AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS

K093773 · Amsino International, Inc. · FPA · Mar 10, 2010 · General Hospital

Device Facts

• Record ID: K093773
• Device Name: AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
• Applicant: Amsino International, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The AMSINO I.V. Administration Set is a single-use, sterile, gravity-feed device used to deliver fluids from a container to a patient's vascular system via an intravenous catheter. The device consists of various components including a bag spike, drip chamber, tubing, flow controller, clamps, injection sites (latex-free/needleless), and luer connectors. It is used in clinical settings to manage fluid administration. The healthcare provider connects the set to a fluid container and the patient's catheter, adjusting flow via the integrated regulator. This facilitates controlled fluid delivery to the patient. The device is manufactured from DEHP-free PVC and sterilized using Ethylene Oxide.

Clinical Evidence

Bench testing only. Testing included ISO 8536-4 performance criteria (spike, drip chamber, flow regulator, connector tensile strength, leakage), biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility), sterility validation (ISO 11135-1:2007), pyrogenicity, and microbial ingress challenge (4-log reduction).

Technological Characteristics

Materials: High-grade extruded DEHP-free PVC. Components: Spike, drip chamber, tubing, flow controller, injection sites, luer connectors. Energy: Gravity-fed (no external power). Sterilization: Ethylene Oxide per ISO 11135-1:2007. Standards: ISO 8536-4 (performance), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for administration of fluids from a container to a patient's vascular system via an intravenous catheter. No specific age or gender restrictions noted.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AMSURE I.V. ADMINISTRATION SET (k973107)

Reference Devices

• AMSINO I.V. ADMINISTRATION SET (k971037)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Toll Free: 1-800-MD-AMSINO http://www.amsino.com e-mail: [e-mail]

### 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 [phone], extension 127 or at [e-mail]

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, Inc<br>855 Towne Center Drive,<br>Pomona, CA 91767<br>Jesus T. Farinas<br>Manager, Quality Assurance and Regulatory Affairs<br>Telephone Number : [phone], ext 127<br>Email: [e-mail] |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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:

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)

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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 | Bag Spike | Filter | Bag Hanger |
|--------------------------------|-----------------|-----------------------------|------------|
| Drip Chamber | Clamp | Rotating male luer<br>lock | Y-site |
| Needleless injection<br>site | Flow Controller | Male or Female luer<br>lock | stopcock |
| Split Septum<br>Injection 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:

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.

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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 [phone] or [phone] 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

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