(168 days)
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Not Found
No
The summary describes a mechanical device for probe alignment and needle guidance, with no mention of AI/ML, image processing, or performance studies typically associated with AI/ML-driven devices.
Yes
The device is used for radioactive seed implantation in the treatment of prostate cancer, which is a therapeutic intervention.
No
The device is used for precision ultrasound probe alignment and radioactive seed implantation for treatment, not for diagnosing a condition.
No
The device description explicitly lists three hardware components: an adjustable height base, an adjustable multi-axis head, and an ultrasound probe holder and needle guide. This indicates it is a physical medical device, not software-only.
Based on the provided information, the Tayman Medical, Inc. Stepping and Stabilization System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is used for "precision ultrasound probe alignment and radioactive seed implantation." This is a procedure performed on the patient's body, not a test performed on a sample from the body.
- Intended Use: The intended use is for "treatment of prostate cancer," which is a therapeutic application, not a diagnostic one in the IVD sense.
The device is a medical device used for a therapeutic procedure guided by imaging, but it does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.
Product codes
79FZX
Device Description
The seeding device is comprised of three basic components. The adjustable height base. The adjustable, multi-axis head. The ultrasound probe holder and needle guide.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
FEB - 6 1997
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মিনিটের মাধ্যমে সামনে প্রতিষ্ঠান করে আমার প্রতিষ্ঠান করে তার করে পারেন।
প্রকল্পিত
কার্যালয়ের সামন্ত্রী
মানুষ
মানুষ
Section XI - Summary of Safety and Effectiveness
| Date of Preparation: | August 16, 1996 |
|---|---|
| Device Name: | Tayman Medical, Inc. Stepping and Stabilization System |
| Classification Name: | Guide Surgical Instrument 79FZX |
| Manufacturer: | Tayman Medical, Inc. located at 15 Foxhunt Drive, |
| Chesterfield, Missouri 63017 | |
| Predicate Device: | The Tayman Medical, Inc. Seeding Device is substantially |
| equivalent in intended use, safety and effectiveness and | |
| construction to the Teknar, Inc. Seeding device. That device | |
| was produced and marketed by Teknar, Inc. formally located at | |
| 267 Wolfner Drive, Fenton, Missouri 63026. | |
| Device Description: | The seeding device is comprised of three basic components. |
| The adjustable height base. The adjustable, multi-axis head. | |
| The ultrasound probe holder and needle guide. | |
| Intended Use: | The Tayman Medical, Inc. Stepping and Stabilization System |
| is used to provide precision ultrasound probe alignment and | |
| radioactive seed implantation in the treatment of prostate | |
| cancer. | |
| Clinical and Non-Clinical | |
| Similarities and Differences: | The Tayman Medical, Inc. Stepping and Stabilization System |
| is substantially equivalent to the Teknar, Inc. Seeding device | |
| since they both are used to provide precision ultrasound probe | |
| alignment and radioactive seed implantation in the treatment | |
| of prostate cancer. They are operated in the exact same way | |
| and are made from the same materials. |