INFUSION ADAPTER C100

K110023 · Carmel Pharma Ab. · LHI · Apr 12, 2011 · General Hospital

Device Facts

• Record ID: K110023
• Device Name: INFUSION ADAPTER C100
• Applicant: Carmel Pharma Ab.
• Product Code: LHI · General Hospital
• Decision Date: Apr 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The intended use of this device is to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Device Story

Infusion Adapter C100 is a sterile, single-use component of the PhaSeal closed system drug transfer device; facilitates connection between IV bags and external IV lines; enables drug admixing into infusion solutions via sealed double-membrane technique; prevents drug spillage into environment; used in clinical settings by healthcare professionals; ensures safe transfer of parenteral drugs; benefits patients and clinicians by reducing exposure to hazardous substances.

Clinical Evidence

Bench testing only. Performance testing verified device integrity and compatibility with PhaSeal components, including pulling force, torque, liquid flow, air tightness, and handling. Material testing confirmed functional/mechanical properties after 24h and 72h exposure to Etoposide, Taxol, and Busulfan. Biocompatibility testing included systemic injection, cytotoxicity, hemolysis, dermal sensitization, intracutaneous, and physicochemical tests.

Technological Characteristics

Materials: Spike port (TPE), Spike housing (PP), Spike Cap (PP). Connection: Spike housing to injector/infusion bag; Spike port to external spike. Sterilization: EtO. Device is a mechanical fluid transfer adapter for closed system drug transfer.

Indications for Use

Indicated for admixing drugs into IV containers and the administration/transfer of drugs from containers to external IV lines, while minimizing exposure to hazardous drug aerosols and spills during admixing, administration, and disposal processes.

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

• Infusion Adapter C100 (K023747)

Submission Summary (Full Text)

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KI10023 1981

# ATTACHMENT 5

APR 1 2 2011

## 510(K) SUMMARY

### Summarv of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Carmel Pharma ab summary for the Infusion Adapter C100 included in:

PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs

SUBMITTER'S NAME: Carmel Pharma AB . ้า Aminogatan 30 ADDRESS: SE-43153 Mölndal Sweden . . . . . . . . . . . ..............................................................................................................................................................................

> CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION:

Kiell Andreasson [phone] [phone] December 10, 2010

#### 1. Identification of device

| Proprietary Name: | PhaSeal Infusion Adapter |
|------------------------|------------------------------|
| Common Name: | I.V.-Fluid-Transfer-Set |
| Classification Status: | Class II per 21 CFR 880.5440 |
| Product code: | LHI |

#### 2. Equivalent devices

Infusion Adapter C100 is previously cleared in K023747.

#### Description of the Device 3.

The Injector is a sterile device for single-use within the PhaSeal® closed transfer device system for preparation and administration of parenteral drugs.

#### Intended use. 4.

The intended use of this device is to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.


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K110023 pg 2

:

### Technological characteristics, comparison to predicate device. 5.

### Infusion Adapter

:4

…

: \

| Subject | C100 | C100 K023747 | Equiv. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indication for use | The indication for use is<br>admixing of drug into an IV<br>container and<br>administration/transfer of drug<br>from the container to an<br>external IV line, while<br>minimizing exposure to<br>potentially hazardous drugs<br>aerosols and spills that can<br>occur during the admixing,<br>administration and disposal<br>process. | The Infusion Adapter serves as<br>the connecting part between the<br>IV bag and an external IV line<br>(e.g. IV regulators). The Infusion<br>Adapter has a built in Connector<br>which makes it possible to admix<br>drugs into the infusion solution<br>using the sealed PhaSeal double<br>membrane technique | Yes |
| Intended use | The intended use of this device<br>is to administer fluids from a<br>container to a patient's vascular<br>system through a needle or<br>catheter inserted into the vein. | The intended use of this device is<br>to administer fluids from one a<br>container to a patient's vascular<br>system through a needle or<br>catheter inserted to a vein. The<br>infusion adapter mates with the<br>PhaSeal injector bayonet fitting<br>which prevents drug spillage into<br>the environment | Yes |
| Flushing of system<br>prior to use | No | Yes | |
| Material | Spike port: TPE<br>Spike housing: PP<br>Spike Cap: PP | Spike port: TPE<br>Spike housing: ABS<br>Spike Cap: PP | Yes |
| Fitting connection | Spike housing: to Injector and<br>to infusion bag<br>Spike port: to external spike<br>included in an administration<br>set | Spike housing: to Injector and<br>to infusion bag<br>Spike port: to external spike<br>included in an administration<br>set | Yes |
| Sterilization method | EtO | EtO | Yes |

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#### Summary of design control activities 6.

### Performance testing – general performance

| Modification | Test Performed | Passed |
|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------|
| Performance testing refer to verify integrity of the<br>device and compatibility with the relevant other<br>PhaSeal components. | Pulling force, torque test in<br>connection to other PhaSeal<br>components, liquid flow, air<br>tightness, handling tests, | Yes |

### Material testing – specific requirements

| Modification | Test Performed | Passed |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------|
| Specific requirements refer to integrity of the<br>material in combination with the aggressive<br>chemicals. | Functional and mechanical<br>properties on product after 24h<br>and 72h of chemical exposure<br>with Etopside, Taxo and<br>Busulfani | Yes |

### Biocompatibility

な

| Modification | Test Performed | Passed |
|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------|
| The Infusion Adapter is indirect invasive,<br>duration normally 1-2 hours, may be 24-48<br>hours if patient is hospitalised. | Systemic Injection test,<br>Cytotoxicity, Hemolysis, Dermal<br>sensitization, Intracutaneous test<br>and Physicochemical tests -<br>plastic. | Yes |

#### 7. Discussion of performance testing.

The tests performed show that that Infusion Adapter C100 fulfil the stated requirements and therefore comply with the claims of the intended use.

#### 8. Conclusion

Based on comparison to the predicate device, we come to the conclusion that the Infusion Adapter C100 included in the PhaSeal System, is substantially equivalent to previously cleared predicate devices and presents no new concerns about safety and effectiveness.

p47

12110023

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three stripes representing the feathers. The eagle is facing to the right.

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

Mr. Kjell Andreasson Manager, Regulatory Affairs Carmel Pharma AB Aminogatan 30 Mölndal SWEDEN S431 53

APR 1 2 2011

Re: K110023

Trade/Device Name: Infusion Adapter C100 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 1, 2011 Received: March 8, 2011

Dear Mr. Andreasson:

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. 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 - Mr. Andreasson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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.

hh fo

Anthony Watson, B.S., M.S., M.B.A. 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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# Attachment 1

# Indications for Use Statement

| 510(k) Number (if known) | K110023 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Infusion Adapter C100 |
| Indications for Use | The indication for use is admixing of drug into an IV container and administration/transfer of drug from the container to an external IV line, while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the admixing, administration and disposal process. |

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

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

Prescription Use: Yes (Per 21 CFR 801. 109)

OR Over-The-Counter Use: No

RC. 4/8/11

(Division Sign-Off)

(Division Sign-Off)
Division of Anesthesiology, General Hospita
Infection Control and Dental Devices
510(k) Number:

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