(240 days)
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No
The device description focuses on mechanical and pressure-based mechanisms for blood collection and transfer, with no mention of AI or ML technologies. The performance studies also focus on standard medical device testing (biocompatibility, performance under simulated conditions) rather than AI/ML validation.
Yes
The device is intended for evacuation, collection, and reinfusion of blood and air, prevention of fluid/air re-accumulation, and facilitation of lung re-expansion, all of which are direct actions to treat a patient's medical condition. Additionally, the device itself is classified as an "Auto-transfusion Device," which falls under therapeutic modalities.
No
Explanation: The device is described as an "Auto-transfusion Device" for the collection and reinfusion of blood and/or air, not for diagnosing conditions. Its intended uses are therapeutic (evacuation, collection, reinfusion, prevention of re-accumulation, facilitation of lung re-expansion), not diagnostic.
No
The device description clearly outlines physical components like a blood bag, air-tight vessel, input line, sealed opening, spike port "Y" connector, vacuum line, suction port, and shut-off valves. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on the collection and reinfusion of blood and/or air from the body (mediastinal and pleural cavity). This is a therapeutic and collection function, not a diagnostic one.
- Device Description: The description details a system for collecting and transferring blood for reinfusion. It describes a mechanical process of creating a pressure differential to draw blood. There is no mention of analyzing the blood or air for diagnostic purposes.
- Classification: The device is classified as an "Auto-transfusion Device", Class II under section 868.5830 of the CFR. This classification is for devices used in the process of autotransfusion, which is a medical procedure, not an in vitro diagnostic test.
- Lack of Diagnostic Elements: There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing. The device's function is purely mechanical for collection and transfer.
In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not perform such analysis.
N/A
Intended Use / Indications for Use
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory is a sterile , single-use accessory to the Argyle Aqua-Seal® All Purpose Autotransfusion CDU and is intended to be used for the purpose of transferring the lost blood recovered by the CDU into a conventional blood bag. The blood can subsequently be re-infused back into the patient using a conventional pressure cuff or by gravity means.
- Evacuation and collection of blood and/or air from the mediastinal and pleural cavity in post-operative and trauma situations.
- Collection and reinfusion of autologous blood from the mediastinal and pleural cavity in post-operative and trauma situations.
- Prevention of fluid and/or air re-accumulation in the mediastinal and pleural cavity.
- Facilitation of complete lung re-expansion and restoration of normal breathing dynamics.
Product codes
CAC
Device Description
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory consists of a conventional blood bag contained in an air-tight vessel. The input line from the bag passes through a sealed opening located at the top of the vessel. This line attaches to the spike port "Y" connector of the infusion tube assembly of the CDU. Transfer of blood from the CDU to the bag commences when a vacuum line is removed from the CDU and attached to the suction port of the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory. The pressure differential across the surface of the bag compels the bag to expand and thereby drawing blood from the CDU into the bag.
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
mediastinal and pleural cavity
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory has undergone testing to ensure that the device meets the applicable blood handling requirements outlined in the American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices. Biocompatibility testing in accordance with ISO 10993 requirements has been done, as has performance testing under simulated conditions of use. Results of all testing demonstrate the safety and effectiveness of the Argyle Aqua-Seal® Evacuating Autotransfusion Accessory for its intended use.
The Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit with the two new features has undergone testing to ensure that the device meets the applicable blood handling requirements outlined in the American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices. Biocompatibility testing in accordance with ISO 10993 requirements has been done, as has performance testing under simulated conditions of use. Results of all testing demonstrate the safety and effectiveness of the Argyle® Aqua-Seal® All Purpose Autotransfusion CDU for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).
0
ATTACHMENT # 1. 510 (k) Summary of Safety and Efficacy -Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory
NOV - 5 1997
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| Submitted by: | Sherwood - Davis & Geck |
|---|---|
| 1915 Olive St. | |
| St. Louis, MO 63103 | |
| (314) 621-7788 | |
| Contact: | Vanada Johnson |
| ﺮﻳﺎﻟﻴﺎﺗﻬﺎ ﻟﻠﻤﺎﻧﻴﺔ ﺍﻟﻤﺘﺎﺯﻳﺔ ﺍﻟﻤﺘﺎﺯﻳﺔ ﺍﻟﻤﺘﺎﺯﻳﺔ ﺍﻟﻤﺘﺎﺯﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | T allava J Villovn |
|---|---|
| Date Prepared: | 4 March, 1997 |
The Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit (CDU) and Argyle Aqua-Seal" Evacuating Autotransfusion Accessory (Evacuating Accessory) is classified as an "Auto-transfusion Device", Class II (performance standards) under section 868.5830 of the Code of Federal Regulations (CFR).
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory is a sterile , single-use accessory to the Argyle Aqua-Seal® All Purpose Autotransfusion CDU and is intended to be used for the purpose of transferring the lost blood recovered by the CDU into a conventional blood bag. The blood can subsequently be re-infused back into the patient using a conventional pressure cuff or by gravity means.
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory consists of a conventional blood bag contained in an air-tight vessel. The input line from the bag passes through a sealed opening located at the top of the vessel. This line attaches to the spike port "Y" connector of the infusion tube assembly of the CDU. Transfer of blood from the CDU to the bag commences when a vacuum line is removed from the CDU and attached to the suction port of the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory. The pressure differential across the surface of the bag compels the bag to expand and thereby drawing blood from the CDU into the bag.
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory is substantially equivalent to the Atrium Self-Sealing ATS bag in that:
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- Each device allows for the batch transfer of a patient's lost post-operative blood from the CDU into an external container bag.
- Each device operates on the principle that fluid will rush to fill a vacuum. The 2. Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory utilizes hospital vacuum while the Atrium Self-Sealing ATS bag creates its own vacuum by means of a spring.
- Each device is designed for single use only. 3.
The differences between the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory and the Atrium Self-Sealing ATS bag are:
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- The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory overates on hospital vacuum while the Atrium Self-Sealing ATS bag utilizes the stored potential energy of a fully compressed metal spring.
2
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- The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory is a conventional PVC blood bag. The Atrium Self-Sealing ATS bag is thick PVC and inflexible because of the pressure plates and spring built within. As such the Atrium Self-Sealing ATS bag will not fit in a conventional pressure cuff.
In addition, the Argyle Aqua-Seal® Evacuating Autotransfusion Accessory has undergone testing to ensure that the device meets the applicable blood handling requirements outlined in the American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices. Biocompatibility testing in accordance with ISO 10993 requirements has been done, as has performance testing under simulated conditions of use. Results of all testing demonstrate the safety and effectiveness of the Argyle Aqua-Seal® Evacuating Autotransfusion Accessory for its intended use.
- The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory is a conventional PVC blood bag. The Atrium Self-Sealing ATS bag is thick PVC and inflexible because of the pressure plates and spring built within. As such the Atrium Self-Sealing ATS bag will not fit in a conventional pressure cuff.
The Argyle Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit is also substantially equivalent to the Argyle Aqua-Seal® Continuous Autotransfusion Chest Drainage Unit and to the Atrium Multipurpose Chest Drainage Unit in design, function and appearance. The only differences between the two are:
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- The Argyle Aqua-Seal® All Purpose Autotransfusion CDU incorporates the automatic negative pressure relief valve with a manual override feature whereas the Argyle Aqua-Seal® Continuous Autotransfusion CDU and the Atrium Multipurpose CDU utilize a strictly manual negative pressure relief valve.
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- While all three CDU's incorporate shut-off valves to prevent the loss of the water seal, the shut-off valves on the Argyle® Aqua-Seal® All Purpose Autotransfusion CDU and the Atrium Multipurpose CDU are flow sensing. Therefore, at low flow rates associated with the autotransfusion process, the valve "shuttles" and remains open to allow for improved blood collection times.
The Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit with the two new features has undergone testing to ensure that the device meets the applicable blood handling requirements outlined in the American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices. Biocompatibility testing in accordance with ISO 10993 requirements has been done, as has performance testing under simulated conditions of use. Results of all testing demonstrate the safety and effectiveness of the Argyle® Aqua-Seal® All Purpose Autotransfusion CDU for its intended use.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1997
Mr. Vanada Johnson Regulatory Affairs Specialist Sherwood Davis & Geck .. _ .. _ _ _ 444 McDonnell Boulevard Hazelwood, Montana 63042-2516
Re: K970857 Argyle® Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit Regulatory Class: II (Two) Product Code: CAC Dated: Auqust 6, 1997 August 7, 1997 Received:
Dear Mr. Johnson:
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 regulatory 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. Vanada Johnson
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 regulation 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 Radioloqical Health
Enclosure
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868 - 5830 - CAC IF ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
K 970857 -510(k) Number (if known):
S 001 Device Name:
Indications For Use:
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- Evacuation and collection of blood and/or air from the mediastinal and pleural cavity in post-operative and trauma situations.
Autouranotession
- Evacuation and collection of blood and/or air from the mediastinal and pleural cavity in post-operative and trauma situations.
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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- Collection and reinfusion of autologous blood from the mediastinal and pleural cavity in post-operative and trauma situations.
-
- Prevention of fluid and/or air re-accumulation in the mediastinal and pleural cavity.
-
- Facilitation of complete lung re-expansion and restoration of normal breathing dynamics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bess A. Campise
ivision Sign-Off ision of Cardiovascular. Respiratory, and Neurological Devices
510(k) Number K970
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)