PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM

K110456 · Pharmajet, Inc. · KZE · Mar 2, 2011 · General Hospital

Device Facts

• Record ID: K110456
• Device Name: PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
• Applicant: Pharmajet, Inc.
• Product Code: KZE · General Hospital
• Decision Date: Mar 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5430
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may also be used by patients authorized by their physicians to self-inject, or have other individuals administer injections of prescribed medication.

Device Story

Compact, spring-loaded, needle-free hypodermic injector; delivers medication/vaccines intradermally via high-velocity fluid jet. System components: reusable injector, reset station, single-use sterile filling adapter, single-use sterile needle-free syringe. Operation: injector spring reset in station; filling adapter draws liquid into syringe; syringe attached to injector; trigger release discharges plunger to expel fluid through small orifice. Used in clinical settings or home by patients/caregivers. Output: intradermal injection. Benefits: needle-free administration; avoids sharps-related injuries.

Clinical Evidence

No human clinical trials. Animal testing compared subject device to Terumo 1cc Allergy Syringe; endpoints included bleb diameter, depth of penetration, dye dermal contact area, and skin volume occupied. Bench testing per ISO 21649:2006 included dose accuracy, life cycle, temperature, vibration, shock, and microbial ingress. Biocompatibility and disinfection robustness (glutaraldehyde/peroxide) confirmed.

Technological Characteristics

Mechanical spring-actuated injector. Materials: stainless steel, polyetherimide (injector/reset station); polypropylene (syringe barrel); polycarbonate (filling adapter); silicone (plunger seal). Orifice diameter: 0.007". Sterilization: electron beam radiation. Complies with ISO 21649:2006. Non-electrical.

Indications for Use

Indicated for intradermal delivery of medications and vaccines in adults and children. Suitable for use by healthcare providers or patients/caregivers authorized for self-injection.

Regulatory Classification

Identification

A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

Predicate Devices

• PharmaJet 0.5 ml Needle-free Injection System (K081532)
• Terumo 1 cc Allergy Syringe (K980796)

Submission Summary (Full Text)

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6 December 2010

MAR - 2 2011

| <b>-510(k) Summary-</b> | <b>KII</b> |
|-------------------------|------------|
|-------------------------|------------|

| Device Name - Proprietary , Common, Classification, and Panel | |
|---------------------------------------------------------------|----------------------------------------------|
| Proprietary: | PharmaJet 0.1 ml Needle-free Injector System |
| Common: | Injector, Fluid, Non-Electrically Powered |

| Injector, Fluid, Non-Electrically Powered |
|---------------------------------------------|
| 21 CFR 880.5430; Product Code KZE, Class II |
| General Hospital |

Application Information

Applicant:

Classification:

Device Panel:

Date Prepared:

PharmaJet, Inc. 400 Corporate Circle, Suite N Golden, CO 80401

[phone]

[phone]

Telephone:

FAX:

Establishment Registration: 3004977013

Owner/Operator: 9063237

## Submission Correspondent Information

Michael J. Ryan, R.A. Manager Contact: Telephone: [phone] Ext. 4172

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### Reason for Premarket Notification

New Device

#### Predicate Devices

PharmaJet 0.5 ml Needle-free Injection System, K081532 Terumo 1 cc Allergy Syringe, K980796

#### Description of the Device

The PharmaJet 0.1 ml Needle-free Iniection System (PharmaJet Svstem) is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet System consists of an injector; a reset station; a single use, sterile disposable filling adapter; and, a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet System are unique and cannot be used with any other needle-free system.

An injector is placed in the reset station and the lid is depressed to reset the spring in the injector. A health care worker puts a filling adapter into a vial of liquid medicine or vaccine. A Needle-free syringe is placed into the filling adapter, the liquid is drawn into the Needle-free syringe and is slightly over filled. The filled Needle-free syringe is removed from the adapter and the plunger is broken off and discarded. The Needle-free syringe is placed into the injector with a ¼ turn to the right, which positions the plunger so that a 0.1ml dose is ready for use. The Needle-free syringe is placed against the injection site; gentle pressure is applied until the inner housing stops. This action allows the trigger to be released. By depressing the trigger the spring is released and the plunger moves forward into the needle-free syringe barrel discharging the contents. Once the injection has been performed, the Needle-free syringe is properly disposed of and a new syringe may be filled, injector reset, and the system again prepped for use.

#### Injector

The Injector is a reusable compact spring-actuated needle-free hypodermic injector consisting of the body, inner body/safety collar, trigger, and spring. The injector is made with stainless steel and injection molded amorphous thermoplastic polyetherimide.

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### Needle-free syringe

The Needle-free syringe is a sterile, single use, transparent, disposable, polypropylene container consisting of the barrel to hold 0.1ml of medicine or vaccine, a plunger to discharge the medicine or vaccine through a small diameter orifice at the forward end of the barrel, and a silicone seal on the plunger to prevent leakage of the medicine or vaccine rearward.

### Reset Station

The Reset Station is used to prepare (reset) the spring, within the injector, for an injection. The reset station is made with stainless steel and injection molded amorphous thermoplastic polyetherimide.

### Filling Adapter

The filling adapter allows the needle-free syringe to be filled from medicine or vaccine storage vials. The filling adapter, which does not contact the patient, is made of injection-molded polycarbonate.

### Indication for Use

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

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Technological Characteristics

| Characteristic | PharmaJet 0.1 ml Needle-free Injection System | PharmaJet 0.5 ml Needle-free Injection System | Terumo Allergy Syringe |
|--------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Actuation feature | Trigger | Trigger | Standard piston syringe |
| Trigger safety | Yes | Yes | Not Applicable (NA) |
| Spring life cycle | 20,000 | 20,000 | NA |
| Method of power | Mechanical spring | Mechanical spring | Standard piston syringe |
| Method of spring reset | External resetting device | External resetting device | NA |
| Method of medicine and/or vaccine transfer | Filling adapter | Filling adapter | Fixed hypodermic single lumen 27 gauge, 1/2"or 3/8" needle, with an intradermal bevel. |
| ISO 21649: 2006 compliance | Yes | Yes | NA |
| Volume: | 0.1ml | 0.5ml | 0.1 - 1.0 ml |
| Material | Body - polypropylene<br>Plunger - polycarbonate<br>Seal - silicone rubber | Body - polypropylene<br>Plunger - polycarbonate<br>Seal - silicone rubber | Unknown |
| Orifice Diameter | 0.007" | 0.009" | NA |
| Tip Ring Diameter | 0.419" | 0.529" | NA |
| Disposable | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Sterilization Method | Electron beam radiation | Electron beam radiation | Unknown |

## Discussion of Non-clinical Tests

The purpose of the Bench Testing for the PharmaJet Needle-free Injection System was to establish that the system meets the requirements of the PharmaJet 0.1ml Product and Engineering Specifications with regard to robustness for customer needs and meet the essential requirements of ISO21649:2006 Needle-free injectors for medical use -------------------------------------------------------------------------------------------------------------------------methods.

The following tests have been successfully completed:

- Temperature, storage temperature, free-fall, vibration, shock, dose o accuracy, life cycle, performance profile upper and lower acceptance limits and emitted noise testing according to ISO21649:2006 Needlefree injectors for medical use -Requirements and test methods
- Needle-free Syringe Irradiated Dose Test for Robustness o
- Microbial Ingress Testing o

Confidential

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Animal testing was performed to demonstrate substantial equivalence to an intradermal injection using the Terumo 1cc Allergy syringe. The test results indicate that the PharmaJet 0.1 ml Needle-free Injection System is substantial equivalence to the Terumo 1 cc Allergy Syringe with regards to the three primary endpoints: bleb diameter, depth of penetration based on dermal height, dye dermal contact area, and the secondary calculated endpoint of skin volume occupied by the dye.

Maximum irradiated sterility dose test was done on the needle-free syringe to demonstrate material robustness and microbial ingress testing on the Filling Adapter was done to demonstrate that the Filling Adaptor can be disinfected using common disinfection techniques.

Biological testing conducted demonstrate that the PharmaJet Needle-free Syringe and Filling Adapter meet the requirements for safe short term exposure,

Functional testing after Gluteraldehyde-based and peroxide-based high level disinfection show no degradation of performance or damage to Injectors or Reset Stations.

### Conclusion

Pre-clinical testing and bench testing have shown that for intradermal delivery with needle-free jet injection the PharmaJet 0.1 ml Needle-free Injection System is as effective, as safe, and performs as well as, or better than one of the predicate devices.

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

Pharmajet. Incorporated C/O Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709

MAR - 2 2011

Re: K110456

Trade/Device Name: PharmaJet 0.1ml Intra-dermal Needle-Free Injection System Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically Powder Fluid Injector Regulatory Class: II Product Code: KZE Dated: February 14, 2011 Received: February 16, 2011

Dear Mr. Rongero:

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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Page Mr. Rongero

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 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.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,

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

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Indications for Use

x110456_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): Device Name: PharmaJet, Inc., PharmaJet 0.1ml Intra-dermal Needle-free Injection System Indications for Use: The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may also be used by patients authorized by their physicians to self-inject, or have other individuals administer injections of prescribed medication.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

All C. Chyn 3/3/4

Division Sign-Off) livision of Anesthesiology, General Hospital ifection Control, Dental Devices

510(k) Number: __

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