(89 days)
The Device allows for the connection of a manual resuscitation bag without the disconnection of the ventilator circuit/system or the removal of the ASPR-Care™ CSS dual swivel T-piece connector.
The Argyle ASPR-Care Manual Resuscitation Bag Adapter is an accessory to the Argyle Closed Suction System. The adapter provides the trained clinician with an accessory that facilitates the manual ventilation of the patient, without requiring the opening of the ventilator circuit or removal of the closed suction system from a patient 's artificial airway. The accessory is designed for use strictly with the Argyle ASPR-Care Closed Suction System.
The provided text describes a 510(k) submission for the Argyle® ASPR-Care™ Closed Suction System Accessory Manual Resuscitation Bag Adapter. The focus of the submission is to demonstrate substantial equivalence to a previously cleared device (K955831) and certify its functional performance and biocompatibility.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance: Maintain ventilator circuit integrity and allow manual ventilation without disconnection upon adapter insertion (with or without bag attached). | Time to Alarm (without bag): Instantaneous upon installing the adapter without a bag. |
| Time to Alarm (with bag): Alarm went off at the beginning of the next breathing cycle when the adapter was installed with a bag attached. | |
| Biocompatibility: Meet standards as per ISO 10993 and ANSI/AAMI 10993. | Biocompatibility: The component has been tested for Biocompatibility. The materials are the same and were also used and tested in 510k, K955831 for the Argyle ASPR-Care Closed Suction System. |
Study Details
It's important to note that the provided 510(k) summary is generally brief and focuses on demonstrating substantial equivalence rather than a detailed clinical trial. Therefore, some of your requested information, particularly regarding detailed human reader studies or large-scale outcome data, is not present in this type of submission.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size (Functional Test): Not explicitly stated. The text mentions "various ventilators" were tested, but not the specific number of units or test cycles.
- Data Provenance: Not specified. It's presumably conducted by the manufacturer (Sherwood Davis and Geck) in the USA, given the submission location, but this is not explicitly stated. The testing appears to be prospective for the functional evaluation of the accessory itself.
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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):
- Not Applicable / Not Provided. This type of information is typically relevant for diagnostic imaging or clinical decision support AI, where expert consensus is needed to define a "ground truth" for disease detection or classification. For this device (a medical accessory adapter), the "ground truth" for functional performance is based on direct observation of alarm activation and system behavior, not expert interpretation of complex data. The evaluation was done by "trained clinicians" but no specific number or qualifications are given beyond "trained."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods are typically used when there's subjective interpretation or disagreement among experts trying to establish a ground truth. For the functional testing described (alarm activation time), the outcomes are objective and directly observed.
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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 not relevant for this medical device accessory. MRMC studies are used for evaluating diagnostic or decision-making AI systems, often in imaging. This device is a mechanical accessory; it does not involve human readers interpreting data or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes (in principle, for the functional test). The "functional test" described (time to alarm) evaluates the device's inherent mechanical and system-level performance. While a "trained clinician" performs the installation, the core measurement (alarm activation) is a standalone function of the device's interaction with the ventilator. However, this is not an "algorithm" in the AI sense.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Functional Measurement/Observation. For biocompatibility, the ground truth is established by adherence to recognized standards (ISO 10993, ANSI/AAMI 10993) and prior testing of the same materials. For functional performance, the "ground truth" is the objective observation of alarm activation in response to specific actions (insertion without bag, insertion with bag, during the breathing cycle).
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The sample size for the training set:
- Not Applicable / Not Provided. This device does not use an "AI algorithm" that requires a training set in the conventional sense (e.g., for machine learning). The functional performance is based on its mechanical design and interaction with existing systems.
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How the ground truth for the training set was established:
- Not Applicable / Not Provided. As noted above, there is no "training set" for an AI algorithm for this device.
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510k Summary of Safety and Effectiveness
Argyle® ASPR-Care™ Closed Suction System Accessory Manual Resuscitation Bag Adapter:
Submitted by : Sherwood Davis and Geck 444 McDonnell Blvd. Hazelwood, MO 63042
SEP - 3 1997
Stephen J. Tamsett, Contact: Regulatory Affairs Manager
Date of Summary: May 31, 1997
The Argyle ASPR-Care Manual Resuscitation Bag Adapter is an accessory to the Argyle Closed Suction System. The Argyle ASPR-Care Closed Suction System has been determined to be Substantially Equivalent to the Devices marketed in interstate commerce prior to May 28, 1976 under 510k, K955831. The adapter provides the trained clinician with an accessory that facilitates the manual ventilation of the patient, without requiring the opening of the ventilator circuit or removal of the closed suction system from a patient 's artificial airway. The accessory is designed for use strictly with the Argyle ASPR-Care Closed Suction System.
The accessory was tested for the time to alarm with various ventilators. The test was completed after insertion of the Manual Resuscitation Bag Adapter through the Dual Swivel T-Piece accessory port. For all ventilators tested in this manner, the time to alarm was instantaneous upon installing the adapter without a bag. When the adapter was installed with a bag attached the alarm went off at the beginning of the next breathing cycle. This was verification that the accessory worked properly when incorporated into the patient's artificial airway.
Per ISO 10993 and ANSI/AAMI 10993 the component has been tested for Biocompatibility. The materials are the same and were also used and tested in 510k, K955831 for the Argyle ASPR-Care Closed Suction System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP - 3 1997
:
Mr. Stephen J. Tamsett Sherwood Davis & Geck Medical-Company 444 McDonnell Boulevard Hazelwood, Missouri 63042-2516
K972139 Re: Arqyle™ ASPR-Care™ Closed Suction System Regulatory Class: II (two) Product Code: 73 BTM Dated: May 31, 1997 Received: June 6, 1997
Dear Mr. Tamsett:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Stephen J. Tamsetti Warran J
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K972139
Device Name: Sherwood-Davis & Geck. ASPR-Care™ Manual Resuscitation Adapter; -- ------Accessory
Indications for Use: The Device allows for the connection of a manual resuscitation bag without the disconnection of the ventilator circuit/system or the removal of the ASPR-Care™ CSS dual swivel T-piece connector.
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Ciarkowski.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K972139 510(k) Number _
Prescription Use OR (Per 21 CFR 801.109)
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.. -Over-the-Counter Use (optional format 1-2-96)
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).