(240 days)
- 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.
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® 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.
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 provided text describes two devices, the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory and the Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit (CDU), highlighting their substantial equivalence to existing predicate devices and stating that testing was performed to demonstrate their safety and effectiveness. However, it does not contain specific acceptance criteria, detailed performance results, or a study that rigorously proves the device meets those criteria in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, AUC).
The document is a 510(k) summary for a medical device that is a physical product (an autotransfusion accessory). Therefore, many of the questions related to AI/ML device testing methodologies (like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," etc.) are not applicable in this context.
Based on the available information, here's an attempt to answer the relevant questions as best as possible within the scope of the provided text:
Acceptance Criteria and Study for the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory and All Purpose Autotransfusion Chest Drainage Unit
This submission is for a medical device (autotransfusion system), not an AI/ML device. Therefore, the acceptance criteria and study detailed differ significantly from those typically used for software-based diagnostic tools. The document indicates that testing was performed to ensure compliance with relevant standards and demonstrate safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format. Instead, it broadly states that testing was conducted to ensure compliance with established standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory: | |
| Compliance with Applicable Blood Handling Requirements | 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 | Biocompatibility testing in accordance with ISO 10993 requirements has been done. |
| Performance under Simulated Conditions of Use | Performance testing under simulated conditions of use has been done. |
| Overall Conclusion (for Accessory): | Results of all testing demonstrate the safety and effectiveness of the Argyle Aqua-Seal® Evacuating Autotransfusion Accessory for its intended use. |
| Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit: | |
| Compliance with Applicable Blood Handling Requirements (with new features) | 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 (with new features) | Biocompatibility testing in accordance with ISO 10993 requirements has been done. |
| Performance under Simulated Conditions of Use (with new features) | Performance testing under simulated conditions of use has been done. |
| Overall Conclusion (for CDU): | Results of all testing demonstrate the safety and effectiveness of the Argyle Aqua-Seal® All Purpose Autotransfusion CDU for its intended use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing appears to be primarily laboratory-based performance testing, biocompatibility testing, and compliance verification against standards, rather than a clinical study with a "test set" of patient data.
- Data Provenance: Not applicable in the context of device performance testing against engineering standards. The testing would have been conducted internally by Sherwood - Davis & Geck or a qualified third-party lab under simulated conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of this device involves physical performance metrics (e.g., blood handling, vacuum generation, flow rates, sterility, biocompatibility) measured against engineering and medical device standards, rather than expert interpretation of medical data.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described as this is not a study involving human interpretation of data where consensus or tie-breaking would be needed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data, which is not the primary function of this physical autotransfusion device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm. Its "standalone performance" refers to its mechanical and functional operation as per its design specifications and relevant standards.
7. The type of ground truth used:
- The "ground truth" for this device would be objective measurements and verified compliance with:
- American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices
- ISO 10993 requirements for biocompatibility
- Pre-defined performance specifications under simulated conditions of use.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable (as above).
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ATTACHMENT # 1. 510 (k) Summary of Safety and Efficacy -Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory
NOV - 5 1997
{1}------------------------------------------------
| 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:
-
- 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:
-
- 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}------------------------------------------------
-
- 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:
-
- 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.
-
- 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.
{3}------------------------------------------------
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
{5}------------------------------------------------
868 - 5830 - CAC IF ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
K 970857 -510(k) Number (if known):
S 001 Device Name:
Indications For Use:
-
- 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
-
- 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)
§ 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).