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.

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.

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.

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K023917 510(k) Summary, the acceptance criteria are implicitly tied to the performance of the predicate device and the prevention of needlestick injuries. The document does not explicitly state quantitative acceptance criteria with specific thresholds (e.g., "99% activation rate"). Instead, it focuses on achieving the same results as the predicate device regarding needle tip protection.

Acceptance Criteria (Implied)	Reported Device Performance
Minimize accidental needlestick injuries	Successful simulated use study
Shield the needle effectively after use	Needle tip is protected inside the device after use
Substantially equivalent to predicate devices in function	Achieves the same results as predicate device (Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document mentions "a successful simulated use study" but does not provide details on the number of units or uses tested.
Data Provenance: The study was conducted by Kawasumi Laboratories, Inc., located in Tokyo, Japan. The study is described as a "simulated use study," implying it was conducted in a controlled environment, likely within their facility. It is a prospective study as it was conducted specifically to demonstrate the device's performance for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given text. The study is described as a "simulated use study" but does not mention the involvement of experts in establishing ground truth or evaluating the results. The determination of "success" likely relied on internal assessment criteria by Kawasumi Laboratories.

4. Adjudication Method for the Test Set

This information is not provided in the given text. There is no mention of independent reviewers or an adjudication process for the "simulated use study."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret medical images with or without AI assistance. The device in question is a medical device designed to prevent needlestick injuries, and such a study would not be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device described. The device is a physical product (winged needle set with an antineedle stick protector), not an algorithm or software. Its performance inherently involves human interaction during its use to activate the protector.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would likely be a direct observation of whether the needle tip was successfully shielded or retracted after simulated use, thereby preventing accidental needlestick. The text states: "In both devices, the needle tip is protected inside the device after use." This implies the ground truth for success was the successful physical enclosure of the needle tip.

8. The Sample Size for the Training Set

This question is not applicable as there is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set."

Summary

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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: 81-3-376-1151 81-3-376-3235 Fax: Contact: Mr. K. So

Authorized Contact

Kawasumi Laboratories America, Inc. 5905 C Hampton Oaks Parkway Tampa, Fl 33610 Phone: 813-630-5554 813-630-5033 Fax: Contact: Mr. Jack Pavlo

1. Name of Device: Winged Needle Sets with an Antineedle Stick Protector
  Common Name: Needle stick protector
1. 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
1. 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
1. 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.
1. 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.
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. 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.
1. 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

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human figures, one behind the other, with their arms raised.

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 (301) 594-4618. 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/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

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.