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 text describes a 510(k) summary for a "Blood Collection Needle" and largely focuses on its substantial equivalence to a predicate device. This type of submission does not typically involve the detailed performance studies, particularly those related to AI algorithms or diagnostic accuracy, that your request for "acceptance criteria and reported device performance" (especially with specifics like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) implies.

Blood collection needles are low-risk devices where performance demonstration usually revolves around adherence to established international standards for physical characteristics, sterility, and biocompatibility, rather than diagnostic accuracy metrics.

Therefore, many of the specific questions in your prompt cannot be directly answered from the provided document because they are not relevant to the type of device (a hypodermic needle) or the nature of its 510(k) submission.

Here's an attempt to answer as much as possible, interpreting "acceptance criteria and reported device performance" as compliance with relevant standards and basic physical properties mentioned:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Adhered To)	Reported Device Performance (Compliance Statement)
Physical Performance:
ISO 7864:1993 (Sterile hypodermic needles)	"The performances of the applicant device of blood collection needle comply with ISO 7864:1993"
ISO 9626:1991/AMD:2001 (Stainless steel needle tubing for the manufacture of medical devices)	"The performances of the applicant device of blood collection needle comply with ... ISO9626:1991/AMD: 2001."
Biocompatibility:
ISO 10993-1:2003(E) Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing	"The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, 'Biological Evaluation of Medical Devices'. The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility."
Specific Biocompatibility Tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemocompatibility	All necessary tests were conducted and complied with ISO 10993 requirements.
Device Size/Gauge:
Availability of common gauges	"The applicant device of blood collection needle is available in 20G, 21G and 22G."
Sterility:	"sterile" (mentioned in device description)
Disposable Nature:	"disposable" (mentioned in device description)

Study Details (Based on available information and understanding of 510(k) for this device type)

Sample size used for the test set and the data provenance: Not explicitly stated. For compliance with ISO standards for physical characteristics and biocompatibility, samples would be drawn from production batches and subjected to laboratory testing. The data provenance would be laboratory test reports, likely conducted in China given the manufacturing location. This is not "data" in the sense of patient imaging or clinical records.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For these types of devices, "ground truth" refers to objective measurements against ISO standards (e.g., needle diameter, tensile strength, sterility testing results, cytotoxicity assays), not expert interpretation of medical images or conditions.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations, not objective performance testing against standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. MRMC studies are used for diagnostic imaging devices to assess human reader performance, often with and without AI assistance. This is a physical medical device (a needle), not a diagnostic tool where human interpretation is involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve algorithms or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Objective measurements against predefined ISO standard specifications and validated laboratory test methodologies for physical properties, sterility, and biocompatibility.
The sample size for the training set: Not applicable. This device does not use machine learning or AI models, so there is no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary of what the document implies about "studies":

The "studies" for this device are laboratory-based performance tests and biocompatibility assessments conducted to demonstrate compliance with recognized international standards (ISO 7864, ISO 9626, ISO 10993). The conclusion of the submission is that "The applicant device is Substantially Equivalent (SE) to the predicate device," based on having the "same classification information, same indications and intended use, similar product design, same performance effectiveness, performance safety." This reliance on substantial equivalence, supported by standard compliance, is typical for 510(k) submissions of low-to-moderate risk medical devices without complex diagnostic or algorithmic components.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is:

1. Applicant Device Information

Trade/Proprietary Name: Blood Collection Needle Classification Information:

DEC 2 0 2007

(1) Classification Name: Needle, Hypodermic, Single Lumen

(2) Regulation Number: 880.5570

(3) Product Code: FMI

(4) Class: II

(5) Review Panel: General Hospital

2. Submitter Information

Manufacturer Name:

ShanDong WeiGao Group Medical Polymer Products Co., LTD No.312, Shichang Road Weihai, Shandong, China, 264209

Contact Person of the Submission:

Ms. Diana. Hong Mr. Eric. Chen Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, China 20030 Phone: +86-21-64264467 x 152

Fax: +86-21-64264468 x 809

Email: Diana.hong@mid-link.net Eric.chen@mid-link.net

3. Predicate Device

K number: K061483

Trade Name: VACUETTE® VISIO PLUS Blood Collection Needles Common Name: Blood Collection Needles

Shanghai Midlink Business Consulting Co.,Ltd

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Kop3107; 062

Classification Name: Needle, Hypodermic, Single Lumen Product Code: FMI

4. Device Description

The performances of the applicant device of blood collection needle comply with ISO 7864:1993 and ISO9626:1991/AMD: 2001.

The applicant device of blood collection needle is available in 20G, 21G and 22G.

5. Substantially Equivalence Determination

Comparison Analysis:

The applicant device has same classification information, same indications and intended use, similar product design, same performance effectiveness, performance safety as the predicate device.

Conclusion:

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.

6. Effectiveness and Safety Considerations

Effectiveness:

All the variant models of the applicant device are evaluated regarding the performance.

Safety Considerations:

With accordance with the Table 1 Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization or Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemo-compatibility.

Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO

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K(0.310) 33

10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.

Shanghai Midlink Business Consulting Co.,Ltd

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three curved lines representing its body and wings, giving it a modern and abstract appearance. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2007

ShanDong WeiGao Group Medical Polymer Products Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19, Lane 999 Zhongshan No. 2 Road Shanghai CHINA 200030

Re: K073127

Trade/Device Name: Blood Collection Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 31, 2007 Received: November 6, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Hong

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 Federal 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runne

Chiu Lin, Ph.D.
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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Korgu 121

Indications for Use

510(k) Number:_

Device Name: _ Blood Collection Needle

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page

Anthony D. Mnt
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).