(48 days)
For use in invasive physiological pressure measurements which require continuous regulated flow to maintain catheter patency.
Invasive physiological pressure monitoring requires a number of components that include an IV administration set, a pressure transducer, a monitoring line and a catheter. Because of the potential for clot formation over the course of physiologic monitoring, a continuous flush device can be included in these systems for slow flush of the monitoring line. This minimizes the possibility that blood clots will form within the catheter and at the catheter tip. The Argon Continuous Flush Device is a slow flush device that is intended to be used with the components identified above for slow and continuous flushing of indwelling lines to minimize the formation of clots that would interfere with monitoring integrity.
The Argon Continuous Flush Device is manufactured in two distinct configurations, a 3 ml/hr flow rate device and a 30 ml/hour flow rate device. The design difference which results in continuous flow rates of 3 ml/hr and 30 ml/hr for each of the two models of devices is achieved by the diameter of a laser-drilled flow control orifice in each unit. The orifice diameter is predefined for each version to correlate to the desired output flow rate. The two devices are distinguished from one another by the color of the flush device cap. The 3 ml/hr continuous flush device has a clear cap and the 30 ml/hr continuous flush device has a yellow cap.
Both devices are connected to an IV administration system including a pressurized bag of saline that typically is heparinized. Applied pressure from the bag (300 mmHg) initiates the flow through the IV administration set and the flush device. The slow flow prevents over-infusion, and minimizes clot formation. The "fast flush" feature of the device assists in priming and removing bubbles from the lines or catheters and supplying a fast flow of intravenous fluid to the patient to assess the integrity of the entire monitoring system. This feature is actuated by squeezing the tabs on either side of the device or by pulling up the pull tab on the top of the device.
The provided document, K070384, is a 510(k) summary for the Argon Continuous Flush Device. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not include a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or a performance validation study for a new algorithm would.
Instead, the document states: "Non-clinical performance data demonstrates that the Argon Continuous Flush Device performed in an equivalent manner to the predicate and is suitable for its intended use." This indicates that bench testing was performed to show equivalence to the predicate device, but the specifics of what was measured, what the acceptance criteria were, and the results against those criteria are not delineated in this summary.
Therefore, many of the requested fields cannot be filled directly from this document. I will fill in what can be inferred and explicitly state when information is not available.
Acceptance Criteria and Device Performance Study Analysis: Argon Continuous Flush Device (K070384)
The provided 510(k) summary for the Argon Continuous Flush Device describes bench testing to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving a device meets specific, quantitative acceptance criteria for an AI/algorithm. Thus, much of the requested information regarding complex studies, expert ground truth, and sample sizes for AI/algorithmic performance isn't present.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the 510(k) summary, the primary performance criteria revolve around the specified flow rates. The acceptance criteria would likely be a range around these nominal values, and the reported performance would be that the device achieved these rates.
| Acceptance Criteria (Inferred from device description) | Reported Device Performance (Inferred from 510(k) Summary) |
|---|---|
| Nominal continuous flush flow rate of 3 ml/hr | Device performs as specified (3 ml/hr nominal flow) |
| Nominal continuous flush flow rate of 30 ml/hr | Device performs as specified (30 ml/hr nominal flow) |
| Functionality of "fast flush" feature | Fast flush feature operates as intended |
| Compatibility with IV administration systems | Compatible with standard IV administration systems |
| Equivalence to predicate devices (Edwards Uniflow Flush Device, American Pharmaseal Blood Pressure Transducer) in material and design characteristics | Demonstrated equivalence to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The document states: "Non-clinical performance data demonstrates that the Argon Continuous Flush Device performed in an equivalent manner to the predicate and is suitable for its intended use." This indicates bench testing was performed to establish that the Argon device's flow rates and functional characteristics (e.g., fast flush) are comparable to the predicate devices. The exact details of this "non-clinical performance data" are not provided in this 510(k) summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. As this is a physical medical device (a flush device, not an AI algorithm), the "test set" would refer to the number of individual devices tested during the non-clinical performance evaluation.
- Data Provenance: The testing would have been conducted by Argon Medical Devices, likely in the USA. The data would be prospective, gathered specifically for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device where performance is measured objectively (e.g., fluid flow rate). There is no "ground truth" requiring expert human interpretation or consensus in the context of an AI/ML study. Performance is validated through engineering and laboratory measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 a physical medical device (continuous flush device), not an AI or imaging diagnostic algorithm. Therefore, no MRMC study involving human readers or AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. No algorithm is involved in its direct function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For this physical device, "ground truth" would be established by direct, objective physical measurements (e.g., volumetric flow rate measurements under specified pressure conditions) and comparison to the predicate device's established performance specifications.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical medical device.
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2007
1445 Flat Creek Rd . Athens, Texas 75751USA Tel: 903-675-9321 · Fax: 903-677-9397
510(k) Summary
| Owner: | Argon Medical Devices |
|---|---|
| Address: | 1445 Flat Creek RoadAthens, TX 75751 |
| Contact Person: | Amy Windham |
| Phone/Fax/Email: | 903-677-9352/903-676-4227/amy.windham@argonmedical.com |
Date of Summary: February 8, 2007
Device Information
| Trade Name | Argon Continuous Flush Device |
|---|---|
| Common Name | Continuous Flush Device |
| Classification Name/Product Code | Catheter, Continuous Flush / 870.1210/KRA |
Predicate Device
Edwards Uniflow Flush Device and American Pharmaseal Blood Pressure Transducer including a continuous flush device are the predicate devices for the Argon Continuous Flush Device. The 510(k) for the original Edwards Uniflow Flush Device is K792141. filed by the Edwards Critical Care Division of Baxter Healthcare. K832907 was filed by American Pharmaseal, also a Baxter Edwards company, for a blood pressure transducer that included a continuous flush device. The flush device included as an integral part of the American Pharmaseal transducer is also sold individually by Edwards Lifesciences. This device was used for the bench testing.
Description of the Device
Invasive physiological pressure monitoring requires a number of components that include an IV administration set, a pressure transducer, a monitoring line and a catheter. Because of the potential for clot formation over the course of physiologic monitoring, a continuous flush device can be included in these systems for slow flush of the monitoring line. This minimizes the possibility that blood clots will form within the catheter and at the catheter tip. The Argon Continuous Flush Device is a slow flush device that is intended to be used with the components identified above for slow and continuous flushing of indwelling lines to minimize the formation of clots that would interfere with monitoring integrity.
The Argon Continuous Flush Device is manufactured in two distinct configurations, a 3 ml/hr flow rate device and a 30 ml/hour flow rate device. The design difference which results in continuous flow rates of 3 ml/hr and 30 ml/hr for each of the two models of devices is achieved by the diameter of a laser-drilled flow control orifice in each unit.
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The orifice diameter is predefined for each version to correlate to the desired output flow rate. The two devices are distinguished from one another by the color of the flush device cap. The 3 ml/hr continuous flush device has a clear cap and the 30 ml/hr continuous flush device has a yellow cap.
Both devices are connected to an IV administration system including a pressurized bag of saline that typically is heparinized. Applied pressure from the bag (300 mmHg) initiates the flow through the IV administration set and the flush device. The slow flow prevents over-infusion, and minimizes clot formation. The "fast flush" feature of the device assists in priming and removing bubbles from the lines or catheters and supplying a fast flow of intravenous fluid to the patient to assess the integrity of the entire monitoring system. This feature is actuated by squeezing the tabs on either side of the device or by pulling up the pull tab on the top of the device.
Intended Use of the Device
Argon's Continuous Flush Device is intended for use in invasive physiological pressure measurements which require continuous regulated flow to maintain catheter patency.
Technological Characteristics Compared to Predicate Device
Both the Argon Continuous Flush Device and Edwards Uniflow Flush Device are manufactured using industry standard plastics and silicone. Specific material information for the Argon Continuous Flow Device is detailed in another section of the 510(k). Design characteristics of each device are very similar. Both Argon's and Edwards' device includes a squeeze actuator and a pull tab for fast flush. Configurations vary with female/male or glue sites to connect to a transducer or monitoring line. Each device has a specified orifice diameter that allows either a nominal 3 ml/hr or a nominal 30 ml/hr fluid flow.
Performance Summary
Non-clinical performance data demonstrates that the Argon Continuous Flush Device performed in an equivalent manner to the predicate and is suitable for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2007
Argon Medical Devices Inc. c/o Ms. Amy Windham Quality Manager 1445 Flat Creek Road Athens, TX 75751
Re: K070384
Argon Continuous Flush Device Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: II (two) Product Code: KRA Dated: February 8, 2007 Received: February 9, 2007
Dear Ms. Windham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Amy Windham
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blummenthal
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _______________
Device Name: _Continuous Flush Device
Indications for Use:
For use in invasive physiological pressure measurements which require continuous regulated flow to maintain catheter patency.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.B. Bummer
Division of Cardiovascular Devices 510(k) Number
Page 1 of 1
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).