(259 days)
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No
The document describes a mechanical auto-injector and does not mention any AI or ML components or functionalities.
No.
The device description indicates that the Lobster Auto-injector is a reusable, spring-loaded injection device that is used to deliver medications, but it does not directly treat a disease or condition itself.
No
The device is described as an "auto-injector" and "reusable injection device" for "subcutaneous injection of FDA approved drugs," indicating its function is to deliver medication, not to diagnose a condition.
No
The device description explicitly states it is a reusable, spring-loaded injection device that is for use with pre-filled glass syringes, indicating it is a hardware device. The performance studies also focus on physical characteristics like activation force and injection time, further supporting it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "subcutaneous injection of FDA approved drugs." This describes a device used to administer medication directly into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a "reusable, spring-loaded injection device" for use with pre-filled syringes. This aligns with a drug delivery device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely for drug delivery.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KZH
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
For single patient or individual use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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: 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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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 (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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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: