The AMSINO® I.V. 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

The AMSINO® I.V. ADMINISTRATION 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. It is comprised of various components such as: bag, spike, drip chamber (vented and non-vented), Y-site, burette, tubing, flow controller, drip selector, clamp, check valve, latex-free injection site, needleless injection site, flashbulb, filter, manifold, stopcock, flash bulb, luer connectors and bag hanger.

This submission is an extension of the original approval (K973107) and covers the following AMSINO Product Line:

AMSINO® STANDARD I.V. ADMINISTRATION SET AMSafe® I.V. ADMINISTRATION SET (identical to the Amsino Standard I.V. Administration set, except it is marketed for Emergency Medical Services group/personnel)

AMSafe3® I.V. ADMINISTRATION SET (identical to AmSafe I.V. Administration Set, with the exception of the drip selector option.)

AMSINO offers both standard and custom sets with tubing of various sizes and lengths with a choice of 10, 15, 20 and 60 drops per ml to meet customer requirements and specifications. Customers may request I.V. Administration sets with varying configuration containing any combination of the parts per the table:

Tubing
Drip Chamber
Needleless injection site
Split Septum Injection Site
Bag Spike
Clamp
Flow Controller
Drip Selector
Filter
Rotating male luer lock
Male or Female luer lock
Check Valve
Bag Hanger
Y-site
stopcock
manifold

AI/ML Overview

The provided document describes a Special 510(k) Premarket Notification for a modification to the AMSINO® I.V. ADMINISTRATION SET. This submission primarily focuses on demonstrating substantial equivalence to a previously cleared device (K973107) rather than a de novo device requiring extensive clinical studies to establish safety and effectiveness.

Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a human clinical trial is not applicable here. Instead, the submission relies on bench performance testing, biocompatibility, and sterilization validations to show that the modified device performs as intended and is as safe and effective as the predicate device.

Here's an analysis of the provided information based on your requested categories:

1. A table of acceptance criteria and the reported device performance

The document lists several performance criteria the device meets, primarily referencing ISO standards and/or AMSINO's internal testing criteria. However, specific quantitative acceptance criteria values and corresponding reported device performance values are generally not provided in this summary document. Instead, it makes statements of compliance.

Acceptance Criterion (Test Type)	Reported Device Performance
Bench Performance Testing:	Meets requirements according to ISO 8536-4 (when appropriate) and/or AMSINO's testing and acceptance criteria
Closure Piercing Device (Spike) Features	Meets requirements
Air Inlet Device Characteristics	Meets requirements
Connector Performance (to prevent leakage)	Meets requirements
Drip Chamber and Drip Tube Performance	Meets requirements
Flow Regulator Performance	Meets requirements
Flow characteristics	Meets requirements
Tensile Strength of Connectors	Meets requirements
Self-sealing injection site challenge test	Meets requirements
Injection Port Access to Failure (needleless)	Meets requirements
Biocompatibility & Hemocompatibility:	Biocompatible and Hemocompatible; test results indicate neither sensitivity nor toxicity (based on ISO 10993-1 guidelines including Cytotoxicity, Sensitization, Irritation, Systemic Cytotoxicity, and Hemocompatibility testing)
Sterility:	Sterilized by Ethylene Oxide (validated per ISO 11135-1:2007)
Pyrogenicity:	Tested for pyrogenicity (status: meets requirements)
Microbial Ingress Challenge Test:	Demonstrates a 4-log reduction of microorganisms against gram negative and gram positive organisms using proper aseptic technique

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the various bench tests, biocompatibility tests, or microbial ingress tests. It only states that these tests were conducted and the device "meets requirements" or "demonstrates a 4-log reduction." The data provenance is internal to Amsino International, Inc. (Pomona, CA, USA) and the testing would be considered prospective for the purpose of this submission, meaning the tests were conducted specifically to support this application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable to this type of device and submission. The "ground truth" for the performance criteria is established by recognized international standards (like ISO) and internal engineering/quality specifications, not expert consensus in the medical image interpretation sense. The experts involved would be the engineers and quality assurance personnel at Amsino International responsible for designing, testing, and validating the device and its manufacturing processes. Their qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., images) by multiple readers. This is not applicable to the bench testing, biocompatibility, or sterilization validation performed for this I.V. administration set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an I.V. administration set, not an AI-powered diagnostic tool requiring human readability studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on established engineering and materials science principles, international standards (e.g., ISO 8536-4, ISO 10993-1, ISO 11135-1), and Amsino's internal product specifications. This would involve:

Physical/Mechanical Properties: Measured values against predefined tolerance ranges.
Biocompatibility: Laboratory test results (e.g., cell viability, irritation scores) compared against acceptable limits derived from ISO 10993.
Sterility: Sterility assurance levels (SAL) achieved through validated processes per ISO 11135-1.
Microbial Ingress: Measured reduction in microbial count against a defined log reduction target.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

Summary

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K093773

MAR 1 0 2010

Image /page/0/Picture/2 description: The image shows the word "AMSINO" in large, bold, white letters against a black background. Below the word, there is a black bar, and below that, the words "Advancing Healthcare Worldwide" are written in a smaller font. The text is also white against a black background.

Amsino International, 855 Towne Center Drive Pomona, CA 91767 USA

Tel: (909) 626-5888 Fax: (909) 626-3888 Toll Free: 1-800-MD-AMSINO http://www.amsino.com e-mail: amsino@amsino.com

SPECIAL 510k PREMARKET NOTIFICATION

February 11, 2010

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (WO66-0609) 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Reference:

Dear Madam/Sir:

AMSINO International, Inc. hereby submits this Special 510(k): for AMSURE ® I.V. Administration Set, a modification of our previously cleared AMSURE® I.V. ADMINISTRATION SET (K973107). We consider our intent to market this device as confidential commercial information and requests that it be treated as such by FDA. We have taken precautions to protect the confidentiality of the intent to marketthese devices. We understand that the submission to the government of false information is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q).

Thank you in advance for your consideration of our application. If there are any questions, please feel free to contact me at (909) 626-5888, extension 127 or at jesus_farinas@amsino.com

Sincerely,

Jesus T. Farinas

Manager, Ouality Assurance and Regulatory Affairs

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Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (WO66-0609) 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

February 11, 2010 · Re SPECIAL 510(k) Submission AMSINO® I.V. ADMINISTRATION SET

Attention Document Mail Clerk

AMSINO INTERNATIONAL, INC. is requesting marketing clearance for the AMSINO 9 I.V. ADMINISTRATION SET, a modification of a previously cleared device: AMSURE® I.V. ADMINISTRATION SET, (K973107) The premarket notification information required by 21 CFR 807.87 is as follows:

a. Classification Name:	Set, Administration, Intravascular
b. Common/Usual Name	I.V. Administration Set

・

FDA Establishment Registration Number 2085175 C.
Owner/Operator Identification Number 9008588 d.
Classification: e.

Class II device Classification Number: FPA 880. 5440

Statement of Intended Use: f.
The AMSINO® I.V. 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.
Label/Labeling/Advertisements: A sample of the AMSINO® I.V. ADMINISTRATION SET AND g. package labeling are enclosed (Appendices 2 & 3).
Substantial Equivalence: The AMSINO® I.V. ADMINISTRATION SET is made from the same h. material, manufactured and processed in the same manner and has the same intended use as the predicate device, the AMSINO® I.V. ADMINISTRATION SET (K973107)

In addition, the AMSINO® I.V. ADMINISTRATION SET is substantially equivalent to currently legally marketed predicate devices in material, technology and intended use as the AMSINO® I.V. ADMINISTRATION SET (K971037).

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Statement of Technological Characteristic of the Device:

The AMSINO® I.V. ADMINISTRATION SET meets the Bench performance testing requirement according to ISO 8536-4 when appropriate and/or AMSINO's testing and acceptance criteria: (see Appendix 4)

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 membranes.

Biocompatibility and Hemocompatibility: Biocompatibility assessment of the AMSINO® I.V. ADMINISTRATION SET has been conducted based on the guidelines established by various governmental and standard setting organizations such as ISO 10993-1- Biological Evaluation of Medical Devices. Based upon the results of this prolonged duration, indirect blood path containing device assessment; (Cytoxicity, Sensitization, Systemic Cytoxicity and Hemocompatibility testing) the materials used to fabricate the AMSINO® I.V. ADMINISTRATION SET, have been shown to be biocompatible, hemocompatible, and appropriate for its intended use. (See Appendix 6)

Sterility: AMSINO® I.V. ADMINISTRATION SET is sterilized by Ethylene Oxide as validated per ISO 11135-1:2007-Sterilization of Healthcare products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. ( See Appendix 7)

Pyrogenicity: AMSINO® I.V. ADMINISTRATION SET is tested for pyrogenicity (see Bench Test table). (See Appendix 4)

Microbial Ingress Challenge Test: Amsino's testing of potential microbial ingress demonstrates a 4-log reduction of micro-organisms against gram negative and gram positive organisms using the proper aseptic technique. ( See Appendix 5)

The AMSINO® I.V. ADMINISTRATION is substantially equivalent to the predicate devices in technology, materials used and intended use as the AMSINO® I.V. ADMINISTRATION SET (K973107).

Sincerely Yours,

Jesus Farinas

Manager, Quality Assurance and Regulatory Affairs

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SPECIAL 510k SUMMARY

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, Inc855 Towne Center Drive,Pomona, CA 91767Jesus T. FarinasManager, Quality Assurance and Regulatory AffairsTelephone Number : (909) 626-5888, ext 127Email: jesus_farinas@amsino.com
Establishment Number:	2085175
Name of the Device:
Classification Name:	Set, Administration, Intravascular
Proprietary Name:	AMSINO® I.V. ADMINISTRATION SET
510k number:	K093773
Regulation Number:	880.5440
Class:	II

Predicate Devices:

Class:

AMSINO® I.V ADMINISTRATION SET (K973107)

Intended use of the Device:

Classification Product Code:

The AMSINO® I.V. 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.

FPA

Device Description:

This submission is an extension of the original approval (K973107) and covers the following AMSINO Product Line:

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AMSafe3® I.V. ADMINISTRATION SET (identical to AmSafe I.V. Administration Set, with the exception of the drip selector option.)

Tubing	Bag Spike	Filter	Bag Hanger
Drip Chamber	Clamp	Rotating male luerlock	Y-site
Needleless injectionsite	Flow Controller	Male or Female luerlock	stopcock
Split SeptumInjection Site	Drip Selector	Check Valve	manifold

Technological Characteristics Summary:

AMSINO® I.V. ADMINISTRATION SET is 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 is 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).

Performance Data

The AMSINO® I.V. ADMINISTRATION SET meets the Bench performance testing requirement according to ISO 8536-4 when appropriate and/or AMSINO's testing and acceptance criteria:

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Biocompatibility and Haemocompatibility: Biocompatibility assessment of the AMSINO® I.V. Blocompatibility and Hatemocompaniucted based on the guidelines established by various ADMINISTION BET Tias been other organizations such as ISO 10993-1- Biological Evaluation of governmental and standard setting organizations organization, indirect blood path. Medical Device assessment, (Cytoxicity, Sensitization, Irritation, Systemic Cytoxicity and Hemocompatibility testing) the materials used to fabricate the AMSINO® I.V. Hemocompatibility tosting) "the manshown to be biocompatible, hemocompatible, and ADMINIST NATION ODT, have been east results indicate neither sensitivity, nor toxicity and appropriate for its intended ase: The test ISBNO I.V. Administration Set. Test data demonstrate that the AMSINO I.V. Administration Set is haemocompatible.

Sterility: AMSINO® I.V. ADMINISTRATION SET is sterilized by Ethylene Oxide as validated Steringy. 711201110- 11:2007-Sterilization of Healthcare products - Ethylene Oxide - Part 1: per 130 11155-1.2007-Sternzation of Frientant Routine Control of a Sterilization Process for Medical Devices.

Pyrogenicity: AMSINO® I.V. ADMINISTRATION SET is tested for pyrogenicity (see Bench Test table).

Microbial Ingress Testing: Amsino's testing of potential microbial ingress demonstrates a 4-Microbial Ingross Troomly. This against gram negative and gram positive organisms using the proper aseptic technique.

The AMSINO® I.V. ADMINISTRATION SET is substantially equivalent to the predicate I he HMDITO - 11/11/2017 materials used and intended use as the AMSINO® I.V. ADMINISTRATION SET (K973107).

Prepared by:

Jesus Farinas, QA/RA Manager

11 FEB 2010

Date

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Public Health Service

MAR ] 0 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jesus T. Farinas Manager, Quality Assurance and Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive Pomona, California 91767

Re: K093773

Trade/Device Name: AMSINO® I.V. ADMINISTRATION SET Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 11, 2010 Received: February 12, 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.

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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 (QS) 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/CDRHOffices/ ucm 1 1 5809.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 CDRH'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,

Th 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

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Indications for Use

510(k) Number: K093773

AMSINO® I.V. ADMINISTRATION SET Device Name: Indications For Use:

The AMSINO® I.V. 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.

Prescription Use × (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)

Au Sti for CZ

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of

510(k) Number:	Ko93773------------------------------------------------------------------------------------------------------------------------------------------------------------------------------of the street and and the comments of
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Regulation Number and Section

§ 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.