NIPRO BLOOD COLLECTION NEEDLE by NIPRO MEDICAL CORP.

The Nipro Blood collection needles that we intend to market include gauges 18, 20, 21, and 22. Each gauge is available in various lengths from 20 to 40 mm. Blood Collection Needles are described in hypodermic single lumen needle (21 CFR 880.5570). The materials used for the components include stainless steel SUS 304 (SS), synthetic rubber, and polypropylene (PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.

AI/ML Overview

The provided document is a 510(k) summary for the Nipro® Blood Collection Needle. It establishes substantial equivalence to a predicate device (Exel International Blood collection needle, K861152A).

However, a 510(k) submission generally does not include detailed studies demonstrating device performance against specific acceptance criteria for a new, novel device, especially for a well-established product type like a blood collection needle. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details about acceptance criteria and a study proving the device meets them will not be explicitly present in this type of document because the type of study conducted for a 510(k) for a blood collection needle is primarily a comparison to a predicate, not a de novo clinical trial with new performance metrics.

Here's an analysis based on the provided text, highlighting what can be answered and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness (equivalent to predicate)	"The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical." This implies equivalent safety and effectiveness based on identical design to a legally marketed predicate.
Material Composition (equivalent to predicate)	Materials include stainless steel SUS 304, synthetic rubber, polypropylene, epoxy resin, and silicone oil, matching common materials for such devices and presumably matching the predicate.
Indications for Use (equivalent to predicate)	"Intended to be used to collect blood for various blood tests." This matches the intended use of the predicate.
Gauge and Length Availability (equivalent to predicate)	Available in gauges 18, 20, 21, 22 and lengths 20 to 40 mm, consistent with standard blood collection needles and likely the predicate.

Explanation: The document's core statement is that the Nipro and Exel devices "are exactly the same devices, therefore, all technical characteristics are identical." This is the primary "performance" metric accepted for a 510(k) for this type of device – proving substantial equivalence by demonstrating identical characteristics to a predicate. There are no explicit quantitative performance acceptance criteria (e.g., "blood flow rate must exceed X ml/min") or detailed test results presented in this summary, as the nature of a 510(k) for a Class II device like this relies heavily on comparison rather than novel performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For a device like a blood collection needle seeking substantial equivalence, a formal "test set" in the context of clinical studies with specific sample sizes might not be required if the technical characteristics are deemed identical to a predicate. The "data provenance" would likely refer to manufacturing and design specifications rather than clinical study data.

3. 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)

This information is not applicable and not provided. This type of detail is typical for diagnostic algorithms or subjective interpretation studies, not for a hardware device like a blood collection needle demonstrating substantial equivalence through technical comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for studies where expert consensus is needed to establish ground truth from subjective observations (e.g., image interpretation), which is not the case for this 510(k) submission.

5. 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 not applicable and not provided. This type of study is specific to AI or diagnostic imaging devices where human interpretation is involved. The Nipro Blood Collection Needle is a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable and not provided. This refers to AI algorithm performance, which is irrelevant for a blood collection needle.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the Nipro Blood Collection Needle in the context of this 510(k) is implicitly the technical specifications and performance of the legally marketed predicate device (Exel International Blood collection needle K861152A). The claim is that the Nipro device is "exactly the same" as the predicate in all technical characteristics, therefore it is substantially equivalent in safety and effectiveness.

8. The sample size for the training set

This is not applicable and not provided. This concept relates to machine learning models, not a physical medical device like a blood collection needle.

9. How the ground truth for the training set was established

This is not applicable and not provided. As above, this applies to machine learning, not this device.

In summary:

This 510(k) submission for the Nipro Blood Collection Needle demonstrates substantial equivalence primarily by stating that its technical characteristics, materials, and intended use are "exactly the same" as a legally marketed predicate device (Exel International Blood collection needle, K861152A). The "study" proving this amounts to the submission of design specifications, material compositions, and intended use statements that were reviewed and accepted by the FDA as being identical to the predicate. The document does not contain information about clinical trials, expert consensus, or AI performance metrics because such studies are not typically required for a 510(k) for this class and type of device when substantial equivalence to a predicate is established by identical technical characteristics.

Summary

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K99^{2699}

FEB 1 4 2000

Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined double helix symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. The logo is black and white.

NIPRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami, Florida 33172 Tel.: (305) 599-7174 Fax: (305) 599-8454

SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® BLOOD COLLECTION NEEDLE

8807.92 (a)(1)

Contact Person:

Luis Candelario General Manager

August 2, 1999 Date of Summary Preparation:

$807.92 (a)(2)

Trade Name: Nipro® Blood Collection Needle

Blood Collection Needle Common Name:

Classification Name: Hypodermic Single Lumen Needle (21 CFR 880.5570) Establishment Registration Number: 9611446 Class: II Panel: 80 Procodes: FMI

$807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: Exel International Blood collection needle (K861152A)

$807.92 (a)(4)

Description of Device:	The Nipro Blood collection needles that we intend tomarket include gauges 18, 20, 21, and 22. Each gauge isavailable in various lengths from 20 to 40 mm.
Blood Collection Needles are described in hypodermicsingle lumen needle (21 CFR 880.5570).
The materials used for the components include stainlesssteel SUS 304 (SS), synthetic rubber, and polypropylene

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(PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.

8807.92 (a)(5)

The blood collection needles are intended to be used to collect Intended Use: blood for various blood tests.

§807.92 (a)(6)

Comparison of Technical Characteristics:

The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above them that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2000

Nipro Medical Corporation c/o Ms. Kaelyn B. Hadley Nipro Medical Corporation Consultant C.L. McIntosh & Associates, Incorporated 1384 Copperfield Court Lexington, Kentucky 40514-1268

Re: K992699 Nipro® Blood Collection Needle Trade Name: Regulatory Class: II Product Code: FMI Dated: November 24, 1999 November 26, 1999 Received:

Dear Ms. Hadley:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Paqe 2 - Ms. Hadley

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.

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) 594-4692. 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 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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) Device Name: Nipro Blood Collection Needle

Indications for Use: The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

Palica monite
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital, Devices
510(k) Number 4995499

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Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).