CHEMOLOCK, CHEMOLOCK PORT

K131549 · Icu Medical, Inc. · ONB · Jul 26, 2013 · General Hospital

Device Facts

• Record ID: K131549
• Device Name: CHEMOLOCK, CHEMOLOCK PORT
• Applicant: Icu Medical, Inc.
• Product Code: ONB · General Hospital
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Device Story

ChemoLock is a needlefree, single-use Closed System Drug Transfer Device (CSTD) comprising a two-piece system (ChemoLock and Port). It facilitates the transfer of cytotoxic drugs between vials, bags, and syringes. The device uses passive, self-sealing elastomeric double-membrane mechanisms to maintain a closed system, preventing drug/vapor escape and environmental/bacterial ingress. It connects to standard ISO-594 luer systems. Operated by healthcare personnel in clinical environments, the device ensures a dry, leak-proof disconnection. By maintaining a closed fluid path, it protects clinicians from hazardous drug exposure and needlestick injuries, while protecting patients from microbial contamination.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including microbial ingress testing and chemical egress studies (cyclophosphamide compounding trials). Testing demonstrated effective prevention of bacterial ingress and surface contamination. Performance testing followed guidance for intravascular administration sets.

Technological Characteristics

Materials: Biocompatible thermoplastics and silicone. Principle: Passive, self-sealing elastomeric double-membrane mechanism for closed fluid transfer and pressure equalization. Connectivity: Standard ISO-594 luer compatibility with permanent locking features. Sterilization: E-beam. Form factor: Two-piece system (ChemoLock and Port).

Indications for Use

Indicated for healthcare personnel handling cytotoxic medications to prevent needlestick injuries and exposure to drugs or vapors, and to prevent environmental/bacterial contamination of the system. Applicable for use in clinical settings where cytotoxic drugs are prepared or administered.

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

• BD Phaseal Closed System Drug Transfer Device (K123213)
• ChemoClave Cytotoxic Medication Preparation and Delivery System (K081361)
• Spinning Spiros (K082806)

Submission Summary (Full Text)

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K131549

# JUL 2 6 2013

### Section 5 510(k) Summary

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Company Name: | ICU Medical, Inc.<br>4455 Atherton Drive |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Salt Lake City, UT 84123 |
| Contact Person: | Katherine Kenner<br>Regulatory Affairs Specialist<br>ICU Medical, Inc.<br>Phone: [phone]<br>Fax: [phone] |
| Preparation Date: | May 28, 2013 |
| Device (Trade Name): | ChemoLock Closed System Drug Transfer Device |
| Common/Usual Name: | Closed System Drug Transfer Device |
| Classification Names: | 21 CFR 880.5440. Closed System Drug Transfer Device. Product Code:<br>800NB and 80FPA. |
| Predicate Device: | K123213 BD Phaseal Closed System Drug Transfer Device<br>K081361 ChemoClave Cytotoxic Medication Preparation and Delivery<br>System<br>K082806 Spinning Spiros |
| Device Description: | The ChemoLock is a needlefree, single-use, Closed System Drug Transfer<br>Device (CSTD). The ChemoLock has a mechanical means to prevent the<br>transfer of environmental contaminants into the system, and the escape of<br>drug or vapor concentrations outside the system. The system includes<br>closed vial and bag access devices, a closed syringe adapter and closed<br>patient administration sets. All components of the system include passive<br>self-sealing mechanisms which cannot be deactivated and remain<br>protective through disposal. |
| Intended Use: | The ChemoLock Closed System Drug Transfer Device prevents the<br>transfer of environmental contaminants, including bacterial and airborne<br>contaminants into the system, and the escape of drug or vapor<br>concentrations outside the system. The ChemoLock is needlefree and<br>cannot be deactivated, which will passively aid in preventing needlestick<br>injuries and the exposure to cytotoxic medications for healthcare<br>personnel. |
| Technology: | The ChemoLock Closed System Drug Transfer Device employs the same<br>fundamental scientific technology as its predicate devices. Please see<br>Table 1 for more information. |

| Feature | ChemoClave | Spinning Spiros | Phaseal | ChemoLock | Comparison |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510K<br>NUMBER | K081361 | K082806 | K123213 | K131549 | N/A |
| Equalizes<br>Vial Pressure<br>when<br>Accessed | Yes | Not Applicable | Yes | Yes | Identical to<br>K123213 and<br>K081361 |
| Feature | ChemoClave | Spinning Spiros | Phaseal | ChemoLock | Comparison |
| Prevents<br>Escape of<br>Drug or<br>Vapor<br>Concentratio | Yes | Yes | Yes | Yes | Identical |
| Closed Drug<br>Transfer<br>Mechanism | Elastomeric<br>single membrane<br>(ISO) | Elastomeric<br>double<br>membrane (ISO) | Elastomeric<br>double<br>membrane (non-<br>ISO) | Elastomeric<br>double<br>membrane (non-<br>ISO) | Identical to<br>K123213 |
| Activation<br>Mechanism | ISO Luer locking | ISO Luer Locking | Non-ISO push-<br>together<br>connection with<br>bayonet lock | Non-ISO push-<br>together<br>connection with<br>clip locks | Similar to<br>K123213 |
| Available<br>Accessories<br>and Useable<br>Components | Vial Access, Bag<br>Access, Syringe<br>Adapter and<br>Patient<br>Administration<br>Sets | Syringe Adapter<br>and Patient<br>Administration<br>Sets | Vial Access, Bag<br>Access, Syringe<br>Adapter, Injection<br>Port Adapter | Vial Access, Bag<br>Access, Syringe<br>Adapter and<br>Patient<br>Administration<br>Sets | Identical to<br>K081361 |
| NeedleFree | NeedleFree | NeedleFree | No, 18G needle<br>with safety sleeve<br>and/or steel spike | NeedleFree | Identical to<br>K081361 and<br>K082806 |
| Connection<br>to External<br>Equipment | Standard ISO luer<br>connection | Standard ISO Luer<br>connection with<br>permanent<br>locking feature<br>which prevents<br>removal and stays<br>protective<br>through disposal | Standard ISO Luer<br>Connections and<br>Vial Spikes | Standard ISO luer<br>connection with<br>permanent<br>locking feature<br>which prevents<br>removal and stays<br>protective<br>through disposal | Identical to<br>K082806 |
| Microbial<br>Barrier | Yes | Yes | Yes for Vial<br>Access<br>No for Syringe<br>Adapter | Yes | Identical to<br>K081361 and<br>K082806 |
| Sterilization | Ebeam | Ebeam | EO | Ebeam | Identical to<br>K081361 and<br>K082806 |
| Materials of<br>Construction | Biocompatible<br>thermoplastics<br>and silicone | Biocompatible<br>thermoplastics<br>and silicone | Biocompatible<br>thermoplastics,<br>silicone and<br>stainless steel | Biocompatible<br>thermoplastics<br>and silicone | Identical to<br>K081361 and<br>K082806 |
| Single Use | Yes | Yes | Yes | Yes | Identical |

#### Table 1: Summary Comparison of Technological Characteristics Table

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Determination of Substantial Equivalence:

Non Clinical Performance Data Summary The demonstration of substantial equivalence is based on a comparison of features to the predicate devices and an assessment of non-clinical performance data. Information is included with this 510(k) submission that supports this determination.

The ChemoLock Closed System Drug Transfer Device is intended to be used with closed vial and bag access devices, closed syringe adapters, and closed patient administration sets. The two piece system, comprised of two components called the ChemoLock and the ChemoLock Port (or Port), is intended to allow the user to adapt an ISO-594 luer system to a custom adapted, Closed System Drug Transfer Device. The female luer end of the ChemoLock is compatible with all male 150 connections and the other side is only compatible with the Port. The male end of the Port is compatible with all female ISO connections while the other side is only compatible with the ChemoLock.

The ChemoLock and Port will prevent leakage of fluid when in the inactivated state. When the ChemoLock is connected to the Port, the fluid path is activated and becomes an onen two way conduit. When disconnected, the ChemoLock and Port will self-seal and offer a dry, leak proof disconnection.

Microbial Ingress testing as provided in this submission shows that the ChemoLock Closed System Drug Transfer Device has the ability to prevent bacterial ingress. Said testing shows that the device will prevent bacterial ingress completely if used in accordance with the directions for use. The prevention of bacterial ingress is specifically important for pediatrics and immune-compromised patients that would otherwise be at risk of infections.

The Evaluation of Closed-system Drug Transfer Devices as provided in this submission shows that the ChemoLock Closed System Drug Transfer Device is able to prevent the egress of chemicals both during preparation and transfer of the cytotoxic agent. Results of the study suggest that the ChemoLock system was effective in preventing detectible surface contamination during three separate trials of compounding activities with known amounts of cyclophosphamide. The prevention of environmental contamination is specifically important for the containment of cytotoxic pharmaceuticals which will passively prevent the exposure to such chemicals by healthcare workers.

The ChemoLock Closed System Drug Transfer Device has been tested in accordance with its performance specification which accommodates known functional requirements.

The ChemoLock Closed System Drug Transfer Device configurations are individually packaged and pre-sterilized in a peel type, Multivac pouch with sealed Tyvek lidding.. The device can be included as part of a closed vial or bag access device, closed syringe adapter, or closed patient administration set. This device may be included as part of a custom kit or set - as prescribed by a physician. ICU Medical performs analysis and design verification testing based on predetermined criteria, which is documented in the Performance Specification contained in this

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submission. All testing meets these performance criteria as defined for the device.

ICU Medical has also performed testing that is recommended by the guidance document "Intravascular Administration Sets Premarket Notification Submissions [510(k)]" and successful testing is included as part of this submission in the Extended Use Protocol Results document.

Conclusion:

Performance testing included within this 510(k) demonstrates that the ChemoLock Closed System Drug Transfer Device is safe, effective and performs in an equivalent manner to the predicate devices and in accordance with its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2013

ICU Medical, Incorporated Ms. Katherine Kenner Regulatory Affairs Specialist 4455 Atherton Drive SALT LAKE CITY UT 84123

Re: K131549

Trade/Device Name: ChemoLock Closed System Drug Transfer Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ONB, FPA Dated: May 28, 2013 Received: May 29, 2013

Dear Ms. Kenner:

This letter corrects our substantially equivalent letter of July 26, 2013.

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

**Mary S. Runner -S**

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4 Indications For Use

Page 1 of 1

510(k) Number (if known): K1315-49

ChamoLock Closed System Drug Transfar Device Device Name:

The ChemoLock Closed System Drug Transfer Device prevents the transfer of Indications for Use: environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

| Prescription Use ✓<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use __ |
|--------------------------------------------|-------------------------------------------|--------------------------|
| | Richard C. Chapman<br>2013.07.25 09:44:14 | (Optional Format 1-2-96) |

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

| 510(k) Number: | K131549 |
|----------------|---------|
|----------------|---------|

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