WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR

K023917 · Kawasumi Laboratories, Inc. · FPA · Feb 26, 2003 · General Hospital

Device Facts

• Record ID: K023917
• Device Name: WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
• Applicant: Kawasumi Laboratories, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles for Kawasumi products manufactured with a wing and needle assembly for solution infusion and blood sampling.

Device Story

Polymeric antineedle stick protector integrated into winged needle sets; used for peripheral venous access during solution infusion or blood collection. Device shields needle tip upon removal from patient to minimize accidental needlestick injuries. Operated by clinicians in clinical settings. Provides physical barrier between user and contaminated needle post-procedure. Benefits include reduced risk of occupational bloodborne pathogen exposure.

Clinical Evidence

Bench testing only. Successful simulated use study conducted to determine acceptability for minimizing accidental needlestick injuries.

Technological Characteristics

Polymeric construction; integrated active safety shield; winged needle assembly; sterile; single-use.

Indications for Use

Indicated for peripheral venous access for solution administration or blood collection in patients requiring infusion or sampling. Single-use, sterile device.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set (K013488)
• Kawasumi Winged Collection Set w/ Multi-Sample Luer Adapter
• Kawasumi Small Vein Infusion Set

Submission Summary (Full Text)

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FEB 2 6 2003

# EXHBIT 29

K023917

## 510(k) SUMMARY

### 1. Submitter

Kawasumi Laboratories, Inc. 3-28-15 Minami-Ohi Shinagawa-Ku, Tokyo 140 Japan Phone: [phone] Fax: Contact: Mr. K. So

Authorized Contact

Kawasumi Laboratories America, Inc. 5905 C Hampton Oaks Parkway Tampa, Fl 33610 Phone: [phone] Fax: Contact: Mr. Jack Pavlo

- 2. Name of Device: Winged Needle Sets with an Antineedle Stick Protector
Common Name: Needle stick protector

- 3. Predicate Device: Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set Kawasumi Winged Collection Set w/ Multi-Sample Luer Adapter Kawasumi Small Vein Infusion Set
- 4. Description of the Device: The Antineedle Stick Protector is a polymeric device designed to be used integral with winged needle sets and shields the needle when the needle with hub and wing assembly is removed from the patient
- 5. Intended Use: The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles for Kawasumi products manufactured with a wing and needle assembly for solution infusion and blood sampling.
- 6. Technological Characteristics: The Antineedle Stick Protector is substantially equivalent to the Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set, Kawasumi Winged Collection Set w/ Multi-Sample Luer Adapter, and Kawasumi Small Vein Infusion Sets. The antineedle stick protector is activated in a different manner than the BD Safety-Lok Blood Collection Set, but achieve the same results. In both devices, the needle tip is protected inside the device after use.
- 7. Performance Data: Kawasumi Laboratories has conducted a successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries. Kawasumi Laboratories believes the successful simulated use study shows the device is suitable for its intended use and is substantially equivalent to the predicate device.
- 8. Conclusions: The device is as safe as the predicate device and performs as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kawasumi Laboratories, Incorporated C/O Mr. Donald Stone Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, N.W. Suite 200 Washington, DC 20036

Re: K023917

Trade/Device Name: Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector, Small Vein Infusion Set with Antineedle Stick Protector Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 12, 2003 Received: February 13, 2003

Dear Mr. Stone:

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 - Mr. Stone

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/dsma/dsmamain.html

Sincerely vours.

Susan Runner

Susan Runner, DDS, MA Interim 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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### Exhibit 12

#### Indications for Use

510(k) Number: K023917

Device Name: Small Vein Infusion Set with Antineedle Stick Protector

- Indications for Use: The Small Vein Infusion Set with Antineedle Stick Protector is a single use, sterile device used for peripheral venous access for solution administration or blood collection. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.
Device Name: Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector

Indications for Use The Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector is a single use, sterile, blood collection device used for peripheral venous access for blood sampling. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.

Lucia Cucurati

510(k) Number: K023917