KAWASUMI LABORATORIES PHILEBOTOMY SET

K994323 · Kawasumi Laboratories Co., Ltd. · LHI · Mar 8, 2000 · General Hospital

Device Facts

• Record ID: K994323
• Device Name: KAWASUMI LABORATORIES PHILEBOTOMY SET
• Applicant: Kawasumi Laboratories Co., Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Mar 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THE PHLEBOTOMY SET IS USED TO REMOVE BLOQD FROM A PATIENT INTO A VACUUM BOTTLE.

Device Story

Sterile, single-use phlebotomy set; functions as a conduit for withdrawing blood from a patient's vein into a vacuum bottle reservoir. Used in clinical settings for blood collection. Device facilitates blood removal to aid in treatment of disease or other conditions. No complex processing or electronic components involved.

Clinical Evidence

Bench testing only. Biocompatibility and pyrogenicity testing performed on body fluid contacting materials; results met all requirements.

Technological Characteristics

Sterile, single-use conduit for blood collection. Materials are biocompatible. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for blood removal from a patient to a vacuum bottle to aid in the treatment of a disease or other condition.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Abbott Laboratories Blood Collection Set

Submission Summary (Full Text)

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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:[phone] FAX: CONTACT: MR. S. SUWA

### AGENT

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

TAMPA, FL 33610 PHONE: [phone] FAX: [phone] CONTACT: MR. JACK PAVLO

- 2. NAME OF DEVICE: KAWASUMI LABORATORIES PHLEBOTOMY SET
COMMON NAME: PHLEBOTOMY SET

- PREDICATE DEVICE: ABBOTT LABORATORIES BLOOD COLLECION SET 3.
- 4. 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.
- 7. 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.
- 8. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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