CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX

K081361 · Icu Medical, Inc. · FPA · Aug 28, 2008 · General Hospital

Device Facts

• Record ID: K081361
• Device Name: CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROS™, GENIE™, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

Device Story

ChemoCLAVE is a system of previously cleared, needleless, passively closed components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, Admin Sets) used for preparing and delivering cytotoxic medications. System enables safe, closed-system transfer of drugs from vials to administration sets for patient delivery. Used in clinical settings by healthcare providers. Components are packaged individually or as custom sets. System provides a closed alternative to traditional preparation methods, reducing exposure risk to cytotoxic agents during medication handling and administration.

Clinical Evidence

Bench testing only. The system relies on the established safety and performance history of its individual, previously cleared components. No new clinical data was required or provided for this submission.

Technological Characteristics

System consists of needleless, passively closed components including connectors, spikes, and administration sets. Materials, design, and assembly are identical to previously cleared predicates. Sterilization is achieved via Gamma radiation. Components are packaged in blister packs with Tyvek lidding. Sterility Assurance Level (SAL) meets 10^-6. Compatible with lipids and cytotoxic agents.

Indications for Use

Indicated for the preparation and administration of cytotoxic medications in patients requiring chemotherapy.

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

• Clave Connector (K970855)
• Genie™ (K070633)
• Clave Vial Access Spike (K934591)
• Spiros (K070532)
• Universal Vial Access Spike (K080989)
• Primary IV Set (K964435)
• Single Use Syringe (K070856)
• Chemo Dispensing Pin (K024239)
• Chemo-AIDE (K003730)
• Taxol Administration Set (K003513)
• Chemo Spike II Reconstitution Device (K974431)

Submission Summary (Full Text)

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## ICU MEDICAL INC.

4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Mr. Tracv S. Best, Sr. Regulatory Affairs Specialist Preparation Date: August 26th 2008

Image /page/0/Picture/2 description: The image contains the logo for ICU Medical, Inc. along with a horse graphic. Above the logo, there is a handwritten number, K081361. The logo is in bold, black font.

AUG 2 8 2008

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

| Trade Name: | ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System |
|----------------------|---------------------------------------------------------------------------------------------------|
| Common Name: | Chemotherapy I.V. Preparation, Transfer and Administration Sets |
| Classification Name: | Set, I.V. Fluid Transfer & Set, Administration, Intravascular<br>21 CFR 880.5440, Class II Device |
| Product Codes: | Primary Code – LHI, Secondary Code – FPA |

### Legally Marketed Predicate Devices for Substantial Equivalence:

*Clave Connector - K970855 *Genie™ - K070633 *Clave Vial Access Spike - K934591 *Spiros - K070532 *Universal Vial Access Spike - K080989 *Primary IV Set - K964435 *Single Use Syringe - K070856

*Chemo Dispensing Pin - K024239 *Chemo-AIDE - K003730 *Taxol Administration Set - K003513 *Chemo Spike II Reconstitution Device - K974431

## Rationale for SE:

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery Systems are a combination of ICU Medical devices that are already legally marketed around the world. In short, we are incorporating these previously cleared devices to withdraw cytotoxic agents from a vial for transfer to the administration set and finally, to the patient. All of the predicate devices listed above left are part of this submission.

## Description of Submitted Device:

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a combination of ICU Medical's products and tested for compatibility with lipids and/or cytotoxic agents. The "System" part is where these devices are packaged individually or sold together as a custom set upon order of the physician for the purpose of enabling the user a safe and inexpensive alternative to other passively closed systems. The predicate devices have been successfully used in the practice of administration of chemotherapy agents to patients for many years. In this submission, we are specifically requesting to market the name "ChemoCLAVE Cytotoxic Medication Preparation and Delivery System."

### Intended Use:

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROS™, GENIE™, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

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| Device: | CLAVE® | SPIKES | SPIROST™ | GENIETM | VIAL ACCESS | ADMIN SETS |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------------|---------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| The<br>ChemoCLAVE<br>Cytotoxic<br>Medication<br>Preparation<br>and Delivery<br>System is any<br>combination of<br>these already<br>approved &<br>marketed<br>devices. | Same<br>design,<br>materials,<br>assembly | Purchased<br>and<br>qualified<br>component | Same<br>design,<br>materials,<br>& assembly | Same<br>design,<br>materials,<br>& assembly | Materials &<br>assembly similar | Same design<br>and materials<br>and assembly |
| | Needleless | Needleless | Needleless | Needleless | Needleless | N/A |
| | Passively<br>closed | N/A | Passively<br>Closed | Passively<br>Closed | N/A | N/A |
| | Gamma | Gamma | Gamma | Gamma | Gamma | Gamma |
| | K970855 | K964435<br>& OEM | K070532 | K070633 | K934591;<br>K934561 &<br>K080989 | K964435 &<br>OEM |
| | C1000;<br>B3300;<br>CH3000;<br>etc. | CH-12;<br>CH-13;<br>CH-14;<br>CH-15;<br>etc. | CH2000;<br>CH3000;<br>etc. | CH-77; etc.<br>(vial size) | CH-10; CH-50;<br>CH-51; CH-52;<br>CH-55; CH-60;<br>CH-70; etc. (vial<br>size) | Too numerous<br>to list ( due to<br>tubing length &<br>and accessories) |

# Technological Characteristics and Substantial Equivalence Table:

#### Safety and Performance:

ICU Medical conforms to international standards in the design, development, and manufacturing of all of their unique disposable medical devices. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting a 10t4 level. The single use ChemoCLAVE Cytotoxic Medication Preparation and Delivery System components are packaged in blister packs with Tyvek lidding.

### Conclusion:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2008

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

Re: K081361

Trade/Device Name: ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, LHI Dated: August 21, 2008 Received: August 22, 2008

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 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); 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 yours,

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): K081361

Device Name: ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System:

Indications for Use:

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROS™, GENIE™, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

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)

Anthony D. m

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

K681361 510(k) Number: __