(69 days)
K00142
K00142
No
The description focuses on the physical components and function of a filter administration set, with no mention of AI or ML capabilities.
No
This device is an add-on filter administration set used to filter IV solutions, not to treat a disease or condition. Its purpose is to facilitate the safe delivery of IV fluids, not to provide therapy itself.
No
The device is described as an IV add-on filter administration set, used for filtering solutions during intravascular administration. Its function is to deliver fluids, not to diagnose a condition.
No
The device description clearly describes a physical, sterile, single-use administration set with a filter and potentially a needle-free valve, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter solutions during intravascular administration to a patient's vascular system. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description details a sterile, single-use set for delivering IV fluid to a patient. It focuses on the physical process of filtration and delivery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition. IVDs are designed to perform tests on these samples to aid in diagnosis, monitoring, or screening.
This device is clearly intended for direct patient treatment and fluid delivery, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
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.
Product codes
FPA
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.
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)
K00142
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
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
-
- 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
- NAME OF DEVICE: KAWASUMI LABORATORIES IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
-
- PREDICATE DEVICE: K00142 KAWASUMI LABORATORIES IV ADMINISTRATION SET
-
- 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.
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- 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.
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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.
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- 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.
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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.
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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 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.
2
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
3
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:
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.
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: _______________________________________________________________________________________________________________________________________________________________