MICRONJET 600

K092746 · Nanopass Technologies , Ltd. · FMI · Feb 3, 2010 · General Hospital

Device Facts

• Record ID: K092746
• Device Name: MICRONJET 600
• Applicant: Nanopass Technologies , Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Feb 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for intradermal injections of any substance or drug approved for this delivery route.

Device Story

MicronJet 600 is a sterile, single-use microneedle device consisting of a plastic female luer adapter equipped with a chip containing three microneedles. It is designed to mate with standard Luer Slip or Luer Lock syringes. The device is used by clinicians to perform intradermal injections of approved substances or drugs. By facilitating delivery into the intradermal space, the device provides an alternative to traditional hypodermic needles for fluid administration. Safety and effectiveness were established through bench, animal, and clinical testing.

Clinical Evidence

Performance testing included bench, animal, and clinical studies to assess safety and effectiveness. Results demonstrated that the MicronJet 600 is as safe and effective as the predicate devices for the stated indications.

Technological Characteristics

Small plastic adapter (female luer) with a chip containing three microneedles. Compatible with standard Luer Slip or Luer Lock syringes. Sterile, single-use device.

Indications for Use

Indicated for intradermal injections of any substance or drug approved for intradermal delivery in patients requiring such administration.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Terumo Allergy Syringe (K980796)
• BD PrecisionGlide™ (K021475)
• Becton Dickinson SafetyGlide™ Syringe (K992734)

Submission Summary (Full Text)

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

K092746

## 510(k) SUMMARY

#### NanoPass's MicronJet 600

FEB - 3 2010

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

NanoPass Technologies Ltd. 3 Golda Meir St. Nes Ziona, 74036 Israel Tel: [phone] Fax: [phone]

Contact Person:

Ofer Sharon, VP Medical Development 972-52-3335429 [e-mail]

Date Prepared: September 8, 2009

## Name of Device and Name/Address of Sponsor

MicronJet 600

NanoPass Technologies Ltd. 3 Golda Meir St. Nes Ziona, Israel

## Common or Usual Name

Microneedles Device

# Classification Name

Hypodermic Single Lumen Needle, Product Code FMI, 21 C.F.R. § 880.5570

Piston Syringe, Product Code FMF, 21 C.F.R. § 880.5860

#### Device Trade Name:

MicronJet 600 Needle

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

## Predicate Devices

- 1. Terumo Medical Corporation Terumo Allergy Syringe (K980796)
- 2. BD Medical Surgical BD PrecisionGlide™ (K021475)
- 3. Becton Dickinson SafetyGlide™ Syringe (K992734)

## Intended Use / Indications for Use

The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for use in intradermal injections of any substance or drug approved for intradermal delivery.

## Technological Characteristics

The MicronJet 600 Needle is a small plastic adapter (female luer) equipped with a chip having three microneedles designed to mate with any standard syringe (Luer Slip or Luer Lock). The MicronJet 600 is a sterile, single use device.

#### Performance Testing

Bench, animal and clinical testing was performed to assess the safety and effectiveness of the device for the stated indications for use. Performance testing demonstrated that the MicornJet 600 is as safe and effective as the predicate devices.

#### Substantial Equivalence

The MicronJet 600 is substantially equivalent to its predicate devices (Terumo Allergy Syringe (K980796), BD Precisionglide™ hypodermic needle (K021475), and SafetyGlide™ Syringe (K0992734)). The MicronJet 600 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the MicronJet 600 and its predicate devices raise no new issues of safety or effectiveness. Performance data generated by the Company and detailed further in this notification, demonstrate that the MicronJet 600 is as safe and effective as its predicates for the stated indication. Thus, the MicronJet 600 is substantially equivalent.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Nanopass Technologies, Limited C/O Mr. Jonathan Kahan Regulatory Counsel Hogan & Hartson LLP 555 13th Street NW Washington, District of Columbia 20004

Re: K092746

Trade/Device Name: MicronJet 600 Regulation Number: 21CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Il Product Code: FMI Dated: September 8, 2009 Received: September 8, 2009

Dear Mr. Kahan:

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.

# FEB - 3 2010

:

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

## Page 2 -Mr. Kahan

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 (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.

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/ReportalProblem/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,

Chinton D. Avis

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

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

Indications for Use Statement

510(k) Number (if known): 14 (19 2 746

Device Name: MicronJet 600

Indications for Use:

The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for intradermal injections of any substance or drug approved for this delivery route.

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)

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

510(k) Number: K092746

14

\\\DC - 028796/00001 - 2955294 v2