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 Description

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 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector (K060580). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through extensive clinical trials. Therefore, the information provided for acceptance criteria and studies is limited and different from what would be expected for a novel device requiring a PMA (Premarket Approval).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Metric	Reported Device Performance
Biocompatibility requirements	"The device meets all the biocompatibility... test requirements."
Pyrogenicity test requirements	"The device meets all the... pyrogenicity test requirements."
Minimize accidental needlestick injuries (efficacy of antineedle stick protector)	"Kawasumi Laboratories has conducted a successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries." "The Antineedle stick protector has successfully been clinically evaluated." Conclusion: "...Antineedle stick protector... performs as well as the predicate device" for preventing accidental needle stick injuries.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for simulated use study or clinical evaluation.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to have been conducted by Kawasumi Laboratories. Given they are based in Japan with a U.S. agent, the studies could have been conducted in either region. The studies were likely prospective as they were specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The "simulated use study" and "clinically evaluated" phrases do not detail the methodology for expert involvement or ground truth establishment.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study or AI component: This device is a physical medical device (infusion set with a safety mechanism), not an AI/software device. Therefore, an MRMC study or AI-related effectiveness is not applicable and was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable: As noted above, this is a physical device, not an algorithm.

7. The type of ground truth used:

For Biocompatibility and Pyrogenicity: Established by laboratory test standards and methodologies for these specific tests (e.g., ISO standards for biocompatibility).
For Antineedle Stick Protector Efficacy: Based on the results of the "simulated use study" and "clinical evaluation." The specific "ground truth" for these would likely be defined by the study protocols themselves, such as absence of needlestick injuries in the simulated tasks or real-world use for the clinical evaluation. The document states the device was found "acceptable for use to minimize accidental needlestick injuries" and that it "successfully been clinically evaluated." The ultimate ground truth is implied to be actual prevention of needlestick injuries.

8. The sample size for the training set:

Not Applicable: There is no "training set" in the context of this physical device.

9. How the ground truth for the training set was established:

Not Applicable: As there is no training set, this question is not applicable.

Summary

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K060580

Page 1 of 2

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: 81-3-376-1151 FAX: 81-3-376-3235 CONTACT: Mr. Kuroiwa

KAWASUMI LABORATORIES AMERICA, INC 4723 Oak Fair Blvd. Tampa, FL 33610 PHONE: (813) 630-5554 (813) 630-5033 FAX: CONTACT: Mr. Jack Pavlo

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

1. PREDICATE DEVICE: Exel Int Secure Touch Safety Huber Infusion Set
1. 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.
1. 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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1. 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.
1. 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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

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Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.