(312 days)
K#882601
K#882601
No
The description focuses on the physical characteristics and intended use of a needle for MRI procedures, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device description indicates that the MRI needles are used for procedures like puncture, aspiration, injection, biopsies, and diagnostic sampling, but there is no mention of treating a disease or condition therapeutically.
Yes
The device is used for "diagnostic sampling," which is a component of the diagnostic process.
No
The device description clearly describes a physical needle made of materials used in medical device manufacturing, with specified dimensions and sterility. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the MRI needles are used for procedures within the body, such as initial puncture, aspiration, injection, biopsies, and diagnostic sampling. These are interventional procedures, not tests performed on specimens outside the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze or test a specimen after it has been collected. The needle is the tool for obtaining the specimen or performing the procedure, not the diagnostic test itself.
Therefore, based on the provided information, the MRI needle is a medical device used for interventional procedures, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
79GAA, 79MJG, 79DWO
Device Description
The MRJ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#882601
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.
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510(k) Premarket Notification MRI Needles COOK INCORPORATED
963565
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS J.
Submitted By:
April Lavender, RAC
COOK INCORPORATED
925 South Curry Pike P.O. Box 489 Bloomington, IN 47401 4 September 1996
Device:
Trade Name: Proposed Classification Name: MRI Needles 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 MRJ 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.
JUL 14 1997
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three heads facing right, representing health, human services, and the USA. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circumference of the circle.
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
K963565 Re: MRI Needles II Requlatory Class: Product Code: FCG Dated: May 1, 1997 Received: May 2, 1997
JUL 1 4 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 Requlations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 (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
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510(k) Premarket Notification MRI Needles COOK INCORPORATED
510(k) Number (if known): K9633565
ﻟﻠﻤﺴﺎﻧ
MRI Needles Device Name:
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
busello
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number.