Vial Adapter 15mm

K171796 · Medimop Medical Project , Ltd. · LHI · Oct 12, 2017 · General Hospital

Device Facts

• Record ID: K171796
• Device Name: Vial Adapter 15mm
• Applicant: Medimop Medical Project , Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Oct 12, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials

Device Story

Vial Adapter 15mm is a single-piece molded polycarbonate device; facilitates reconstitution and transfer of drugs from vials. Device features integrated piercing spike and Luer fitting; spike pierces elastomeric septum of drug vial; "tight grip" legs seat securely around vial ferrule. User connects standard Luer Lock syringe to Luer fitting; performs reconstitution and drug removal. Used in healthcare facilities or home environments by patients or caregivers. Device is single-use and discarded after drug removal. Benefits include safe, secure access to drug vials for medication administration.

Clinical Evidence

Bench testing only. Performance testing included total penetration force, removal from blister, detachment force, spike tip ductility, fluid leakage, and packaging integrity (ISO 11607-1). Biocompatibility testing conducted per ISO 10993-1, -4, -5, -10, -11, ASTM F756, and USP <151> (cytotoxicity, sensitization, hemolysis, intracutaneous reactivity, systemic toxicity, and pyrogenicity). Sterilization validated per ISO 11137-1, -2 and AAMI TIR 33.

Technological Characteristics

Material: Polycarbonate. Design: Single-piece molded with integrated piercing spike and Luer fitting. Size: 15mm. Sterilization: Gamma irradiation (SAL 10^-6) per ISO 11137-1/2 and AAMI TIR 33. Biocompatibility: Externally communicating, limited contact (<24h), indirect blood path. No software or electronic components.

Indications for Use

Indicated for the transfer and mixing of drugs contained in vials for patients requiring prescribed treatment and therapy 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

• Mixject Dispensing Pin (K963583)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are black and are arranged in a way that suggests a flock of birds in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.

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

October 12, 2017

Medimop Medical Project Ltd. Mr. Jeffrey Ravel Director, Regulatory Affairs 17 Hatidhar Street Ra'anana, 43665 ISRAEL

Re: K171796

Trade/Device Name: Vial Adapter 15mm Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: September 19, 2017 Received: September 20, 2017

Dear Mr. Jeffrey Ravel:

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. Isting 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.

{1}------------------------------------------------

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 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" (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 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 -
s

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

{2}------------------------------------------------

# Change Control Table, Change History

# Change Control Table

| Version | Document Author | Document Approver | Date Approved |
|---------|---------------------|---------------------|---------------|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |

Complete Change Control Table (all versions) retained in SWIFT Docs.

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K171796

Device Name Vial Adapter 15mm

Indications for Use (Describe)

The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(K) SUMMARY K171796

### Company Name:

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

### Contact Person:

Jeffrey D. Ravel 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: 15 June 2017

### Classification:

| Regulation Name: | Intravascular Administration Set |
|-----------------------|----------------------------------|
| Trade Name: | Vial Adapter 15mm |
| Common/Usual Name: | Set, I.V. Fluid Transfer |
| Product Code: | LHI |
| Regulation No.: | 880.5440 |
| Class: | II |
| Panel Identification: | General Hospital Panel |
| Predicate Devices: | Mixject Dispensing Pin - K963583 |

{5}------------------------------------------------

# Device Description

The vial adapter is a one piece molded polycarbonate device that is used to aide in the reconstitution and transfer of drugs contained in vials. The sterile device pierces the elastomeric septum of a drug vial with its integrated spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the "legs" of the vial adapter. The opposing side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the drug vial. After drug removal, the syringe is removed and the vial adapter is properly discarded with the drug vial.

The proposed device, Vial Adapter 15mm, 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, Vial Adapter 15mm is a 15mm version of the currently available 13mm Vial Adapter or 20mm Vial Adapter. The device consists of a piercing spike and integrated Vial Adapter (15mm) for access to the drug/solution vial.

The device does not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.

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

### Indications for use

The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials.

There are no differences between the predicate and proposed devices indication for use.

### Technological Characteristics and Substantial Equivalence Discussion:

The proposed device, Vial Adapter 15mm, has the same indications for use and principle of operation as the predicate device, MixJect Dispensing Pin, from Medical Projects, Ltd, cleared by 510(k) number K963583.

The following modifications have been made to the Vial Adapter originally cleared by 510(k) K963583:

- Proposed device size offering includes addition of a 15mm Vial Adapter ●
- The vial adapter body was redesigned to include "tight grip" feature to improve adherence ● of the vial adapter to the drug vial. Subsequently the geometry of the individual blister package was modified to adapt the "tight grip" modification (larger internal diameter)
- The packaging dimension has been changed from the current marketed 13 and 20mm Vial ● Adapters to accommodate a 15mm Vial Adapter.

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

{6}------------------------------------------------

The predicate and proposed devices share the same principle of operation and fundamental technology when utilizing the Vial Adapter 15mm.

| Areas for<br>Comparison | Claimed Substantially<br>Equivalent Product<br>20mm / 13mm Vial Adapter<br>K963583 | Proposed Device<br>Vial Adapter 15mm<br>Subject 510(k) | Comparison |
|---------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------|
| Indication for<br>Use | Transfer and mixing of drugs<br>contained in vials | Transfer and mixing of<br>drugs contained in vials | Identical |
| Sterilization<br>Method | Gamma Irradiation | Gamma Irradiation | Identical |
| Sterility<br>Assurance Level | SAL 10-6 | SAL 10-6 | Identical |
| Single use | Yes | Yes | Identical |
| Body Material | Polycarbonate | Polycarbonate | Identical |
| Expiration Date | 5 years | 5 years | Identical |
| Vial Adapter Size | 20mm / 13mm | 15mm | Modified |
| Labeling | Predicate device labeling<br>(IFU) includes transfer and<br>mixing instructions | Proposed device labeling<br>(IFU) includes transfer and<br>mixing instructions | Identical |
| Piercing Spike | Plastic - Single Lumen | Plastic - Single Lumen | Identical |
| Vial Adapter Fit<br>(Vial Side) | Snap Fit to Vial | Snap Fit to Vial<br>"Tight Grip" Feature | Modified |
| Packaging Size | Dimensioned for 13/20mm VA | Dimensioned for 15mm VA | Modified |

### 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, Vial Adapter 15mm, as a result of the risk assessment to ensure the all potential risks associated with the device modifications were mitigated to acceptable levels.

- Total Penetration Force

{7}------------------------------------------------

- Removal From Blister ●
- Vial Adapter Detachment Force from Drug Vial
- Spike Tip Ductility Test ●
- . Fluid Leakage Test
- . Packaging

| Performance Testing Summary | |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Test Name | Testing Standard |
| Total Penetration Force | Tested to internal performance standards |
| Removal From Blister | Tested to internal performance standards |
| Vial Adapter Detachment Force<br>from Drug Vial | Tested to internal performance standards |
| Spike Tip Ductility Test | Tested to internal performance standards |
| Fluid Leakage Test | Tested to internal performance standards |
| Packaging<br>Visual Peel Test Seal Test Methylene Blue Bubble Leak | Tested per ISO 11607-1 |
| Biocompatibility | Tested per ISO 10993-1 ISO 10993-4 ISO 10993-5 ISO 10993-10 ISO 10993-11 USP <151> |

{8}------------------------------------------------

All testing met the required acceptance criteria.

### Sterilization

- The Vial Adapter 15mm is sterilized by Gamma irradiation in a method validated according to standard ISO 11137-1, ISO 11137-2 and AAMI TIR 33. The sterilization subcontractor is Sor-Van Radiation Ltd.
- The sterilization process is validated to a minimum SAL 10-6. ●

### 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. ●
- . The sensitivity of the LAL assay is 0.005 EU/ml.
- A biocompatibility assessment was conducted according to ISO 10993-1 and the FDA Blue ● Book Memorandum # G95-1 for this material following Gamma Irradiation. The Vial Adapter 15mm has been classified as follows:
- Category: Externally Communicating O
- Contact Duration: Limited (Less than 24 hours) O
- Device Body Contact: Blood Path Indirect o
- 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

{9}------------------------------------------------

# Conclusion

The evaluation of the proposed device, Vial Adapter 15mm, has demonstrated through functional performance testing to be substantially equivalent to the predicate device, Mixject Dispensing Pin – K963583.