GENIE, MODEL CH-200

K070633 · Icu Medical, Inc. · FMF · Jun 5, 2007 · General Hospital

Device Facts

• Record ID: K070633
• Device Name: GENIE, MODEL CH-200
• Applicant: Icu Medical, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

Device Story

Genie is a needleless vial access device used as an accessory to a piston syringe; facilitates sterile drug withdrawal from vials. Device features an internal balloon mechanism for automatic pressure equalization during fluid withdrawal; prevents aerosolization of hazardous drugs and eliminates need for conventional needles. Used in clinical settings by healthcare workers during medication preparation, administration, and dispensing. By equalizing pressure, device reduces risk of spills, hazardous aerosol exposure, and accidental needle sticks, enhancing worker safety while maintaining system sterility.

Clinical Evidence

Bench testing only. The device was tested post-sterilization and met all functional acceptance criteria and performance claims.

Technological Characteristics

Needleless vial access device; accessory to piston syringe. Features internal balloon for pressure equalization. Materials qualified per ISO 10993-1:2003. Regulated under 21 CFR 880.5860.

Indications for Use

Indicated for healthcare workers as a needleless accessory to syringes for sterile access to drug vials, intended to reduce exposure to hazardous drug aerosols and accidental needle sticks.

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

• K001368

Submission Summary (Full Text)

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K070633 page 1 of 2

ICU Medical, Inc. - Genie Traditional 510(k) / February 2006

# 5. Traditional 510(k) Summary

| Name of Submitter: | ICU Medical, Incorporated<br>4455 Atherton Drive<br>Salt Lake City, Utah 84123 | JUN - 5 2007 |
|--------------------|--------------------------------------------------------------------------------|--------------|
|--------------------|--------------------------------------------------------------------------------|--------------|

### Manufacturer and Establishment Registration Number:

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

# Proprietary or Trade Name of Proposed Device: Genie™

Common Name: Vial Access Device

Device Classification: Class II

Product Code: FMF, MEG

### Performance Standards:

There is a performance standard for this Classification Product Code FMF (Primary) and MEG (Secondary) under Section 514 of the Food, Drug and Cosmetic Act for Syringe, Piston, Needleless. This device is an accessory to a Piston Syringe, and is regulated within 21 CFR 880.5860.

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#### Intended Use / Indications for Use:

The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

### Proposed Device Description:

The Genie™ is intended for use as an accessory to an I.V. set. The Genie™ is used to adapt a standard medication vial for needle free access and to maintain the sterile system. In addition, the Genie™ automatically equalizes vial pressure as fluids are withdrawn and therefore reduces the risk for health-care workers for exposure to potentially hazardous drug aerosols, spills or needle sticks that can occur during the preparation, administration and dispensing process.

#### Summary of Substantial Equivalence:

#### Similarities:

- 1. The predicate and subject devices have the same or similar intended use.
- 2. The predicate and subject devices have the same or similar indications for use.
- 3. The predicate and subject devices contain the components made from materials tested and qualified per ISO 10993-1:2003.

#### Differences:

- 1. The subject device will use an internal balloon for pressure equalization, while the predicate device (K001368) uses an external balloon or a filtered vent.
#### Statement of Safety and Effectiveness:

The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria. The Genie™ vial access device 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 devices described in this document.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN -5 2007

Re: K070633

Trade/Device Name: Genie™ Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 6, 2007 Received: March 7, 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 (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 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,

Chris Liu, 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

510(k) Number (if known): __K070633

Device Name: Genie™M

Indications for Use:

The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

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)

Anton Doma

ision Sign-Off) Civision of Anesthesiology, General Hospital, In schon Control, Dental Devices

510(k) Number: k092633

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