K Number
K973107
Device Name
AMSINO I.V. ADMINISTRATION SET
Manufacturer
Date Cleared
1997-10-02

(44 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AMSINO INTRAVASCULAR ADMINISTRATION 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
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More Information

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No
The summary describes a standard intravascular administration set and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

No
The device is used to administer fluids, not to directly treat a disease or condition. While essential for certain treatments, the administration set itself is a delivery mechanism, not a therapeutic agent.

No
The device is described as an "intravascular administration set" intended to "administer fluids" to a patient's vascular system. This function is therapeutic/administrative, not diagnostic.

No

The device description clearly indicates it is an "INTRAVASCULAR ADMINISTRATION SET," which is a physical medical device used to administer fluids. There is no mention of software as the primary or sole component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for administering fluids to a patient's vascular system. This is an in-vivo (within a living organism) application.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such examinations.

Therefore, the AMSINO INTRAVASCULAR ADMINISTRATION SET is a medical device used for direct patient treatment, not for in-vitro diagnostic testing.

N/A

Intended Use / Indications for Use

AMSINO INTRAVASCULAR ADMINISTRATION 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

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Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Patient's vascular system

Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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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).

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§ 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

OCT - 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Richard Y. Li, Ph.D. President Amsino International, Incorporated 833 Towne Center Drive Pomona, California 91767

Re : K973107 Amsino I.V. Administration Set Trade Name: Requlatory Class: II FPA Product Code: Dated: August 18, 1997 Received: August 19, 1997

Dear Dr. Li:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (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. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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

Image /page/0/Picture/8 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human figures or shapes, arranged in a cascading or layered manner.

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Page 2 - Dr. Li

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 requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 che regulation chercroal "hirbbanding as "Starter 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

2

K973107

Page of

510(k) Number (if known):

Device Name: AMSINO I.V. ADMINISTRATION SET

Indications For Use:

AMSINO INTRAVASCULAR ADMINISTRATION SET IS A DEVICE INTENDED TO ADMINISTER FLUIDS FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A CATHETER INSERTED INTO A VEIN.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrici Cucinate

(Division Sign-Off) Division of Dental, In and General Hos 510(k) Numbe

Prescription Use ﺎﺕ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)