(259 days)
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.
For single patient or individual use only.
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.
The provided text describes the 510(k) summary for the Lobster Auto-injector, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with an AI component.
Therefore, the information required to answer the prompt (acceptance criteria, details of a study proving the device meets them, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, and training set details) is not present in the provided text.
The text does mention performance data in Section 5.8:
"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 requirements and specifications."
However, this is a general statement about meeting ISO standard requirements for mechanical performance, not a detailed description of an AI-driven system's study. The ISO standard itself would contain the "acceptance criteria," but those are not explicitly stated here.
In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves an AI-driven device meets them. The Lobster Auto-injector is a mechanical auto-injector, not an AI or imaging device.
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KIZ4026
3 2013
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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: 954-725-2046 E-mail: James.Haynes@shl-group.com
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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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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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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:
§ 880.6920 Syringe needle introducer.
(a)
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.(b)
Classification. Class II (performance standards).