VACU-MED® Blood Collection Needles are manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is 1" or 1½" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity. VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").

AI/ML Overview

This document is a 510(k) Premarket Notification for the SHINA CORPORATION VACU-MED® Blood Collection Needles. It does not contain the level of detail typically found in a clinical study report for evaluating AI/ML-based medical devices.

The information provided focuses on demonstrating substantial equivalence to a predicate device based on descriptive data and compliance with standards, rather than a detailed performance study with acceptance criteria in the way you've outlined for AI/ML devices.

Therefore, many of your requested items cannot be directly extracted from this document, as they are not applicable to a 510(k) submission for a non-AI/ML medical device like blood collection needles.

Here's an analysis based on the provided text, addressing what can be inferred and explicitly stating when information is not present:

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

This document does not present acceptance criteria or reported device performance in the format of a clinical study with numerical metrics like sensitivity, specificity, or accuracy.

Instead, the "acceptance criteria" are implied by compliance with established international standards for medical devices of this type, and the device's technological characteristics being similar to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 7864 (Sterile Hypodermic Needles for Single Use)	Stated as compliant with the standard.
Compliance with ISO 7886-1 (Sterile Hypodermic Syringes for Single Use)	Stated as compliant with the standard. (Note: While for syringes, needles are part of the system).
Compliance with ISO 9626 (Stainless Steel Needle Tubing for Medical Devices)	Stated as compliant with the standard. Materials are "made from the same materials (stainless steel needle tubing, polypropylene hub and needle caps, rubber needle sleeve) as the Greiner VACUETTE® blood collection needles."
Compliance with ISO 6009 (Hypodermic Needles - Colour Coding)	Stated as compliant with the standard.
Substantially equivalent in intended use, function, and basic composition to predicate device.	Stated: "The VACU-MED® Blood Collection Needles are substantially equivalent in intended use, function and basic composition to the currently marketed Greiner VACUETTE®..."
Non-toxic and non-pyrogenic.	Stated: "The needles are non-toxic and non-pyrogenic."
Sterile single-use disposable product.	Stated: "VACU-MED® Blood Collection Needles are a sterile single-use disposable product."

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 submission relies on descriptive data and compliance with standards, not on a specific clinical "test set" or patient 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 therefore not provided. This is a submission for a physical medical device (blood collection needles), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data.

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

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system requiring adjudication of interpretations.

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 therefore not provided. This is for a physical medical device, not an AI/ML system involving human readers.

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

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is compliance with established international performance standards (ISO) for hypodermic needles and the demonstrable equivalence of its physical and material properties to a legally marketed predicate device. There is no biological or diagnostic "ground truth" derived from patient data involved in this type of submission.

8. The sample size for the training set

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system that uses a training set.

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

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system that uses a training set.

Summary of the Study Proving Acceptance Criteria:

The "study" in this context is the comparison against the predicate device (Greiner VACUETTE®) and compliance with relevant international standards.

Methodology: The manufacturer (SHINA CORPORATION) submitted descriptive data comparing their VACU-MED® Blood Collection Needles to the predicate device. They asserted that their device has "similar technological characteristics" and is "made from the same materials" (stainless steel needle tubing, polypropylene hub and needle caps, rubber needle sleeve) as the predicate.
Standards Compliance: The submission explicitly states that the VACU-MED® Blood Collection Needles meet the following device-specific standards:
- ISO 7864 (Sterile Hypodermic Needles for Single Use)
- ISO 7886-1 (Sterile Hypodermic Syringes for Single Use)
- ISO 9626 (Stainless Steel Needle Tubing for Manufacture of Medical Devices)
- ISO 6009 (Hypodermic Needles for Single Use - Colour Coding for Identification)
Conclusion: Based on this descriptive data and compliance with standards, the manufacturer concluded that the VACU-MED® Blood Collection Needles are "substantially equivalent" to the predicate devices. The FDA concurred with this finding, indicating that the device meets the regulatory requirements for market clearance without requiring a full-scale clinical trial typical for more novel or higher-risk devices.

Summary

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SHINA CORPORATION VACU-MED® Blood Collection Needles Premarket Notification

001 1 8 780

510(k) Summary

Submitter

Date Prepared July 11, 2007

SHINA CORPORATION 691-1, Boheong-Lee Woosung-Myun Kongju Choongchungnam-Do Republic of Korea Contact Person: Y. N. Shin Telephone: (82) 31 711 8180 Fax: (82) 31 711 8190

Name of Device

Common Name:	Disposable blood collection needles
Proprietary Name:	VACU-MED® Blood Collection Needles (available in 20G, 21G, and 22G by 1" and 1½" lengths)
Classification Name:	Hypodermic single lumen needles
Regulation:	880.5570
Class:	Class II
Product Code:	FMI

Predicate Devices

The VACU-MED® Blood Collection Needles are substantially equivalent in intended use, function and basic composition to the currently marketed Greiner VACUETTE® (available in 20G, 21G, and 22G by 1" and 11/2" lengths), K973620.

Device Description

VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").

Intended Use

VACU-MED® Blood Collection Needles are designed for use in venous blood collection.

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<071947 Page

SHINA CORPORATION VACU-MED® Blood Collection Needles Premarket Notifie

Technological Characteristics

The VACU-MED® Blood Collection Needles have similar technological characteristics to the currently marketed predicate devices listed above. The VACU-MED® Blood Collection Needles are made from the same materials (stainless steel needle tubing, polypropylene hub and needle caps, rubber needle sleeve) as the Greiner VACUETTE® blood collection needles. The VACU-MED® Blood Collection Needles meet the following device specific standards:

ISO 7864 (1993), Sterile Hypodermic Needles for Single Use ISO 7886-1 (1993), Sterile Hypodermic Syringes for Single Use ISO 9626 (1991), Stainless Steel Needle Tubing for Manufacture of Medical Devices ISO 6009 (1992), Hypodermic Needles for Single Use - Colour Coding for Identification

Performance Data (non-clinical or clinical)

The VACU-MED® Blood Collection Needles are substantially equivalent to the predicate devices based on the descriptive data, compliance with standards, and indications for use.

Conclusion

The technological characteristics and performance data for the VACU-MED® Blood Collection Needles demonstrates they are substantially equivalent to the predicate devices.

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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 stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.

OCT 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shina Corporation Ms. Carole Stamp Senior Principal Regulatory and Quality Advisor Regulatory and Clinical Research Institute, Incorporation 5353 Wayzata Boulevard, Suite 305 Minneapolis, Minnesota 55416

Re: K071947

Trade/Device Name: Shina Corporation VACU-MED® Blood Collection Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen needle Regulatory Class: II Product Code: FMI Dated: July 11, 2007 Received: July 31, 2007

Dear Ms. Stamp:

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. Stamp

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 (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.

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) 276-0120. 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,

Qurs
Chiu Lin, Ph.D.

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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SHINA CORPORATION VACU-MED® Blood Collection Needles Premarket Notification

Indications for Use

510(k) Number: Not assigned

K07-1947

Device Name: Shina Corporation VACU-MED® Blood Collection Needles

Indications For Use:

VACU-MED® Blood Collection Needles are designed for use in venous blood collection.

Prescription Use X AND/OR (21 CFR 801.Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Vision Sign-Off)

nsion of Anesthesiology. General Hospital nection Control, Dental Devices

*10(k) Number: K071947

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).