(259 days)
The Flexi-Q DV Auto-injector is indicated for the transfer and automated subcutaneous injection of FDA approved drugs and biologics in compatible vials.
The Flexi-Q DV Auto-injector is intended for use in the home environment by the patient or care-giver after training by a Health Care Professional.
The Flexi-Q DV Auto-injector (also called: FUDAI DV)) is designed to allow people with or without minor dexterity problems (or with a help of a care giver) to aspirate a drug in solution form from a standard 13mm vial and automatically inject themselves subcutaneously with the drug.
The device is comprised of the following parts;
- -Housing: The outer shell/covering of the device. The Housing which encloses and protects the inner components including the syringe, is designed to be used while held with one hand and provides the user with visibility of the solution/ drug before, during and after injection via a window.
- -Syringe: A standard 1mL long glass syringe is assembled within the Housing. The syringe includes a staked 1/2 27G needle and an elastomeric syringe piston. The syringe is marked with a single graduation line indicating the dose volume to be aspirated and delivered (any dosage between 0.3 to 1.0mL is possible; e.g., 0.3 or 0.4 or 0.5 or 0.6 etc. up to 1.0mL). i.e., different Flexi-Q Auto-injector versions will be available, each for a single dosage volume, and according to physician prescription, the patient will use the Flexi-Q Auto-injector version specifically marked for his/her prescribed dose volume. The "single dose - single device" Flexi-Q auto-injectors are illustrated in page 11-13, Figure I. The syringe needle is used to penetrate the Vial Adaptor septum (for solution/reconstituted drug aspiration) and then to administer the subcutaneous injection to the patient.
- -Needle Shield: The needle shield covers the needle before injection. When depressed against the skin, the shield "unlocks" the Trigger Button to allow activation and injection. After the injection is completed, the shield locks in place, keeping the needle from being accessible and helping protect the user from accidental needle stick injury.
- Plunger Rod: A rigid rod that is connected to the syringe piston and protrudes out of the Auto-injector's Housing. The Plunger Rod is used to aspirate the solution/reconstituted drug into the syringe and adjust the volume to be injected to the predefined dosage.
- Trigger Button (Red INJECT Button): This button enables the user to activate the injection process after is has been unlocked by the user pressing the shield against the skin at the injection site. Once pressed the device advances the injection needle into the subcutaneous tissue followed by injection of the drug.
- One Vial Adaptor (Gray Connector): The Sterile, Single use Vial Adaptor . functions as a connector between the Auto-injector and the drug vial and provides a fluid path to enable aspiration of the drug. The syringe needle penetrates a septum (assembled inside the Vial Adaptor) made of thermoplastic elastomer while a plastic spike (part of the Vial Adaptor) penetrates the vial stopper. While attached to the Auto-injector, the Vial Adaptor conceals the Needle Shield and thus preventing inadvertent activation.
In certain cases when additional vial may be used (per drug prescription), additional sterile vial adaptor(s), may be used.
The provided 510(k) summary for the Flexi-Q DV Auto-injector (K111467) does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of an AI-powered device or a direct clinical effectiveness study with human readers.
Based on the document, the device is a mechanical auto-injector, not an AI-powered medical device. Therefore, many of the questions related to AI performance, ground truth establishment for AI models, and multi-reader multi-case studies are not applicable.
The document primarily focuses on establishing substantial equivalence to predicate devices (Mixject Dispensing Pin and Autoject 2) based on intended use and principle of operation. It does not describe specific performance studies with quantitative acceptance criteria for the Flexi-Q DV Auto-injector itself beyond stating that the "evaluation of the Flexi-Q DV Auto-injector does not raise any additional concerns regarding safety and effectiveness."
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document for the Flexi-Q DV Auto-injector. The document establishes substantial equivalence by comparing its intended use and principle of operation to predicate devices, implying that if it functions similarly, it meets acceptable performance. Quantitative performance metrics or specific acceptance criteria are not detailed in this summary.
| Acceptance Criteria (e.g., Accuracy, Precision, Usability) | Reported Device Performance |
|---|---|
| Not explicit in filing. Implicitly, device should perform safe and effective drug transfer and automated subcutaneous injection. | The device is described as allowing aspiration of a drug and automatically injecting subcutaneously. It features include: - Visibility of solution/drug via a window. - Syringe marked with a single graduation line for dose volume (0.3 to 1.0mL). - Needle shield covers the needle before injection, "unlocks" trigger when depressed against skin, and locks after injection to prevent accidental needle stick injury. - Plunger rod for aspiration and volume adjustment. - Trigger Button for activating injection after being unlocked. - Vial Adaptor for connecting to drug vial and concealing needle shield to prevent inadvertent activation. |
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly stated. The document does not describe a specific "test set" in the context of clinical or performance validation data for the device. The evaluation mentioned is likely a part of the regulatory submission process, which may involve bench testing and engineering analysis rather than a human-user test set as typically understood for AI or diagnostic devices.
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This question is typically relevant for studies involving the interpretation of data (e.g., medical images) where expert consensus is needed to define the "ground truth" against which an algorithm is evaluated. The Flexi-Q DV Auto-injector is a mechanical device, and its performance would be assessed through engineering tests and usability evaluations, not by establishing a ground truth in the same manner.
4. Adjudication Method for the Test Set
Not applicable. As the document doesn't describe a test set or ground truth establishment relevant to data interpretation, an adjudication method is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or described. This type of study is typically performed for diagnostic devices (especially those involving image interpretation) to evaluate the impact of an AI system on human reader performance. The Flexi-Q DV Auto-injector is a mechanical auto-injector, not a diagnostic AI system.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The Flexi-Q DV Auto-injector is a mechanical device, not an algorithm. There is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
Not applicable in the context of AI or diagnostic interpretation. For a mechanical device like an auto-injector, "ground truth" might refer to engineering specifications, physical measurements (e.g., injection volume accuracy, injection force, needle penetration depth), or successful drug delivery as per design. These specific performance metrics or their "ground truth" type are not detailed in the summary.
8. The Sample Size for the Training Set
Not applicable. The device is a mechanical auto-injector and does not rely on a "training set" in the machine learning sense. Its design and manufacturing are based on engineering principles and quality systems, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI model, there is no corresponding ground truth for it.
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FEB - 9 2012
510(k) Summary: Flexi-Q DV Auto-injector
Company Name:
Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 13860, Israel
Contact Person:
Mr. Shay Shaham VP Quality and R.A Telephone: +972-4-698-8875 Fax: +972-4-632-0777 E-mail: shay.shaham@elcam.co.il
Authorized US Agent:
Mr. Lloyd Fishman Elcam Medical, Inc. 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA
Phone: 201-457-1120 201-457-1125 Fax: E-mail: Lloyd.Fishman@elcam-medical.com
Date prepared: January 5, 2012
Trade Name: Flexi-Q DV Auto-injector
Classification name: Syringe needle introducer
Class: II
Panel identification: General Hospital
Product code: KZH
Regulation number: 880.6920
- Ms. Tali Hazan Or R.A Consultant Telephone: +972-50-5292304 Fax: +972-72-2448981 E-mail: tali hazan@talmed.co.il
Image /page/0/Picture/19 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" on the left, followed by the words "Elcam" and "MEDICAL" stacked on top of each other. Below the logo is the tagline "Where everything connects."
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Image /page/1/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol on the left, followed by the words "Elcam" in large, bold letters on the top line and "MEDICAL" in smaller, bold letters on the second line. Below the company name is the tagline "Where everything connects" in a smaller font.
Predicate Devices: Mixject Dispensing Pin with Detachable Vial Holder and Preattached Needle from Medical Projects Ltd, Ra'anana, Israel, cleared under 510(k) K001293 and Autoject 2 from Owen Mumford USA Inc, Marietta, GA, USA, cleared under 510(k) K013362.
Device description:
The Flexi-Q DV Auto-injector (also called: FUDAI DV)) is designed to allow people with or without minor dexterity problems (or with a help of a care giver) to aspirate a drug in solution form from a standard 13mm vial and automatically inject themselves subcutaneously with the drug.
The device is comprised of the following parts;
- -Housing: The outer shell/covering of the device. The Housing which encloses and protects the inner components including the syringe, is designed to be used while held with one hand and provides the user with visibility of the solution/ drug before, during and after injection via a window.
- -Syringe: A standard 1mL long glass syringe is assembled within the Housing. The syringe includes a staked 1/2 27G needle and an elastomeric syringe piston. The syringe is marked with a single graduation line indicating the dose volume to be aspirated and delivered (any dosage between 0.3 to 1.0mL is possible; e.g., 0.3 or 0.4 or 0.5 or 0.6 etc. up to 1.0mL). i.e., different Flexi-Q Auto-injector versions will be available, each for a single dosage volume, and according to physician prescription, the patient will use the Flexi-Q Auto-injector version specifically marked for his/her prescribed dose volume. The "single dose - single device" Flexi-Q auto-injectors are illustrated in page 11-13, Figure I. The syringe needle is used to penetrate the Vial Adaptor septum (for solution/reconstituted drug aspiration) and then to administer the subcutaneous injection to the patient.
- -Needle Shield: The needle shield covers the needle before injection. When depressed against the skin, the shield "unlocks" the Trigger Button to allow activation and injection. After the injection is completed, the shield locks in place, keeping the needle from being accessible and helping protect the user from accidental needle stick injury.
- Plunger Rod: A rigid rod that is connected to the syringe piston and protrudes out of the Auto-injector's Housing. The Plunger Rod is used to aspirate the solution/reconstituted drug into the syringe and adjust the volume to be injected to the predefined dosage.
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Image /page/2/Picture/0 description: The image shows the logo for Elcam MEDICAL. The logo consists of a stylized letter E on the left, followed by the word "Elcam" in bold, uppercase letters. Below "Elcam" is the word "MEDICAL" in a similar bold, uppercase font. Underneath the entire logo is the tagline "Where everything connects" in a smaller, sans-serif font.
- Trigger Button (Red INJECT Button): This button enables the user to activate the injection process after is has been unlocked by the user pressing the shield against the skin at the injection site. Once pressed the device advances the injection needle into the subcutaneous tissue followed by injection of the drug.
- One Vial Adaptor (Gray Connector): The Sterile, Single use Vial Adaptor . functions as a connector between the Auto-injector and the drug vial and provides a fluid path to enable aspiration of the drug. The syringe needle penetrates a septum (assembled inside the Vial Adaptor) made of thermoplastic elastomer while a plastic spike (part of the Vial Adaptor) penetrates the vial stopper. While attached to the Auto-injector, the Vial Adaptor conceals the Needle Shield and thus preventing inadvertent activation.
In certain cases when additional vial may be used (per drug prescription), additional sterile vial adaptor(s), may be used.
Indications for Use:
The Flexi-Q DV Auto-injector is indicated for the transfer and automated subcutaneous injection of FDA approved drugs and biologics in compatible vials.
The Flexi-Q DV Auto-injector is intended for use in the home environment by the patient or care-giver after training by a Health Care Professional.
Substantial Equivalence:
The Flexi-Q DV Auto-injector has the same intended use and the same principle of operation as the Mixject Dispensing Pin with Detachable Vial Holder and Preattached Needle from Medical Projects, Ltd, Ra'anana, Israel, cleared under 510(k) number K001293 and Autoject 2 from Owen Mumford USA Inc, Marietta, GA, USA, cleared under 510(k) number K013362 when used together and is therefore substantially equivalent to the predicate devices.
Conclusion:
The evaluation of the Flexi-Q DV Auto-injector does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Shav Shaham VP Quality & Regulatory Affairs Elcam Medical A.C.A.L. Kibbutz Bar'am D.N. Merom HaGalil ISRAEL 13860
FEB - 9 2012
Re: K111467
Trade/Device Name: Flexi-Q DV Auto-Injector Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: January 11, 2012 Received: January 18, 2012
Dear Mr. Shaham:
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. Shaham
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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
· Sincerely yours,
es La Anthony D. Watson
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
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Image /page/5/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter E on the left, followed by the words "Elcam" in large, bold letters. Below "Elcam" is the word "MEDICAL" in a smaller, but still bold, font. Underneath the logo is the tagline "Where everything connects".
Indications for Use
510(k) Number (if known): K111467
Device Name: Flexi-Q DV Auto-injector
Indications for Use:
The Flexi-Q DV Auto-injector is indicated for the transfer and automated subcutaneous injection of FDA approved drugs and biologics in compatible vials.
The Flexi-Q DV Auto-injector is intended for use in the home environment by the patient or care-giver after training by a Health Care Professional.
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)
Lijdl for RZC feb 9, 2012
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K111467
§ 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).