Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
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Prostate Lesion, Documentation, System
- Page Type
- Product Code
- Definition
- Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
- Physical State
- Cart-based system consisting of a hand-held rectal probe attached to a computer with proprietary image reconstruction software.
- Technical Method
- Uses an array of pressure sensors and image reconstruction software to create a 3-D map showing areas of relative tissue hardness or softness within the prostate.
- Target Area
- Prostate, rectum.
- Regulation Medical Specialty
- Gastroenterology and Urology
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 876.2050
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 876.2050 Prostate lesion documentation system
§ 876.2050 Prostate lesion documentation system.
(a) Identification. A prostate lesion documentation system is a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image.
(2) Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
(5) Methods and instructions for reprocessing of any reusable components must be properly validated.
(6) The labeling must include specific information needed to ensure proper use of the device.
[80 FR 72900, Nov. 23, 2015]