PRIMARY IV SET

K964435 · Icu Medical, Inc. · FMG · Apr 2, 1997 · General Hospital

Device Facts

• Record ID: K964435
• Device Name: PRIMARY IV SET
• Applicant: Icu Medical, Inc.
• Product Code: FMG · General Hospital
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

Device Story

Intravascular administration set; single-use, sterile, non-pyrogenic tubing assembly. Provides fluid path from container to patient vein via needle or catheter. Components include spike/drip chambers, clamps, injection sites, filters, backcheck valves, and male luer fitments. Used in clinical settings for fluid delivery. Healthcare providers configure sets based on specific patient/procedure needs. Benefits include reliable, sterile fluid access for therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tubing of various lengths/diameters; components include spike/drip chambers, clamps, injection sites, filters, backcheck valves, male luer fitments. Materials: medical grade. Packaging: fiber-free peelable paper lidding and pouching. Sterilization: sterile fluid pathway.

Indications for Use

Indicated for patients requiring intravenous fluid administration via needle or catheter access to the vascular system.

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

• Medical Product Specialists I.V./Secondary Sets
• McGaw Intravenous Administration Sets
• Churchill Medical Systems IV/Extension Sets

Submission Summary (Full Text)

{0}

APR 01 '97 07:59 FR ICU MEDICAL
714 366 8368 TO 13014803002
P.05/06
K964435
ICU Medical Inc.
Intravascular Administration Set
APR -2 1997
510(k) Notification
Page 17 of 50

## 14. Appendix F. 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K964435

### Applicant Information:

Date Prepared: May 29, 1996
Name: ICU Medical Inc.
Address: 951 Calle Amanecer
San Clemente, CA 92673

Contact Person: Richard Waters
Phone Number: [phone]
Fax Number: [phone]

### Device Information:

Trade Name: Intravascular Administration Set
Common Name: IV Set
Classification Name: Intravascular Administration Set

### Equivalent Devices:

Medical Product Specialists I.V./Secondary Sets
McGaw Intravenous Administration Sets
Churchill Medical Systems IV/Extension Sets

### Device Description:

The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). Each set will be manufactured to unique specifications using dimensions, components and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU Medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged.

### Intended Use:

The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

510(k), Primary Sets

{1}

APR 01 '97 07:59 FR ICU MEDICAL
714 366 8368 TO 13014803002
P.06/06
ICU Medical Inc.
Intravascular Administration Set
510(k) Notification
Page 18 of 50

Comparison To Predicate Device:

| Characteristic Compared | ICU MEDICAL INTRAVASCULAR ADMINISTRATION SET | PREDICATE INTRAVASCULAR ADMINISTRATION SET |
| --- | --- | --- |
| Product Labeling | Single Use, Non-pyrogenic, Sterile fluid pathway in un-opened, undamaged package. Directions for use on labeling | Single Use, Non-pyrogenic, Sterile fluid pathway in un-opened, undamaged package. Directions for use on labeling |
| Intended Use | Single use, Sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). | Single use, Sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). |
| Design | Tubing of various lengths and inside diameters are configured with some or all of the following: spike/drip chambers (as part of a set only), clamps, injection site(s), filters, backcheck valves and male luer fitments. Packaged in medical grade fiber-free peelable paper lidding and pouching material. | Tubing of various lengths and inside diameters are configured with some or all of the following: spike/drip chambers, clamps, injection site(s), filters, backcheck valves and male luer fitments, huber needle. Packaged in medical grade fiber-free peelable paper lidding and pouching material. |

510(k), Primary Sets
**TOTAL PAGE.06**