INFUSION SYRINGE SET

K131661 · Innovative Medical Manufacturing Co. · FMF · Nov 5, 2013 · General Hospital

Device Facts

• Record ID: K131661
• Device Name: INFUSION SYRINGE SET
• Applicant: Innovative Medical Manufacturing Co.
• Product Code: FMF · General Hospital
• Decision Date: Nov 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.

Device Story

IMM Infusion Syringe Set is a single-use, sterile, manual fluid delivery system. Components include a spike inlet for fluid reservoir connection, PVC tubing, a dual check valve, and a 12ml control syringe. The device is operated manually by clinicians to deliver controlled volumes of fluids from a solution bag to an access device (e.g., needle). The distal end features a 6% taper luer fitting for secure connection. The device facilitates fluid administration in clinical settings. Benefits include controlled, manual fluid delivery and ease of use/replacement. The device is disposed of after single patient use.

Clinical Evidence

Bench testing only. No clinical data provided. Functional performance testing demonstrated compliance with ISO8536-4 (infusion sets) and ISO7886-1 (sterile hypodermic syringes). Biocompatibility testing conducted in accordance with ISO10993.

Technological Characteristics

Materials: PP, PVC, PC, ABS. Sensing/Actuation: Manual piston syringe with dual check valve. Energy: Manual. Connectivity: None. Sterilization: Ethylene Oxide (EtO). Standards: ISO8536-4, ISO7886-1, ISO10993. Form factor: Single-use infusion set with 12ml syringe and 6% taper luer fitting.

Indications for Use

Indicated for patients requiring controlled volume fluid delivery from reservoirs via manual operation. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Vascular Auto-Fill Syringe Kit (K063851)
• Multi-Ad Dispensing system (K792227)

Submission Summary (Full Text)

{0}------------------------------------------------

# Innovative Medical Manufacturing Company

107, Lane 181, Sec.1, Yong Jane Rd., Chunan, Miaoli 350, Taiwan, ROC TEL:[phone] FAX:[phone] E-mail:[e-mail] Unified Code:16980249

#### 510(k) Summary of Safety and Effectiveness

#### 1. General Information

| Submitted by: | Innovative Medical Manufacturing Company<br>107, Lane 181, Sec. 1., Yong Jane Road<br>Chunan, Miaoli 350, Taiwan (ROC) |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Lucy Huang, Regulatory Specialist<br>Tel: [phone]<br>Fax: [phone] |
| Date of preparation: | 10/14/2013 |
| | NOV 05 2013 |

## 2. Device Information

| Common Name: | Syringe Kit |
|-------------------|--------------------------------------------------|
| Proprietary Name: | IMMTM Infusion Syringe Set |
| Classification | Piston Syringe; Intravascular Administration Set |
| Name: | |
| Product code: | FMF(880.5860)<br>FPA (880.5440) |

#### 3. Predicate Device

| Trade Name | 510(k) Number | Decision Date |
|--------------------------------|---------------|---------------|
| Vascular Auto-Fill Syringe Kit | K063851 | 2007/1/26 |
| Multi-Ad Dispensing system | K792227 | 1979/12/20 |

## 4. Device Description

IMM 110 Infusion Syringe Set is single use product which contains disposable parts of one spike infusion set for connecting to fluid reservoir and fluid delivery, and a control syringe for delivery fluid supply from a solution bag to access device for purpose of delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation. The distal end of the set is a dual valve with 6% taper design for connecting to other access device such as needles before use. The IMM Infusion Syringe Set is provided sterile in fluid path, and to be disposed after single patient use.

{1}------------------------------------------------

# Innovative Medical Manufacturing Company

107, Lane 181, Sec.1, Yong Jane Rd., Chunan, Miaoli 350, Taiwan, ROC TEL:[phone] FAX:[phone] E-mail:[e-mail] Unified Code:16980249

# 5. Indication for Use

IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.

## 6. Technological Characteristics

The IMM™ Infusion Syringe Set is single use device, and can be delivered in unit sterile package or in bulk non-sterile shipment for further packaging. It allows easy operation and replacement before use.

## 7. Substantial equivalence

The IMM™ Infusion Syringe Set has the same indication for use and similar characters with the predicated device. The technological characteristics of the IMM device are as same as the predicate device.

| Element of<br>Comparison | Subject Device<br>K131661 | Vascular<br>K063851 | B. Braun<br>K792227 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------|
| Intended Use | For delivering<br>controlled volume<br>of fluids from<br>reservoirs of<br>labeled route of<br>administration of<br>fluids by manual<br>operation | Same | Similar |
| Construction | Spike inlet, PVC<br>tubing, dual check<br>valve, syringe | Similar, except<br>additional<br>extension | Spike inlet, PVC<br>tubing, dual check<br>valve, syringe |
| Transparency | Tubing of fluid line<br>is transparency | Same | Same |
| Tubing/fitting<br>bonding<br>strength | Tensile strength<br>>15 N | Similar | Similar |
| Flow regulator<br>Clamping<br>efficacy | From zero to<br>maximum in<br>gravity use | Same | Same |
| Syringe | 12ml | 12ml | 10ml |
| Interface | Luer fitting | Luer fitting | Luer fitting |
| Material | PP, PVC, PC, ABS | PP, PVC, PC, ABS | Similar |
| Sterility | Single use | Same | Same |
| Sterilization<br>method | EtO | EtO | EtO |

{2}------------------------------------------------

# Innovative Medical Manufacturing Company

107, Lane 181, Sec.1, Yong Jane Rd., Chunan, Miaoli 350, Taiwan, ROC TEL: [phone] FAX:[phone] E-mail:[e-mail] Unified Code:16980249

## 8. Performance Summary

The non-clinical functional and performance tests demonstrated that IMM™ Infusion Syringe Kit meets the specific requirements established in voluntary standards: ISO8536-4 and ISO7886-1.

#### 9. Material

The Infusion syringe set is composed of materials that have been tested in accordance with ISO10993 and have been determined to be suitable for the intended use of this product.

#### 10. Safety and Effectiveness

All verification and validation test data indicated that the IMM Infusion syringe set can perform as intended use and is substantially equivalent to the predicate device.

5-3

{3}------------------------------------------------

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

November 5,2013

Innovative Medical Manufacturing Company Ms. Lucy Huang Regulation Specialist No .. 107, Lane 181, Sect 1., Yong Jane Road Chunan, MIAOLI CHINA 350

Re: K131661

Trade/Device Name: IMM™ Infusion Syringe Set Regulation Number: 21 CFR 880.5860, 21 CFR 880.5840 Regulation Name: Piston Syringe, Intravascular Administration Set Regulatory Class: II Product Code: FMF, FPA Dated: September 13, 2013 Received: September 25, 2013

Dear Ms.Huang:

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 - Ms. Huang

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Image /page/4/Picture/7 description: The image shows the text "Mary Surfammer -S". The text is in a bold, sans-serif font. The word "Mary" is in a larger font size than the rest of the text. The word "Surfammer" is stylized with a wave-like design. The "-S" is in a smaller font size than the rest of the text.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

K131661 510(k) Number (if known):

Device Name: IMM™ Infusion Syringe Set

Indications for Use:

IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.

Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart AND/OR (21 CFR 801 Subpart C) D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _1_ of __ 1_

Image /page/5/Picture/9 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is in black and white and features the letters "FDA" in a stylized, geometric font. The letters are outlined with multiple lines, giving them a three-dimensional appearance. The "A" in FDA is shaped like a triangle.

Richard C. Chapman 2013.11.04 16:10:11 -05'00'