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510(k) Data Aggregation
(443 days)
NEW REGULATION NUMBER: 21 CFR 868.5095
CLASSIFICATION: Class II
PRODUCT CODE: QCX
BACKGROUND
follows:
Product Code: QCX Device Type: Retrograde intubation device Class: II Regulation Number: 21 CFR 868.5095
The Retrograde Intubation Set is intended to assist in intubation during difficult or emergency airway access procedures in adult and pediatric patients.
The 6 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 2.5 mm or larger.
The 11 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 4 mm or larger.
The 14 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 5 mm or larger.
When used for high pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 12 years of age.
The basic components included in the subject device, the Retrograde Intubation Set, are an introducer needle, catheter needle, syringe, hemostat, wire guide with wire guide inserter, intubation catheter, and Rapi-Fit® adapter. While the wire guide, intubation catheter, and Rapi-Fit® adapters are the subject of this De Novo request, this device is intended to be used with legally marketed needles, syringes, and hemostats.
The needle and syringe are used to puncture the patient cricothyroid membrane and confirm needle placement in the patient airway. Then, a wire guide is inserted via the needle into a patient's trachea and exits via mouth or nose (i.e., retrograde). An intubating catheter is inserted orally or nasally over the wire guide into the trachea prior to intubation.
This device offers optional Rapi-Fit adapters (attached to the intubating catheter) to facilitate supplemental oxygen delivery in adults prior to intubation with an endotracheal tube (ETT).
Here's a breakdown of the acceptance criteria and the study information for the Retrograde Intubation Set, as extracted from the provided text:
Retrograde Intubation Set: Acceptance Criteria & Study Information
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a medical device for emergency intubation assistance, the "performance" is largely assessed through successful bench testing demonstrating functionality and adherence to safety standards. Unlike diagnostic AI models, there isn't a direct "accuracy" or "sensitivity/specificity" metric reported for the overall device. Instead, the acceptance criteria relate to specific physical properties and functionalities.
| Acceptance Criteria (Special Controls) | Reported Device Performance/Evidence |
|---|---|
| A. Wire guide tensile, flex, fracture, and corrosion testing | Corrosion Test: Visual signs of corrosion observed after 3 years, but Tensile Testing (post-corrosion): peak load preceding failure ≥ 10 N for each test article (acceptable performance despite corrosion). |
| Fracture Testing: Tested for 3 complete turns (deviation from ISO 11070's 8 turns, justified by typical clinical use not exceeding a 90° bend). | |
| Tensile & Flex Testing: Methods and results acceptable (ISO 11070). | |
| B. Catheter tensile strength testing at likely points of failure | 6 & 11 Fr Catheters: Demonstrated tensile strength greater than the 15 N acceptance criterion. |
| 14 Fr Catheter: Met tensile strength acceptance criterion at catheter and sideport. | |
| Rapi-Fit Adapter Separation Force: Demonstrated separation forces greater than 15 N (mitigates risk of disconnection). | |
| (Acceptance criterion based on EN/ISO 10555-1:2013 and prior testing of intubation catheters, with 15 N being larger than likely clinical force). | |
| C. Catheter kink radius testing | 6 & 11 Fr Catheters: Acceptance criteria based on airway anatomy (48.17 mm for adults, 19 mm for pediatrics) deemed clinically appropriate. Less emphasis on patency when kinked as these are not for oxygenation. |
| 14 Fr Catheter (for oxygenation): Conducted according to Annex H of AAMI/ISO 5361:2012. All samples met stated minimally acceptable kink radius criteria. | |
| D. Compatibility of device components that interact, including compatibility in connection, disconnection, and ability to transfer fluids | Rapi-Fit Adapter Testing (Connectivity): Luer Lock connector tested per ISO 594-2. 15 mm connector tested per ISO 5356-1:2015. Methods and results acceptable. |
| Validation Testing on Retrograde Intubation (Manikin Study): Catheters supported intubation of child and adolescent models with ETTs from 2.5 mm to 6.5 mm. | |
| E. Dimensional validation | Not explicitly detailed as a separate test, but implied by adherence to specifications (e.g., wire guide diameter/length, catheter diameter/length). |
| F. Accuracy testing of markings | 14 Fr Catheter Marking Accuracy: Labeled markings (every 5 ± 0.5 cm) and non-labeled increments (1 ± 0.2 cm) were measured. Max/min distance between labeled marks was 5.1 and 5.0 cm (within specifications). Non-labeled marks were 1.0 cm for all samples. Results acceptable. |
| G. Validation of the maximum airway pressure | High Pressure Oxygenation Testing: Tested using the Luer Lock connector (worst-case scenario). In the child model (> 2 years to 12 years), some test articles of the 14 Fr intubation introducer showed average maximum airway pressure > 28 cm H2O. Limitation: Oxygenation feature on 14 Fr intubation catheter with Luer Lock Rapi-Fit adapter not permissible in patients ≤ 12 years old due to high barotrauma risk. Remaining results acceptable for other populations. |
| Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. | Shelf-Life Claim: (b)(4) years supported by 5-year accelerated aging (ASTM F1980) of finished device packages. |
| Tests conducted: Visual inspection, seal strength (ASTM F88-09), dye penetration (ASTM F1929-12). Results acceptable. | |
| Sterilization Validation: Ethylene Oxide (EO) sterilization via overkill approach at SAL of 10^-6 (ISO 11135-1:2007). Worst-case sample (stylet within intubating catheter) used. Sterilant residuals acceptable (ISO10993-7). | |
| The device must be demonstrated to be biocompatible. | Biocompatibility Evaluation: Performed a biological risk assessment in accordance with FDA guidance (ISO 10993-1). Evaluated per ISO 10993 (subparts) for limited duration contact (≤ 24 hours) for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogen testing on patient-contacting components (catheters, wire guide, Rapi-Fit adapters). Methods for extractions acceptable. Mitigates biocompatibility concerns. |
| Labeling must include: A. Instructions for use; and B. Package labels that clearly identify the minimum compatible size of endotracheal tube. | Device labeling instructs users on proper procedures and specifies minimum compatible ETT sizes on the package label. This is a labeling requirement that the sponsor would need to demonstrate they meet by providing the actual labeling. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Bench/Performance Studies): Specific sample sizes for each bench test (tensile, kink, marking accuracy, etc.) are not always explicitly stated as a single number. For example, "all samples tested" for marking accuracy, or "each test article" for wire guide testing. The studies were prospective bench tests performed in a laboratory setting by the manufacturer (Cook Incorporated). Country of origin is not explicitly stated for individual tests but the company is based in Bloomington, Indiana, USA.
- Clinical Evidence (Literature Review): The primary "clinical evidence" is a retrospective literature review, primarily relying on a publication by Sanchez in 1993 ("The retrograde cookbook"). This publication summarized 539 patient cases up to 1993, describing techniques, indications, contraindications, complications, and failures. The provenance is global (published literature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Bench/Performance Studies: No "clinical experts" were used to establish ground truth for the bench tests. Ground truth was based on engineering specifications, recognized international standards (ISO, ASTM, EN), and clinical understanding of airway anatomy/forces.
- Clinical Evidence (Literature Review): The "ground truth" for clinical effectiveness and safety was established by published medical literature and case reports summarized by Sanchez (1993) and subsequent reviews. The "experts" in this context are the clinicians who performed the procedures and published their findings, compiled and analyzed by Sanchez. No specific number of experts or their qualifications for establishing ground truth are provided within this document, beyond the general acceptance of the medical literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Bench/Performance Studies: No adjudication method like 2+1 or 3+1 described. Performance was assessed against pre-defined engineering and safety criteria from recognized standards.
- Clinical Evidence (Literature Review): No formal adjudication method described for the literature review. It was a summary and analysis of existing published data.
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 physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study with AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device. The "performance" is inherently based on human operators using the device according to standard techniques. There is no standalone algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench/Performance Studies: Ground truth was based on engineering specifications, recognized international standards (ISO, ASTM, EN), and the successful functional demonstration in manikin models against the intended use.
- Clinical Evidence (Literature Review): Ground truth was based on patient outcomes data and clinical experience reported in published medical literature (case reports and case series).
8. The sample size for the training set
Not applicable. This is a physical medical device undergoing engineering and clinical literature review for approval, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for a machine learning model.
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