(55 days)
These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.
A. Intended Use: These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow. B. Materials: 304 Stainless Steel and polycarbonate or similar material. For more detail about materials refer to Section I - Attachments A. C. 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.
Here's an analysis of the provided text regarding acceptance criteria and study details:
The provided documents do not contain information about acceptance criteria or a study that proves the device meets those criteria.
The documents are a 510(k) summary and an FDA clearance letter for a "Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study with the details you've requested.
Here's a breakdown of why each point you asked for cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary describes the device's intended use and materials, but no performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No experts, ground truth establishment, or test set is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned as there's no test set described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is completely irrelevant to a bone marrow aspiration needle. MRMC studies are typically for imaging devices or AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable to this device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.
In summary: The provided 510(k) documents focus on demonstrating that the "Bone Marrow Aspiration Needle" is substantially equivalent to existing devices based on its intended use, materials, and design, rather than presenting a performance study against specific acceptance criteria. For devices like this, substantial equivalence is often established through comparison of design features, materials, and intended use, sometimes supported by basic engineering tests (e.g., strength, sterility), but not typically detailed clinical performance studies in the way you're asking for.
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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.
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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.
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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
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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)
§ 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.