PHASEAL PROTECTOR P14, P21, P28 AND P50

K090634 · Carmel Pharma Ab. · LHI · Mar 23, 2009 · General Hospital

Device Facts

• Record ID: K090634
• Device Name: PHASEAL PROTECTOR P14, P21, P28 AND P50
• Applicant: Carmel Pharma Ab.
• Product Code: LHI · General Hospital
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Drug Vial Adapter for closed reconstitution of parenteral drugs.

Device Story

Protector P14, P21, P28, and P50 are single-lumen docking stations for drug vials used in parenteral drug preparation. The device attaches to a drug vial; an Injector connects to the Protector to facilitate liquid transfer. Operation relies on tightly fitting elastomeric double membranes to prevent leakage. The device includes an expansion chamber to equilibrate pressure differences occurring during fluid or air addition/removal. Used in clinical settings by healthcare professionals for closed system drug transfer. Benefits include reduced clinician exposure to hazardous drugs and prevention of spills during reconstitution and administration.

Clinical Evidence

Bench testing only. The devices were tested and found in compliance with applicable requirements and standards specifications.

Technological Characteristics

Materials: Polypropylene, stainless steel or plastic spike. Expansion chamber: 20 ml or 50 ml. Sterilization: EtO. Sensing/Actuation: Mechanical pressure equilibration via expansion chamber and elastomeric double membranes. Form factor: Single-lumen docking station for 13mm, 20mm, or 28mm vials.

Indications for Use

Indicated for reconstitution and transfer of drug solutions between containers while minimizing exposure to hazardous drug aerosols and spills during reconstitution, 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

• Protector P14, P21 and P50 (K001368)

Submission Summary (Full Text)

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# ATTACHMENT 5

KOGOGZA 1 of 3

# 510(K) SUMMARY

Mar 2 3 2009

## Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Carmel Pharma ab summary for the Protector P14, P21, P28 and P50 included in: PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs

| SUBMITTER'S NAME: | Carmel Pharma ab |
|-------------------|------------------------------------------|
| ADDRESS: | Box 5352<br>SE 402 28 Goteborg<br>Sweden |

| CONTACT PERSON: | Kjell Andreasson |
|---------------------|-------------------|
| TELEPHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| DATE OF SUBMISSION: | February 20, 2009 |

### Identification of device 1.

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

PhaSeal Protector I.V. Fluid Transfer Set Class II per 21 CFR 880.5440 rHI

#### 2. Equivalent devices

Protector P14, P21 and P50 cleared in K001368

#### 3. Description of the Device

The single lumen docking station of the Protector is fitted to the drug vial for the parenteral drug. The Injector is connected to the Protector and liquid transfer takes place through tightly fitting elastomeric double membranes to minimize leakage during reconstitution, administration and disposal processes. The Protector equilibrates the pressure difference which occurs when fluid or air is added to, or removed from the drug vial.

#### 4. Intended use

Drug Vial Adapter for closed reconstitution of parenteral drugs.

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K090634

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

# Comparison table
Protector 14

| Subject | Modified P14 | Predicate P14, K001368 | Equivalent |
|-------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------|
| Intended use | Drug Vial Adapter for closed<br>reconstitusion of parenteral<br>drugs. | Drug Vial Adapter for closed<br>reconstitusion of parenteral<br>drugs. | Yes |
| Material | Polypropylene | Polypropylene | Yes |
| Spike | Stainless steel | Stainless steel | Yes |
| Drug vial size | Ø 13 mm | Ø 13 mm | Yes |
| Expansion<br>chamber | 20 ml | 20 ml | Yes |
| Sterilization<br>method | EtO | EtO | Yes |

### Protector 21

| Subject | Modified P21 | Predicate P21, K001368 | Equivalent |
|----------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------|
| Intended use | Drug Vial Adapter for closed reconstitution of parenteral drugs. | Drug Vial Adapter for closed reconstitution of parenteral drugs. | Yes |
| Material | Polypropylene | Polypropylene | Yes |
| Spike | Stainless steel | Stainless steel | Yes |
| Drug vial size | Ø 20 mm | Ø 20 mm | Yes |
| Expansion chamber | 20 ml | 20 ml | Yes |
| Sterilization method | EtO | EtO | Yes |

## Protector 28

| Subject | Modified P28 | Predicate P50, K001368 | Equivalent |
|-------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------|
| Intended use | Drug Vial Adapter for closed<br>reconstitution of parenteral<br>drugs. | Drug Vial Adapter for closed<br>reconstitution of parenteral<br>drugs. | Yes |
| Material | Polypropylene | Polypropylene | Yes |
| Spike | Plastic | Stainless steel | No |
| Drug vial size | Ø 28 mm | Ø 28 mm | Yes |
| Expansion<br>chamber | 50 ml | 50 ml | Yes |
| Sterilization<br>method | EtO | EtO | Yes |

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| Protector 50 | | | |
|----------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------|
| Subject | Modified P50 | Predicate P50, K001368 | Equivalent |
| Intended use | Drug Vial Adapter for closed reconstitution of parenteral drugs. | Drug Vial Adapter for closed reconstitution of parenteral drugs. | Yes |
| Material | Polypropylene | Polypropylene | Yes |
| Spike | Stainless steel | Stainless steel | Yes |
| Drug vial size | Ø 20 mm | Ø 20 mm | Yes |
| Expansion chamber | 50 ml | 50 ml | Yes |
| Sterilization method | EtO | EtO | Yes |

### 6. Discussion of performance testing.

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

### 7. Conclusion

Based on comparison to the predicate device, we come to the conclusion that the Protectors P14, P21, P28 and P50 included in the PhaSeal System, are substantially equivalent to previously cleared predicate devices and presents no new concerns about safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 2 & 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kjell Andreasson President Quality Assurance and Regulatory Affairs Carmel Pharma AB Box 5352 SE 402 28 Goteborg SWEDEN

Re: K090634

> Trade/Device Name: Protector P14, P21, P28 and P50 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: February 20, 2009 Received: March 9, 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 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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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 (OS) 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,

Sattie J. Michael Ows.

Ginette Y. Michaud, M.D. Acting 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 | Protector P14, P21, P28 and P50 |
| Indications for Use | The indication for use is 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)
OR
Over-The-Counter Use: No

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

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510(k) Number: K090634