AUTOJECT 2 FOR GLASSY SYRINGE

K122837 · Owen Mumford, Ltd. · KZH · Oct 15, 2012 · General Hospital

Device Facts

• Record ID: K122837
• Device Name: AUTOJECT 2 FOR GLASSY SYRINGE
• Applicant: Owen Mumford, Ltd.
• Product Code: KZH · General Hospital
• Decision Date: Oct 15, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Autoject® II for glass syringe is a non-sterile fully automatic injection device. The device is intended for the subcutaneous delivery of an FDA approved drug.

Device Story

Handheld mechanical injection device; uses plastic injection-molded parts and stainless steel springs. Designed for 1ml fixed-needle pre-filled glass syringes. Operated by patient in home setting for self-administration of FDA-approved drugs. Device features a modified damper component to improve syringe handling and reduce stress on syringe flanges during activation. User loads syringe, activates device to deliver injection, and monitors 'end of injection indicator'. Benefits include safe, simple, and consistent subcutaneous drug delivery. No electronic or software components.

Clinical Evidence

No clinical data submitted. Performance established via bench testing, including verification of needle exposure length, delivered volume, dose delivery time, visibility of end-of-injection indicator, and Finite Elemental Analysis (FEA) to compare syringe stress levels.

Technological Characteristics

Mechanical, non-sterile, handheld injection device. Materials: plastic injection-molded parts and stainless steel springs. Dimensions: 190mm length, 25mm width. Depth of penetration: 4-12mm. Activation force: 4.0-10.0N. Safety release force: 1.0-2.5N. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring subcutaneous administration of an FDA-approved drug using a 1ml fixed-needle pre-filled glass syringe. For home use to aid and support injection.

Regulatory Classification

Identification

A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Predicate Devices

• Autoject® II for glass syringe (K013362)

Submission Summary (Full Text)

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K122837

| S<br>. . | 1<br>- |
|----------|--------|
| | |

| Title: | Autoject II For Glass Syringe Special 510(k) Submission |
|-----------|---------------------------------------------------------|
| Section: | 6.0 - 510(k) Summary |
| Revision: | 01 |
| Date: | September 2012 |

 OWEN MUMFORD
Making a World of Difference

### SECTION 6.0

OCT 15 2012

### 510(k) SUMMARY

# (AS REQUIRED BY SECTION 807.92(c))

#### Applicants Name & Address:

Mr. Darren Mansell

Owen Mumford Ltd. Brook Hill Woodstock. Oxfordshire OX20 1TU United Kingdom

Device Classifications:

Common Name: Classification Name: CFR Number: Panel: FDA Classification:

Autoject® If for glass syringe Syringe Needle Introducer 880.6920 80.HO General Hospital ll

#### Legally Marketed Device To Which This Document Claims Substantial Equivalence:

- Predicate Device: .
Autoiect® II for glass syringe

- K013362 Predicate Device 510(k) Number: .
- Predicate Device Manufacturer: .

Owen Mumford Ltd Brook Hill Woodstock Oxfordshire OX20 1TU England

- Predicate Device Manufacturer FDA Device Establishment Registration Number: 8021764
< Continued Over Page >

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K122837

| Title: | Autoject® II For Glass Syringe Special 510(k)<br>Submission | | |
|-----------|-------------------------------------------------------------|--|--|
| Section: | 6.0 - 510(k) Summary | | |
| Revision: | 01 | | |
| Date: | September 2012 | | |

Making a World of Difference

### SECTION 6.0

### 510(k) SUMMARY

## (AS REQUIRED BY SECTION 807.92(c)) < CONTINUED >

#### Predicate Device Details:

Common Name: Classification Name: Class: Classification: Panel Code: CFR Number: 510(k) Number:

Autoject® II for glass syringe Syringe Needle Introducer 11 General Hospital 80 880.6920 K013362

#### Description Of The Device & Intended Use:

The 'Autoject® II for glass syringe' is composed of simple plastic injection moulded parts and stainless steel springs.

The device is a non-sterile, handheld mechanical device intended for self-administered, I rie device is a non been of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked necale pro hilled groupen. It has been developed to provide a safe and simple procedure to the patient.

#### < Continued Over Page >

Page 18 of 43

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K122837 page 3

OWEN MUMFORD

Making a World of Difference

### SECTION 6.0

### 510(k) SUMMARY

# (AS REQUIRED BY SECTION 807.92(c)) < CONTINUED >

Technological Characteristics - Compared To Predicate Device:

Autoject® II For Glass Syringe Special 510(k)

Submission 6.0 - 510(k) Summary

September 2012

01

Title:

Section: Revision:

Date:

| Test/Characteristic | Submission Device<br>Autoject for glass<br>syringe (modified) | Predicate Device<br>Autoject II (K013362) |
|-------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------|
| Drug | FDA approved drug | FDA approved drug |
| Primary container | 1ml fixed needle pre-filled<br>glass syringe | 1ml fixed needle pre-filled<br>glass syringe |
| Patient target group | Those requiring<br>administration of an FDA<br>approved drug | Those requiring<br>administration of an FDA<br>approved drug |
| Dose system | One injection per syringe | One injection per syringe |
| Depth of penetration | 4-12mm | 4-12mm |
| Accessories | 1ml fixed needle pre-filled<br>glass syringe | 1ml fixed needle pre-filled<br>glass syringe |
| Maximum force required to load<br>the device (Newtons) | 20.0N | 20.0N |
| Force required to activate the<br>device (Newtons). | 4.0-10.0N | 4.0-10.0N |
| Force required to release the<br>safety mechanism (Newtons). | 1.0-2.5N | 1.0-2.5N |
| Overall length of device<br>(millimetres) | 190 | 190 |
| Overall width of device - at widest<br>point (Millimetres) | 25 | 25 |
| Syringe handling forces -<br>maximum stress exerted on<br>syringe | 82 - 160 MPa | 125 - 250 MPa |
| Base materials | Identical to predicate device | Identical to predicate device |

The summary table above shows the comparison of the technical characteristics between the The Summary table above above oredicate device. Additionally, the raw materials for each submission action and processedion 9.2). It was noted that all of the materials are the same for each component on both devices. Furthermore, the mode of operation is exactly the same for each device, the only difference is the fact that the submission device incorporates a same for each devide, the only anterended to improve the handling of the syringe inside the device.

The technical characteristics are exactly the same between the modified device, and the f he technodi onlardenotion of the syringe handling forces. The maximum stress exerted on the syringe is lower on the modified device. This is a direct result of the modified excited on the oyinge is lower which improves the syringe handling capabilities damper computerit on the modified donion which immention to reduce the stress exerted on on the syringe during normal use. The reason why a range is shown for the syringe handling force in the table above is explained further in Section 10.2.

Autoject® II For Glass Syringe Special 510(k) Submission September 2012

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K122837 page 4
Owen MUMFORD

Making a World of Difference

## SECTION 6.0

### 510(k) SUMMARY

# (AS REQUIRED BY SECTION 807.92(c)) < CONTINUED >

#### Non-Clinical Performance Data:

Submission 6.0 - 510(k) Summary

September 2012

01

Title:

Date:

Section: Revision:

> A number of tests have been performed proving that the device operates safely and effectively, and displays performance characteristics equivalent to those of the predicate device:-

- Verification of needle exposure (exposed needle length). .
Autoject® II For Glass Syringe Special 510(k)

- Verification of delivered volume. ●
- Verification of dose delivery time. .
- Verification that the 'end of injection indicator' is visible on the device ●

Furthermore, Finite Elemental Analysis (FEA) testing was initiated to confirm that the modified damper component in the submission device conferred reduced stresses on the syringe, compared to the damper component on the predicate device. The FEA studies synnige, compared to the damper on the syringe flanges as the device is activated and the syringe travels through the device.

#### Clinical Performance Data:

Clinical performance data has not been submitted, and is therefore not included in this Special 510(k) document.

#### Conclusions From Performance Data:

The results from the testing noted above (see Section 10.0) demonstrate that the submission device shows equivalent performance to the predicate device. Furthermore the results help to de now that the submission device is safe, performs as per its intended use, and will pose no additional risk to a patient, compared to the predicate Autoject® II device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

> 5 2012

Owen Mumford, Limited C/O Mr. Darren Mansell Regulatory Affairs Manager Brook Hill, Woodstock Oxfordshire OX20 1TU United Kingdom

Re: K122837

Trade/Device Name: Autoject® II for glass syringe Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: September 13, 2012 Received: September 17, 2012

Dear Mr. Mansell:

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 2 – Mr. Mansell

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/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,

R. Sheth
Strodtman MD

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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# (122837

## SECTION 5.0

# INDICATIONS FOR USE STATEMENT

#### 510(K) Number: TBC

Device Name: 'Autoject® II for glass syringe'

Indications For Use:

The Autoject® II for glass syringe is a non-sterile fully automatic injection device. The device The Autoject" If for glass synnge is non-steine fully automatic information of the device of the development of subcutaneous delivery of an FDA approved drug.

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)

Red C. 10/12/12

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

510(k) Number: K122837