Vial2Bag Direct Connect

K170095 · Medimop Medical Project , Ltd. · LHI · Mar 8, 2017 · General Hospital

Device Facts

• Record ID: K170095
• Device Name: Vial2Bag Direct Connect
• Applicant: Medimop Medical Project , Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Mar 8, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

Device Story

Vial2Bag Direct Connect is a sterile, single-use mechanical connector; facilitates drug reconstitution and admixture from standard drug vials into IV infusion solutions. Device components include a piercing spike, cover, twist-off connector, and integrated vial adapter (13mm or 20mm). Up to three devices can be connected consecutively by inserting the spike of one into the twist-off connector of another. Used in healthcare facilities or home settings by patients or caregivers to support prescribed therapy. Device does not contain medicinal substances. Healthcare providers use the device to prepare IV medications; output is a reconstituted drug solution ready for infusion. Benefits include simplified, closed-system drug transfer and administration.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included product functionality, penetration force, cap/vial adapter detachment force, breaking torque, spike tip ductility, air leakage, and packaging integrity (ISO 11607-1). Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, hemolysis (ASTM F756), intracutaneous reactivity, systemic toxicity, and pyrogenicity.

Technological Characteristics

Materials: Polycarbonate. Sterilization: Ethylene Oxide (ISO 11135-1:2007, SAL 10^-6). Form factor: Piercing spike with integrated vial adapter (13mm or 20mm). Connectivity: Mechanical connection to IV bags and lines. Single-use. Packaging: PETG blister with Tyvek seal.

Indications for Use

Indicated for use as a connector between IV bags and external IV lines to facilitate drug reconstitution and admixture from vials into infusion solutions in healthcare facilities or home environments.

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

• Vial2Bag Direct Connect (K140730)

Submission Summary (Full Text)

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TMENT OF H

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

March 8, 2017

Medimop Medical Project Ltd. Ms. Ilanit Goldgraber Director, Regulatory Affairs 17 Hatidhar Street Ra'anana, 43665 ISRAEL

Re: K170095

Trade/Device Name: Vial2Bag™ Direct Connect Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: January 9, 2017 Received: January 11, 2017

Dear Ms. Ilanit Goldgraber:

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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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang -

Tina Kiang, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known) K170095

Device Name Vial2Bag Direct Connect

Indications for Use (Describe)

The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) SUMMARY (K170095)

### Company Name:

Medimop Medical Projects Ltd 17 Hatidhar St Ra'anana 4366519 Israel Phone: [phone] Fax: [phone]

# Contact Person:

Ilanit Goldgraber Director, Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

# US Agent:

Kevin Lentz Sr. Director, Regulatory Affairs West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341 Phone: [phone] Email: [e-mail]

### Preparation date:

3/7/2017

### Classification:

| Regulation Name: | Intravascular Administration Set |
|-----------------------|----------------------------------------------------|
| Trade Name: | Vial2Bag Direct Connect |
| Common/Usual Name: | Vial2Bag DC |
| Product Code: | LHI |
| Regulation No.: | 880.5440 |
| Class: | II |
| Panel Identification: | General Hospital Panel |
| Predicate Devices: | Vial2Bag Direct Connect, cleared by 510(k) K140730 |

### Device Description

The proposed device, Vial2Bag Direct Connect, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.

The proposed device. Vial2Bag Direct Connect is available with 13mm Vial Adapter or 20mm Vial Adapter. The device consists of the Vial2Bag piercing spike and cover, the twist-off connector and an integrated Vial Adapter (13mm or 20mm) for access to the drug/solution vial.

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Up to 3 Vial2Bag Direct Connect can be consecutively connected by inserting the spike of one device into the twist off connector of the previous device.

The device does not contain any medicinal substances, and can be used with standard drug vials.

#### Indications for use

The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

#### Technological Characteristics and Substantial Equivalence Discussion:

The proposed device, Vial2Bag Direct Connect, has the same indications for use and principle of operation as the predicate device. Vial2Bag Direct Connect. from Medical Projects, Ltd. cleared by 510(k) number K140730.

The following modifications have been made to the Vial2Bag Direct Connect originally cleared by 510(k) K140730:

- Proposed device labeling (IFU) includes optional instructions for the connection of up to 3 Vial2Bag Direct Connect for consecutive connection by inserting the spike of one device into the twist off connector of the previous device.
- Vial2Bag Direct Connect 20mm S (Short) Spike option reduces the vial piercing spike length . compared to the predicate device
- . Vial2Bag Direct Connect 20mm C-Spike option contains larger diameter spike compared to the predicate device
- Packaging changed from Ethyl Vinyl Acetate (EVA) / Tyvek pouch to a PETG blister with Tyvek seal cover stock.
-

The predicate and proposed devices are designed and manufactured by the same organization and share the same materials and function.

The predicate and proposed devices share the same principle of operation and fundamental technology when utilizing the Vial2Bag Direct Connect.

| Areas for<br>Comparison | Claimed Substantially<br>Equivalent Product<br>Vial2Bag Direct Connect<br>K140730 | Proposed Device<br>Vial2Bag Direct Connect | Comparison |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication<br>for Use | The Vial2Bag™ Direct Connect is<br>indicated to serve as a connecting<br>part between the IV bag and an<br>external IV line. The integrated<br>vial adapter is used to reconstitute<br>and admix drugs from a vial into<br>the infusion solution. | The Vial2Bag™ Direct Connect is<br>indicated to serve as a connecting<br>part between the IV bag and an<br>external IV line. The integrated<br>vial adapter is used to reconstitute<br>and admix drugs from a vial into<br>the infusion solution. | Identical |
| Areas for<br>Comparison | Claimed Substantially<br>Equivalent Product<br>Vial2Bag Direct Connect<br>K140730 | Proposed Device<br>Vial2Bag Direct Connect | Comparison |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterility<br>Assurance<br>Level | SAL 10-6 | SAL 10-6 | Identical |
| Single use | Yes | Yes | Identical |
| Body<br>Material | Polycarbonate | Polycarbonate | Identical |
| Expiration<br>Date | 5 years | 3 years | Modified |
| Vial<br>Adapter<br>Diameter | 30.4mm to fit 20mm Vials<br>18.5mm to fit 13mm Vials | 30.4mm to fit 20mm Vials<br>18.5mm to fit 13mm Vials | Identical |
| Labeling | Predicate device labeling (IFU)<br>includes connection instructions to<br>IV bag | Proposed device labeling (IFU)<br>includes optional instructions for<br>the connection of up to 3 Vial2Bag<br>Direct Connect for consecutive<br>connection by inserting the spike<br>of one device into the twist off<br>connector of the previous device. | Modified |
| Piercing<br>Spike | Plastic - Single Lumen | Vial2Bag Direct Connect 20mm S<br>(Short) Spike reduces the vial<br>piercing spike length compared to<br>the predicate device<br>Vial2Bag Direct Connect 20mm<br>C-Spike contains larger diameter<br>spike compared to the predicate<br>device | Modified |
| "Tight<br>Grip"<br>feature | Included | Included | Identical |
| Packaging<br>Material | Tyvek / Ethyl Vinyl Acetate<br>(EVA) | PETG blister and Tyvek seal | Modified |

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# Performance Testing:

The modifications to the proposed device were evaluated within the Medimop design control system. A risk assessment was performed to ensure that the proposed device modifications did not introduce any new potential risks. The following tests were performed on the proposed device, Vial2Bag Direct Connect, as a result of the risk assessment to ensure the all potential risks associated with the device modifications were mitigated to acceptable levels.

- Product Functionality According to IFU ●
- . Total Penetration Force
- Cap Detachment Force
- Vial Adapter Detachment Force from Drug Vial
- Breaking Torque Test
- Spike Tip Ductility Test ●
- . Air Leakage Test
- . Packaging

| Performance Testing Summary | |
|-------------------------------------------------|------------------------------------------|
| Test Name | Testing Standard |
| Product Functionality According<br>to IFU | Tested to internal performance standards |
| Total Penetration<br>Force | Tested to internal performance standards |
| Detachment Force | Tested to internal performance standards |
| Vial Adapter Detachment Force<br>from Drug Vial | Tested to internal performance standards |
| Breaking Torque Test | Tested to internal performance standards |
| Spike Tip Ductility Test | Tested to internal performance standards |
| Air Leakage Test | Tested to internal performance standards |
| Packaging | Tested per ISO 11607-1 |

All testing met the required acceptance criteria.

### Sterilization

- The Vial2Bag Direct Connect is sterilized by Ethylene Oxide in a cycle validated according to ● standard ISO11135-1:2007 using the "overkill method". The sterilization subcontractor is Mediplast Israel Ltd.

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- The sterilization process is validated to a minimum SAL 106. Residuals of ETO and ECH were . tested after two sterilization cycle and met the requirements os ISO 10993-7:2008 for prolonged exposure.
# Biocompatibility

- Representative samples from every lot of product are tested for bacterial endotoxin by a validated ● Limulus Amoebocyte Lysate (LAL) method.
- The acceptable Endotoxin level is 0.5 EU/ml (Endotoxin Units) or 20 EU/device. O
- The sensitivity of the LAL assay is 0.005 EU/ml. o
- A biocompatibility assessment was conducted according to ISO 10993-1 and the FDA Blue Book . Memorandum # G95-1 for this material following Double EtO. The Vial2Bag™ DC has been classified as follows:
- O Category: Externally Communicating
- Contact Duration: Prolonged o
- O Device Body Contact: Blood Path Indirect
- Based upon this assessment, the following biocompatibility testing has been successfully ● completed.
- Cytotoxicity (Tested to ISO 10993-5) O
- Sensitization (Tested to ISO 10993-10 O
- ASTM Hemolysis (Tested to ASTM F756 and ISO 10993-4) O
- Intracutaneous Reactivity (Tested to ISO 10993-10) o
- Systemic Toxicity (Acute Systemic Injection) (Tested to ISO 10993-11) O
- USP Rabbit Pyrogen (Material Mediated Pyrogenicity) (Tested to USP 151) O

### Conclusion

The evaluation of the proposed device, Vial2Bag Direct Connect, does not raise any additional concerns regarding safety and effectiveness and is considered to be substantially equivalent to the predicate device, Vial2Bag Direct Connect, 510(k) K140730.