(108 days)
The Whisper JECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
The WhisperJECT™ autoinjector is a reusable, spring-loaded injection device that is for general use with 1.0 ml pre-filled glass syringes. WhisperJECTTM autoinjector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.
The provided text is a 510(k) summary for the WhisperJECT Autoinjector. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not include detailed information regarding specific acceptance criteria, reported device performance against those criteria, or the study specifics that would prove the device meets these criteria. The section "Performance Data 5.8" only states that the device will be assessed using ISO 11608:2012 and that it is intended to meet all requirements and specifications. It explicitly says "WhisperJECT™ auto-injector is intended to meet all requirements and specifications prior to being marketed. As per SHL Pharma's commitment included in section 9.0, WhisperJECT autoinjector device will only be marketed after required testing has been completed and all acceptance criteria met." This means the results of the studies were not included in this 510(k) summary.
Therefore, I cannot provide accurate answers to most of your questions based only on the provided text.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states that performance data will be assessed and that the device is intended to meet all requirements, but it does not provide the actual acceptance criteria or the reported performance data.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. The document mentions that applicable sections and methods specified in ISO 11608:2012 will be used for assessment, but it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not available in the provided document. As this is a medical device (autoinjector) and not an AI/diagnostic software, the concept of "ground truth established by experts" in the way it's typically applied to diagnostic AI models (e.g., radiologists interpreting images) is not directly relevant here. The performance is assessed against engineering and physical standards (ISO 11608:2012).
4. Adjudication Method for the Test Set
Not applicable/Not available in the provided document. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device (autoinjector), not a diagnostic AI system with human-in-the-loop performance measurement. Therefore, an MRMC study with human readers assisting AI or without AI assistance is not applicable.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. As this is a physical medical device (autoinjector), the concept of an "algorithm only" standalone performance is not relevant in the context of AI. The performance assessment mentioned (activation force, needle extension, injection time, completeness of injection, functionality, and robustness) refers to the physical device's characteristics.
7. The Type of Ground Truth Used
Not applicable. As this is a physical medical device, the "ground truth" refers to engineering specifications and performance standards as outlined in ISO 11608:2012 (e.g., calibrated measurements of force, time, distance, successful drug delivery) rather than expert consensus, pathology, or outcomes data in a diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2014
Scandinavian Health Limited c/o Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K141384
Trade/Device Name: WhisperJECT Autoinjector Regulation Number: 21 CFR 880.6920 Regulation Name: Introducer, Syringe needle Regulatory Class: II Product Code: KZH Dated: August 28, 2014 Received: August 29, 2014
Dear Mr. Job
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. Job
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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) K141384
Device Name WhisperJECT Autoinjector
Indications for Use (Describe)
The Whisper JECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for SHL Group. The logo consists of a blue and green abstract graphic to the left of the text "SHL GROUP". The text is in a gray sans-serif font.
510(k) Summary of Safety and Effectiveness (21 CFR 807.92(a)) 5.
Date Prepared: April 24, 2014
5.1 Submitted By:
James Haynes Manager Regulatory Affairs
Scandinavian Health Ltd. Phone: +1-954-725-2046 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 |
5.3 Predicate Devices:
| Device name: | Lobster Auto-injector |
|---|---|
| 510(k) number: | K124026 |
| Device name: | Autoject 2 |
| 510(k) number: | K945660 |
| Device name: | Autoject 2 |
| 510(k) number: | K013362 |
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Image /page/4/Picture/0 description: The image shows the logo for SHL Group. The logo consists of a blue and green abstract symbol on the left, followed by the text "SHL GROUP" in gray. The symbol appears to be made up of three curved lines that are connected.
Substantial Equivalence 5.4
The WhisperJECT™ autoinjector has the same intended use and the same principle of operation as the Lobster auto-injector from Scandinavian Health Limited and Autoject 2 from Owen Mumford. In addition, the equivalence is supported by the performance characteristics and materials used.
Device Description ર્સ્ડ
The WhisperJECT™ autoinjector is a reusable, spring-loaded injection device that is for general use with 1.0 ml pre-filled glass syringes. WhisperJECTTM autoinjector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.
5.6 Intended Use
The WhisperJECT™ autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
5.7 Technological Characteristics
The WhisperJECT™ autoinjector has similar technological characteristics to the Scandinavian Health Limited's Lobster auto-injector and Owen Mumford's Autoject 2. Differences between the devices do not raise any significant issues of safety and effectiveness.
Performance Data 5.8
WhisperJECT™ autoinjector is being 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 and robustness will --be assessed: WhisperJECT™ auto-injector is intended to meet all requirements and specifications prior to being marketed. As per SHL Pharma's commitment included in section 9.0, WhisperJECT autoinjector device will only be marketed after required testing has been completed and all acceptance criteria met.
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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 is made up of three curved lines in shades of blue and green. The text "SHL GROUP" is in a bold, sans-serif font and is colored gray.
5.9 Conclusion
Based on the information presented herein, the WhisperJECT™ autoinjector is substantially equivalent to similar products that have received FDA clearance and are currently legally marketed in the USA.
§ 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).