(57 days)
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Not Found
No
The summary describes a mechanical needle guide for a stereotactic device and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a needle guide used for precise needle placement during a breast biopsy, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device is a needle guide used for precise needle placement during a breast biopsy, which is a procedure to collect tissue for analysis, not to diagnose a condition itself.
No
The device description explicitly states it is a "Needle Guide for Lorad Stereotactic Device," which is a physical component designed to hold a needle. This indicates a hardware device, not software only.
Based on the provided information, the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's intended use is to "hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast." This is a mechanical guide used during a medical procedure (biopsy) performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, this device falls under the category of a medical device used in a surgical or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intendended use of the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is to hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast. This device is intended to be used with the Lorad Stereotactic Device only.
Product codes
90 IZH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
breast
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 1998
Gary A. Lamoureux President Worldwide Medical Technologies 125 Main St. N. Woodbury, CT 06798
Re:
Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device Dated: April 17, 1998 Received: April 23, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Lamoureux:
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 (OS) for Medical Devices: General regulation (2) 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 result in recult in reculatory 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 vitne diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
5 10(k) Number (if known):
Device Naune: ----------------------------------------------------------------------------------------------------------------------------------------------------------------Indications For Use:
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The intendended use of the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is to hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast. This device is intended to be used with the Lorad Stereotactic Device only.
(PLEASE DO NOT WRITE BELOW TIUS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBO)
Concurrence of CDRH, Office of Dovice Evaluation (ODE)
David B. Skjerven
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
Prescription Usc (Pcr 21 CFR 801.109)
ાર
Over-The-Counter Use
(Optional Formal 1-2-96)