(19 days)
Not Found
None
No
The summary describes a physical needle guide for mammography and contains no mention of AI, ML, or image processing.
No
The device aids in needle placement during mammographic x-ray procedures, but it does not directly treat a disease or condition. Its function is to guide a needle, which is a procedural aid, rather than a therapeutic intervention itself.
No
Explanation: The device is described as a "Needle Guide" used to "aid in needle placement" during mammographic x-rays. Its purpose is to guide a physical procedure, not to diagnose a condition.
No
The device description "Needle Guide" and the intended use "to aid in needle placement" strongly suggest a physical, hardware component used during a procedure, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description states the device is a "Needle Guide" used to "aid in needle placement" during mammographic x-ray procedures. This indicates it's a tool used during a medical procedure on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing performed on bodily fluids or tissues.
Therefore, this device falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Needle Guides shall be single use only and are to be used by a mammographic x-ray specialist in a healthcare setting to aid in needle placement.
Product codes
90 IZH
Device Description
Needle Guide
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
mammographic x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
mammographic x-ray specialist in a healthcare setting
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
Re:
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 NOV
Steve Woody Quality Assurance Coordinator Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005
K983621 Needle Guide Dated: October 8, 1998 Received: October 15, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Woody:
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 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.
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) 594-4613. Additionally, for question 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/dsmardsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throu and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/0/Picture/14 description: The image shows a partial view of a seal or emblem, specifically the logo of the Department of Health & Human Services. The emblem features a stylized design, possibly representing a human form or abstract symbol, rendered in black. The text "DEPARTMENT OF HEALTH & HUMAN" is visible, arranged in a circular fashion around the emblem, suggesting it is part of a larger official seal.
1
Remington Medical, Inc.
Appendix B
Indication for Use Statement
510(k) Number (if known): Pending 510(k) Request
Device Name: Needle Guide
Indications for Use:
Needle Guides shall be single use only and are to be used by a mammographic x-ray specialist in a healthcare setting to aid in needle placement.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Schmidt A. Seyram
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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