(79 days)
No
The device description and performance studies focus on the physical components and mechanical performance of a standard IV administration extension set. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as an "I.V. ADMINISTRATION EXTENSION SET" used to administer fluids, not to directly treat or diagnose a disease. While it aids in the delivery of a therapeutic substance, it is a delivery mechanism rather than a therapeutic device itself.
No
The device is described as an "I.V. ADMINISTRATION EXTENSION SET" used to "administer fluids from a container to a patient's vascular system." It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines physical components such as tubing, connectors, clamps, and a drip chamber, indicating it is a hardware 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 to "administer fluids from a container to a patient's vascular system through a catheter inserted into a vein." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose a condition.
- Device Description: The description details components like tubing, connectors, clamps, etc., which are typical for fluid administration sets. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the AMSINO® I.V. ADMINISTRATION EXTENSION SET is a medical device used for fluid delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. The EXTENSION SET will provide a tubing extension to increase the length of an I.V. set or a syringe. The Extension Set consists of various parts such as: drip chamber, luer adapter/connectors, clamp, tubing, flow controller, Y-site, latex-free injection port, needleless injection port, stopcock, flashbulb, filter and manifold.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
The AMSINO® I.V. ADMINISTRATION SETS K973107), and (K093773) have been shown t0 meet the Bench performance testing requirement according to ISO 8536-4 when appropriate and/or AMSINO's testing and acceptance criteria:
Closure Piercing Device (Spike) Features Air Inlet Device Characteristics Connector Performance criteria: i.e. to prevent leakage Drip Chamber and Drip Tube Performance Flow Regulator Performance Flow characteristics Tensile Strength of Connectors Self-sealing injection site challenge test The number of injection port access to failure for needleless port with valves, diaphragms or membrane.
Additional testing for Leakage (Vacuum Tightness and Air Tightness), and Flow Rate of Infusion Fluid, of extension sets attached to a master IV Administration Set was performed to demonstrate the stability of the extension set.
Biocompatibility assessment of the AMSINO® I.V. ADMINISTRATION SET has been conducted (see K093773) based on the guidelines established by various governmental and standard setting (360 kb) 5 / 5) based on the garasting ical Evaluation of Medical Devices. Based upon the results of this prolonged duration, indirect blood path containing device assessment; (Cytoxicity, Sensitization, Irritation, Systemic Cytoxicity and Hemocompatibility testing) the materials used to fabricate the AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET, has been shown to be biocompatible, hemocompatible, and appropriate for its intended use.
AMSINO® I.V. ADMINISTRATION EXTENSION SET is sterilized by Ethylene Oxide as AMSINO I.V. ADMINISTRATION IIITION IIITEN OF Healthcare products – Ethylene Oxide - Part 1: validated per 130 111554.2007 Bleinianon of Routine Control of a Sterilization Process for Medical Devices. (See K093773)
AMSINO® I.V. ADMINISTRATION EXTENSION SET is tested for pyrogenicity (See K093773)).
Amsino's testing of potential microbial ingross demonstrates a 4-Microbial ingless Testing: "Thissio of testing of promisms of gram positive organisms using the proper aseptic technique. (See K093773)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AMSINO® I.V ADMINISTRATION SET (K973107), (K093773)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
1101956
SEP 2 9 2010
SPECIAL 510k SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Submitter and Contact Person:
AMSINO International, Inc 855 Towne Center Drive, Pomona, CA 91767 Jesus T. Farinas Manager, Quality Assurance and Regulatory Affairs
2085175
Establishment Number: Name of the Device: Classification Name: Proprietary Name:
Set, Administration, Intravascular AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET
| 510k number: |
|---|
| Regulation Number: |
| Class: |
| Classification Product Code: |
880.5440 II FPA
Predicate Devices:
AMSINO® I.V ADMINISTRATION SET (K973107)and (K093773)
Intended use of the Device:
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Device Description:
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. The EXTENSION SET will provide a tubing extension to increase the length of an I.V. set or a syringe. The Extension Set consists of various parts such as: drip chamber, luer adapter/connectors, clamp, tubing, flow controller, Y-site, latex-free injection port, needleless injection port, stopcock, flashbulb, filter and manifold.
This submission is an extension of the original approval (per K973107) and (K093773).
1
Technological Characteristics Summary:
AMSINO® I.V. ADMINISTRATION EXTENSION SET are constructed of high grade extruded DEHP-free PVC. Component material list is herewith attached (see device drawings). The intended use, the basic design, function and the materials used to construct the IV Administration Set and the Extension Sets are identical to the predicate device and other devices currently legally marketed and are substantially equivalent. This premarket notification is an update of the performance and biocompatibility data of the currently approved predicate device - the Amsino I.V. Administration Set (K971037) and (K093773)
Performance Data
membrane.
The AMSINO® I.V. ADMINISTRATION SETS K973107), and (K093773) have been shown t0 meet the Bench performance testing requirement according to ISO 8536-4 when appropriate and/or AMSINO's testing and acceptance criteria:
Closure Piercing Device (Spike) Features Air Inlet Device Characteristics Connector Performance criteria: i.e. to prevent leakage Drip Chamber and Drip Tube Performance Flow Regulator Performance Flow characteristics Tensile Strength of Connectors Self-sealing injection site challenge test The number of injection port access to failure for needleless port with valves, diaphragms or
Additional testing for Leakage (Vacuum Tightness and Air Tightness), and Flow Rate of Infusion Fluid, of extension sets attached to a master IV Administration Set was performed to demonstrate the stability of the extension set.
Biocompatibility and Hemocompatibility:
Biocompatibility assessment of the AMSINO® I.V. ADMINISTRATION SET has been conducted (see K093773) based on the guidelines established by various governmental and standard setting (360 kb) 5 / 5) based on the garasting ical Evaluation of Medical Devices. Based upon the results of this prolonged duration, indirect blood path containing device assessment; (Cytoxicity, Sensitization, Irritation, Systemic Cytoxicity and Hemocompatibility testing) the materials used to fabricate the AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET, has been shown to be biocompatible, hemocompatible, and appropriate for its intended use.
1 0
2
Sterility:
AMSINO® I.V. ADMINISTRATION EXTENSION SET is sterilized by Ethylene Oxide as AMSINO I.V. ADMINISTRATION IIITION IIITEN OF Healthcare products – Ethylene Oxide - Part 1: validated per 130 111554.2007 Bleinianon of Routine Control of a Sterilization Process for Medical Devices. (See K093773)
Pyrogenicity: AMSINO® I.V. ADMINISTRATION EXTENSION SET is tested for pyrogenicity (See K093773)).
Microbial Ingress Testing: Amsino's testing of potential microbial ingross demonstrates a 4-Microbial ingless Testing: "Thissio of testing of promisms of gram positive organisms using the proper aseptic technique. (See K093773)
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is substantially equivalent to the AMSINO " I.V. ADMINDATE 2120218 Sused and intended use as the AMSINO® I.V. Set and Futures in the predicate devices in technology , - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -(K093773).
Submitted by:
Jesus Farinas
Senior Manager, QA/RA
Date 07:50 July 2010
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, with three curved lines forming the body and head.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jesus Farinas Manager, Quality Assurance and Regulatory Affairs AMSINO International, Incorporated 855 Towne Center Drive Pomona, California 91767
SEP 2 9 2010
Re: K101958
Trade/Device Name: AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET
Regulation Number: 21 CFR 880.5440 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FPA Dated: September 9, 2010 Received: September 10, 2010
Dear Mr. Farinas:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2- Mr. Farinas
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRFICes/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRF's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
SEP 2 9 2010
K101958 510(k) Number (if known):
AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET Device Name:
Indications For Use:
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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) 9/27/10
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K101958 |
|---|---|
| ---------------- | --------- |
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