SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM

K072511 · Medimop Medical Projects, Ltd. · LHI · Dec 13, 2007 · General Hospital

Device Facts

• Record ID: K072511
• Device Name: SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
• Applicant: Medimop Medical Projects, Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Dec 13, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial

Device Story

Swabable Vial Adapter facilitates safe, needleless transfer of liquid drugs/diluents between vials and syringes. Device consists of double-lumen spike for vial stopper penetration, body, and luer-connection cap; optional hydrophobic medium included. User attaches standard luer-compatible accessory (e.g., syringe) to adapter; spike pierces vial stopper to create sterile fluid path. Enables mixing of powder drugs with diluents and subsequent aspiration of solution. Single-use device; disposed of after vial contents exhausted. Used in clinical settings for drug preparation; operated by healthcare professionals. Benefits include needleless access, reduced contamination risk, and ergonomic drug transfer.

Clinical Evidence

No clinical data. Bench testing only, including physical testing and visual examination of finished products to ensure compliance with release specifications.

Technological Characteristics

Assembly of three components: double-lumen spike, body, and luer-connection cap. Optional hydrophobic medium. Materials tested per ISO 10993-1 and USP VI. Sterile, single-use, ergonomic design. No software or electronic components.

Indications for Use

Indicated for multiple needleless accesses to injection medication vials to facilitate withdrawal or addition of drugs/solutions.

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

• ROBERTSITE VIAL ADAPTER (K040634)
• SMARTSITE VENTED VIAL ACCESS DEVICE (K052790)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS LTD. The logo features the letters "MOP" in a bold, sans-serif font, with a circular graphic element placed behind the letters. Below the letters, the word "MEDIMOP" is printed in a smaller, sans-serif font. Underneath that, the text "MEDICAL PROJECTS LTD." is printed in an even smaller, sans-serif font.

K4725ii (G.108.2)

17 Hatidhar St., P.O.B 2499 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. [phone] E-mail: [e-mail] www.medimop.com

# 510(k) summary for the SWABABLE VIAL ADAPTER

(as required by section 807.92)

510(k) Notification submitted by:

Medimop Medical Projects Ltd. DEC 1 3 2007 17 Hatidhar St. P.O. Box 2499 Ra'anana 43665 Israel
Phone: + 972 (9) 7757122 DEC-J- \$ 2007-- In
Forme: + 972 (9) 7486016 Fax: [phone]

Nachum Naveh Manager, Quality Assurance and Regulatory Affairs

August 24, 2007

Swabable Vial Adapter

General Hospital Class II, 80LHI Per 21 CFR 880.5440 Intravascular administration set

Same as Trade name

ROBERTSITE VIAL ADAPTER 510(k) No. K040634 Halkey-Roberts

SMARTSITE VENTED VIAL ACCESS DEVICE 510(k) No. K052790 Cardinal Healthcare - Alaris Products

Medimop Medical Projects Ltd. 17 Hatidhar St. P.O. Box 2499 Ra'anana 43665 Israel

Contact person:

Date Summary Prepared Trade Name: Classification name:

Common device name: Predicate devices:

Manufacturer:

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Image /page/1/Picture/0 description: The image shows a logo with the letters 'MOP' in a bold, sans-serif font. The 'O' in 'MOP' is stylized as a sphere. Below 'MOP' is the word 'MEDIMOP' in a smaller, sans-serif font. Underneath 'MEDIMOP' is the text 'MEDICAL PROJECTS LTD.' in an even smaller, sans-serif font.

17 Hatidhar St., P.O.B 2499 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. [phone] E-mail: info(@medimop.com www.medimop.com

Kψ72511 (P.2 of 2)

#### Material:

The Swabable Vial Adapter is composed of materials that were tested in accordance with the ISO 10993-1 standard and/or USP VI requirements and were determined suitable for the Indications for Use of this product.

### Device Description:

The Swabable Vial Adapter is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.

The Swabable Vial Adapter is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a luer connection) is attached to the sub-assembly.

#### Indications for Use:

The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial

#### Technological comparison to Predicate Device:

The Swabable Vial Adapter has Indications for Use identical to the Robertsite Vial Adapter and similar to the Smartsite Vented Vial Access Device- all are intended for transferring and mixing drugs and diluents contained in vials. All products have multiple access valves and piercing spikes, which enable the users to create a direct passage to and from vials, in a sterile manner.

The Swabable Vial Adapter allows the connection any standard accessory with a luer conncction to be connected to a vial. Once mixing of the diluent and the drug is complete the drug solution is ready for use and may be aspirated into an accessory (e.g. syringe). This can be repeated until the contents of the vial are fully removed. The adapter vial assembly is a single use device and should be disposed of after use.

All devices are packaged sterile and designed ergonomically.

Any differences between the Swabable Vial Adapter solution and the equivalent devices have no significant influence on safety or effectiveness.

# Safety and Effectiveness:

All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing, visual cxamination (in-process and finished product).

# Conclusion:

It is our conclusion that the Swabable Vial Adapter and its predicates are substantially equivalent in their Indications for Use, design, material, sterility and packaging.

The Swabable Vial Adapter is to be used in a similar manner to the predicate devices and introduces no new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is black and the background is white. The text is aligned to the left.

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEC 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medimop Medical Projects, Limited C/O Mr. Ari Y. Sobel Director, Regulatory Affairs West Pharmaceutical Services 101 Gordon Drive Lionville. Pensylvania 19341

Re: K072511

Trade/Device Name: Swabable Vial Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: December 6, 2007 Received: December 7, 2007

Dear Mr. Sobel:

Wc 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. Sobel

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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): K072511

Device Name: Swabable Vial Adapter

Indications for Use: The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial

ling ha

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

510(k) Number:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

CONFIDENTIAL Medimop Medical Projects Ltd. SWABABLE VIAL ADAPTER: 510(k) Submission August 24, 2007

App. 9 - pg 2 of 2