MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE by MEDSOL CORP.

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Medsol Goldenberg Bone Marrow Biopsy Needle." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing detailed study results or acceptance criteria for a new device's performance.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria, as it relates to performance metrics (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for an AI/CAD system), cannot be extracted from this document.

This letter confirms that the device is substantially equivalent to a pre-amendments device and can be marketed subject to general controls. It does not contain data from performance studies in the way modern AI device submissions do.

In summary, based on the provided text:

Table of acceptance criteria and reported device performance: Not available. The document is a clearance letter, not a performance study report.
Sample size for test set and data provenance: Not applicable. Performance study details are not provided.
Number and qualifications of experts for ground truth: Not applicable. Performance study details are not provided.
Adjudication method for test set: Not applicable. Performance study details are not provided.
MRMC comparative effectiveness study and effect size: Not applicable. This device is a biopsy needle, not an AI/CAD system for which MRMC studies are typically conducted.
Standalone performance study: Not applicable. Performance study details are not provided.
Type of ground truth used: Not applicable. Performance study details are not provided.
Sample size for training set: Not applicable. This device is a physical medical instrument, not an AI model that requires a training set.
How ground truth for training set was established: Not applicable. This device is a physical medical instrument, not an AI model.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1998

Mr. Alec S. Goldenberg, M.D. President Medsol Corporation 4 Washington Square Village New York, New York 10012

Re: K983187

Trade Name: Medsol Goldenberg Bone Marrow Biopsy Needle Regulatory Class: II Product Code: KNW Dated: September 10, 1998 Received: September 11, 1998

Dear Dr. Goldenberg:

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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 - Alec S. Goldenberg, M.D.

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 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

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510(k) Number (if known): K 98 3187

Device Name: Madsol Goldenberg Bone Marrow Biopsy Needle

Indications For Use:

For procuring bone marrow core biopsies from patients with hematologic abnounalities

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Optional Format 3-10-98)

Restorative Devices

15983187

Regulation Number and Section

§ 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.