(32 days)
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No
The 510(k) summary describes a mechanical biopsy needle and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is used to obtain a sample for diagnosis, not for treatment or therapy.
Yes
Explanation: The intended use of the device is to obtain a bone marrow sample for histological examination in the diagnosis and treatment of various diseases. Obtaining a sample specifically for "diagnosis" indicates that the device has a diagnostic purpose.
No
The device description explicitly states "Bone Marrow Biopsy Needle," which is a physical hardware device used for obtaining a sample. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided information, the Worldwide Medical Technologies Bone Marrow Biopsy Needle 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body to analyze these samples.
- Device Function: The Bone Marrow Biopsy Needle is a tool used to obtain the sample of bone marrow. It is a surgical or procedural device used on the patient's body.
- Intended Use: The intended use is to "obtain a sample of bone marrow for histological examination." The histological examination itself, which is performed on the obtained sample, would be an in vitro diagnostic procedure, but the needle used to get the sample is not.
Therefore, the needle is a device used in a procedure that facilitates an IVD test, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The intended use of the Worldwide Medical Technologies Bone Marrow Biopsy Needle is to obtain a sample of bone marrow for histological examination in the diagnosis and treatment of various diseases. The sample is typically taken by percutaneous puncture of the posterior iliac creast of the pelvis.
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
posterior iliac creast of the pelvis
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains an image of a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 1998
Mr. Gary Lamoureux President Worldwide Medical Technologies 125 Main Street, North P.O. Box 505 Woodbury, Connecticut 06798-0505
Re: K974794
Trade Name: Worldwide Medical Technologies Bone Marrow Biopsy Needle Regulatory Class: II Product Code: KNW Dated: December 15, 1997 Received: December 22, 1997
Dear Mr. Lamoureux:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.
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Page 2 - Mr. Lamoureux
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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
2
510(k) Number (if known):
Device Name: Worldwide Medical Technologies Bone Marrow Biopsy Needle
Indications For Use:
The intended use of the Worldwide Medical Technologies Bone Marrow Biopsy Needle is to obtain a sample of bone marrow for histological examination in the diagnosis and treatment of various diseases. The sample is typically taken by percutaneous puncture of the posterior iliac creast of the pelvis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| of General Restorative Devices | |
| 510(k) Number |
| Prescription Use | |
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OR
| Over-The-Counter Use | |
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(Optional Format 1-2-96)
EXHIBIT 1