(93 days)
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No
The document describes a purely mechanical device for airway suctioning and makes no mention of AI or ML technologies.
No
The device is used to aspirate secretions from patient airways, which is a supportive rather than therapeutic function.
No
The device is described as "a safe and effective conduit for ventilator gases and allows efficient tracheal and oral suctioning capabilities," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly lists physical components (dual swivel T-piece, sheathed suction catheter, suction control valve) that form a hardware system for aspiration.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for aspirating secretions from patient airways. This is a direct medical intervention on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a mechanical system for suctioning, not a system for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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 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 inserted. Having two separate size fenestration seals allows for 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 Argyle® ASPR-Care™ Sputum Trap allows for the collection of a sputum sample during the routine suctioning of a patient without having to disconnect the patient from the ventilator circuit.
Product codes
73BSY
Device Description
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 Bronchoscope adapter is a sterile, single use device comprised of an adapter and a fenestration seal with a plugged orifice. The fenestration seal comes in two sizes, 0.15" and 0.183" diameter orifice.
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient airways who have endotracheal or tracheostomy tubes
Indicated Patient Age Range
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Intended User / Care Setting
clinician, critical care units
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 gases and allows efficient tracheal and oral suctioning capabilities.
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 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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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.