MRI NEEDLES

K963565 · Cook, Inc. · FCG · Jul 14, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963565
• Device Name: MRI NEEDLES
• Applicant: Cook, Inc.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

MRI needles are intended for use with 1.5 Tesla (or lower field strength) Magnetic Resonance Imaging procedures, including initial puncture, aspiration and injection, biopsies and diagnostic sampling.

Device Story

MRI Needles are sterile, disposable/reusable needles designed for interventional procedures performed under 1.5 Tesla or lower field strength MRI guidance. Used by clinicians for initial puncture, aspiration, injection, biopsy, and diagnostic sampling. Device functions as a physical tool for accessing tissue or fluid sites within the MRI environment. Output is the successful placement of the needle for the intended clinical procedure, enabling diagnostic or therapeutic intervention. Benefits include compatibility with MRI imaging environments, allowing real-time guidance for minimally invasive procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence is supported by design validation studies and verification of biocompatibility for materials used.

Technological Characteristics

Needles available in 16 to 25 gage diameters and 2.5 cm to 20 cm lengths. Constructed from biocompatible materials. Designed for use in 1.5 Tesla or lower MRI fields. Supplied sterile.

Indications for Use

Indicated for patients undergoing 1.5 Tesla or lower field strength MRI procedures requiring initial puncture, aspiration, injection, biopsy, or diagnostic sampling.

Regulatory Classification

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.

Predicate Devices

• E-Z-EM, INC. magnetic resonance imaging needles (K882601)
• COOK INCORPORATED pre-Amendment needles
• William Cook Europe A/S needles

Submission Summary (Full Text)

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510(k) Premarket Notification
MRI Needles
COOK INCORPORATED

K963565

J. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL 14 1997

Submitted By:
Soni Lavender, RAC
COOK INCORPORATED
925 South Curry Pike
P.O. Box 489
Bloomington, IN 47401
4 September 1996

Device:
Trade Name: MRI Needles
Proposed Classification Name: Class I exempt, §878.4800
Needles, Aspiration and Injection, All Types, 79GAA
Needles, Percutaneous Biopsy, All Types, 79MJG
Needles, Biopsy Cardiovascular, 79DWO

Indications for Use
MRI needles are intended for use with 1.5 Tesla (or lower field strength) magnetic resonance imaging procedures, including initial puncture, aspiration and injection, biopsies and diagnostic sampling.

Predicate Devices:
The MRI Needle is substantially equivalent to other devices intended for use in conjunction with magnetic resonance imaging in terms of indications for use, design, construction and materials’ equivalence. Specifically, this device is similar to COOK INCORPORATED pre-Amendment and predicate disposable and reusable needles, magnetic resonance imaging needles manufactured by E-Z-EM®, INC. in Westbury, New York, (K#882601), and devices marketed in Europe by William Cook Europe A/S, Denmark.

Device Description:
The MRI Needle is intended for use for the same indications as the predicate devices listed above. These indications include initial puncture, aspiration and injection, biopsies, diagnostic sampling and other interventional procedures. The materials used in this device are widely used in medical device manufacturing and their biocompatibility has been verified. In addition, design validation studies have been performed to assure the device can be expected to perform its intended function when used according to the recommendations in the product’s labeling which will be provided with the device. The device will be made in 25 to 16 gage diameters, in lengths from 2.5 cm to 20 cm. It will be supplied sterile.

Substantial Equivalence
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by COOK INCORPORATED. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

April Lavender, RAC
Vice President, Regulatory Affairs
Cook, Inc.
925 South Curry Pike
P.O. Box 489
Bloomington, Indiana 47402

Re: K963565
MRI Needles
Regulatory Class: II
Product Code: FCG
Dated: May 1, 1997
Received: May 2, 1997

JUL 14 1997

Dear Ms. Lavender:

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 (QS) inspections, the Food and Drug

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Page 2 - April Lavender, RAC

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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iii

510(k) Premarket Notification
MRI Needles
COOK INCORPORATED

510(k) Number (if known): K963565

Device Name: MRI Needles

Indications for Use:

MRI needles are intended for use with 1.5 Tesla (or lower field strength) Magnetic Resonance Imaging procedures, including initial puncture, aspiration and injection, biopsies and diagnostic sampling.

(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)
OR
Over-the-Counter Use ☐