Blood collection needle is a sterile and disposable medical device. It is consist of a puncturing needle which is punctured into vein, a bottle needle which is insert to the blood collection bottle to collect blood, a needle holder which connects the puncturing needle and bottle needle, two needle caps which protect puncturing needle and bottle needle and a latex cover to protect bottle needle.

AI/ML Overview

The provided document is a 510(k) summary for a Disposable Blood Collection Needle and does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for software or AI-driven medical devices.

Instead, this document describes a traditional medical device (a needle) and its substantial equivalence to a predicate device. The "testing" section refers to adherence to international standards and biological evaluation, not performance against specific acceptance criteria for characteristics like sensitivity, specificity, or accuracy, which are common in AI/software device evaluations.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) submission. I will fill in what information is available and indicate where the information is not present.

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

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Design Specifications	Not explicitly stated as acceptance criteria, but implies adherence to standard design principles.	"met all design specifications"
Substantial Equivalence	To predicate device K073127 based on: - Similar indications for use - Similar design features - Similar functional features - Same safety compliance	"substantially equivalent (SE) to the predicate devices."
Material Properties (Stainless Steel)	Conformance to ISO 9626:1991 (Stainless steel needle tubing for the manufacture of medical devices/Amendment:2001)	Implied by "designed, tested and will be manufactured in accordance with"
Sterility & Single Use	Conformance to ISO 7864:1993 (Sterile hypodermic needles for single use)	Implied by "designed, tested and will be manufactured in accordance with"
Biocompatibility/Biological Safety	Conformance to ISO 10993 series: - ISO 10993-1 (Guidance on selection of tests) - ISO 10993-4 (Interactions with Blood) - ISO 10993-5 (In vitro cytotoxicity) - ISO 10993-10 (Irritation and delayed-type hypersensitivity) - ISO 10993-11 (Systemic toxicity) - ISO 10993-12 (Sample preparation and reference materials)	Implied by "designed, tested and will be manufactured in accordance with" and "Laboratory testing was conducted to validate and verify... that the proposed device... met all design specifications"

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 document. The document refers to "Laboratory testing" and "Biological Evaluation," but does not specify sample sizes for these tests, nor the origin or type of data (retrospective/prospective, country of origin).

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 is a physical medical device (a needle), not an AI/software device requiring expert interpretation for ground truth establishment.

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

This information is not applicable and not provided. As above, this type of adjudication is typically for image or data interpretation, not for a physical device like a blood collection needle.

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 information is not applicable and not provided. An MRMC study is for evaluating diagnostic performance, often for AI-assisted image interpretation. This document is about a physical blood collection needle.

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

This information is not applicable and not provided. This concept relates to AI algorithm performance, which is not relevant to this device. The device itself is a standalone physical product.

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

This information is not applicable and not provided in the context of an AI-driven ground truth. The "ground truth" for this device's performance would be its adherence to the specified ISO standards for materials, sterility, and biocompatibility, as confirmed by laboratory testing.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided. There is no "training set" or corresponding ground truth establishment methodology in the context of this device.

Summary

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APR - 6 2011

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510(k) Report for Disposable Blood Collection Needle- Section 111 510(k) Summary

Section III. 510(k) Summary

Disposable Blood Collection Needle

Weihai Hongyu Medical Devices Co., Ltd.

(As required by 21 CFR 807.92)

1. Date Prepared: Nov.18, 2010

2. Sponsor Information

Weihai Hongyu Medical Devices Co., Ltd. No.86, Shenzhen Road, Weihai City, China. 264205 Contract Person: YanPing. Li Phone: +86-631-3636943 Fax: +86-631-3636910 Email: whlyp1979@vip.sina.com

3. Submission Correspondent

Ms. Diana Hong Mr. Tarzan Wang Shanghai Mid-Link Business Consulting Co., Ltd P.O. BOX 237-023 Shanghai, 200237, China Tel: +86-21-64264467 Fax:+86-21-64264468 Email: Diana.hong(@mid-link.net

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4. Proposed Device Information

Device Common or Usual name: Disposable Blood Collection Needle; Device Trade or Proprietary Name: Blood Collection Needle Classification Name: Needle, Hypodermic, Single Lumen; Regulatory Class: II Regulation number: 21CFR 880.5570; Product Code: FMI; Panel: General Hospital Model: 18G, 20G, 21G, 22G, 23G

5. Predicate Device

Blood Collection Needle (K073127)

6. Device Description

7. Intended use

Disposable Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.

8. Substantial Equivalence

The Disposable Blood Collection Needles shares the similar indications for use, design features, functional features, same safety compliance. Therefore the proposed device is substantially equivalent (SE) to the predicate devices.

9. Testing

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The Disposable Blood Collection Needle is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

ISO 7864:1993 Sterile hypodermic needles for single use;

ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices/ Amendment:2001

ISO 10993, Biological Evaluation of Medical Devices; Including:

ISO 10993-1:2003, Biological Evaluation of Medical Devices - Part 1: Guidance on selection of tests:

ISO 10993-4:2002, Biological Evaluation of Medical Devices – Part 4: Selection of test for interactions with Blood

ISO 10993-5:1999, Biological Evaluation of Medical Devices - Part 5: Test for in vitro cytotoxicity;

ISO 10993-10:2002, Biological Evaluation of Medical Devices - Part 10: Tests for irritation and delayed-type hypersensitivity;

ISO 10993-11:2006, Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity;

ISO 10993-12:2002, Biological Evaluation of Medical Devices – Part 12: Sample preparation and reference materials

Non-Clinical Conclusion:

Laboratory testing was conducted to validate and verify that the proposed device, Disposable Blood Collection Needle met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~~WO66~~G609 Silver Spring, MD 20993-0002

Weihai Hongyu Medical Devices Company, Limited C/O Ms. Diana Hong Shanghai Mid-Link Business Consulting Company, Limited P.O. Box 237-023 Shanghai CHINA 264200

APR - 6 2011

Re: K103587

Trade/Device Name: Disposable Blood Collection Needle 18G, 20G, 21G, 23G, 23G Regulation Number: 21 CFR 880.5570

Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 18, 2011 Received: March 21, 2011

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any l'ederal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Jams I Desotud
for 7

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section II. Indications for Use Statement

510(k) Number: Device Name:

Disposable Blood Collection Needle 18G, 20G, 21G, 22G, 23G

Indications for Use:

Disposable Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.

Prescription Use ____X AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Chiga 4/6/11

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K10358

Page 1 of 1

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).