MIXJECT WITH SPRAY HEAD

K122023 · Medimop Medical Projects, Ltd. · FMF · Oct 4, 2012 · General Hospital

Device Facts

• Record ID: K122023
• Device Name: MIXJECT WITH SPRAY HEAD
• Applicant: Medimop Medical Projects, Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Oct 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials

Device Story

Mixject with Spray Head facilitates drug reconstitution and delivery. Device connects to a drug vial via a dispensing pin (vial adapter) and a syringe at the luer-lock end. User injects diluent into the vial for mixing; reconstituted drug is aspirated into the syringe. Removing the dispensing pin rotates an internal core, transitioning the device from an aspiration position to a fixed spray position. This enables topical spray application of the drug. Used in clinical settings for drug administration. Benefits include simplified reconstitution and integrated delivery mechanism for topical applications.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mechanical device consisting of a dispensing pin (vial adapter), luer-lock syringe interface, and spray head. Operates via manual fluid transfer and mechanical switching of a turning core to transition between aspiration and spray modes. Designed for drugs with viscosity up to 4.7cP.

Indications for Use

Indicated for the transfer, mixing, and topical spray application or delivery of drugs with a viscosity up to 4.7cP contained in vials.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Mixject Dispensing Pin with Detachable Vial Holder (K963583)
• Mixject Dispensing Pin with Detachable Vial Holder (K001293)
• Laryngo-Tracheal Mucosal Atomization Device (MADGIC), (K002255)

Submission Summary (Full Text)

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

KI22023

ОСТ

# Attachment 5

4 2012

# 510(k) Summary

# 1. Submitter Information

| Submitter Information<br>Name: | Medimop Medical Projects Ltd |
|--------------------------------|----------------------------------------------------|
| Address: | 17 Hatidhar St |
| | Ra'anana 4366519 |
| | Israel |
| Telephone Number: | 972-9-7778666 |
| Fax Number: | 972-9-7485916 |
| Contact person: | Ilanit Goldgraber |
| | Director of RA |
| Telephone Number: | 972-9-7778666 Extension 219 |
| Fax Number: | 972-9-7485916 |
| E-mail: | [e-mail] |
| US Agent: | Deborah M. Thomas |
| | West Pharmaceutical Services, Inc. |
| Address: | 101 Gordon Dr. |
| | Lionville, PA 19341 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | 05 July 2012 |
| Device Name | |
| Device Trade Name: | Mixject™ with Spray Head |
| Common Name: | Mixject with Spray Head |
| Classification name: | Syringe, Piston |
| Classification | |
| Product Code: | FMF |
| Regulation No.: | 880.5860 |
| Class: | II |
| Panel identification: | General Hospital Panel |
| Predicate Devices | |
| Predicate 1: | Mixject Dispensing Pin with Detachable Vial Holder |
| | (K963583) |
| Predicate 2: | Mixject Dispensing Pin with Detachable Vial Holder |
| | (K001293) |
| Predicate 3: | Laryngo-Tracheal Mucosal Atomization Device |
| | (MADGIC), (K002255) |

02 October 2012

2.

3.

4.

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

## 5. Device description

The Medimop Mixject with Spray Head device enables injection of a diluent into a drug vial connected to the Dispensing pin (Vial adapter), for reconstitution and aspiration of the reconstituted drug into a syringe attached to the luer-lock end of the body. The vial and the Dispensing pin (Vial adapter) can be removed by turning the Dispensing pin (Vial adapter). The removal of the Dispensing pin (Vial adapter) turns the turning core from the aspiration position to the fixed spray position allowing spray application / delivery of the drug onto the desired surface.

## 6. Indications for use

Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials

#### 7. Technological Characteristics and Substantial Equivalence

The Mixject with Spray Head and has the same principle of operation as the predicate devices Mixject Dispensing Pin with Detachable Vial Holder (K963583) and (K001293) and the Laryngo-Tracheal mucosal Atomization Device (MADGIC) (K002255), described as the predicate devices and is therefore substantially equivalent to this devices.

#### 8. Nonclinical Testing

Bench testing was performed to demonstrate the ability of the proposed Mixject with Spray Head to effectively transfer, mix and application of drugs contained in vials.

## 9. Conclusion

Comparative analysis of technological characteristics between proposed and predicate devices and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate devices. Any differences between the proposed and predicate devices do not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

OCT 4 2012

Medimop Medical Projects, Limited C/O Ms. Deborah M. Thomas West Pharmaceutical Services, Incorporated 101 Gordon Drive Lionville, Pennsylvania 19341

Re: K122023

Trade/Device Name: Mixject™ with Spray Head Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 9, 2012 Received: July 11, 2012

Dear Ms. Thomas:

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.

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

## Page 2- Ms. Thomas

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

B. P. Shette M.D.

Physician

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K122023

MixJect with Spray Head

Traditional 510(k)

# Indications for Use

510(k) Number (if known):

Device Name: Mixject with Spray Head

#### Indications for Use:

Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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)

Page 1_ of 1

Richard C. Chapa 10/4/12

eneral Hospital

**510(k) Number:** K122023

02 October 2012