SPIROS

K070532 · Icu Medical, Inc. · FPA · Mar 20, 2007 · General Hospital

Device Facts

• Record ID: K070532
• Device Name: SPIROS
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Spiros, a CML, is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

Device Story

Spiros is a closed male luer (CML) accessory for IV administration sets; functions as a normally closed, swab-able, bi-directional valve. Prevents fluid leakage and air ingress when inactivated; provides open conduit for fluid flow when activated. Compatible with standard female luers and needlefree connectors. Used in clinical settings by healthcare providers to facilitate fluid administration from containers to patient vascular systems via catheters or needles. Device design includes two internal o-ring seals and an ultrasonically welded female luer. Benefits include maintaining a closed system during IV access, reducing risk of contamination and air embolism.

Clinical Evidence

Bench testing only. Device passed all post-sterilization acceptance criteria and functional performance claims.

Technological Characteristics

Closed male luer valve; polycarbonate construction; two internal o-ring seals; ultrasonically welded female luer; normally closed design; bi-directional flow; sterile; non-pyrogenic; single-use.

Indications for Use

Indicated for use as an accessory to an Intravascular Administration Set to provide fluid access from a container to a patient's vascular system via an indwelling needle or catheter. Single-use, sterile, non-pyrogenic, swab-able, bi-directional valve.

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.

Submission Summary (Full Text)

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ICU Medical, Inc. - CML TM Special 510(k) / February 2006

| Special 510(k) Summary |
|------------------------|
|------------------------|

Name of Submitter: ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

Manufacturer and Establishment Registration Number:

| Manufacturer: | Sterilization Site: |
|-----------------------------------|-------------------------------------|
| ICU Medical (Utah), Inc | Establishment |
| 4455 Atherton Drive | ICU Medical de Mexico, S.A. de C.V. |
| Salt Lake City, Utah 84123 | Avenida Cuarzo #250 |
| | Colonia Rancho Santa clara |
| Site Registration Number: 1713468 | El Valle de Maneadero |
| | Ensenada, B.B., MEXICO 22790 |
| | Site Registration Number: 9617594 |
| Or | |
| N/A | Beam-One LLC |
| | 9020 Activity Rd., suite D |
| | San Diego, California 92126 |
| | Site Registration Number: 2030598 |

Proprietary or Trade Name of Proposed Device: Spiros™

Common Name: Closed Male Luer

Device Classification: Class II

ProCode: FPA

- Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for set, administration, intravascular. Set, administration, intravascular are regulated within 21 CFR 880,5440.
Intended Use / Indications for Use: The Spiros, a CML, is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

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ICU Medical, Inc. - CML TM Special 510(k) / February 2006

Proposed Device Description: The Spiros is a closed connector which is compatible with and used to access, standard female luers and known needlefree connectors. The Spiros is a normally closed design which will prevent the leakage of fluid or ingress of air when in the inactivated state. When activated the luer is an open two-way conduit for fluid flow. The Spiros will be an accessory to an IV administration device including tubing sets and syringes, such that an integral female luer is used to connect to such devices.

## Summary of Substantial Equivalence:

#### Similarities:

- 1. The predicate and subject devices have the same intended use.
- 2. The predicate and subject devices have the same indications for use.
- 3. The predicate and subject devices contain the components made from the same materials with the one exception noted below.

#### Differences:

- 1. The subject device will use a Polycarbonate material from a different vendor than the predicate device. This material is used on another legally marketed device by ICU Medical, Inc.
- 2. The subject device contains two internal o-ring seals while the predicate device contains one internal o-ring seal
- 3. The subject device contains a female luer ultrasonically welded to it; the predicate device contains a female luer that is solvent bonded to a short piece of tubing which is in turn solvent bonded to the device.

## Statement of Safety and Effectiveness:

The Spiros™ closed male luer device has been tested post sterilization and passed all acceptance criteria. The Spiros™ closed male luer meets the functional claims and intended use as described in the product labeling and is safe and effective in terms of substantial equivalence as the predicate device described in this document.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Martin Maier Senior Quality Assurance Engineer ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

MAR 2 0 2007

Re: K070532

Trade/Device Name: SpirosTM Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 23, 2007 Received: February 26, 2007

Dear Mr. Maier:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Maier

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. 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

k 000532 1

510(k) Number (if known):

Device Name: Spiros™

Indications for Use: The Spiros™ is a single use, sterile, non-pyrogenic, swab-able, bidirectional valve device intended for use as an accessory to Intravascular Administration Set. The Spiros™ provides access of the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

Prescription Use X (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 OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

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