(93 days)
The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.
The Argyle® ASPR-Care™ Closed Suction System consists of three discreet components: a dual swivel T-piece, a sheathed suction catheter, and a suction control valve. When connected together, these components form a closed system suction catheter similar in form and function to the closed system catheters available from Ballard and Concord/Portex.
This document is a 510(k) summary for the Argyle® ASPR-Care™ Closed Suction System, not a study evaluating acceptance criteria against reported device performance as might be found for AI/ML-driven medical devices. Therefore, much of the requested information (e.g., sample sizes, expert qualifications, MRMC studies, training set details) is not applicable or cannot be extracted directly from this type of regulatory submission.
However, I can extract the general acceptance criteria in terms of "substantial equivalence" and the types of tests performed.
1. Table of Acceptance Criteria and Reported Aevice Performance
| Acceptance Criteria (based on 'substantial equivalence' to predicate devices and recognized standards) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Primary Closed Suction System: | |
| - Allow aspiration of patient secretions without loss of mechanical ventilation (PEEP, FiO2) | The Argyle® ASPR-Care™ Closed Suction System is "similar in form and function" to predicate devices (Ballard Trach Care™ and Concord/Portex Steri-Cath™). It "allows for the aspiration of patient secretions without the loss of mechanical ventilation." Clinical objectives are to "reduce the loss of Positive End-Expiratory Pressure (PEEP) and Fraction of Inspired Oxygen (FIO2) while suctioning patient airways" and "reduce the possibility of hypoxia and cardiac irregularities during suctioning." |
| - Enclosed in a clear plastic sleeve to protect clinician from patient secretions | "Each system is enclosed in a clear plastic sleeve to protect the clinician from patient secretions." Clinical objective is "to protect the clinician from patient secretions." |
| - Adapter (connector) to eliminate strain between mechanical ventilator circuit and ET/tracheostomy tube | "Each system comes with an adapter (connector) to eliminate strain between the mechanical ventilator circuit and the endotracheal tube or tracheostomy tube." |
| - Suction control valve for vacuum application | "Each system comes with a suction control valve that allows for the application of vacuum (suction) as necessary to remove secretions from the patient's airway." |
| - Allows introduction of irrigation to clean catheter and lavage patient | "Each system allows for the introduction of irrigation to clean the catheter and lavage the patient." |
| - Catheter contains depth marks | "Each catheter contains depth marks which allows the clinician to determine the depth the catheter has been inserted into the patient's trachea." |
| - Biocompatibility (ISO 10993 Part 1 for surface device, prolonged contact with mucosal membrane) | The device "has passed the following battery of tests; cytotoxicity, sensitization, irritation, systemic toxicity and implantation." |
| - Safe and effective conduit for ventilator gases and efficient tracheal/oral suctioning | "Sherwood Medical has conducted a battery of tests comparing the performance of the Argyle® ASPR-Care™ Closed Suction System and ancillary components with those devices to which we are claiming substantial equivalence. This testing was conducted to ensure Sherwood's device provides a safe and effective conduit for ventilator qases and allows efficient tracheal and oral suctioning capabilities." (Specific results not detailed in summary). A Failure Modes Affect Analysis (FMEA) was conducted to identify preventive and corrective actions for safety during design and manufacturing. |
| Bronchoscope Adapter: | |
| - Allow introduction of bronchoscope into artificial airway without loss of ventilation, facilitating bronchoscopy without disconnecting patient | Substantially equivalent to Portex Fiberoptic Swivel Adapter. "They both allow for the introduction of a bronchoscope to be inserted into the artificial airway without the loss of ventilation to the patient. Which in turn allows the clinician to perform a bronchoscopy without having to disconnect the patient from the ventilator circuit." |
| - Biocompatibility (indirect patient contact) | "Has only undergone and passed cytotoxicity testing." |
| Sputum Trap: | |
| - Collect sputum sample during routine suctioning without disconnecting patient | "Allows for the collection of a sputum sample during the routine suctioning of a patient without having to disconnect the patient from the ventilator incircuit." |
| - Contain a manifold for in-line placement in suction circuit | Substantially equivalent to Argyle® Lukens Specimen Container. "They both contain a manifold that allows the trap to be placed in-line in the suction circuit." |
| - Contain a cap to seal vial after sample collection | "They both contain a cap to seal the vial after a sputum sample has been collected and the manifold has been removed." |
| - Biocompatibility (non-patient contact) | "Has only undergone and passed cytotoxicity testing." |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of AI/ML performance evaluation. The "testing" referred to is for device performance characteristics and biocompatibility.
- For performance, "Sherwood Medical has conducted a battery of tests comparing the performance of the Argyle® ASPR-Care™ Closed Suction System and ancillary components with those devices to which we are claiming substantial equivalence." No sample sizes or data provenance (country, retrospective/prospective) are mentioned for these tests in this summary.
- For biocompatibility, the tests were conducted according to ISO 10993 Part 1. Specific sample sizes for these biological tests (e.g., number of animals for systemic toxicity, number of cell cultures for cytotoxicity) are not provided in this summary, nor is the provenance of the samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Ground truth is typically based on laboratory assay results (e.g., cell viability for cytotoxicity, skin reaction for irritation, systemic effects in animal models).
- For performance: Ground truth would be based on engineering specifications, physical measurements (e.g., airflow, pressure integrity, suction flow rates), and functional testing against design requirements and comparison to predicate devices. The summary indicates that testing was "conducted to ensure Sherwood's device provides a safe and effective conduit for ventilator qases and allows efficient tracheal and oral suctioning capabilities," implying functional validation.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable.
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510 (k) Summary of Safety & Efficacy -Arqyle® ASPR-Care™ Closed Suction System
Sherwood Medical Co., 1915 Olive St., Submitted by: St. Louis, MO 63103, (314) 241-5700 Dennis Pozzo, Regulatory Affairs Manager Contact : Date Prepared: November 7, 1995
The Argyle® ASPR-Care™ Closed Suction System is classified as a The Right Thial Suction Catheter, Class I device per 21 CFR Section 868.6810 and is a Class I device, Procode: 73BSY.
The Argyle® ASPR-Care™ Closed Suction System consists of three discreet components: a dual swivel T-piece, a sheathed suction catheter, and a suction control valve. When connected together, these components form a closed system suction catheter similar in form and function to the closed system catheters available from Ballard and Concord/Portex.
The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.
The objectives of closed suction systems are:
- to reduce the loss of Positive End-Expiratory Pressure 1) (PEEP) and Fraction of Inspired Oxygen (FIO2) while suctioning patient airways,
- to reduce the possibility of hypoxia and cardiac 2) irreqularities during suctioning, and
- to protect the clinician from patient secretions. 3)
The Arqyle® ASPR-Care™ Closed Suction System utilizes Sherwood Medical's previously marketed DeLee Tip® Suction Catheter enclosed by a sheath. The major difference between the two devices is the ASPR-Care™ is a closed system suction catheter, whereas the DeLee Tip is an open system.
The Argyle® ASPR-Care™ Closed Suction System is substantially equivalent to the Ballard Medical Products Trach Care™ Closed Suction System and the Concord/Portex Steri-Cath™ Closed Suction System in that:
- each system is a closed system suction catheter that allows 1. for the aspiration of patient secretions without the loss of mechanical ventilation to patient's who have artificial airways,
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510(k) Summary - ASPR-Care™ CSS November 7, 1995 page 2
- each system is enclosed in a clear plastic sleeve to protect 2. the clinician from patient secretions,
- each system comes with an adapter (connector) to eliminate 3. strain between the mechanical ventilator circuit and the endotracheal tube or tracheostomy tube,
- each system comes with a suction control valve that allows 4 for the application of vacuum (suction) as necessary to remove secretions from the patient's airway,
- each system allows for the introduction of irrigation to 5. clean the catheter and lavage the patient and
- each catheter contains depth marks which allows the 6. clinician to determine the depth the catheter has been inserted into the patient's trachea.
The Argyle® ASPR-Care™ System is also comprised of two ancillary adapters; a Bronchoscope and Sputum Trap Adapter.
The bronchoscope adapter is a sterile, single use device comprised of an adapter and a fenestration seal with a plugged The fenestration seal comes in two sizes, 0.15" and orifice. 0.183" diameter orifice. The fenestration seal forms an airtight seal between the endoscope and the adapter.
The Arqyle® ASPR-Care™ Bronchoscope Adapter is intended for use as a seal of the normally closed accessory port of the Closed Suction System Swivel Adapter through which a bronchoscope can be Having two separate size fenestration seals allows for inserted. the appropriate bronchoscope to be inserted into the artificial airway without the loss of ventilation to the patient. This adapter allows the clinician to perform a bronchoscopy without having to disconnect the patient from the ventilator circuit.
The Bronchoscope Adapter is substantially equivalent to the currently marketed Portex Fiberoptic Swivel Adapter in that they both allow for the introduction of a bronchoscope to be inserted into the artificial airway without the loss of ventilation to the Which in turn allows the clinician to perform a patient. bronchoscopy without having to disconnect the patient from the ventilator circuit.
The sputum trap is a sterile, single use device comprised of three components: a manifold (sputum trap cap), a collection vial, and a cap (vial cap).
The Argyle® ASPR-Care™ Sputum Trap allows for the collection of a sputum sample during the routine suctioning of a patient
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510(k) Summary - ASPR-Care™ CSS November 7, 1995 page 3
without having to disconnect the patient from the ventilator The manifold allows the sputum trap to be connected incircuit. line between the sheathed catheter and Suction Control Valve. Once the sputum sample has been aspirated into the vial, the trap is removed from the circuit and then the sheathed catheter and Suction Control Valve are re-connected. The manifold is then removed from the vial and the vial is sealed with the cap.
The Sputum Trap is substantially equivalent to the currently marketed Argyle® Lukens Specimen Container (preamendment device) in that: 1) they are both used for the collection of a sputum sample taken through a suction catheter during routine suctioning of a patient, 2) they both contain a manifold that allows the trap to be placed in-line in the suction circuit, and 3) they both contain a cap to seal the vial after a sputum sample has been collected and the manifold has been removed.
Per ISO 10993 Part 1 "Biological Evaluation for Medical Devices" the Argyle ASPR-Care™ CSS is classified as a surface device of prolonged contact with mucosal membrane and as such, has passed the following battery of tests; cytotoxicity, sensitization, irritation, systemic toxicity and implantation. The Bronchoscope Adapter (indirect patient contact) and Sputum Trap (non-patient contact) have only undergone and passed cytotoxicity testing.
Sherwood Medical has conducted a battery of tests comparing the performance of the Argyle® ASPR-Care™ Closed Suction System and ancillary components with those devices to which we are claiming substantial equivalence. This testing was conducted to ensure Sherwood's device provides a safe and effective conduit for ventilator qases and allows efficient tracheal and oral suctioning capabilities.
Sherwood Medical also conducted a Failure Modes Affect Analysis (FMEA) on the Arqyle® ASPR Care™ Suction System. The FMEA was conducted as part of the device's design process to identify preventive and corrective actions to ensure the device design is safe for its intended use. In addition, the FMEA also identified preventive and corrective actions that will require manufacturing controls.
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.