LOBSTER AUTO-INJECTOR

K124026 · Scandinavian Health Limited · KZH · Sep 13, 2013 · General Hospital

Device Facts

• Record ID: K124026
• Device Name: LOBSTER AUTO-INJECTOR
• Applicant: Scandinavian Health Limited
• Product Code: KZH · General Hospital
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For single patient or individual use only. The Lobster device is intended for use with a 1mL glass syringe, containing a fixed needle of 27G to 29G gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.

Device Story

Lobster Auto-injector is a reusable, spring-loaded mechanical device designed for subcutaneous self-injection of drugs. It consists of two subassemblies that house a 1.0 mL pre-filled glass syringe with a staked needle (27G-29G). The user loads the syringe into the device, which then facilitates the injection process. It is intended for individual patient use in home or clinical settings. The device provides a controlled delivery mechanism for drug solutions with viscosities between 1 and 4 mPa*s, potentially improving patient compliance and ease of administration for chronic conditions requiring regular injections.

Clinical Evidence

Bench testing only. The device was assessed according to ISO 11608:2012, 'Needle-based injection systems for medical use - Requirements and test methods - Part 1'. Testing included activation force, needle extension, injection time, completeness of injection, functionality, and robustness. The device met all requirements and specifications.

Technological Characteristics

Reusable, spring-loaded mechanical injection device. Compatible with 1.0 mL pre-filled glass syringes with staked needles (27G-29G). Designed for drug solutions with viscosity 1-4 mPa*s. Operates via mechanical spring energy. Complies with ISO 11608:2012 standards for needle-based injection systems.

Indications for Use

Indicated for subcutaneous injection of FDA-approved drugs in patients requiring self-injection. Compatible with 1mL glass syringes with 27G-29G fixed needles and drug solutions with viscosity 1-4 mPa*s. For single-patient use; suitable for prescription or OTC use.

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 2 (K945660)
• Autoject 2 (K013362)
• Personal InjectorTM (K033696)

Submission Summary (Full Text)

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# KIZ4026

3 2013

Image /page/0/Picture/1 description: The image contains the logo for SHL Group. The logo consists of a stylized graphic to the left of the text "SHL GROUP". The graphic appears to be two horizontal lines with angled ends, resembling an abstract design. The text is in a bold, sans-serif font.

#### 510(k) Summary of Safety and Effectiveness (21 CFR 807.92(a)) 5.

Date Prepared: September 6, 2013

#### 5.1 Submitted By:

Scandinavian Health Ltd. 136, Kuo Sheng 2nd Street Taoyuan City 330, Taiwan

Contact: James Haynes Manager, Regulatory Affairs SHL Pharma LLC Phone: [phone] E-mail: [e-mail]

#### 5.2 Name of Device:

| Common Name: | Auto-Injector |
|----------------------|---------------------------|
| Regulation Number: | 880.6920 |
| Classification Name: | Syringe Needle Introducer |
| Classification: | Class II |
| Product Code: | KZH |

#### Predicate Devices: 5.3

| Device name: | Autoject 2 |
|----------------|---------------------|
| 510(k) number: | K945660 |
| Device name: | Autoject 2 |
| 510(k) number: | K013362 |
| Device name: | Personal InjectorTM |
| 510(k) number: | K033696 |

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Image /page/1/Picture/0 description: The image shows the logo for SHL Group. The logo consists of a stylized graphic to the left of the text "SHL GROUP". The graphic appears to be a stylized representation of two arrows pointing in opposite directions. The text is in a bold, sans-serif font.

#### 5.4 Substantial Equivalence

The Lobster Auto-injector has a similar intended use and the same principle of operation as the Autoject 2 from Owen Mumford and Personal Injector™ from Union Medico. In addition, the equivalence is supported by the performance characteristics and materials as compared to the Autoject 2 that was also the predicate devices for Personal Injector™. The Lobster Auto-injector shares the same intended use and marketing intent (e.g. prescription and OTC use) as Union Medico's Personal Injector™.

#### ર્સ્ડ Device Description

The Lobster Auto-injector is a reusable, spring-loaded injection device that is for use with 1.0 ml pre-filled glass syringes with staked needle. Lobster Auto-injector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.

#### ર્સ્વ Intended Use

For single patient or individual use only.

The Lobster device is intended for use with a 1mL glass syringe, containing a fixed needle of 27G to 29G gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.

#### 5.7 Technological Characteristics

The Lobster Auto-injector has similar technological characteristics to the Owen Mumford's Autoject 2. Differences between the devices do not raise any significant issues of safety and effectiveness.

#### 5.8 Performance Data

Lobster Auto-injector was assessed using the applicable sections and methods specified in the ISO standard, ISO 11608:2012, "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems". Activation force, needle extension, injection time, completeness of injection, functionality, and robustness were assessed; Lobster auto-injector met all

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Image /page/2/Picture/0 description: The image shows the logo for SHL Group. The logo consists of a stylized arrow pointing to the right, followed by the text "SHL GROUP" in bold, sans-serif font. The arrow is made up of two horizontal lines, one above the other, with a gap in the middle.

requirements and specifications.

#### 5.9 Conclusion

Based on the information presented herein, the Lobster Auto-injector is substantially equivalent to similar products that have received FDA clearance and are currently legally marketed in the USA.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

## September 13, 2013

Scandinavian Health Limited C/O Mr. James Haynes Manager, Regulatory Affairs SHL Pharma LLC 588 Jim Moran Boulevard DEERFIELD BEACH FL 33442

Re: K124026

Trade/Device Name: Lobster Auto-Injector Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: July 25, 2013 Received: July 29, 2013

Dear Mr. Haynes:

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 I ho general ocharity 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. Haynes

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours.

# Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for SHL Group. The logo consists of a stylized graphic to the left of the text "SHL GROUP". The graphic appears to be a stylized representation of a mechanical or engineering component.

## Indications for Use

510(k) Number (if known): K124026

Device Name: Lobster Auto-injector

Indications for Use:

The Lobster device is intended for use with a ImL glass syringe, containing a fixed needle of 27G to 29G gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use_ 2 (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 2013.09.13 1 1:24:41 -04'00'

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

510(k) Number: