MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE

K073705 · Shandong Qiaopai Group Co., Ltd. · FMI · Mar 24, 2008 · General Hospital

Device Facts

• Record ID: K073705
• Device Name: MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE
• Applicant: Shandong Qiaopai Group Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood. Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.

Device Story

Scalp Vein Set and Sterile Hypodermic Needles are single-use, sterile devices for vascular access or fluid injection/withdrawal. Scalp Vein Set functions as an in-dwelling device for intravenous fluid administration or blood sampling. Hypodermic needles facilitate fluid transfer. Used in clinical settings by healthcare providers. Devices provide physical access to the vascular system or body tissues; no electronic or automated processing involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, sterile, stainless steel needles. Scalp Vein Set includes tubing and needle assembly. Various gauges (16G-26G) and lengths provided. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring intravenous fluid administration, blood sampling, or injection/withdrawal of fluids from the body. For use by healthcare professionals.

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.

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion.

MAR 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shandong Qiaopai Group Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 53313

Re: K073705

Trade/Device Name: Scalp Vein Set for Single Use Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI, FOZ Dated: March 8, 2008 Received: March 10, 2008

Dear Mr. Job:

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 vour 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 - Mr. Job

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 [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,

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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Image /page/2/Picture/0 description: The image shows the logo for QIAOPAI GROUP. The logo consists of a circular symbol with Chinese characters inside, followed by the text "QIAOPAI GROUP" in capital letters. The symbol appears to be a registered trademark symbol.

# Indications for Use

510(k) Number (if known):

Device Name: Scalp Vein Set for single use

Indications for Use:

Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.

| Scalp vein set for single use | |
|-------------------------------|----------------------------|
| Specification<br>mm | Length of outside(l)<br>mm |
| 0.45 (26G) | 16±1.5 |
| 0.5 (25G) | 18±1.5 |
| 0.55 (24G) | 18±1.5 |
| 0.6 (23G) | 23±1.5 |
| 0.7 (22G) | 23±1.5 |
| 0.8 (21G) | 26±1.5 |
| 0.9 (20G) | 28±1.5 |

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Cinthony D, m

Oivision Sign-Off) vision of Anesthesiology, General Hospital fection Control, Dental Devices

K473745 510(k) Number: _

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## ® QIAOPAI GROUP

# Indications for Use

510(k) Number (if known):

Device Name: Sterile hypodermic needles for single use

Indications for Use:

Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.

| Sterile Hypodermic needle for single use | |
|------------------------------------------|-------------------------|
| Specification mm | Length of outside(l) mm |
| 0.45(26G) | 13±1.0 |
| 0. 5(25G) | 18±1.0 |
| 0.6(23G) | 25±1.5 |
| 0.7(22G) | 30±1.5 |
| 0.8(21G) | 36±1.5 |
| 0.9(20G) | 36±1.5 |
| 1.1(19G) | 36±1.5 |
| 1.2(18G) | 36±1.5 |
| 1.6(16G) | 36±1.5 |

Prescription Use V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Dimmer antin

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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