SPINNING SPIROS, MODEL CH-2000

K082806 · Icu Medical, Inc. · FPA · Apr 6, 2009 · General Hospital

Device Facts

• Record ID: K082806
• Device Name: SPINNING SPIROS, MODEL CH-2000
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 6, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Spiros is a single use, sterile, non-pyrogenic, swab-able, bidirectional 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

Spinning Spiros is a closed, male luer (CML) connector accessory for IV administration sets and syringes. Device features a spin collar to prevent accidental disconnection from syringes. In inactivated state, device is passively closed to prevent fluid leakage or air ingress; when activated, it functions as a bidirectional conduit for fluid flow. Used in clinical settings by healthcare providers to access standard female luers and needle-free connectors. Device facilitates safe fluid administration to patients via vascular access devices.

Clinical Evidence

Bench testing only. Device tested post-sterilization and passed all acceptance criteria for functional performance and safety.

Technological Characteristics

Passively closed male luer (CML) connector. Features a spin collar for secure attachment. Bidirectional valve mechanism. Single-use, sterile, non-pyrogenic. Compatible with standard female luers and needle-free connectors.

Indications for Use

Indicated for use as an accessory to an Intravascular Administration Set to provide access for fluid administration from a container to a patient's vascular system via an indwelling needle or catheter.

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

• Spiros - ICU Medical, Inc. (K070532)

Submission Summary (Full Text)

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ICU MEDICAL INC.

R - 3 2009

## 4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: April 06, 2009

APR - 6 2009

edical. Inc.

#### SPECIAL 510(K) Summary of Safety and Effectiveness for the:

Trade Name: Spinning Spiros

Common Name: Accessory to Piston Syringe, Needleless

Classification Name: I.V. Administration Set, Accessory 21 CFR 880.5440, Class II Device

Product Code: FPA

# Legally Marketed Predicate Devices for Substantial Equivalence:

*K070532 - Spiros - ICU Medical, Inc.

#### Rationale for SE:

The Spinning Spiros device is a passively closed - closed male luer or CML. This device is equivalent to the predicate device because it does not modify the claim. The few dimensional changes are necessary for larger cavity molds and for eventual automated assembly. The spin collar adds the feature that the Spinning Spiros won't accidentally back off of a syringe.

#### Description of Submitted Device:

The Spinning Spiros is a closed connector which is compatible with and used to access, standard female luers and known needle-free connectors. The Spinning Spiros is a passively closed design which will prevent the leakage of fluid or ingress of air when in the inactivated (resting) state. When activated the luer is an open twoway conduit for fluid flow. The Spinning Spiros is 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.

#### Intended Use:

The Spiros is a single use, sterile, non-pyrogenic, swab-able, bidirectional 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).

#### Safety and Performance:

ICU Medical Spinning Spiros closed male luer device has been tested post sterilization and passed all acceptance criteria. The Spinning Spiros closed mate 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.

#### Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and safe and effective for their intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing segments, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR - 6 2009

Re: K082806

> Trade/Device Name: Spinning Spiros Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 9, 2009 Received: March 10, 2009

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.

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 vour 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); 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Shula A. Mayberg, MD for S. Rumm, DDS

Susan Runner, D.D.S., MA Acting 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 (if known):

K082806

Device Name:

Spinning 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 an Intravascular Administration Set. The Spiros provides access for the administration needle or catheter (which is inserted into the vein or artery).

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)

J.A.Oull.

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

510(k) Number: _ Korz 04