HIGH PRESSURE SETS-400 PSI

K100576 · Icu Medical, Inc. · FPA · Dec 17, 2010 · General Hospital

Device Facts

• Record ID: K100576
• Device Name: HIGH PRESSURE SETS-400 PSI
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.

Device Story

High pressure extension sets serve as sterile fluid conduits between injectors and patient access devices (cannula/catheter). Input: fluids (contrast media, medications, blood) from manual or electronic injectors. Transformation: provides high-pressure-rated (up to 400 psi) pathway using integrated needleless connectors (CLAVE, MicroCLAVE, Y-CLAVE, CLC2000). Output: fluid delivery to patient. Used in clinical settings (e.g., cardiovascular procedures) by healthcare professionals. Benefits: prevents needlesticks via needleless connectivity; facilitates safe high-pressure contrast injection; allows custom lengths/configurations per facility needs.

Clinical Evidence

No clinical data. Bench testing only. Simulated use testing conducted per product specifications to validate 400 psi pressure rating and performance criteria. Biocompatibility testing performed per ISO 10993-1:2003.

Technological Characteristics

Materials: PVC tubing, PC/PVC luers. Energy: Passive fluid conduit. Dimensions: Custom lengths. Connectivity: Universal luer connection (ISO 594-1/594-2) with integrated needleless connectors (CLAVE, MicroCLAVE, Y-CLAVE, CLC2000). Sterilization: Gamma radiation. Pressure rating: 400 psi.

Indications for Use

Indicated for patients requiring fluid delivery (contrast media, medications, blood products) via electronic or manual injector through a venous or arterial cannula/catheter. For use by healthcare professionals. No specific age/gender restrictions.

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

• Smart Site Valve Sets (K061285)
• High Pressure Tubing (K941978)
• High Pressure Injection Linc (K963749)

Submission Summary (Full Text)

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### 510(K) Summary

ICU MEDICAL INC.

4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: 05/28/2010

DEC 1 7 2010

K100576

# Summary of Safety and Effectiveness for the:

| Trade Name: | High Pressure Sets - 400 psi |
|----------------------|------------------------------------------------------------------------------------------------------|
| Common Name: | High Pressure Infusion Devices |
| Classification Name: | Primary 21 CFR 880.5440, Class II Device, 80FPA<br>Secondary 21 CFR 870.4290, Class II Device, 74DTL |

#### Legally Marketed Predicate Devices for Substantial Equivalence:

*K061285 - Smart Site Valve Sets - Cardinal Health, Inc.

*K941978 - High Pressure Tubing, - Abbott Labs (submission acquired by ICU Medical Inc.) *K963749 - High Pressure Injection Linc, Maxim Medical, Inc.

#### Rationale for SE:

The ICU Medical High Pressure Sets are substantially equivalent to the predicate devices that offer needleless connectivity and international lucr compatibility. The use of ICU's legacy line of connectors is complimentary to these pre-assembled, individually packaged, and pre-sterilized high pressure sets. High pressure sets are used in cardiovascular procedures where contrast media is injected using control syringes or power injectors is common among all devices, which are safe for use up to 400 psi. These features are substantially equivalent to the predicate devices in that they also utilize male luers; female luers or locking luer connectors. Components of the devices are made from materials that are substantially cquivalent to the predicate devices listed above and this submission includes comprehensive biocompatibility testing for all device materials included in this submission. Additionally, all devices have a proven and invaluable history in the medical device market.

#### Description of Submitted Device:

The High Pressure Sets are a group of luer compatible connection devices that aid in the prevention of needlesticks and offer ease of use in the environment for the healthcare professional. The use of the CLAVE®; MicroCLAVE™; Y-CLAVE™; and CLC2000™ is a natural fit with the high pressure sets. Testing included with this submission, validates the 400 psi claim with these unique connectors. The functional technology of the high pressure set has not changed but is augmented by the addition of the ICU connectors. The devices are sterilized to ensure a 10ª SAL and they have been tested under the ISO 10993-1:2003 ~ Biological evaluation of medical devices ~ Part 1: Evaluation and resting and the results from these tests were found to be acceptable and are enclosed in this submission.

#### Non-Clinical Testing:

Testing (simulated use) has been conducted according to the product specification and that testing demonstrates that the device is safe and effective by meeting predefined criteria. Test data is part of this submission as evidence.

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## Intended Uses of the ICU Medical High Pressure Sets:

The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.

| Component | ICU Medical<br>High Pressure<br>Sets | Cardinal Health<br>Smart Site Valve<br>Sets | Abbott Labs<br>(submission<br>acquired by ICU<br>Medical) | Maxxim Medical<br>High Pressure<br>Injection Line |
|-------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------|
| Materials | Tubing-PVC<br>Luers - PC, PVC<br>& proprietary<br>needleless devices | Tubing - PVC<br>Luers - PC &<br>proprietary<br>needleless devices | Tubing - PVC<br>Luers - PC &<br>PVC | Tubing - PVC<br>Luers - Plastic (PC<br>assumed) |
| Functional<br>use | High pressure<br>infusion | High pressure<br>infusion | High pressure<br>infusion | High pressure<br>infusion |
| Sterilization<br>Method | Gamma | EtO | EtO and Gamma | Unknown |
| Packaging | Peel pouch | Peel pouch | Peel pouch | Peel pouch |
| 510(k)<br>Approval | This submission | K061285 | K941978 | K963749 |

### Technological Characteristics and Substantial Equivalence Table:

## Safety and Performance:

ICU Medical's commitment to quality and the high pressure sets that we currently make with the acquired K941978 submission are part of this submission. The use of these devices at pressures up to 400 psi has been tested and thoroughly proven to be safe and effective when coupled with the CLAVE; MicroCLAVE; Y-CLAVE; and COC2000. These high pressure sets are individually packaged and pre-sterilized in a peel type pouch. Devices are obtainable at custom lengths, according to facility needs and physician preference, including the type of luer ends used. Additionally, ICU Mcdical performs analysis and design verification icsting based on predecermined criteria, which is presented in the Performance Specifications in this submission. All testing meets these performance criteria as defined for the high-pressure. The design of the proprietary needleless connectors allow lucr connections as defined by ISO 594-1 and ISO 594-2 which is considered to be an industry standard.

## Conclusion:

The materials, performance, and operational features of the submitted devices and the predicate devices are substantially equivalent to one another and effective for their intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Mr. Tracy Best Senior Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

DEC 17 2010

Re: K100576

Trade/Device Name: High Pressure Sets - 400 psi Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 30, 2010 Received: November 5, 2010

Dear Mr. Best:

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. Best

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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

DEC 17 2010

#### 510(k) Number (if known): K100576

Device Name: High Pressure Sets - 400 psi

Indications for Use:

The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mih C. Chape 12/19/10

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

510(k) Number: K100576