PHARMAJET NEEDLE-FREE INJECTION SYSTEM

K081532 · Pharmajet, Inc. · KZE · Feb 26, 2009 · General Hospital

Device Facts

• Record ID: K081532
• Device Name: PHARMAJET NEEDLE-FREE INJECTION SYSTEM
• Applicant: Pharmajet, Inc.
• Product Code: KZE · General Hospital
• Decision Date: Feb 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5430
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. 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.

Device Story

PharmaJet Needle-free Injection System is a spring-loaded, non-electrically powered device for intramuscular or subcutaneous drug/vaccine delivery. System components include a reusable injector, cocking device, disposable filling adapter, and disposable needle-free syringe. Operation: user cocks spring via cocking device; fills syringe from vial using adapter; attaches syringe to injector; places against skin; triggers spring release. High-pressure fluid jet penetrates skin. Used in clinical settings by healthcare providers or at home by patients/caregivers. Benefits include needle-free administration, reducing needle-stick risks and patient anxiety. Output is precise 0.5ml dose delivery.

Clinical Evidence

No human clinical trials. Evidence based on preclinical animal models (pigs for adults/children, lambs for infants/geriatrics) to validate depth of penetration for IM/SC delivery. Bench testing per ISO 21649:2006 confirmed dose accuracy, life cycle, and robustness. Biocompatibility and sterility testing (electron beam) performed.

Technological Characteristics

Mechanical spring-actuated jet injector. Materials: stainless steel, polyetherimide (injector/cocking device), polypropylene (syringe barrel), polycarbonate (filling adapter), silicone (seal). Dimensions: 0.5ml capacity, 0.009" orifice. Sterilization: electron beam radiation. Complies with ISO 21649:2006.

Indications for Use

Indicated for intramuscular or subcutaneous 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

• Genesis Medical Technologies, Inc. PharmaJet Needle-free Injector (K041239)
• Bioject, Inc. Biojector 2000 Needle-free Injection Management System (K960373)

Submission Summary (Full Text)

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K08 1532
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510(k) Premarket Notification PharmaJet, Inc. PharmaJet Needle-free Injection System -510(k) Summary-

FEB 2 62009

22 4 22 2 2014

### Date prepared: 5/30/2008

Device Name - Proprietary, Common, Classification, and Panel

Owner's Name and Address:

PharmaJet, Inc. 221 Corporate Circle Suite D Golden, CO 80401

General Hospital

Ron Bauer

[phone]

[phone]

3004977013

Device Name - Proprietary:

Device Name - Common and Classification

PharmaJet Needle-free Injector

Injector Fluid, Non-Electrically Powered (21CFR 880.5430, Product Code KZE, Class II)

Device Panel:

Application Information

Contact:

Telephone:

FAX:

Establishment Registration Number:

9063237

Owner/Operator Number:

Submission Correspondent Information:

Address:

PharmaJet, Inc. 221 Corporate Circle Suite D Golden, CO 80401 Ron Bauer

Contact:

Telephone:

[phone]

Confidential

7/17/2008

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# Reason for Premarket Notification

New Device

# Predicate Devices with Associated 510(k) Number

K041239 Genesis Medical Technologies, Inc. PharmaJet Needle-free Injector

K960373 Bioject, Inc. Biojector 2000 Needle-free Injection Management System

# Description of Device

The PharmaJet, Inc. PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of two (2) injectors (One is the light injector suitable for infants up to two years old, geriatric adults or locations with thin skin and minimal adipose tissue and one is the heavy injector suitable for adults and children two years and older, or locations with thicker skin and more adipose tissue.), a cocking device, a single use, sterile, disposable filling adapter, and a single use, sterile, disposable needle-free svringe.

An iniector is placed in the cocking device and the lid is depressed to cock the spring in the injector. The healthcare worker puts a filling adapter into a vial of liquid medicine or vaccine. A needle-free syringe is placed into the filling adapter and the liquid is drawn into the needle-free syringe and is slightly over filled. The plunger is broken off and discarded. With the adapter, needle-free syringe, and vial still engaged the needle-free syringe is placed into the injector with a ¼ turn to the right, this returns excess medicine or vaccine back into the vial and positions the plunger to deliver a 0.5ml dose. The adapter and filled needle-free syringe can now be separated. The needle-free syringe is placed against the injection site, which displaces the safety interlock. By depressing the trigger the spring is released and the plunger moves forward into the needle-free syringe barrel discharging the contents. As the medicine or vaccine passes through the orifice under high pressure, it forms a jet of fluid that penetrates the skin.

# Iniector

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 single use, transparent, disposable, polypropylene container consisting of the barrel to hold 0.5ml 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.

### Cocking Device

The cocking device is used to prepare (cock) the spring, within the injector, for injection. The cocking device is made with stainless steel and injection molded amorphous thermoplastic polvetherimide.

#### Filling Adapter

The filling adapter allows the needle-free syringe to be filled with medicine or vaccine from medicine or vaccine storage vials.

The filling adapter material, which does not contact the patient, is injection-molded polycarbonate.

## Intended Use

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. 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.

# Technological Characteristics

| Characteristic | PharmaJet<br>Needle-free<br>Injection System | Genesis Medical<br>Technologies<br>PharmaJet<br>Injector | Bioject Biojector<br>2000 |
|--------------------------------------------|----------------------------------------------|----------------------------------------------------------|---------------------------|
| Trigger safety | Yes | Yes | No |
| Spring life cycle | 20,000 | 600 | N/A |
| Method of power | Mechanical spring | Mechanical spring | CO2 compressed gas |
| Method of spring reset | External cocking device | External cocking device | N/A |
| Method of medicine and/or vaccine transfer | Filling adapter | Standard needle or other similar device | Filling adapter |
| Volume: | 0.5ml | 0.5ml | 0.1 to 1.0 ml |

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K081532
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# rnar

| Expelled volume<br>tolerance | ± 5% | ± 5% | Unknown |
|------------------------------|------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------|
| Material | Body -<br>polypropylene<br>Plunger -<br>polycarbonate<br>Seal - silicone<br>rubber | Body and<br>plunger-<br>polypropylene | Body -<br>Polycarbonate<br>Plunger - Unknown<br>Seal - Silicone<br>rubber |
| Orifice Diameter | 0.009" | 0.007" | 0.004<br>0.006<br>0.008<br>0.010<br>0.014 |
| Disposable | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Sterilization Method | Electron beam<br>radiation | Electron beam<br>radiation | Ethylene oxide |

# Discussion of the Non-clinical Tests

Pigs have been determined to be predictive models for depth of penetration studies for healthy adults and children two years and older, or locations with thicker skin and more adipose tissue for injection into the deltoid, lateral thigh, or buttocks. Lambs have been determined to be predictive models for depth of penetration studies in infants up to two years old, geriatric adults or locations with thin skin and minimal adipose tissue. Preclinical animal testing using these two animal models have been completed for intramuscular and subcutaneous delivery to demonstrate substantial equivalence to a predicate device. It was found in these tests that the variability in the PharmaJet Injector's depth of penetration is equal to or less than the variability of the Bioject B2000 iniector's depth of penetration. Overall there is no difference in accuracy of the two injectors and for subcutaneous injections the PharmaJet injector is more accurate than the Bioject injector.

Bench testing has been completed to establish that the system meets customer requirements for performance and robustness by meeting the essential requirements of ISO21649:2006 Needle-free iniectors for medical use -Requirements and test methods. These include operating temperature, storage temperature, free-fall, vibration, shock, dose accuracy, life cycle, performance profile upper and lower acceptance limits, and emitted noise.

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 Adapter can be disinfected using common disinfection techniques.

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

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Image /page/4/Picture/0 description: The image shows the word "Pharmajet" in a bold, black font. The letters are large and spaced closely together. A small registered trademark symbol is located to the right of the "t" in "Pharmajet".

Functional testing after Glutaraldehyde-based and peroxide-based high level disinfection shows no degradation of performance or damage to Injectors or Cocking Devices

## Conclusion

Pre-clinical testing and bench testing have shown that for intramuscular and subcutaneous delivery with needle-free jet injection the PharmaJet 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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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font and is centered horizontally. The words are arranged on a single line.

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ron Bauer Executive Director of Regulatory and Quality Assurance PharmaJet, Incorporated 221 Corporate Circle, Suite D Golden, Colorado 80401

FEB 2 6 2009

Re: K081532

> Trade/Device Name: PharmaJet Needle-Free Injection System Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: January 28, 2009 Received: February 2, 2009

Dear Mr. Bauer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 2 - Mr. Bauer

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Anthony V. Newton ber

Ginette Y. Michaud, M.D. Acting 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

K 08 15 3 2

510(k) Number (if known):

Device Name:

Indications for Use:

PharmaJet, Inc., PharmaJet Needle-free Injection System

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. 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.

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)

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

510(k) Number. K081532

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