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The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their healthcare practitioner to self inject, or have other individuals administer injections of prescribed medication.

The addition of the intradermal indication is facilitated by using the new Intradermal Spacer with a No. 2 Syringe. Intradermal injections of vaccines and other pharmaceuticals are performed on the same patient populations that are now being treated with the Biojector® 2000 for the previously cleared indications.

The Bioject® 2000 Needle-Free Injection Management System is designed to deliver vaccines and other pharmaceutical injectables by producing a high pressure injectate stream that penetrates the dermis. The system is composed of three major components: (1) the injector -Biojector® 2000; (2) sterile single use disposables - syringes in multiple orifice sizes, safety cap, filling adapter and intradermal spacer (packaged for use with a No. 2 syringe only); and (3) power source - carbon dioxide (CO2) cartridge or tank.

The depth of injectate penetration is dependant upon the svringe orifice diameter. In general. the larger the diameter of the syringe orifice, the deeper into the tissue the fluid will be deposited. Disposable syringes with a variable volume from 0.1 ml to 1 ml are numbered 2, 3, 4, 5 and 7, and have increasing syringe orifice diameters, 0.04", 0.08", 0.10" and 0.14" respectively. Intradermal injections (ID) are only performed using a No. 2 syringe (the smallest diameter) and an ID Spacer. As the distance from the syringe orifice to the skin is increased, the energy density of the fluid stream is decreased. The ID Spacer utilizes this principle to provide the optimum distance from the syringe to the skin to provide enough energy for the injectate to penetrate the epidermis, but not enough energy to transverse the underlying dermal tissue Subcutaneous (SC) injections are performed using a No. 2 syringe that is in direct contact with the skin, no spacer is utilized. Intramuscular (IM) injections are performed using syringes in contact with the skin and with larger orifice diameters.

The disposable syringe assemblies are provided sterile in a Tyvek blister peel pouch. The ID Spacer is manufactured from a high density polyethylene that meets the same environmental, biocompatibility and sterility requirements as the disposable syringes. The ID Spacer is packaged as a component with Biojector® No. 2 syringe assemblies.

This looks like a 510(k) premarket notification for a medical device, not an AI/ML medical device. The information requested (such as expert consensus, MRMC studies, or training set data) is typically relevant for evaluating AI/ML device performance and isn't provided in traditional medical device submissions like this.

However, I can extract the closest equivalent information from the given text based on how a traditional medical device's performance is demonstrated to meet its acceptance criteria.

Here's the analysis of the provided text in the context of your questions:

The submission K121270 is for the Biojector® 2000 Needle-Free Injection Management System to add a new Indication for Use for administering intradermal injections using an ID Spacer. The primary method of demonstrating acceptance is through non-clinical performance testing and a comparative animal study against predicates.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily derived from the international standard ISO 21649:2006 for Needle-free injectors and biocompatibility/sterilization standards. For the intradermal indication, the performance is also evaluated against a needle and syringe and a predicate needle-free injector concerning specific injection characteristics.

2. Sample size used for the test set and the data provenance

• Non-Clinical Performance Testing (ISO 21649:2006, Biocompatibility, Sterilization): The document does not specify the exact sample sizes for these tests (e.g., how many devices were tested for dose accuracy, how many samples for biocompatibility). These are typically standard tests with defined sample sizes per the respective ISO standards. The data provenance is from non-clinical laboratory testing presumably conducted by or for Bioject, Inc. (manufacturer).
• Animal Studies: The text states, "Testing in an accepted porcine model was conducted." The exact number of animals or injections performed is not specified. The provenance is prospective animal (porcine) study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in this type of submission. Ground truth for device performance in this context is established through objective measurements (e.g., instrument readings for dose accuracy, histological analysis in animal studies) rather than expert human interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretation or clinical outcomes, which is not relevant to the non-clinical and animal studies described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is a submission for a mechanical medical device, not an AI device, so MRMC studies involving human readers with/without AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• For Non-Clinical Performance (e.g., Dose Accuracy, ISO 21649:2006): The ground truth is based on objective measurement standards and engineering specifications.
• For Biocompatibility and Sterilization: The ground truth is based on defined biological responses or chemical analyses as per the ISO standards.
• For Intradermal Injection Equivalence (Animal Study): The ground truth was established by direct observation and measurement within the porcine model for "wheal size, depth of penetration, and dye dermal contact area." This would likely involve histological analysis or other direct measurement techniques after injection.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device, and therefore does not have a "training set" in that context. The device's design and engineering would have involved iterative development and testing, but not in the sense of an AI training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

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The Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration.

The Vial Adapter component's physical design, description and performance are identical to that of the previously cleared predicate device, Q-Cap ™ Reconstitution 13mm Vial Adapter: K041654 Ko4166 H. Packaging and sterilization of the Vial Adapter are identical to that of the previously cleared predicate device, Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter: K044654 Ko41564. The clear polycarbonate component is General Electric Lexan® 144R. No color additives are present in this component. Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety.

Here's a summary of the acceptance criteria and the study details for the Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter, based on the provided text:

Acceptance Criteria and Device Performance

• FSH: Syringe (78.6 U/Vial), Q-Cap (79.8 U/Vial)
• LH: Syringe (77.1 U/Vial), Q-Cap (77.4 U/Vial)
  The results are virtually identical and within the experimental error range of the assay, demonstrating no substantial differences in biological activity. |
  | Physical Design, Description, and Performance (Vial Adapter Component) | Identical to the previously cleared predicate device, Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041654 K041564). |
  | Packaging and Sterilization | Identical to the previously cleared predicate device, Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041654 K041564). Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety. |
  | Non-Cytotoxicity of Materials | The clear polycarbonate component (General Electric Lexan® 144R) in contact with the drug was previously established as non-cytotoxic with other cleared Ferring fertility drugs. No color additives are present. |
  | No other safety issues | No other safety issues have been identified for the device component via the testing performed for this notification. |

Study Details

1. Sample size used for the test set and the data provenance:

   • The test set involved comparing the biological activity of Menopur® (FSH and LH) when prepared with the Q-Cap™ Vial Adapter versus a standard needle and syringe.
   • The exact sample size (number of vials, number of tests performed) for this specific biological activity comparison is not explicitly stated in the provided text.
   • The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be a prospective laboratory study conducted by the manufacturer or a contracted lab to generate data for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This was a laboratory assay for biological activity of a drug, not a diagnostic device requiring expert interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth" in the typical sense (e.g., radiologists) does not apply.
   • The ground truth was established by the quantifiable results of the Menopur® Assay, performed in a lab environment. The qualifications of the personnel conducting the assay are not provided but would typically involve trained laboratory scientists.

3. Adjudication method for the test set:

   • Not applicable, as this was a quantitative biochemical assay, not a case-based interpretation requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical accessory for drug reconstitution, not an AI-powered diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this device is a physical vial adapter, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used was quantitative laboratory assay results for the Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) biological activities of Menopur®.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI algorithm requiring a training set. The "design and performance" were established based on the predicate device and physical/chemical testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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The Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and diluent from vials into an injection syringe for administration.

The device which is the subject of this Notification is a sterile, injection molded component, which will be included into Ferring Pharmaceutical's Repronex® and Bravelle® drug kits to assist in needle-free reconstitution of these lyophilized drugs for injection. The Vial Adapter component's physical design, description and performance are identical to that of a previously cleared device, Bioject Reconstitution Kit & Vial Connector (K010623). Packaging and sterilization of the Vial Adapter are identical to that of a previously cleared devices, Bioject Needle-Free Vial Adapter, (13mm); K963012.

This 510(k) summary describes a medical device, the Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter, and references its performance by comparing it to predicate devices. It does not contain a study report with specific acceptance criteria and reported device performance in the format of a table as requested, nor does it detail a standalone algorithm performance study or an MRMC study.

However, based on the provided text, here's an attempt to extract the relevant information, with some sections marked as "Not Applicable" or "Not Provided" due to the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily relies on the equivalency to predicate devices rather than presenting explicit performance metrics against predefined acceptance criteria for the new device. The performance is assessed by stating that the device is "identical" or that certain aspects "support product safety."

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not explicitly provided. The document relies on equivalence to previously cleared devices rather than new extensive testing for this 510(k) application.
• Data provenance: Not explicitly provided for new testing. The reference to predicate devices implies that past testing data from these devices (Bioject Reconstitution Kit & Vial Connector (K010623) and Bioject Needle-Free Vial Adapter (K963012)) would be the primary provenance. The document indicates that biocompatibility was "demonstrated" and that "testing support(s) product safety," implying some form of testing was performed, but details on sample size or provenance are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a medical accessory, and the regulatory submission focuses on physical and biological safety/performance equivalence, not diagnostic accuracy requiring expert ground truth establishment in the traditional sense of image analysis or diagnostic algorithms.

4. Adjudication method for the test set

• Not Applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a medical device (vial adapter) and not an AI/software as a medical device (SaMD). Therefore, MRMC studies are not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. For this type of device, "ground truth" relates more to material specifications, sterility, absence of extractables, and functionality (e.g., proper fit, ease of use, no leakage) as demonstrated by engineering and biological testing, rather than a diagnostic 'truth'. The document states that "biocompatibility...is demonstrated" and "testing support additional product safety," implying laboratory-based testing results served as the "ground truth" for these safety aspects.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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