(77 days)
Not found
Not Found
No
The device description and intended use clearly describe a simple blood collection conduit, with no mention of AI/ML or related concepts.
No
The device is described as a conduit for blood removal to aid in the treatment of a disease or condition, but it is not directly treating the disease or condition itself. It's a blood collection system, which is a diagnostic or procedural aid, not a therapeutic device.
No
The device is described as a "conduit for blood removal" for treatment, not for analysis or diagnosis of a disease.
No
The device description clearly states it is a "STERILE, SINGLE USE DEVICE FOR WITHDRAWING BLOOD" and a "CONDUIT USED FOR WITHDRAWING BLOOD FROM THE PATIENT'S VEIN TO A VACUUM BOTTLE RESERVOIR," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A CONDUIT FOR BLOOD REMOVAL FROM A PATIENT TO A VACUUM BOTTLE TO AID IN THE TREATMENT OF A DISEASE OR OTHER CONDITION." This describes a device used for collecting a sample from the patient, not for performing a diagnostic test on the sample.
- Device Description: The description reinforces this by stating it's "A STERILE, SINGLE USE DEVICE FOR WITHDRAWING BLOOD." It's a tool for collection, not analysis.
- Lack of Diagnostic Activity: There is no mention of any analysis, testing, or diagnostic procedure being performed by the device itself or on the collected blood within the context of the device's function. IVDs are designed to perform tests on samples to provide diagnostic information.
- Predicate Device: The predicate device is a "BLOOD COLLECION SET," which aligns with the function of collecting blood, not performing a diagnostic test.
In summary, this device is a blood collection device, which is a medical device used to obtain a sample, but it does not perform any diagnostic testing on that sample. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LHI, KSB
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 biocompatibility and pyrogenicity test requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ABBOTT LABORATORIES BLOOD COLLECION SET
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR - 8 2000
510(K) SUMMARY
-
- 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
- SUBMITTER
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
-
- NAME OF DEVICE: KAWASUMI LABORATORIES PHLEBOTOMY SET
COMMON NAME: PHLEBOTOMY SET
- NAME OF DEVICE: KAWASUMI LABORATORIES PHLEBOTOMY SET
-
PREDICATE DEVICE: ABBOTT LABORATORIES BLOOD COLLECION SET 3.
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- 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.
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- 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.
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- 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.
1
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
3
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