(67 days)
K-864807, K-871413, K-913293, K-963302
No
The summary does not mention AI, ML, deep learning, or any related concepts. The device description and intended use focus on mechanical alignment and implantation, not data analysis or algorithmic decision-making.
No.
The device is described as an alignment tool for precision ultrasound probes and radioactive seed implantation, which assists in brachytherapy treatments, but it does not directly perform the therapy itself.
No
The device is designed for therapeutic purposes (brachytherapy seed implantation) and probe alignment, not for identifying a disease or condition.
No
The summary describes a device for ultrasound probe alignment and radioactive seed implantation, which strongly implies a physical device or system is involved, not just software. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments." This is a therapeutic procedure performed directly on the patient, not a test performed on a sample taken from the patient.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not fit that description.
- Anatomical Site: The device is used on the "prostate," which is an organ within the body, not a sample taken from the body.
- Input Imaging Modality: The use of "ultrasound" is for guiding the procedure on the patient, not for analyzing a sample.
The device is a therapeutic device used in a medical procedure, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The DevMed is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate cancer.
Product codes
90 ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate
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-864807, K-871413, K-913293, K-963302
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
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XII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS. May 30, 1997. [Separate Pagel
I.* Submitter: Greg Wiita, DevMed Inc., 2655 North Ocean Dr., Singer Island FL 33404, Phone: 561-842-7595
II. Classification Names and numbers: Acc. to Ultrasound Probe, Stepping Device, Code ITX
III. Common/Usual Name: Stepping and Stabilization Device
IV. Proprietary Names: DevMed™ Stepping and Stabilizing System
V. Establishment Registration Number: in process
VI. Classification: Acc. to ultrasonic transducer, Class II, CFR 892.1570
VII. Substantial Equivalence: DevMed™ Stepping and Stabilizing System is substantially equivalent to the classified device and those cleared for marketing by the 510(k) process under K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K-963302 (Tayman Medical).
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 DevMed™ Stepping and Stabilizing System 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.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Greg Wiita President DevMed. Inc. 2655 North Ocean Drive Singer Island, FL 33404
Re:
K972152 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DevMed Stepping and Stabilizing System Dated: August 4, 1997 Received: August 5, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Wiita:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified 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 II (Special Controls) or 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 requirement, 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 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 yitro 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.ida.gov/odrh/dsmamain.intml".
Sincerely yours,
H. William Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
VIII.1 Indications for Use: [Separate Page]
510(k) Number: NA
Device Name: Devmed™ Stepping and Stabilizing System
The DevMed is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate cancer.
(PLEASE DO NOT WRITE BELOW THIS: LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, | ||
| and Radiological Devices | ||
| 510(k) Number | K972152 | |
| Prescription Use | ✓ | |
| (Per 21 CFR 801.109 | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |