(1) The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector is a single use, sterile set designed for vascular access for dialysis. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.

(2) The K-Shield Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile set designed for vascular access for blood withdrawal. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles

(3) The K-Shield Phlebotomy Set with Antineedle Stick Protector is a single use, sterile set designed for vascular access for blood withdrawal. The antineedle stick device is an integral, active safety device intended to minimize accidental needles stick injuries when used to shield needles

Name: Kawasumi A.V. Fistula Set

Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.

Name: Kawasumi Laboratory Blood Drawing Kit

Intended Use: This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

Name: Kawasumi Laboratories Phlebotomy Set

Intended Use: This device is intended to be used to access a patient's vein and as a monduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

Device Description

The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and K-Shield Phlebotomy Set with Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's vascular system for dialysis and blood withdrawal. The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector and K-Shield Phlebotomy Set with Antineedle Stick Protector devices are comprised of a needle and wing assembly with tubing and a female luer connector. The K-Shield Blood Drawing Kit is comprised of a needle and wing assembly, tubing and a blood collection bag. The devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.

AI/ML Overview

The provided document describes modifications to existing devices (K-Shield Arterial Venous Fistula Set, K-Shield Blood Drawing Kit, and K-Shield Phlebotomy Set with Antineedle Stick Protector) and their substantial equivalence to predicate devices, rather than an AI/ML device that requires performance metrics like accuracy, sensitivity, and specificity against specific acceptance criteria.

The document focuses on non-clinical testing for safety and effectiveness, particularly related to the anti-needle stick protector mechanism. Therefore, much of the requested information regarding AI/ML device performance, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable or available in this document.

However, I can extract the relevant acceptance criteria and results from the non-clinical testing described.

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied "PASS" for substantial equivalence)	Reported Device Performance
Kawasumi Internal Test: Wing Activation	PASS	PASS
Kawasumi Internal Test: Wing Deactivation	PASS	PASS
Kawasumi Internal Test: Defeat Llocking Mechanism	PASS	PASS
Simulated Use Study (Safety/Effectiveness of Anti-Needle Stick Protector)	No needle sticks during trial; No problems in using devices	No needle sticks occurred during the trial; No problems indicated in using the devices

Non-Applicable Information for this Device (as per the provided document):

The following information is typically relevant for AI/ML device studies, but is not provided or not applicable to this 510(k) submission which describes a modification to a medical device with an anti-needle stick protector:

Sample size used for the test set and the data provenance: Not specified for the internal tests. The "simulated use study" doesn't provide a quantitative sample size for users. No mention of data provenance (country, retrospective/prospective) for these types of engineering tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these tests is defined by the physical function of the device (e.g., whether the wing activates, deactivates, or the locking mechanism can be defeated).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for these engineering tests.
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: Not applicable as this is not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the "PASS" results is based on the device's mechanical function meeting design specifications. For the simulated use study, the ground truth was the absence of needle sticks and user feedback.
The sample size for the training set: Not applicable. No AI/ML model.
How the ground truth for the training set was established: Not applicable. No AI/ML model.

Summary of the Study:

The study described is a series of non-clinical bench tests and a simulated use study to ensure the modified anti-needle stick protector functions correctly and does not introduce new safety concerns. The "study" aims to demonstrate substantial equivalence to predicate devices, focusing on the mechanical and safety features of the device rather than diagnostic accuracy or human performance improvement.

Summary

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K102994
NOV - 3 2010

SPECIAL 510(K): DEVICE MODIFICATION SUMMARY October 8, 2010

SUBMITTER l.

U.S. AGENT:

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. Yuasa

KAWASUMI LABORATORIES AMERICA, INC 4723 Oak Fair Blvd. Tampa, FL 33610 PHONE: (813) 630-5554 FAX: (813) 630-2033 CONTACT: Mr. Jack Pavlo

1. NAME OF DEVICE: Kawasumi Laboratories Arterial Venous Fistula Set with Antineedle Stick Protector, Blood Drawing Kit with Antineedle Stick Protector, and Phlebotomy Set with Antineedle Stick Protector
  COMMON NAME: Arterial Venous Fistula Set, Blood Drawing Kit, Phlebotomy Set
PROPRIETARY NAME: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and K-Shield Phlebotomy Set with 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 880.5570. PRODUCT CODE NUMBER: FMI
1. PREDICATE DEVICE: Kawasumi Laboratories Large With Antineedle Stick Protector (K073257), Medisystems Masterguard (K932074) and the Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set (K980414 ).
1. DESCRIPTION OF THE DEVICE: The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and K-Shield Phlebotomy Set with Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's vascular system for dialysis and blood withdrawal. The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector and K-Shield Phlebotomy Set with Antineedle Stick Protector devices are comprised of a needle and wing assembly with tubing and a female luer connector. The K-Shield Blood Drawing Kit is comprised of a needle and wing assembly, tubing and a blood collection bag. The devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.
- SIGNIFICANT PERFORMANCE CHARACTERISTICS: There are no new performance characteristics of this device compared to the substantially equivalent devices marketed for sale in interstate commerce. All devices are used to access a patient's vascular system for dialysis or for blood collection and provide an integral antineedle stick protector feature.

INDICATIONS FOR USE: 6..

న.

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1. TECHNOLOGICAL CHARACTERISTICS: The design and technological characteristics of the K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and the K-Shield Phlebotomy Set with Antineedle Stick Protector are substantially equivalent to the identified predicate devices. The design technological characteristics of the K-Shield devices are identical to K073257 with the exception of the modification to the antineedle stick protector. This modification improves the performance of the antineedle stick protector and has no significant impact on safety or effectiveness of the devices performance for their intended use.
1. SUMMARY OF NON-CLINICAL TESTING DATA: The following testing was performed to determine the safety and effectiveness of the K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and the K-Shield Phlebotomy Set with Antineedle Stick Protector use 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 Llocking Mechanism	PASS

1. 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 antinedle stick rortector 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.
1. PERFORMANCE DATA: Kawasumi Laboratories believe that the results of these tests show that the device is suitable for its intended use.
1. CONCLUSIONS: The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and K-Shield Phlebotomy Set with Antineedle Stick Protector are substantially equivalent to the identified predicated devices and performs as well as the predicate devices Large Wing Sets with Antineedle Stick Protector (073257), Medisystems Masterguard (K932074) and the Becton Dickinson Vacutiner Safety-Lok Blood Collection Set (980414) for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines emanating from the figure's head.

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

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

NOV - 3 2010

Re: K102994

Trade/Device Name: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, K-Shield Phlebotomy Set with Antineedle Stick Protector Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 8, 2010 Received: October 8, 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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

510(k) Number (if known): K102994

Device Name: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, K-Shield Phlebotomy Set with Antineedle Stick Protector

Indications For Use:

Name: Kawasumi A.V. Fistula Set

Name: Kawasumi Laboratory Blood Drawing Kit

Name: Kawasumi Laboratories Phlebotomy Set

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)

REC Novl, 2010

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:
K102994
Page 1 of

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).