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 Description

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 patient'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.

AI/ML Overview

The provided document details a 510(k) premarket notification for a medical device (Kawasumi Laboratories Small Vein Infusion Set with Antineedle Stick Protector and Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector). This is for a device modification summary, not an AI/ML device, and therefore the provided document does not contain information typically associated with AI/ML model evaluations such as:

Acceptance criteria and reported device performance in terms of AI metrics (e.g., sensitivity, specificity, accuracy).
Sample sizes for test sets in an AI context (e.g., number of images, patient cases).
Data provenance for AI/ML training/test sets.
Number and qualifications of experts for ground truth establishment for AI/ML.
Adjudication methods for AI/ML ground truth.
Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
Standalone performance for an AI algorithm.
Type of ground truth (beyond product testing results).
Training set sample size for an AI model.
How ground truth for a training set was established for an AI model.

Instead, the document focuses on the mechanical and functional performance of a medical device (a winged collection set and small vein infusion set with an antineedle stick protector) and its substantial equivalence to predicate devices.

Based on the provided text, here is an analysis of the acceptance criteria and study for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Kawasumi Internal Test: Wing Activation	Pass	PASS
Kawasumi Internal Test: Wing Deactivation	Pass	PASS
Kawasumi Internal Test: Defeat Locking Mechanism	Pass	PASS
Simulated Use Study: Prevention of Needle Sticks	No needle sticks occurred	No needle sticks occurred
Simulated Use Study: User Feedback	No problems indicated	No problems indicated

Note: The document implicitly defines "PASS" as meeting the acceptance criteria for the internal tests. For the simulated use study, the stated "successful" outcome and specific results serve as the performance and meet the implied acceptance criteria.

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

Test Set: Not explicitly stated as a numerical sample size. The "simulated clinical observations" involved a "simulated use study," but the number of participants or simulated uses is not provided.
Data Provenance: The tests were "Kawasumi Internal Test" and "Simulated Clinical Observations" conducted by Kawasumi Laboratories, indicating an internal, prospective study environment for the modification assessment. The country of origin for the data is Japan (Kawasumi Laboratories, Inc. is based in Tokyo) for the internal tests, and potentially the US for the simulated use study (Kawasumi Laboratories America, Inc. is in Tampa, FL), though this is not explicitly stated.

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

There were no "experts" in the sense of medical professionals establishing a diagnostic ground truth for an AI/ML model. The "ground truth" here is the physical performance and safety features of the device, assessed through internal engineering tests and a simulated use study. The "ground truth" was established by the test results themselves as outlined in the table above.

4. Adjudication Method for the Test Set

Not applicable as this is not an AI/ML model evaluation requiring expert consensus or adjudication. The internal tests have objective Pass/Fail criteria, and the simulated use study collected observations directly.

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

Not applicable. This is not an AI/ML device. The study involves a physical medical device and its safety features.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth used was based on:

Objective measurements and outcomes from internal engineering tests (e.g., verifying wing activation, deactivation, and defeat locking mechanism).
Direct observation of events during a simulated clinical use study (e.g., absence of needle sticks).
User feedback collected via questionnaires during the simulated use study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set." The device was modified and then tested.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's design and intended function was established through engineering specifications, previous predicate device performance, and the modifications made.

Summary

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EXHIBIT 27

KID 2890

OCT 2 1 2010

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

SUBMITTER 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 (813) 230-2033 FAX: CONTACT: Mr. Jack Pavlo

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

1. 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 ).
1. 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.
1. 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.
1. 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

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 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.
1. 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 (800) 638-2041 or (301) 796-7100 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

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.