The Kawasumi Laboratories Empty Solution Container is a sterile, single use device used as a reservoir for the purpose of administering solution to a patient. The Empty Solution Container is filled with the desired solution(s) commonly used in hospitals. After use, the bag is discarded.

Device Description

The device comprises of a plastic bag with an entry port used for the introduction of solution(s) into the bag and two ports for accessing the bag with a solution administration set

AI/ML Overview

The Kawasumi Laboratories Empty Solution Container is a Class II device (product code KPE) intended as a sterile, single-use reservoir for administering solutions to patients in a hospital setting. The device is a plastic bag with an entry port for introducing solutions and two ports for accessing the bag with a solution administration set.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Performance Characteristics	No new performance characteristics compared to the substantially equivalent predicate device.	"There are no new performance characteristics of this device compared to the substantially equivalent device marketed for sale in interstate commerce. Both containers are used to hold solution commonly used in hospitals for the delivery of the solution to the patient."
Technological Characteristics	No new technological characteristics compared to the substantially equivalent predicate device.	"There are no technological characteristics of this device to the substantially equivalent device from Kawasumi Laboratories being marketed for sale in interstate commerce."
Safety - Biocompatibility	Device materials contacting body fluids must meet biocompatibility test requirements.	"Kawasumi Laboratories has conducted 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." "The device meets all the biocompatibility... test requirements."
Safety - Pyrogenicity	Device must meet pyrogenicity test requirements.	"The device meets all the ... pyrogenicity test requirements."
Overall Conclusion	Device is safe and performs as well as the predicate device.	"Therefore, it is safe as the predicate device and performs as well as the predicate device."

2. Sample Sizes and Data Provenance

Test Set Sample Size: Not explicitly stated. The submission mentions "biocompatibility tests" and "pyrogenicity test requirements" were conducted, implying testing on representative device samples, but the specific number of units tested is not provided.
Data Provenance: The studies were conducted by Kawasumi Laboratories. Given the company's location (3-28-15 Minami-Ohi Shinagawa-Ku, Tokyo 140 Japan), the testing was likely conducted in Japan, or under their supervision, to comply with regulatory requirements for their market submission to the FDA in the US. The data is retrospective relative to the submission date.

3. Number of Experts and Qualifications for Ground Truth

This device is a physical medical device, not a diagnostic algorithm. The "ground truth" for its performance is established through standard laboratory and material science testing protocols rather than expert clinical review. Therefore, this section is not applicable in the context of this device.

4. Adjudication Method for the Test Set

Not applicable. As stated above, this device's performance is verified through laboratory testing, not through expert consensus or adjudication of diagnostic findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a physical medical device (an empty solution container), not an AI/algorithm-based diagnostic tool. Therefore, an MRMC study is not applicable.

6. Standalone Performance Study

Yes, implicitly. The biocompatibility and pyrogenicity tests, along with the assessment of performance and technological characteristics, represent standalone performance evaluation of the device itself. The objective was to demonstrate that the device, on its own, meets safety and functional requirements and is substantially equivalent to a predicate device.

7. Type of Ground Truth Used

Standardized Laboratory Testing and Material Science Data: The "ground truth" for this device's safety and performance is based on the results of validated biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) and pyrogenicity tests, conducted according to established international or national standards for medical devices. The functional "ground truth" is based on the device's ability to safely hold and facilitate the administration of solutions, as demonstrated by its "performance characteristics" (e.g., integrity, leak resistance – implied by the claim of no new characteristics compared to the predicate).

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is irrelevant to the device.

Summary

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61197

EXHIBIT 16

JUN 3 0 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: FAX:

KAWASUMI LABORATO
KAWASUMI LABORATORIES AMERICA, INC CONTACT: Mr. Jack Pavlo

NAME OF DEVICE: Kawasumi Laboratories Empty Solution Container COMMON NAME: Empty Solution Container PROPRIETARY NAME: Empty Solution Container CLASSIFICATION: Class II, Codified at 21 CFR 807.92. CLASSIFICATION PANEL: General Hospital PRODUCT CODE NUMBER: KPE
PREDICATE DEVICE: Abbott Laboratories Empty Container
DESCRIPTION OF THE DEVICE: The device comprises of a plastic bag with an entry port used for the introduction of solution(s) into the bag and two ports for accessing the bag with a solution administration set
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 containers are used to hold solution commonly used in hospitals for the delivery of the solution to the patient.
INTENDED USE: The Empty Solution Container is a sterile, single use device used as a reservoir for the purpose of administering solution to a patient. The Empty Solution Container is filled with the desired solutions(s) commonly used in hospitals for the administration of the solution(s) to the patient. The bag is discarded after use.
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.
PERFORMANCE DATA: Kawasumi Laboratories has conducted 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 us.
CONCLUSIONS: The device meets all the biocompatibility and pyrogenicity test requirements. Therefore, it is 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 logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the perimeter of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2006

Mr. Jack Pavlo Technical Services Manager Kawasumi Laboratories America, Incorporated 4723 Oak Fair Boulevard Tampa. Florida 33610

Re: K061197

Trade/Device Name: Empty Solution Container Regulation Number: 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: April 25, 2006 Received: April 28, 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 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 (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 yours.

Suan 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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EXHIBIT 13

Indications for Use

510(k) Number (if known): _ K061197

Device Name: Empty Solution Container

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR CON 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)

Century E. M. A.

(ii-( i) or Anesthesiology, General Hospital, on Conticil. Dental Devices

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Regulation Number and Section

§ 880.5025 I.V. container.

(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).