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510(k) Data Aggregation
(188 days)
Praxis Medical, LLC
The Praxis Medical EndoCore is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. For any patient 18 years and older - requiring tissue sampling.
The EndoCore is intended to be used with endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.
The Praxis Medical EndoCore is a device used with an ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree in patients 18 years and older requiring tissue sampling. The device utilizes a battery-powered internal motor to rotate the needle, facilitating cellular material collection, and employs standard vacuum syringe techniques for biopsy.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-1: Biological Evaluation | Met acceptance criteria. |
| ISO 10993-5: Cytotoxicity | Met acceptance criteria. | |
| ISO 10993-10: Sensitization | Met acceptance criteria. | |
| ISO 10993-10: Intracutaneous Reactivity | Met acceptance criteria. | |
| ISO 10993-11: Acute Systemic Toxicity | Met acceptance criteria. | |
| ISO 10993-11: Material-Mediated Pyrogenicity | Met acceptance criteria. | |
| Bacterial Endotoxin | Met acceptance criteria. | |
| Electromagnetic Compatibility and Electrical Safety | IEC 60601-1: 2005 + A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | Met acceptance criteria. |
| IEC 60601-1-2: 2020 Collateral standard: Electromagnetic Disturbances Requirements and Tests | Met acceptance criteria. | |
| IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Met acceptance criteria. | |
| Bench Testing | ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements | Met acceptance criteria. |
| ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | Met acceptance criteria. | |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods | Met acceptance criteria. | |
| ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires | Met acceptance criteria. | |
| Mechanical, Drop and Transit Testing | Met acceptance criteria. | |
| EndoCore EBUS Adapter Leakage | Met acceptance criteria. | |
| Needle Wobble | Met acceptance criteria. | |
| Radiopacity | Met acceptance criteria. | |
| Scope Compatibility | Met acceptance criteria. | |
| Ultrasound Compatibility | Met acceptance criteria. | |
| Sterility | Gamma Sterilized using the VDmax25 method SAL:10-6 | The device is supplied sterile with a Sterility Assurance Level (SAL) of 10^-6, indicating an effective sterilization process. |
| Shelf Life | One year | The device has a one-year shelf life. This difference from the predicate's three-year shelf life does not raise new safety or efficacy questions. |
| Labeling | Conforms to 21 CFR part 801 | Labeling is compliant with 21 CFR part 801 requirements. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for each "test set" within the non-clinical testing. The non-clinical testing consisted of various laboratory-based tests (Biocompatibility, EMC/Electrical Safety, Bench Testing) and did not involve human patient data test sets. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the context of these specific non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The non-clinical tests described are objective, laboratory-based evaluations against recognized standards (e.g., ISO, IEC). There is no mention of "experts" being used to establish a subjective "ground truth" for these performance tests, nor are there any clinical studies involving expert interpretation of device output.
4. Adjudication Method for the Test Set
This question is not applicable. The non-clinical tests are objective and do not involve adjudication by experts.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement in the provided document. The device is a physical instrument for tissue sampling, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical instrument and does not involve an algorithm working in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance tests is represented by established international and national standards (e.g., ISO 10993, IEC 60601, ISO 80369, ISO 11070) for medical device safety and performance. Device performance was evaluated against the requirements outlined in these standards.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical instrument, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
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(56 days)
Praxis Medical, LLC
The CytoCore is a device to hold a syringe for performing a biopsy of an identified mass with one hand.
The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor oscillates the needle to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.
The Praxis Medical CytoCore is a biopsy instrument intended to hold a syringe for performing a biopsy of an identified mass with one hand. Below is a summary of its acceptance criteria and the study conducted to demonstrate that the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life & Durability | 1-year shelf-life (accelerated aging). Pre and post-aging performance maintained. | Samples subjected to accelerated aging equivalent to 12 months. Performance maintained. |
| Drop Testing | Withstand 6 drops from 1m height onto a hard surface without damage affecting function. | Samples removed from shipping box, dropped twice from each of three orientations (total 6 drops) from 1m onto a 50mm ± 5mm thick hardwood board (hardwood > 600 kg/m3) on a concrete/rigid base. All samples passed. |
| Biocompatibility | No patient contact; therefore, ISO 10993 testing not required. | The subject device has no patient contact. (The user supplies the needle, which contacts the patient). |
| Cellular Harvest Ability (Equivalence) | Ability to harvest or collect cellular materials equivalent to or better than the predicate device. | Comparative cellular harvesting study showed the subject device (CytoCore) averaged 2.59, compared to the predicate's 1.85. The discussion states, "The results demonstrate that the subject device was able to harvest or collect an equivalent to more cellular materials than the predicate. We are making no claim of better performance only equivalence." |
| Electrical Safety & EMC | Compliance with applicable electrical safety and EMC standards. | The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-2-22 Edition 3.1 2012-10 standards for safety and IEC 60601-1-2: 2014 for EMC. |
| Needle Compatibility | Compatible with 22-25 gauge needles. | Performance testing included a 22-25-gauge needle with both the subject and predicate devices. (Implied successful compatibility during testing.) |
2. Sample size used for the test set and the data provenance:
- Cellular Harvest Ability (Comparative Performance Testing): Fifteen licensed physicians utilized the subject device and the predicate. The number of samples (e.g., biopsy procedures, tissue samples) each physician performed is not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given the nature of a comparative performance study with physicians actively using the device, it is most likely a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the cellular harvest ability study, fifteen licensed physicians were used.
- Their specific qualifications beyond "licensed physicians" (e.g., years of experience, specialization) are not detailed in the provided document.
4. Adjudication method for the test set:
- The document states that comparative cellular harvesting was "evaluated and scored." The specific adjudication method (e.g., 2+1, 3+1, independent review) for scoring the cellular harvest quantity/quality is not described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study described is a comparative cellular harvest ability study between two devices (Praxis Medical CytoCore vs. TAO Aspirator and Plastic Finger), not an AI-assisted diagnostic study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the Praxis Medical CytoCore is a physical medical device (a syringe-holding device with an internal motor for needle oscillation), not an algorithm or AI system.
7. The type of ground truth used:
- For the comparative cellular harvest ability study, the ground truth appears to be established through the "evaluation and scoring" of the harvested cellular material, likely by the licensed physicians themselves or by an independent pathologist/cytologist assessing the quality and quantity of the biopsy samples. The exact nature of this "scoring" is not detailed, but it relates to the biological outcome of the biopsy procedure (i.e., how much and how well cellular material was collected).
8. The sample size for the training set:
- This question is not applicable as the Praxis Medical CytoCore is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as #8.
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