(60 days)
Not Found
Not Found
No
The summary describes a physical biopsy needle and does not mention any software, image processing, or AI/ML terms.
No
The device is used to obtain biopsies, which is a diagnostic procedure, not a therapeutic one.
No
The device is described as "Prostate Biopsy Needles" used to "obtain needle biopsies of the prostate," indicating it's a tool for acquiring samples, not for interpreting those samples to make a diagnosis. The act of diagnosis would follow the use of this device, once the biopsy is analyzed.
No
The device is described as "Prostate Biopsy Needles," which are physical instruments used to obtain tissue samples. This clearly indicates a hardware component, not 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 is to "obtain needle biopsies of the prostate." This is a procedure to collect a tissue sample from the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device itself is not performing the diagnostic test; it's the tool used to collect the sample for a potential later diagnostic test.
The device is a surgical instrument used for tissue collection, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Prostate Biopsy Needles shall be single use only and are to be used by a urologist in a healthcare setting to obtain needle biopsies of the prostate.
Product codes
KNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Urologist in a healthcare setting
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1998
Mr. Steve Woody Quality Assurance Coordinator Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, Georgia 30005
Re: K982401 Trade Name: Prostate Biopsy Needle Regulatory Class: II Product Code: KNW Dated: July 7, 1998 Received: July 10, 1998
Dear Mr. Woody:
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 Device Amendments, or to 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 Ouality System Regulation (OS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Steve Woody
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 vour 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Remington Medical, Inc.
Ka8240i
Appendix B
Indication for Use Statement
510(k) Number (if known): Pending 510(k) Request
Device Name: Prostate Biopsy Needle
Indications for Use:
Prostate Biopsy Needles shall be single use only and are to be used by a urologist in a healthcare setting to obtain needle biopsies of the prostate.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature Sign-Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982401
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _