A STERILE, SINGLE USE DEVICE FOR WITHDRAWING BLOOD. BASIC CONCEPT: A CONDUIT USED FOR WITHDRAWING BLOOD FROM THE PATIENT'S VEIN TO A VACUUM BOTTLE RESERVOIR

AI/ML Overview

This document describes a 510(k) submission for a medical device (Kawasumi Laboratories Phlebotomy Set) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with detailed acceptance criteria typically found in AI/ML device submissions.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or available in this type of regulatory submission. The device is a relatively simple, sterile, single-use blood collection set, and the focus is on its basic function and safety.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Device materials contacting body fluids must be suitable for intended use.	Kawasumi Laboratories conducted biocompatibility tests on body fluid-contacting material portions. The data is believed to show the device is suitable for its intended use. (Implied acceptance: No adverse biocompatibility reactions or material toxicity.)
Pyrogenicity: Device must be non-pyrogenic.	The device meets all pyrogenicity test requirements. (Implied acceptance: Absence of fever-inducing substances.)
Performance: Device effectively removes blood from a patient into a vacuum bottle, performing as well as the predicate device.	The device's basic concept is "A conduit used for withdrawing blood from the patient's vein to a vacuum bottle reservoir." The submission states, "There are no significant performance characteristics of this device compared to substantially equivalent devices marketed for sale... The device is used to remove blood from a patient into a vacuum bottle." Conclusion: The device "performs as well as the predicate device."
Safety: Device is as safe as the predicate device.	Conclusion: "Therefore, it is as safe as the predicate device and performs as well as the predicate device."

2. Sample size used for the test set and the data provenance

Not applicable/Available. This submission focuses on demonstrating substantial equivalence through design and material characteristics, along with standard biocompatibility and pyrogenicity testing, rather than a clinical "test set" in the context of AI/ML or diagnostic performance.
Data Provenance: Not specified, but standard regulatory tests (biocompatibility, pyrogenicity) are typically performed in certified laboratories.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Available. There is no "ground truth" establishment in the sense of expert review of data for a diagnostic or AI/ML algorithm. Safety and performance are assessed via specified tests and comparison to a predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Available. No such adjudication method is mentioned or relevant for this type of device submission.

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

No. This is a basic medical device (phlebotomy set), not an AI-assisted diagnostic tool.

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

No. This is a basic medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's performance and safety is based on validated laboratory testing methods (e.g., ISO standards for biocompatibility and pyrogenicity) and the established performance of the predicate device.

8. The sample size for the training set

Not applicable/Available. There is no "training set" in the context of an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable/Available. No training set exists for this device.

Summary

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MAR - 8 2000

510(K) SUMMARY

1. SUBMITTER
  KAWASUMI LABORATORIES, INC. 3-28-15 MINAMI-OHI OAKS PARKWAY SHINAGAWA-KU, TOKYO 140 JAPAN PHONE:81-3-376-1151 81-3-376-3235 FAX: CONTACT: MR. S. SUWA

AGENT

KAWASUMI LABORATORIES AMERICA, INC. ARE NO NEW 5909 C HAMPTON

TAMPA, FL 33610 PHONE: 813-630-5554 FAX: 813-630-2033 CONTACT: MR. JACK PAVLO

1. NAME OF DEVICE: KAWASUMI LABORATORIES PHLEBOTOMY SET
  COMMON NAME: PHLEBOTOMY SET
PREDICATE DEVICE: ABBOTT LABORATORIES BLOOD COLLECION SET 3.
1. DESCRIPTION OF THE DEVICE: A STERILE, SINGLE USE DEVICE FOR WITHDRAWING BLOOD..
- BASIC CONCEPT: A CONDUIT USED FOR WITHDRAWING BLOOD FROM THE PATIENT'S VEIN TO A VACUUM BOTTLE RESERVOIR

SIGNIFICANT PERFORMANCE CHARACTERISTICS: THERE ARE NO SIGNIFICANT PERFORMANCE CHARACTERITICS OF THIS DEVICE COMPARED TO SUBSTANTIALLY EQUIVALENT DEVICES MARKETED FOR SALE IN INTERSTATE COMMERCE. THE DEVICE IS USED TO REMOVE BLOOD FROM A PATIENT INTO A VACUUM BOTTLE.

ર : INTENDED USE: THE PHLEBOTOMY SET IS USED TO REMOVE BLOQD FROM A PATIENT INTO A VACUUM BOTTLE.
TECHNOLOGICAL CHARACTERISTICS: THERE ARE NO TECHNOLOGICAL 6. CHARACTERISTICS OF THIS DEVICE TO THE SUBSTANTIALLY EQUIVALENT DEVICE FROM ABBOTT LABORATORIES BEING MARKETED FOR SALE IN INTERSTATE COMMERCE.
1. 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 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2000

Kawasumi Laboratories, Company, Limited C/O Donald R. Stone, Esq. McKenna and Cuneo, L.L.P. 1900 K Street N.W. Washington, DC 20006

Re : K994323 Trade Name: Kawasumi Laboratories Phlebotomy Set Requlatory Class: II Product Code: LHI and KSB December 21, 1999 Dated: December 22, 1999 Received:

Dear Mr. Stone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Stone

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot dy A. Director Division of Dental, Infection Control. and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

DEVICE NAME: KAWASUMI LABORATORIES PHLEBOTOMY SET

INDICATIONS FOR USE: A CONDUIT FOR BLOOD REMOVAL FROM A PATIENT TO A VACUUM BOTTLE TO AID IN THE TREATMENT OF A DISEASE OR OTHER CONDITION.

Patricia Cuscente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 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.