(55 days)
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Not Found
No
The summary describes a mechanical device for bone marrow biopsy and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used to obtain biopsy samples, which is a diagnostic procedure, not a therapeutic treatment.
Yes
The device is used to obtain biopsy samples of bone marrow, which are then typically analyzed to diagnose medical conditions. Therefore, it is an instrument used to aid in diagnosis.
No
The device description explicitly mentions physical materials (304 Stainless Steel and polycarbonate) and features (Luer fittings, adjustable depth stop, needle dimensions), indicating it is a hardware device for obtaining biopsy samples.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain percutaneous biopsy samples of Bone Marrow." This describes a procedure to collect a sample from the body.
- Device Description: The device is a needle designed for this collection procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine the sample in vitro (outside the body) to diagnose a condition. IVDs are typically reagents, instruments, or systems used to test samples like blood, urine, or tissue to detect diseases or conditions.
This device is a tool for sample collection, which is a step that might precede an IVD test, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.
Product codes
KNW
Device Description
Trade Name: Bone Marrow Aspiration Needle.
Usual Name: Same as Trade Name.
Description: These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.
Materials: 304 Stainless Steel and polycarbonate or similar material.
Additional Features: Currently, Manan (Northbrook, IL) provides features such as: Luer fittings on Cannula and adjustable depth stop (Illinois style). Promex's products will incorporate these features as well. A listing of available needle dimensions is included in Section I - Attachment B.
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
Bone Marrow
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.
0
DEC - 6 1999
510(k) Summary
SECTION I
PRODUCT NAME / DESCRIPTION
Trade Name:
Bone Marrow Aspiration Needle.
Same as Trade Name.
Usual Name:
Description: A. Intended Use:
B. Materials:
C. Additional Features:
These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.
304 Stainless Steel and polycarbonate or similar material. For more detail about materials refer to Section I - Attachments A.
Currently, Manan (Northbrook, IL) provides features such as: Luer fittings on Cannula and adjustable depth stop (Illinois style). Promex's products will incorporate these features as well.
A listing of available needle dimensions is included in Section I - Attachment B.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEC - 6 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph L. Mark Vice President Promex, Inc. 3049 Hudson Street Franklin, Indiana 46131
Re: K993435 Trade Name: Bone Marrow Aspiration Needle Regulatory Class: II Product Code: KNW Dated: October 7, 1999 Received: October 12, 1999
Dear Mr. Mark:
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 requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
2
Page 2 - Mr. Joseph L. Mark
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) 594-4595. 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,
Sincerely, yours,
HyA. Rlwdle
ames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K993435
Device Name: Bone Marrow Aspiration Biopsy Needle
Indications For Use:
These devices are intended to be used to obtain percutaneous aspiration biopsy samples of bone marrow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Rurber
(Division Sign-Off Division of General Restorative Devices K991475 510(k) Number.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)