(67 days)
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No
The summary describes a mechanical biopsy needle and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No.
The device is intended for obtaining biopsies, which is a diagnostic procedure, not a therapeutic one. It is used to collect samples for analysis, not to treat a disease or condition.
Yes
Explanation: The device is a biopsy needle, which is used to obtain tissue for diagnostic purposes. A biopsy is a diagnostic procedure.
No
The device description explicitly states "Ranfac Single Action Biopsy Needle," which is a physical, hardware medical device used for obtaining tissue samples. There is no mention of software as the primary or sole component.
Based on the provided information, the Ranfac Single Action Biopsy Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "obtaining a percutaneous soft tissue biopsy." This describes a procedure performed on a living patient to collect a tissue sample.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) outside of the body to detect diseases, conditions, or infections.
- Device Function: The device is a needle used to collect the sample, not to analyze it.
The Ranfac Single Action Biopsy Needle is a medical device used for a surgical procedure (biopsy), not for performing diagnostic tests on a sample in a lab setting.
N/A
Intended Use / Indications for Use
The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.
Product codes
KNW, FCG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2001
Mr. George J. Hattub, CQE Director, Quality Assurance/Regulatory Affairs Ranfac Corporation 30 Doherty Avenue Avon, Massachusetts 02322
Re: K012224
Trade/Device Name: Ranfac Single Action Biopsy Needle Regulation Number: 876.1075 Regulatory Class: II Product Code: KNW, FCG Dated: July 12, 2001 Received: July 16, 2001
Dear Mr. Hattub:
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 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). 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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. George J. Hattub, CQE
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 nouticate 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 11 you desire specific a in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (201) 59 m 400 ffice of Compliance at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsion.com sumer Assistance at its toll-free number (800) 638-2041 or Mandractarers Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
R. Marlin N. Melkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ KO12224
Device Name: Ranfac Single Action Biopsy Needle
Indications For Use: The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ (per 21 CFR 801.109) Over-the-Counter Use
S. Mark N. Milkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012224