K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)

K102890 · Kawasumi Laboratories America, Inc. · FPA · Oct 21, 2010 · General Hospital

Device Facts

• Record ID: K102890
• Device Name: K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
• Applicant: Kawasumi Laboratories America, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Oct 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle. The K-Shield Small Vein Infusion Set with Antineedle Stick Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.

Device Story

Sterile, single-use winged needle sets for peripheral venous access; includes needle, wing assembly, tubing, and female luer connector. Multisample luer adapter facilitates blood transfer to vacuum tubes. Features integral, active antineedle stick protector to prevent accidental injuries. Used in clinical settings by healthcare providers. Modification from predicate involves streamlined protector design (removed barrel wings/slits) to simplify needle removal. Device provides venous access for infusion or sampling; safety mechanism reduces risk of needlestick injury to clinicians.

Clinical Evidence

Simulated use study performed to assess safety and effectiveness of the antineedle stick protector. Study objectives included identifying design problems, evaluating directions for use, and informing user training. Results: Successful trial with no needle sticks reported; user questionnaires indicated no issues with device operation.

Technological Characteristics

Sterile, single-use winged needle sets. Components include needle, wing assembly, tubing, and female luer connector. Features integral, active antineedle stick protector. Streamlined design removes barrel wings and slits compared to predicate. No specific material standards or software components described.

Indications for Use

Indicated for patients requiring peripheral venous access for blood collection or solution infusion. Intended for use by healthcare professionals. Contraindications not specified.

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

• Kawasumi Laboratories Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector (K023917)
• Small Vein Infusion Set with Antineedle Stick Protector (K023917)
• Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set (K980414)

Submission Summary (Full Text)

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#### EXHIBIT 27

KID 2890

OCT 2 1 2010

### SPECIAL 510(K): DEVICE MODIFICATION SUMMARY September 29, 2010

1. SUBMITTER U.S. AGENT:

KAWASUMI LABORATORIES, INC. 3-28-15 Minami-Ohi Shinagawa-Ku, Tokyo 140 Japan PHONE: [phone] FAX: CONTACT: Mr. Yuasa

KAWASUMI LABORATORIES AMERICA, INC 4723 Oak Fair Blvd. Tampa, FL 33610 PHONE: [phone] [phone] FAX: CONTACT: Mr. Jack Pavlo

2. NAME OF DEVICE: Kawasumi Laboratories Small Vein Infusion Set with Antineedle Stick Protector and Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector COMMON NAME: Winged Collection Set, Small Vein Set PROPRIETARY NAME: K-Shield Small Vein Infusion Set with Antineedle Stick Protector and

K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector [Note: K-Shield is a Registered Trademark for the Kawasumi brand of needle protection devices.] CLASSIFICATION: Class II, Codified at 21 CFR 880.5540. PRODUCT CODE NUMBER: FPA

- 3. PREDICATE DEVICE: Kawasumi Laboratories Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector, and , Small Vein Infusion Set with Antineedle Stick Protector (K023917) and Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set (K980414 ).
- 4. DESCRIPTION OF THE DEVICE: The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are sterile, single use devices commonly used to access a palient's veins for blood collection or solution infusion. Both devices are comprised of a needle and wing assembly with tubing and a female luer connector. The Multisample Luer Connector is used to transfer blood from the Winged Collection Set to a vacuum tube. Both devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.
- 5. SIGNIFICANT PERFORMANCE CHARACTERISTICS: There are no new performance characteristics of this device compared to the substantially equivalent devices marketed for sale in interstate commerce. Both devices are used to access a patient's vein for blood collection or solution infusion and provide an integral antineedle stick protector feature.
- 6. INDICATIONS FOR USE: The K-Shield Small Vein Infusion Set with Antineedle Stick Protector is used to access a patient's vein for solution infusion. The device incorporates an integral, active antineedle stick protector. The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector is used to access a patlent's vein for blood sampling. The device incorporates an integral, active antineedle stick protector
- 7.TECHNOLOGICAL CHARACTERISTICS: The design and technological characteristics of the K-Shield Small Vein Infusion Set with Antineedie Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Connector and Antineedle Stick Protectorg are substantially equivalent to the identified predicate devices. The design technological characteristics of the K-Shield devices are identical to K023917 with the exception of the modification to the antineedle stick protector design which is streamlined to remove the barrel wings and slits. This modification simplifies the needle removal process siteammed to remove inc ourrely or effectiveness of the devices performance for their intended use.

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- SUMMARY OF NON-CLINICAL TESTING DATA: The following testing was performed to 8. determine the safety and effective of the Small Vein Infusion Set with Antineedle Stick Protector and the Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector and assess the product's substantial equivalence to the listed predicate devices:

| Test | Result |
|--------------------------------------------------|--------|
| Kawasumi Internal Test: Wing Activation | PASS |
| Kawasumi Internal Test: Wing Deactivation | PASS |
| Kawasumi Internal Test: Defeat Locking Mechanism | PASS |

- 9. SIMULATED CLINICAL OBSERVATIONS: Kawasumi Laboratories performed a simulated use study to determine the safety and effectiveness of the Antineedle Stick Protector for use with winged needle sets. The study objectives were to identify possible antineedle stick protector design problems, and for directions for use and labeling deficiencies, and to gain information for designing a user training program to facilitate proper use of the antineedle stick protector in the clinical setting.
Results: The simulated use study was successful. No needle sticks occurred during the trial. Comments on the Questionnaires did not indicate any problems in using the proposed Kawasumi winged needle sets with antineedle stick protectors.

- 10. PERFORMANCE DATA: Kawasumi Laboratories belleve that the results of these tests show the device is suitable for its intended use.
- The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the 11. CONCLUSIONS: Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are substantially equivalent to the identified predicate devices and perform as well as the predicate devices Small Vein Infusion Set with Antineedle Stick Protector and the Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector for their intended use.

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Image /page/2/Picture/0 description: The image shows a partial view of a document with the words "DEPARTMENT OF" visible. To the left of the text is a logo or emblem featuring a stylized design with curved lines. The text is in a simple, sans-serif font, and the overall impression is that of an official document or letterhead.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jack Pavlo Manager of Technical Affairs Kawasumi Laboratories America, Incorporated 4723 Oak Fair Boulevard Tampa, Florida 33610

OCT 2 1 2010

Re: K102890

Trade/Device Name: K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 29, 2010 Received: September 30, 2010

Dear Mr. Pavlo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Pavlo ·

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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## Indications for Use

OCT 2 1 2010

510(k) Number (if known): K102890

Device Name: K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector

Indications For Use: The K-Shield Winged Collection Set with Multisample Luer

Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize

accidental needle stick injuries when used to shield the needle.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

l C. A
10/15/10

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

Page 1 of *_*_

510(k) Number: K102890

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# Indications for Use

OCT 2 1 2010

510(k) Number (if known): K102890

Device Name: K-Shield Small Vein Infusion Set with Antineedle Stick Protector

Indications For Use: The K-Shield Small Vein Infusion Set with Antineedle Stick

Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rici C. Ch
10/15/12

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

Page 1 of

510(k) Number: K102890