INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,

K092782 · Carmel Pharma Ab. · LHI · Dec 7, 2009 · General Hospital

Device Facts

• Record ID: K092782
• Device Name: INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
• Applicant: Carmel Pharma Ab.
• Product Code: LHI · General Hospital
• Decision Date: Dec 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The indication for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

Device Story

PhaSeal system components (Injectors N34, N35, N35C; Connectors C35, C45) facilitate closed-system drug transfer. Injectors connect to drug vials for fluid withdrawal/injection; Connectors link Injectors to IV administration sets (e.g., stopcocks, spike admixture channels). Devices utilize elastomeric membranes that seal against other PhaSeal components to prevent drug spillage. Operated by clinicians in clinical settings. Injectors feature stainless steel pencil-point cannulas and 'ErgoMotion' safety sleeves. Connectors provide mechanical interface between system components. System benefits include reduced risk of hazardous drug exposure during reconstitution, administration, and disposal.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Stainless steel cannulas, elastomeric membranes. Sterilization: Ethylene Oxide (EtO). Design: Single-use, closed-system transfer components. Injectors include pencil-point cannulas and ErgoMotion safety sleeves. Connectors feature bayonet fittings and varying lengths (26mm-34mm) for compatibility with IV administration sets (e.g., CLAVE). Connectivity: Mechanical Luer/Luer Lock interfaces. No software or electronic components.

Indications for Use

Indicated for the reconstitution and transfer of drug solutions between containers, including drug vials, primary or secondary IV administration sets, or IV containers, to minimize clinician exposure to hazardous drug aerosols and spills.

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

• Injector N30 (K972527)
• Injector N31 (K001368)
• Connector C40 (K972527)

Submission Summary (Full Text)

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# K092782

# ATTACHMENT 5

# DEC - 7 2009

## 510(K) SUMMARY

### Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Carmel Pharma ab summary for the Injector N30, N31, N34, N35 and N35C and Connector C35, C40 and C45 included in:

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

| SUBMITTER'S NAME: | Carmel Pharma ab |
|-------------------|-----------------------------------------------|
| ADDRESS: | Aminogatan 30<br>SE 431 53 Molndal<br>Sweden. |

CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION: Kjell Andreasson [phone] +46 31.7030404 September 4, 2009

#### Identification of device 1.

Proprietary Name: Common Name: Classification Status: Product code:

PhaSeal Injector and Connector I.V. Fluid Transfer Set Class II per 21 CFR 880.5440 LHI.

#### 2. Equivalent devices

Injector N30 and N31 and Connector C40 cleared in K972527 and K001368.

#### Description of the Device 3.

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

#### 4. Indication for use

The intended use of the Injectors is to inject fluids into, and to withdraw fluids from a drug vial, and then to inject fluids into a primary or secondary IV administration set, or into an IV container.

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The Connector is a connector between the PhaSeal Injector and parts of an IV administration set up such as a stopcock or an admixture channel of the spike for the IV container. The PhaSeal elastomeric membrane seals with the elastomeric membranes of other PhaSeal components to help prevent drug spillage.

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

### Injector Luer N34

| Subject | N34 | Predicate N30, K972527 | Equiv. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Intended use | The intended use of the Injectors is to inject fluids into, and to withdraw fluids from a drug vial, and then to inject fluids into a primary or secondary IV administration set, or into an IV container. | The intended use of the Injectors is to inject fluids into, and to withdraw fluids from a drug vial, and then to inject fluids into a primary or secondary IV administration set, or into an IV container. | Yes |
| Cannula | Stainless steel - pencil point cannula | Stainless steel - cut cannula | Yes |
| Needle safety lock | Safety sleeve “ErgoMotion™” | Safety latch | Yes |
| Fitting connection | Luer - rotation | Luer - no rotation | Yes |
| Sterilization method | EtO | EtO | Yes |

## Injector Luer Lock N35-and N35C (including a cap)

| Subject | Modified N35 and N35C | Predicate N31, K001368 | Equiv |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Intended use | The intended use of the Injectors is<br>to inject fluids into, and to<br>withdraw fluids from a drug vial,<br>and then to inject fluids into a<br>primary or secondary IV<br>administration set, or into an IV<br>container. | The intended use of the Injectors<br>is to inject fluids into, and to<br>withdraw fluids from a drug vial,<br>and then to inject fluids into a<br>primary or secondary IVcontainer. | Yes |
| Cannula | Stainless steel - pencil point<br>cannula | Stainless steel - cut cannula | Yes |
| Needle safety lock | Safety sleeve "ErgoMotionTM" | Safety latch | Yes |
| Fitting connection | Luer Lock -rotation | Luer Lock - no rotation | Yes |
| Sterilization method | EtO | EtO | Yes |

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| Subject | Connector C35 | Predicate C40, K972527 | Equiva |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Intended use | This device is a connector between<br>the PhaSeal Injector and parts of<br>an IV administration set up such as<br>a stopcock or an admixture<br>channel of the spike for the IV<br>container. The PhaSeal elastomeric<br>membrane seals with the<br>elastomeric membranes of other<br>PhaSeal components to help<br>prevent drug spillage. | This device is a connector<br>between the PhaSeal Injector and<br>parts of an IV administration set<br>up such as a stopcock or an<br>admixture channel of the spike<br>for the IV container. The PhaSeal<br>elastomeric membrane seals with<br>the elastomeric membranes of<br>other PhaSeal components to<br>help prevent drug spillage | Yes |
| Bayonet fitting | reduced notches - no click | notches - with a "click" | Yes |
| Length | 26 mm | 26 mm | Yes |
| Sterilization method | EtO | EtO | Yes |

Connector Luer Lock C35

and and the mail of the state of the state of the mail of the

### Connector Luer Lock C45

| Subject | Connector C45 | Predicate C40, K972527 | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Intended use | This device is a connector between<br>the PhaSeal Injector and parts of<br>an IV administration set up such as<br>a stopcock or an admixture<br>channel of the spike for the IV<br>container. The PhaSeal elastomeric<br>membrane seals with the<br>elastomeric membranes of other<br>PhaSeal components to help<br>prevent drug spillage. | This device is a connector<br>between the PhaSeal Injector and<br>parts of an IV administration set<br>up such as a stopcock or an<br>admixture channel of the spike<br>for the IV container. The PhaSeal<br>elastomeric membrane seals with<br>the elastomeric membranes of<br>other PhaSeal components to<br>help prevent drug spillage | Yes |
| Bayonet fitting | reduced notches - no click | notches - with a “click” | Yes |
| Length | 34 mm to provide for CLAVE<br>connection | 26 mm | Yes |
| Sterilization method | EtO | EtO | Yes |

#### Discussion of performance testing. 6.

The Injectors and Connectors have been tested and found in compliance with applicable requirements and standards specifications.

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#### 7. Conclusion

Based on comparison to the predicate device, we come to the conclusion that the Injectors N34, N35, N35C and Connectors C35, C45 included in the PhaSeal System, are substantially equivalent to previously cleared predicate devices and present no new concerns about safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Kjell Andreasson President Quality Assurance and Regulatory Affairs Carmel Pharma AB Aminogatan 30 SE 431 53 Molndal SWEDEN

DEC - 7 2009

K092782 Re:

Trade/Device Name: Injector Luer N34 Injector Luer Lock N35 Iniector Luer Lock N35C Connector Luer Lock C35 Connector Luer Lock C45 Regulation Number: 21 CFR 880.5440

Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 4, 2009 Received: September 10, 2009

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Wh for

Susan Runner, D.D.S., M.A. Acting Division 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) | |
| Device Name | Injector Luer N34<br>Injector Luer Lock N35<br>Injector Luer Lock N35C<br>Connector Luer Lock C35<br>Connector Luer Lock C45 |
| Indications for Use | The indication for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, 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) Over-The-Counter Use: No

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

OR

510(k) Number: Kool3 2222