960
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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:
-
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.
-
The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.
-
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.
-
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.
3
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)
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