K Number
K962977
Device Name
MRI COMPATIBLE BIOPSY NEEDLES
Date Cleared
1997-10-09

(435 days)

Product Code
Regulation Number
876.1075
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.
Device Description
MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle
More Information

Not Found

Not Found

No
The summary describes various types of biopsy needles and their intended use in different imaging modalities. There is no mention of AI, ML, image processing, or any data-driven algorithms.

No
The device is a needle used for obtaining biopsies, which is a diagnostic procedure, not a therapeutic one. It is used to get samples for analysis, not to treat a condition.

No
The device description indicates that these are needles used for obtaining biopsies and localization. While biopsies provide tissue for diagnosis, the needles themselves are tools for sample collection, not for performing the diagnostic analysis of those samples. Therefore, the needles are not diagnostic devices.

No

The device description lists various types of needles, which are physical hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the needles being used in vivo (within the body) for obtaining biopsies of various tissues during imaging procedures (MRI, Fluoroscopy, CT, Mammography).
  • Device Description: The device descriptions are all types of needles used for obtaining tissue samples from the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test kits, analyzers, or software used to analyze biological samples like blood, urine, or tissue after they have been collected.

The device described is a medical device used for obtaining tissue samples from the patient, which are then likely sent to a laboratory for in vitro diagnostic testing. The needles themselves are the tools for collection, not the diagnostic test itself.

N/A

Intended Use / Indications for Use

Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.

Product codes

KNW

Device Description

MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI, Flouroscopic, CT and Mammographic procedures

Anatomical Site

Not Found

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

Not Found

Summary of Performance Studies

Not Found

Key Metrics

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Michael Plishka ·New Product Development Manan Medical Products, Inc. 2200 Carlson Drive Northbrook, Illinois 60062

OCT - 9 1997

Re: K962977

Trade Name: MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle Regulatory Class: II Product Code: KNW Dated: August 26, 1997 Received: September 2, 1997

Dear Mr. Plishka:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions

1

Page 2 - Mr. Michael Plishka

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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

S. - Galix M. Witten, Ph.D., M.D.

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

K962977 510(K) Number (if known):

Device Name:

MRI Chiba Needle MRI Spinal Needle MRI Automatic Cutting Needle MRI General Purpose Introducer Needle MRI Techna-Cut Biopsy Needle MRI Super-Core Biopsy Needle MRI Breast Localization Needle MRI Simon Breast Localization Needle

Indications For Use:

Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.

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

(I

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_________________
-----------------------------------------

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative DevicesK2162977
510(k) Number

page I V