(67 days)
The VeinRx Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
The VeinRx InfusionCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a fixed infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The distal black marker indicates the proximal edge of the infusion length. The proximal black marker is used to properly align the device with the recommended introducer. The InfusionCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.
Here's a breakdown of the requested information based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (InfusionCath Peripheral Infusion Catheter) seeking substantial equivalence to a predicate device. As such, it does not contain the detailed study results, acceptance criteria for performance metrics, or information about AI/ML models typically found in submissions for novel AI/ML-powered devices. The primary goal of a 510(k) is to demonstrate that a new device is "as safe and effective as" a legally marketed predicate device, often by showing it meets similar performance specifications.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific acceptance criteria and reported device performance metrics in the context of quantitative measures (e.g., accuracy, sensitivity, specificity, F1-score) are NOT available. The document states:
- "The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter. All components, subassemblies, and/or full devices met the required specifications for the completed tests."
This indicates that internal design and performance specifications were met, but the specific numerical values of these "specifications" are not detailed in this summary. The nature of this device (a catheter) suggests performance criteria would likely revolve around mechanical integrity, material compatibility, fluid flow rates, and safety, not diagnostic accuracy.
| Acceptance Criteria Category | Acceptance Criteria (Specifics not provided in the document) | Reported Device Performance (Specifics not provided in the document) |
|---|---|---|
| Functional/Mechanical | All required specifications for components, subassemblies, and/or full devices. | Met all required specifications. (Implies satisfactory performance against internal design specifications) |
| Biocompatibility/Material | Materials suitable for intended use. | Materials used in numerous previously cleared products. (Implies suitability and established safety profile) |
| Safety | N/A (General safety is implied) | N/A (General safety is implied) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "Testing Summary" and that "All components, subassemblies, and/or full devices met the required specifications for the completed tests." It does not provide details on how many units or components were tested.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For this physical medical device, the "data" would be results from engineering, bench, and potentially pre-clinical (animal) or limited human clinical compatibility testing. The country of origin of this testing is not specified, but it would have been conducted by or on behalf of VeinRx, Inc., a US-based company. The statement "The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter" suggests a comparison to an existing product's performance profile rather than new, large-scale clinical trials.
- Retrospective or Prospective: Not applicable in the context of clinical data for AI/ML. The testing would have been conducted for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is a physical catheter, not a diagnostic device relying on expert interpretation of data to establish ground truth for a test set. Its performance is assessed through engineering testing, material characterization, and potentially pre-clinical studies, not clinical expert consensus for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. As above, this is not relevant for a physical medical device like a catheter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is a physical medical device (catheter) and does not incorporate AI. Therefore, an MRMC study and analysis of AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical medical device (catheter) and does not incorporate an AI algorithm. Therefore, standalone algorithm performance is not relevant or applicable.
7. The Type of Ground Truth Used
- Not applicable in the AI/ML sense. The "ground truth" for this device would be established by engineering specifications, material standards (e.g., ISO, ASTM, USP), and established biological compatibility requirements. For example, a "ground truth" for a material test would be whether a material passes a specific cytotoxicity test or particulate matter release limit.
8. The Sample Size for the Training Set
- Not applicable. This device does not use AI/ML, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set (no AI/ML), this question is not relevant.
In summary, the provided document is a 510(k) Pre-Market Notification for a conventional medical device (a catheter). It focuses on demonstrating substantial equivalence to a predicate device through manufacturing similarities and meeting established design specifications. It does not involve AI/ML technology, and therefore, many of the questions asked, which are relevant to AI/ML device submissions, are not applicable to this document.
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K 052738
VeinRx, Inc.
2005 DEC. 6
510(k) Summary
| General InformationClassification | Class II |
|---|---|
| Trade Name | InfusionCath™ Peripheral Infusion Catheter |
| Submitter | VeinRx Inc8200 N.W. 27th StreetSuite 102Miami, FL 33122305-716-7005 |
| Contact | Gregory J. MathisonVice President - Regulatory Affairs |
Intended Use
The VeinRx Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Predicate Devices
InfusionCath Peripheral Infusion Catheter Manufactured by VeinRx, Inc.
Device Description
The VeinRx InfusionCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a fixed infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The distal black marker indicates the proximal edge of the infusion length. The proximal black marker is used to properly align the device with the recommended introducer. The InfusionCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.
Materials
All materials used in the manufacture of the InfusionCath Peripheral Infusion Catheter are suitable for this use and have been used in numerous previously cleared products.
Testing Summary
The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter. All components, subassemblies, and/or full devices met the required specifications for the completed tests.
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Summary of Substantial Equivalence
The modified InfusionCath Peripheral Infusion Catheter is equivalent to the predicate product, the original InfusionCath Peripheral Infusion Catheter. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. VeinRx, Inc. believes the modified InfusionCath Peripheral Infusion Catheter is substantially equivalent to existing legally marketed devices
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains an image of an eagle with three lines representing its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is written around the top of the circle. The text is written in a bold, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC 6
Mr. Gregory Mathison Vice President Vein RX, Inc. 8299 NW 27 St. Suite 102 Miami, FL, 33122
Re: K052738
Trade Name: Infusion Catl(TM Regulation Number: 21 CI R 870.3470 Regulation Name: Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: November 08, 2005 Received: November 11, 2005
Dear Mr. Mathison:
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, 1971, 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 provisions of the Pederal Food, Drug,
You may, therefore, market the desire approval of a premarket approval applicat You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing prictice, labeling, and prohibitions against misting 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 cool and class in opecial Confort of Class II (PMA), and (PMA), and Claim
be found in the Code of Foderal Revel, time Title of M. Bleving yo be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FiDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Gregory Mathison
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA S ISSuance of a succession of the requirements of the Act
that FDA has made a determination that your device and accracies. You must that FDA has made a decemination administered by other Federal agencies. You must a or any Federal statures and regulations administered of registration and listing (2)
comply with all the Act's requirements, including, but not limited to: est comply with an the Act 31equirements, moraans, were and and the requirements as set CrK Part 807), labeling (21 CFR Part 820), and if applicable, the electronic form in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections our device as described in your Section 510(k) I his letter will anow you to ocgin mankeang your and equivalence of your device to a legally premarket nother in the PDA miding of backers on the sice 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 If you desire specific advice for your acon (240) 276-0120. Also, please note the regulation entitled, colliact the Office of Comphanes an (21CFR Part 807.97). You may obtain Milsolanding by televelee to premainters in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet and Coliss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dura R. Vochner
A 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
InfusionCath Peripheral Infusion Catheter
K052738 510(k) Number (if known):
Device Name:
Indications For Use:
The InfusionCath Peripheral Infusion Catheter is intended for
The infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ouma R. Vochmer
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K0652738
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).