VACU-MED BLOOD COLLECTION NEEDLES

K071947 · Shina Corp. · FMI · Oct 12, 2007 · General Hospital

Device Facts

• Record ID: K071947
• Device Name: VACU-MED BLOOD COLLECTION NEEDLES
• Applicant: Shina Corp.
• Product Code: FMI · General Hospital
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

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

Device Story

VACU-MED® Blood Collection Needles are sterile, single-use, disposable devices for venous blood collection. The device consists of a double-ended stainless steel needle attached to a threaded polypropylene hub. One end of the needle is designed to connect to a needle holder for insertion into an evacuated blood collection tube; this end features a protective rubber sleeve. The opposite end is used for venipuncture and is available in 20G, 21G, and 22G sizes with 1" or 1½" lengths. The device is operated by healthcare professionals in clinical settings. The needle caps and perforated paper label maintain sterility and indicate integrity until use. The device facilitates the collection of blood samples into evacuated tubes for diagnostic testing.

Clinical Evidence

Bench testing only. The device demonstrated compliance with ISO 7864, ISO 7886-1, ISO 9626, and ISO 6009 standards.

Technological Characteristics

Materials: stainless steel needle tubing, polypropylene hub and needle caps, rubber needle sleeve. Standards: ISO 7864 (sterile needles), ISO 7886-1 (syringes), ISO 9626 (tubing), ISO 6009 (color coding). Form factor: 20G-22G, 1"-1½" lengths. Sterilization: sterile, single-use.

Indications for Use

Indicated for venous blood collection in patients requiring blood sampling.

Regulatory Classification

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.

Predicate Devices

• Greiner VACUETTE® (K973620)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### 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 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").

## 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 [phone]. 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 [phone] or [phone] 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)

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nsion of Anesthesiology. General Hospital nection Control, Dental Devices

*10(k) Number: K071947