K-SHIELD PORT ACCESS INFUSION SET

K060580 · Kawasumi Laboratories, Inc. · FPA · Jun 6, 2006 · General Hospital

Device Facts

• Record ID: K060580
• Device Name: K-SHIELD PORT ACCESS INFUSION SET
• Applicant: Kawasumi Laboratories, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.

Device Story

Sterile, single-use intravascular administration set; features 90-degree non-coring Huber needle; non-DEHP PVC tubing; optional Y-connector or needleless access connector. Integral antineedle stick protector activates upon needle removal from implanted port. Used in hospital settings by clinicians for medication delivery (e.g., chemotherapy) and blood sampling. Protects clinicians from accidental needlestick injuries; maintains fluid delivery functionality equivalent to standard infusion sets.

Clinical Evidence

Bench testing only. Conducted simulated use study to evaluate antineedle stick protector efficacy in minimizing injuries. Performed biocompatibility and pyrogenicity testing on fluid-contacting materials. No clinical trials reported.

Technological Characteristics

Non-coring 90-degree Huber needle; non-DEHP polyvinyl chloride (PVC) tubing; integral mechanical antineedle stick protector. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients requiring access to an implanted medication port for solution infusion and blood sampling. Used by clinicians to minimize accidental needle stick injuries during needle removal.

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

• Exel Int Secure Touch Safety Huber Infusion Set

Submission Summary (Full Text)

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K060580

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#### EXHIBIT 42

## JUN - 6 2006

#### 510(K) SUMMARY

SUBMITTER 1.

U.S. AGENT:

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

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 Port Access Infusion Set with Antineedle Stick Protector COMMON NAME: Port Access Infusion Set or Huber Needle Infusion Set PROPRIETARY NAME: K-Shield Port Access Infusion Set CLASSIFICATION: Class II, Codified at 21 CFR 880.5540. PRODUCT CODE NUMBER: FPA

- 3. PREDICATE DEVICE: Exel Int Secure Touch Safety Huber Infusion Set
- 4. DESCRIPTION OF THE DEVICE: The Port Access Infusion Set with Antineedle Stick Protector is sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector or a needleless access connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries.
- The device is used for accessing an implanted medication port by puncturing the BASIC CONCEPT: septum of the medication port and is used for the delivery of medication and for blood sampling. Fluid administration through the non-DEHP polyvinyl chloride fluid pathway of the port access infusion set are those generally used in hospitals and for delivery of chemotherapy. The device includes an integral antineedle stick device that when used prevent clinician's needle stick injuries
- SIGNIFICANT PERFORMANCE CHARACTERISTICS: There are no new performance characteristics of this device compared to the substantially equivalent device marketed for sale in interstate commerce. Both deliver fluids to the vascular system through a non reactive material and provide an integral antineedle stick protector feature.
- The Port Access Infusion Set with Antineedle Stick Protector is routinely used to 5. INTENDED USE: access implanted medication ports for the delivery of medications. The device incorporates an integral antineedle stick protector used to prevent accidental needle stick injuries to the clinician.
- 6. TECHNOLOGICAL CHARACTERISTICS: There are no technological characteristics of this device to the substantially equivalent device from Kawasumi Laboratories being marketed for sale in interstate commerce.

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- 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. Also, Kawasumi Laboratories has conducted biocompatibility tests on the body fluid contacting material portions of the device and Kawasmi Laboratories believe that the results of these tests and the clinical evaluation show the device is suitable for its intended use.
- 8. CONCLUSIONS: The device meets all the biocompatibility and pyrogenicity test requirements. The Antineedle stick protector has successfully been clinically evaluated. Therefore, it is safe as the predicate device and performs as well as the predicate device

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

Kawasumi Laboratories, Incorporated C/O Mr. Jack Pavlo Authorized Representative Kawasumi Laboratories America, Incorporated 4723 Oak Fair Boulevard Tampa, Florida 33610

Re: K060580

Trade/Device Name: Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 3, 2006 Received: March 8, 2006

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.

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. 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); 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 vour 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 vours.

Cars

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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K060580

### EXHIBIT 40

# Indications for Use

510(k) Number (if known): K060580

Device Name: Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector Indications For Use:

The Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.

Prescription Use ×

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Antony V. min

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 of Andrest resiology, General Hospital, Jon Control, Lontal Devices

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