(15 days)
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Not Found
No
The 510(k) summary describes a physical medical device (a bone marrow aspiration needle) and contains no mention of AI, ML, image processing, or any software-based analytical capabilities.
No
The device is used for obtaining a bone marrow sample for diagnostic purposes, not for treating a disease.
Yes
The device is used to obtain a sample for pathological examination "in the diagnosis and treatment of various diseases," indicating its role in the diagnostic process.
No
The device is a bone marrow aspiration needle, which is a physical medical device, not software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The "I" Type Bone Marrow Aspiration Needle is a device used to obtain a sample of bone marrow. It is a tool for sample collection, not a test performed on the sample itself.
- Intended Use: The intended use clearly states it's for "percutaneous puncture of the sternum to obtain a sample... for pathological examination". The pathological examination is the diagnostic part, which would likely be performed using IVD methods on the collected sample.
Therefore, the needle is a medical device used in a procedure that facilitates an IVD process, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The intended use of the Worldwide Medical Technologies " I " Type Bone Marrow Aspiration Needle is for the percutaneous puncture of the sternum to obtain a sample of the bone marrow for pathological examination in the diagnosis and treatment of various diseases.
Product codes
KNW
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
sternum
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
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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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The symbol and text are all in black, set against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary A. Lamoureux President Worldwide Medical Technologies 125 Main Street, North P.O. Box 505 Woodbury, Connecticut 06798-0505
JAN 23 1998
K980068 Re:
Trade Name: Worldwide Medical Technologies "I" Type Bone Marrow Aspiration Biopsy Needle Regulatory Class: II Product Code: KNW Dated: January 5, 1998 Received: January 8, 1998
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 (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
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Page 2 - Mr. Lamoureux
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 vour 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
Enclosure
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EXHIBIT I
510(k) Number (if known): K980062
Device Naunc: "I " Type Bone Marrow Aspiration Biopsy Needle
Indications For Use:
The intended use of the Worldwide Medical Technologies " I " Type Bone Marrow Aspiration Needle is for the percutaneous puncture of the sternum to obtain a sample of the bone marrow for pathological examination in the diagnosis and treatment of various diseases.
(PLEASE DO NOT WRITE BELOW TIUS LINE - CONTINUE ON ANOTHER PAGE IF NEWBED)
Coucurrence of CDRH, Office of Device Evaluation (ODB)
Division Sign-Off Division of General Restorative Dev 510(k) Number
Prescription Use (Per 21 CFR 801.109)
ાર
Over-The-Counter Use
(Optional Formal 1-2-96)