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510(k) Data Aggregation
(269 days)
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites: ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur
The EZ-IO System previously cleared with K14117 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core change addressed by this submission is the expansion of the "EZ-IO Intraosseous Vascular Access System" indications for use from up to 24 hours to up to 48 hours. Therefore, the primary acceptance criteria revolve around demonstrating the safety and effectiveness of the device for this extended dwell time.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility for Prolonged Contact (up to 48 hours) | Materials of construction evaluated according to ISO 10993-1 for prolonged contact duration (>24 hours to ≤ 30 days) for all relevant components (EZ-IO Needle Set, EZ-Connect extension tubing set, EZ-Stabilizer dressing). Results indicated the materials are biocompatible for this duration. |
| Maintenance of Physical Performance for Extended Use | Performance requirements for physical parameters (tensile strength, torsion strength, bend strength, leak, burst pressure) are not time-dependent and the materials are unchanged. The performance data from the predicate device (K141117) for 24-hour use is considered applicable for 48-hour use without additional testing. |
| Safety of Intraosseous Catheter Retention for 48 Hours | Primary endpoint of the clinical study was the absence of serious complications from IO catheter retention over a 48-hour period. No serious Adverse Events (AEs) or complications were reported for any subjects randomized into the study during a 30-day follow-up. The study concluded that IO access can be maintained for 48 hours without significant risk of serious adverse events. |
| Manageability of Pain during 48-hour Dwell and Infusion | The clinical study demonstrated that pain associated with catheter dwell and infusion can be well-managed. |
| Maintenance of Patency for 48 Hours | The clinical study noted that a slow infusion of 30 mL/hour maintained patency for 48 hours. |
| Identification and Mitigation of Risks for Extended Use | Identified limitations of the study (comparison to actual use, literature limitations) led to restricted Indications for Use (only when alternate IV access is unavailable/unreliable, and only in patients ≥12 years old for the extended duration). "CAUTION" statements were added to the Instructions for Use regarding increased risk for patients with comorbidities, increased risk with longer dwell times, and the importance of frequent monitoring. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): 121 evaluable subjects.
- 79 healthy volunteers
- 39 with diabetes only
- 3 with diabetes and renal insufficiency
- Data Provenance: US single-site, prospective clinical IDE trial.
- Sample Size (Test Set): 121 evaluable subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The study involved clinical trial procedures and observations, including physical examinations and x-rays, but the specific number or qualifications of "experts" establish ground truth in the sense of a diagnostic consensus is not detailed. The "ground truth" here is the clinical outcome (complications, pain, patency) observed in the subjects under the study protocol.
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Adjudication method for the test set:
- Not explicitly stated in detail for all events. However, adverse events were assessed for relatedness to the device, implying a review process. The primary endpoint was the "absence of serious complications," suggesting a clear definition of what constitutes a serious complication and its determination by the study team.
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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 an AI/imaging device. It is a medical device for vascular access.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/algorithm device.
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The type of ground truth used:
- Clinical outcomes data: The ground truth was based on the presence or absence of serious complications, pain reports, patency, and other observed adverse events during the 48-hour indwelling period and subsequent 30-day follow-up of human subjects. This also included objective measures like IO aspirate cultures and x-rays.
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The sample size for the training set:
- N/A. This is a medical device approval, not an AI model requiring a training set. The "development" of the device was based on prior predicate devices and engineering principles, with the clinical study serving as a validation of the extended use.
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How the ground truth for the training set was established:
- N/A. As above, no training set in the AI sense was used.
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(71 days)
Arrow International, Inc. (subsidiary of Teleflex Inc.)
The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.
The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of a handle with an integral needle, a passivelyactivated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter. The catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. The catheter system consists of a catheter body, juncture hub, integrated extension tubing with Luer hub, vent plug to prevent blood leakage during insertion, and a clamp. The catheter is intended for short-term use to permit delivery of infusion therapies. infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance Extended Dwell Peripheral Catheter System is available in single lumen, 18 ga. 20 ga. and 22 ga. configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").
The provided document is a 510(k) summary for the Arrow Endurance™ Extended Dwell Peripheral Catheter System (K163513). It describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but it does not include performance data typically found in clinical studies, nor does it define acceptance criteria in a quantifiable manner for device performance.
Therefore, many of the requested items cannot be answered from the provided text. The document focuses on demonstrating that modifications made to an existing device (guide wire design and catheter release colorant) do not raise new questions of safety or efficacy.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in a quantifiable table format. The document implies acceptance criteria are met if the device performs comparably to the predicate and passes standard tests.
- Reported Device Performance: Not provided in quantifiable metrics. The document states that testing "verified that the changes presented no different questions of safety or efficacy" and that "the results of the risk assessment and resultant testing performed have demonstrated that the proposed guide wire design and catheter release colorant change present no different questions of safety or effectiveness."
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The testing is "Bench testing," meaning it's performed in a laboratory setting, not with human or animal subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving ground truth established by human experts for a diagnostic or interpretative AI device.
4. Adjudication method for the test set:
- Not applicable. This is not a study involving human adjudication of results.
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 document describes a medical device (catheter system), not an AI imaging or diagnostic algorithm. No MRMC study was 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, not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of expert consensus, pathology, or outcomes data, as this is bench testing for a physical device. The "ground truth" for this type of testing is largely based on engineering specifications, material properties, and performance against established industry standards (e.g., ISO 10993-1, ISO 11070).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what can be extracted/inferred from the document:
- Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System
- Purpose of the Submission: To demonstrate substantial equivalence for a modified version of an already marketed device (K152272 & K151513). The modifications are a guide wire design change (shortening flexible distal portion, removal of stainless steel coil/spring) and a catheter release colorant change.
- Nonclinical Testing Performed: Bench testing, including:
- Biocompatibility (in accordance with ISO 10993-1)
- Applicable requirements from ISO 11070 (Surface: Extraneous Matter and Defects, Surface: Lubricant, Guide wire Radio Detectability, Guide wire Fracture, Guide wire Flexure, Guide wire Tensile)
- Guide wire Stiffness
- Simulated Use Testing
- Conclusion of Testing: The testing verified that the changes presented no different questions of safety or efficacy, and the device is considered substantially equivalent to the cited predicate devices.
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(106 days)
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (
The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with a Chlorhexidine-based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.
The catheters will be packaged sterile in kits that will include components to facilitate insertion. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.
The provided text is a 510(k) summary for the "Arrow Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. It does not describe a study to prove a device meets acceptance criteria for an AI/algorithm-based medical device.
Instead, this document details the substantial equivalence of a physical medical device (a catheter) to existing predicate devices based on design characteristics, materials, and non-clinical performance testing. The "Chlorag+ard Technology" mentioned refers to a coating on the catheter that has antimicrobial and antithrombogenic properties, which were evaluated using in vitro and in vivo test methods. This is not an AI or algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input document is for a physical medical device, not an AI/algorithm-based one.
If you can provide a different document that describes an AI/algorithm-based medical device, I would be happy to then attempt to answer the questions you've posed.
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(160 days)
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
The Arrow® Quickflash Arterial Catheterization Device, which is a sterile, single use arterial catheterization device, is designed to permit access to the peripheral arterial circulation or to other small vessels. The Arrow® Quickflash Arterial Catheterization Device is an all-in-one design consisting of a translucent polyurethane, radiopaque single lumen arterial catheter-over-needle device that includes a clear chamber as part of the needle hub which allows visualization of blood flashback. The needle has openings to enhance flashback visibility and the hub is connected proximally to a slotted housing that contains the integral spring wire guide. A handle projects through the slotted housing to permit the advancement of the spring wire guide through the introducer needle into the vessel. This design allows for quick and simple catheter insertion since all of the devices required for insertion are provided together.
The Arrow Quickflash Arterial Catheterization Device is available with and without integrated molded suture wings in 20 gauge configurations with usable lengths of 3.81 cm (1 ½").
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML systems.
Instead, the document is a 510(k) summary for a medical device (Arrow Quickflash Arterial Catheterization Device) and focuses on demonstrating substantial equivalence to a predicate device. The information provided pertains to:
- Substantial Equivalence: The primary goal is to show the new device is substantially equivalent to an older, legally marketed predicate device (Arrow Radial Artery Catheterization Set K810675). This is achieved through comparisons of indications for use, technological characteristics, and non-clinical testing.
- Technological Characteristics Comparison: A table compares design features of the predicate and subject device (e.g., catheter body OD and length, material, blood flashback visualization, integrated guidewire, sterilization method).
- Nonclinical Testing: A list of bench tests performed for design verification (e.g., biocompatibility, corrosion resistance, leakage, tensile testing, luer testing, simulated use, penetration/insertion force, kink resistance, dimensional verification, needle flexing, spring wire guide flexing, catheter resistance to collapse).
Therefore, I cannot provide the requested information about acceptance criteria and device performance as this document does not contain such details relevant to AI/ML or comparative effectiveness studies.
Here's why the requested information cannot be extracted from the provided text:
- AI/ML Context: The device is an "Arterial Catheterization Device" and appears to be a physical medical instrument, not an AI/ML software device.
- Acceptance Criteria & Performance Metrics: The document lists nonclinical testing to demonstrate safety and performance relative to the predicate, but these are not the "acceptance criteria" and "reported device performance" in the sense of accuracy, sensitivity, specificity, or other statistical measures typically associated with AI/ML model evaluation.
- Study Details (Sample Size, Ground Truth, Experts): Since it's not an AI/ML product study, there is no mention of training sets, test sets, data provenance, expert ground truth, adjudication methods, or MRMC studies.
In summary, the provided text is a regulatory submission for a physical medical device and does not contain the specifics required to answer your prompt, which seems to imply an AI/ML driven device evaluation.
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(62 days)
ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.)
The Pressure Injectable PICC with Chlorag+ard Antithrombogenic Technology is indicated for shortterm or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injection equipment used with the pressure injectable PICC may not exceed 300 psi.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test nethods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catherer tip is in the desired location.
The VPS System is indicated for use as alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
The purpose of this premarket notification is to propose design and material modifications to the subject device: the Arrow Vascular Positioning System (VPS) stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS . The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS already loaded into a central catheter. (The Arrow VPS Stylet PLUS and the Arrow VPS Stylet PLUS included in the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS are exactly the same stylet.)
The subject device, the Arrow VPS Stylet PLUS has the following characteristics:
- 6 ft overall length
This document describes the premarket notification (K153487) for the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS. It details modifications made to the device and the nonclinical testing performed to demonstrate substantial equivalence to a predicate device (K141618).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it lists the nonclinical tests performed and their results, which were all "PASS". The implicit acceptance criterion for each test is that the device must pass it.
| Test Device | Test | Reported Device Performance ("Results") |
|---|---|---|
| Stylet | Tensile per ISO 10555-1 | PASS |
| Stylet | Torque strength Per the Coronary and Cerebrovascular Guidewire guidance | PASS |
| Stylet | Tip Flexibility Per the Coronary and Cerebrovascular Guidewire guidance | PASS |
| Stylet | Flexing BS EN ISO 11070 | PASS |
| Stylet | Corrosion BS EN ISO 10555-1 | PASS |
| Stylet | Component Compatibility: Marking accessory grip strength | PASS |
| Stylet | Component Compatibility: Tuohy-Borst Adapter grip strength | PASS |
| Stylet | Tuohy-Borst Leak per 594-1 | PASS |
| Stylet | Physical characteristics | PASS |
| Stylet | X-ray Detectability ASTM F640-07 | PASS |
| Stylet | Electrical Performance: Hi-Pot, Continuity, Doppler Bandwidth, Capacitance, Sensitivity stability | PASS |
| Stylet | Biocompatibility: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity and Hemocompatibility per ISO 10993-1 | PASS |
| Combined device | Electrical Safety and Electromagnetic Compatibility Testing (IEC 60601-1-2, IEC 60601-2-37) | PASS |
| Combined device | Catheter Compatibility Simulated Use Insertion/ Removal | PASS |
| Combined device | Catheter Compatibility Force to Remove stylet from catheter | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical testing (bench testing and biocompatibility) rather than a clinical study with a "test set" from patients. Therefore, information about patient sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided. The tests were performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was nonclinical testing, not a study involving human interpretation of data where expert consensus would establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. This was nonclinical testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This document describes nonclinical, bench, and biocompatibility testing to demonstrate substantial equivalence of a modified medical device to a predicate device. It is not an MRMC comparative effectiveness study, nor does it involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No. This document pertains to a physical medical device (catheter and stylet), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests was established by adherence to specified international standards and guidances (e.g., ISO 10555-1, BS EN ISO 11070, ASTM F640-07, ISO 10993-1, IEC 60601 series). These standards define the test methods and criteria for acceptable functional and safety performance (e.g., tensile strength, corrosion resistance, biocompatibility).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm study requiring a training set. The modifications are to a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/algorithm study requiring a training set.
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(64 days)
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
The Arrow Pressure Injectable JACC with Chlorag+ard Antithrombogenic Technology is indicated for short-term (30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa), The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathyav of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness were evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treating infections.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.
The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.
Limiting but not contraindicated situations for this technique are in palients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology has the following characteristics:
- . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter with or without preloaded VPS stylet
- 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic . catheter with or without preloaded VPS Stylet
- 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic ● catheter with or without preloaded VPS Stylet
The subject device is a CG+ Arrow JACC with or without pre-loaded Arrow VPS Stylet and will be provided in sterile kit configurations. The modifications subject to this submission are additions to the recommended procedural technique to clarify that the catheter devices can be trimmed or cut to the appropriate length based on the specific patient's anatomy.
The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-Lumen and 2-Lumen catheters and 6 mL/sec for the 3-Lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag+ard technology. There are no modifications subject to this premarket notification related to the geometric or material design of the devices modified in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.
The provided text is a 510(k) summary for Arrow International, Inc.'s CG+ Arrow JACC devices. It aims to demonstrate substantial equivalence to a predicate device, focusing on a modification to the recommended procedural technique (catheter trimming instructions).
Here's an analysis of the acceptance criteria and supporting study information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" for performance metrics in the way one might expect for a formal clinical trial or algorithm validation. Instead, the focus is on demonstrating substantial equivalence to a predicate device after a modification to a procedural technique. The "performance" being evaluated is essentially the continued safety and functional equivalence of the modified device.
| Characteristic | Acceptance Criteria (Implied from "SAME" or "Effective") | Reported Device Performance (Subject Device) |
|---|---|---|
| Catheter Trimming Compatibility | Catheter remains functional and safe after trimming. | Verified by internal method. |
| Antimicrobial Efficacy | Effective in reducing microbial colonization (same as predicate). | Effective in reducing microbial colonization. (Evaluated through in vitro and in vivo test methods, but no correlation between these testing methods and clinical outcome has currently been ascertained.) |
| Antithrombogenic Efficacy | Effective in reducing thrombus accumulation (same as predicate). | Effective in reducing thrombus accumulation. |
| Physical/Material Characteristics (Catheter Length, OD, Lumens, Material, Hubs, Ink, Sterilization) | Identical to predicate device. | Same as predicate device. |
| VPS Stylet Characteristics (Diameter, Length, Design, Signal Conductor, Sterilization) | Identical to predicate device. | Same as predicate device. |
| Finished Good Design Validation | The modified design meets specified validation requirements (details not provided). | Completed. |
Important Note: The document explicitly states that "no correlation between these testing methods and clinical outcome has currently been ascertained" for the antimicrobial efficacy. This means while the device has shown antimicrobial activity in lab/animal settings, there isn't clinical evidence in this document proving it translates to reduced infections in humans.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for test sets in a traditional sense. The "testing" mentioned is primarily design verification testing and risk analysis related to the modification (catheter trimming). There is no mention of a patient-based test set with specific sample sizes.
- Data Provenance: The testing mentioned ("internal method", "in vitro and in vivo test methods") points to internal laboratory or animal studies, likely conducted by the manufacturer (Arrow International, Inc./Teleflex Inc.). There is no mention of country of origin for data or whether it's retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given the nature of the submission (510(k) for a procedural modification to an existing device), the "ground truth" for the verification testing would be based on engineering specifications, material science, and established safety standards rather than expert clinical consensus on a patient test set.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. There is no mention of a test set that would require expert adjudication in the context of this submission. The "adjudication" would be performed by the manufacturer's internal quality and regulatory teams, and subsequently by the FDA reviewers, applying regulatory standards to the provided test results.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This submission is for a medical device (catheter) with guidance (VPS Stylet), not an AI-powered diagnostic imaging system that would typically involve human "readers" and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The "VPS Stylet" is a guidance system used by a human operator during a medical procedure, not a standalone AI algorithm.
7. The Type of Ground Truth Used
For the aspects evaluated:
- Catheter Trimming Compatibility & Functional Performance: The "ground truth" would be engineering specifications, established mechanical/material properties, and successful demonstration of absence of adverse effects from trimming through design verification testing.
- Antimicrobial & Antithrombogenic Efficacy: The "ground truth" was established through in vitro and in vivo test methods.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of an "AI algorithm" or a "training set" in this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no "training set" mentioned.
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(103 days)
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.
The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of an ergonomically designed handle with an integral echogenic needle with a passively-activated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter is advanced over the needle and threaded over a guidewire into a peripheral vessel. Throughout catheter insertion. blood is contained within the device to aid in prevention of blood exposure. The catheter system consists of a translucent radiopaque polyurethane catheter, a needle with openings to enhance flashback visibility, a seal in the catheter hub designed to reduce blood exposure, a stabilization with a strain relief nose designed to reduce kinking at the hub of the catheter, integrated extension tubing with Luer hub, vent plug to prevent blood from leaking out during insertion, and a clamp to eliminate blood exposure when the vent plug is removed and replaced with a mating Luer component such as an infusion set or Luer access device.
The catheter is intended for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood.
The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 18, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").
Here's a breakdown of the acceptance criteria and study information for the Arrow Endurance™ Extended Dwell Peripheral Catheter System, based on the provided document:
This document describes a 510(k) submission for a product line extension of an already cleared device, not an entirely new device with a standalone performance study in the traditional sense of evaluating an AI or diagnostic algorithm. Therefore, many of the typical questions for AI/algorithm performance (like sample sizes for test sets, ground truth establishment for training sets, MRMC studies, etc.) are not applicable in this context. The core of this submission is demonstrating substantial equivalence to a previously cleared predicate device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on meeting established international standards and demonstrating functional equivalence to the predicate device. The "reported device performance" is essentially the successful completion of these tests.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria / Standard | Demonstrated Performance / Status |
|---|---|---|
| Biocompatibility | ISO 10993-1, -3, -4, -5, -6, -7, -10, -11, -12 | Testing completed / Device is biocompatible. |
| Physical and Functional Performance (ISO 10555 & 11070 Requirements) | Radio-Detectability | Testing completed / Device is radio-detectable. |
| Surface | Testing completed / Meets surface requirements. | |
| Corrosion Resistance | Testing completed / Device is corrosion-resistant. | |
| Freedom from leakage (Air and Liquid) | Testing completed / Device is free from leakage. | |
| Flow rate | Testing completed / Meets flow rate specifications. | |
| Pressure Injection | Testing completed / Withstands 325 psi. | |
| Tensile Testing | Testing completed / Meets tensile strength requirements. | |
| Blood Containment | Testing completed / Effectively contains blood. | |
| Luer Testing | BS EN 20594-1 (ISO 594-1) & BS EN 1707 | Testing completed / Meets Luer connection standards. |
| Simulated Use | Not specified standard, but indicated as a test | Testing completed / Performs as intended in simulated use. |
| Penetration/Insertion Force | Not specified standard, but indicated as a test | Testing completed / Meets penetration/insertion force requirements. |
| Sharps Safety Feature | CDRH Sharps Guidance and ISO 23908 | Testing completed / Safety feature performs as intended. |
| Catheter Kink Resistance | BS EN 13868 | Testing completed / Device is kink-resistant. |
Study Details (as applicable to a 510(k) of this nature)
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an algorithm's performance with a specific number of patient cases. Instead, it refers to bench testing performed on physical samples of the new catheter configurations (18 gauge and 22 gauge, 6cm and 8cm lengths).
- Data Provenance: The testing was conducted by Arrow International, Inc.
- The nature of the testing is retrospective in the sense that physical samples were manufactured and then subjected to various engineering and biological tests. It is not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for these tests is defined by engineering specifications, international standards (ISO, EN), and regulatory guidance (CDRH).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human interpretations or disagreements to resolve, no adjudication method is used.
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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:
- Not Applicable. This device is a peripheral catheter system, a physical medical device, not an AI or diagnostic tool. Therefore, no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of the catheter is based on engineering specifications, established international standards (ISO, EN), and regulatory guidance (CDRH Sharps Guidance). For example, passing particular flow rate tests, achieving specific tensile strength, or demonstrating a certain level of biocompatibility according to defined protocols and limits.
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of machine learning for this physical device.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an algorithm, this question is not relevant.
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(268 days)
Arrow International, Inc. (Subsidiary of Teleflex Inc.)
The device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.
The Multi-Lumen Acute Hemodialysis Catheter for High Volume (hereafter referred to as the 3-L AHDC) is a short-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in a 12 Fr. triple-lumen configuration with usable lengths of 16-25 cm. The catheters can be used for the injection of contrast media. The maximum recommended pressure injection flow rate is 6 mL/sec.
The catheters are packaged sterile with various components to facilitate insertion.
This document is a 510(k) summary for a medical device called the "Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions," not a study describing AI algorithm. It details the device's indications for use, its substantial equivalence to predicate devices, and non-clinical testing performed.
Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device's performance because the provided text is about a physical medical device (a catheter) and does not mention any AI component or algorithm.
Specifically, there is no mention of:
- Acceptance criteria table and reported device performance for an AI algorithm.
- Sample size for a test set, data provenance, ground truth establishment, or expert qualifications for an AI study.
- Adjudication methods for an AI test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance of an AI algorithm.
- Ground truth types for an AI algorithm.
- Training set sample size or ground truth establishment for an AI algorithm.
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