(63 days)
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Not Found
No
The 510(k) summary describes a mechanical introducer needle and does not mention any AI or ML components or functionalities.
No
The device is an introducer needle used for guiding a biopsy needle to take tissue samples, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device is an introducer needle used to facilitate biopsy, which is a procedure to collect tissue samples. While biopsy is used for diagnosis, the needle itself is a surgical tool for sample collection, not a device that directly analyzes data or provides a diagnosis.
No
The device description clearly states it is an "Introducer Needle for Biopsy Needles," which is a physical, hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used to facilitate the collection of a sample from within the body (biopsy). It does not describe a device used to examine a sample in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description is for an "Introducer Needle for Biopsy Needles," which is a tool for accessing tissue within the body.
- Lack of IVD Characteristics: The provided text does not mention any processes or components related to analyzing biological samples in a lab setting, which is the core function of an IVD.
IVDs are devices used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device is a surgical instrument used for sample collection, not for the diagnostic analysis of the sample.
N/A
Intended Use / Indications for Use
The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.
Product codes
78 FCG
Device Description
Worldwide Medical Technologies Introducer Needle for Biopsy Needles
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
soft tissue organs of the abdomen and thorax
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)
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
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§ 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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 1998
Mr. Gary A. Lamoureux Worldwide Medical Technologies 125 Main Street North Woodbury, CT 06798-0505
Re: K981889
World wide Medical Technologies Introducer Needle Dated: May 21, 1998 Received: May 29, 1998 Regulatory Class: II 21 CFR 876.1075/Procode: 78 FCG
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 (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 substantialion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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 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/odrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): __ K 9 8 1 8 8 9
Device Name: Worldwide Medical Technologies Introducer Needle for Biopsy Needles
Indications For Use:
The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproduction, Abdominal, ENT
Division of Reproductive, Abdominal, ENT. and Radiological Devices
510(k) Number K981889
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
EXHIBIT 1