(188 days)
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.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.