IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR by KAWASUMI LABORATORIES AMERICA, INC.

THE IV ADD-ON FILTER ADMINISTRATION SET USED TO ATTACH TO A NON FILTERED IV ADMINISTRATION SET FOR THE PURPOSE OF FILTERING SOLUTION DURING INTRAVASCULAR ADMINISTRATION. THE DEVICE MAY INCLUDE A NEELE FREE VALVE INJECTION SITE WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES.

Device Description

A STERILE, SINGLE USE ADD-ON FILTER ADMINISTRATION SET USED TO SERVE AS A CONDUIT FOR THE FILTRATION OF IV FLUID FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A NEEDLE OR CATHETER INSERTED INTO A VEIN. THE DEVICE MAY INCLUDE A NEELELESS ACCESS CONECTOR WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES. THE FILTER PORE SIZE WILL BE .22 OR 1.2 MICRON WITH AN EFFECTIVE FILTRATION RATE (EFA) OF 10 CM2.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "IV Add-on Filter Administration Set with and without Y Connect or Needleless Access Connector" by Kawasumi Laboratories. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Device materials in contact with body fluids must be suitable for intended use.	Kawasumi Laboratories conducted biocompatibility tests on body fluid contacting material portions of the device. The conclusion states: "THE DEVICE MEETS ALL BIOCOMPATIBILITY AND PYROGENICITY TEST REQUIREMENTS."
Pyrogenicity: Device must be non-pyrogenic.	The conclusion states: "THE DEVICE MEETS ALL BIOCOMPATIBILITY AND PYROGENICITY TEST REQUIREMENTS."
Filtration Effectiveness: Filter pore size of .22 or 1.2 micron with an Effective Filtration Rate (EFA) of 10 CM2, capable of filtering out particles larger than the specified pore size in IV solution.	The device's description states it has a filter pore size of .22 or 1.2 micron with an EFA of 10 CM². The significant performance characteristics state: "Both devices filter out particles in an IV line administering a solution when those particles are larger than the...22 micron or 1.2 micron pore size of the specific filter chosen." This indicates the new device performs similarly to the predicate device in filtration.
Safety and Performance (Substantial Equivalence): As safe as the predicate device and performs as well as the predicate device.	The conclusion states: "Therefore, it is as safe as the predicate device and performs as well as the predicate device." The FDA's letter confirms substantial equivalence to legally marketed predicate devices.

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

Sample Size: The document does not specify a distinct "test set" sample size for the biocompatibility or pyrogenicity tests. It generically states that tests were "conducted on the body fluid contacting material portions of the device."
Data Provenance: Not explicitly stated. However, given that Kawasumi Laboratories is based in Japan (with a US office), the testing could have been conducted in Japan or by a contract lab. The document does not specify if the data is retrospective or prospective, but testing for a new device would typically involve prospective data generation.

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

This information is not provided in the document. The tests performed (biocompatibility, pyrogenicity, and filtration effectiveness) are laboratory-based and typically follow standardized protocols. Expert "ground truth" establishment in the sense of clinical interpretation (e.g., by radiologists) is not applicable to the type of device and performance characteristics being evaluated here.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements (e.g., chemical analysis for biocompatibility, sterility/endotoxin testing for pyrogenicity, physical measurements for filtration). There is no "adjudication method" in the context of human interpretation of a test set.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers' performance with and without AI assistance) is relevant for diagnostic imaging devices or other software that aids human interpretation. This document is for an IV administration set with a filter, which is a physical medical device, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This concept is also applicable to AI algorithms. This device is a physical filter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is based on standardized laboratory test results for biocompatibility, pyrogenicity, and physical performance characteristics (filtration efficiency, pore size).
- For biocompatibility: Adherence to relevant biocompatibility standards (e.g., ISO 10993 series).
- For pyrogenicity: Absence of pyrogens as per Pharmacopoeial standards.
- For filtration: Physical testing to confirm pore size and effective filtration area and its ability to remove particles.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device. It does not use Machine Learning or AI, and therefore does not have a "training set" in the computational sense. The testing performed is to demonstrate the physical and chemical properties of the device.

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

Not applicable. As stated above, there is no training set for this device.

Summary

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APR 1 5 2003

EXHIBIT 1-B

EXHIBIT 21 510(K) SUMMARY

Ko30385

SUBMITTER AGENT

KAWASUMI LABORATORIES, INC. 3-28-15 MINAMI-OHI SHINAGAWA-KU, TOKYO 140 JAPAN PHONE:011-81-3-376-1151 FAX: 0011-81-3-376-3235 CONTACT: MR. KOJI SO

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 IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
  COMMON NAME: IV FILTER SET
1. PREDICATE DEVICE: K00142 KAWASUMI LABORATORIES IV ADMINISTRATION SET
1. DESCRIPTION OF THE DEVICE: A STERILE, SINGLE USE ADD-ON FILTER ADMINISTRATION SET USED TO SERVE AS A CONDUIT FOR THE FILTRATION OF IV FLUID FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A NEEDLE OR CATHETER INSERTED INTO A VEIN. THE DEVICE MAY INCLUDE A NEELELESS ACCESS CONECTOR WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES. THE FILTER PORE SIZE WILL BE .22 OR 1.2 MICRON WITH AN EFFECTIVE FILTRATION RATE (EFA) OF 10 CM2.
1. INTENDED USE: THE IV ADD-ON FILTER ADMINISTRATION SET IS A STERILE, SINGLE USE DEVICE USED TO ATTACH TO A NON FILTERED IV ADMINISTRATION SET FOR THE PURPOSE OF FILTERING SOLUTION DURING INTRAVASCULAR ADMINISTRATION.
6.. SIGNIFICANT PERFORMANCE CHARACTERISTICS: THERE ARE NO SIGNIFICANT DIFFERENCES IN PERFORMANCE CHARACTERITICS BETWEEN THIS DEVICE AND THOSE OF THE SUBSTANTIALLY EQUIVALENT DEVICES MARKETED FOR SALE IN INTERSTATE COMMERCE. BOTH DEVICES FILTER OUT PARTICLES IN AN IV LINE ADMINISTERING A SOLUTION WHEN THOSE PARTICLES ARE LARGER THAN THE ...22 MICRON OR 1.2 MICRON PORE SIZE OF THE SPECIFIC FILTER CHOSEN.
1. TECHNOLOGICAL CHARACTERISTICS: THERE ARE NO DIFFERENCES BETWEEN THE TECHNOLOGICAL CHARACTERISTICS OF THIS DEVICE AND THOSE OF THE SUBSTANTIALL Y EQUIVALENT DEVICE FROM KAWASUMI LABORATORIES BEING MARKETED FOR SALE IN INTERSTATE COMMERCE.
PERFORMANCE DATA: KAWASUMI LABORATORIES HAS CONDUCTED 8. BIOCOMPATIBILITY TESTS ON THE BODY FLUID CONTACTING MATERIAL PORTIONS OF THE DEVICE AND KL BELIEVES THE BIOCOMPATIBILITY DATA SHOW THE DEVICE IS SUITABLE FOR ITS INTENDED USE.
1. CONCLUSIONS: THE DEVICE MEETS ALL BIOCOMPATIBILITY AND PYROGENICITY TEST REQUIREMENTS. THEREFORE, IT IS AS SAFE AS THE PREDICATE DEVICE AND PERFORMS AS WELL AS THE PREDICATE DEVICE.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2003

Mr. Jack Pavlo Technical Services Manager Kawasumi Laboratories America. Incorporated 5905C Hampton Oaks Parkway Tampa, Florida 33610

Re: K030385

Trade/Device Name: IV Add-on Filter Administration Set with and without Y Connect or Needleless Access Connector Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 4, 2003 Received: February 5, 2003

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 (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 yours.

Susan Ruarey

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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K030385

EXHIBIT 23

INDICATIONS FOR USE

Page of

510 (K) NUMBER (IF KNOWN) :

DEVICE NAME: IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR INDICATIONS FOR USE:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Atucur Cucenta

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Antrol, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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.