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510(k) Data Aggregation
(60 days)
Fresenius Medical Care North America
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(166 days)
CardioSet Medical Ltd.
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(60 days)
Fresenius Medical Care Renal Therapies Group, LLC
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(142 days)
Carestream Health Inc.
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(97 days)
Careverse Technology Pte. Ltd.
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(163 days)
Bayer Medical Care, Inc.
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(54 days)
Blessing Cathay Corporation
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(58 days)
Imperative Care, Inc.
The Symphony Thrombectomy System is intended for:
- The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Symphony 16F 82cm Thrombectomy System is intended for:
- The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony 16F 82cm Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.
The Symphony™ Thrombectomy System is comprised of the following devices:
- 24F Symphony Catheter
- 24F Symphony Standard Dilator
- 24F Symphony Advance™ Long Dilator
- 24F Symphony ProHelix™
- 16F Symphony Catheter
- 16F Symphony Dilator
- 16F Symphony ProHelix™
- Symphony Clot Container
- TRUVIC Generator
- TRUVIC Canister
- TRUVIC Tubeset
The Symphony™ 16F 82cm Thrombectomy System is comprised of the following devices:
- 16F 82cm Symphony Catheter
- 16F 82cm Symphony Length Matched Dilator
- Symphony Clot Container
- TRUVIC Generator
- TRUVIC Canister
- TRUVIC Tubeset
Both Systems are designed to remove thrombus/embolus (also referred to as 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheters and the Symphony 16F 82cm Catheter target aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter.
The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus in the peripheral vasculature or pulmonary anatomy. The 16F 82cm Catheter and compatible Dilator are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of thrombus in the peripheral vasculature. The Symphony 16F 82cm Catheter and compatible Dilator are not intended for use in the pulmonary anatomy. Both the Symphony Catheters and the Symphony 16F 82cm Catheter are used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.
As needed, the Symphony ProHelix may be introduced through a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.
Here's a breakdown of the acceptance criteria and study details for the Imperative Care, Inc. Symphony™ Thrombectomy System, specifically for the expanded pulmonary embolism indication, based on the provided 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|---|
| Primary Efficacy Endpoint: | ||
| Mean Reduction in RV/LV Between Baseline and 48-Hours (assessed by CT Angiography) | Lower one-sided 97.5% confidence interval (CI) bound > 0.20 | 0.44 ± 0.42 (Mean ± SD) |
| Lower one-sided 97.5% CI for Mean: 0.36 | ||
| Met: Yes (0.36 > 0.20) | ||
| Primary Safety Endpoint: | ||
| Composite 48-Hour Major Adverse Events (MAE) Rate (all-cause major bleeding, device-related mortality, and device-related serious adverse events including clinical deterioration, pulmonary vascular injury, or cardiac injury) | Upper one-sided 97.5% CI bound |
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(219 days)
Prior Care Science Technology LTD
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).
The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.
The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.
The mainstream gas analyzers are characterized by the following features:
- Low system integration complexity
- Low power consumption
- Fast startup time
- Low weight
The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.
Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.
However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.
1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):
| Parameter | Medical Gas Analyzer (AG200) Reported Performance | Predicate Device (K123043) | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| CO2 Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | Within ±(0.2 vol% + 2% of reading) for 0 to 15 vol% |
| N2O Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | Within ±(2 vol% + 2% of reading) for 0 to 100 vol% |
| Halothane, Enflurane, Isoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 8 vol% |
| Sevoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 10 vol% |
| Desflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 22 vol% |
| CO2 Accuracy (all conditions) | ±(0.3 vol% + 4% of reading) | ±(0.3 vol% + 4% of reading) | Within ±(0.3 vol% + 4% of reading) |
| N2O Accuracy (all conditions) | ±(2 vol% + 5% of reading) | ±(2 vol% + 5% of reading) | Within ±(2 vol% + 5% of reading) |
| Agents Accuracy (all conditions) | ±(0.2 vol% + 10% of reading) | ±(0.2 vol% + 10% of reading) | Within ±(0.2 vol% + 10% of reading) |
| Respiration Rate Range | 0 to 150 breaths/min | 2 to 150 breaths/min | 0 to 150 breaths/min (implied by compliance with ISO 80601-2-55 despite difference in predicate's lower limit) |
| Respiration Rate Accuracy | ±1 breaths/min | ±1 breaths/min | Within ±1 breaths/min |
| Anaesthetic Agents Threshold | 0.2 vol% | 0.15 vol% (with caveats) | 0.2 vol% deemed acceptable as verified by bench test and compliance with ISO 80601-2-55. |
| Warm-up time | 10-180 seconds |
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(238 days)
Imperative Care, Inc.
The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.
This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.
Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)
| Test Attribute | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensional Verification | All defined guidewire dimensions are within the specified tolerances. | Pass |
| Visual Inspection | The guidewire shall be free of visual defects when removed from packaging. | Pass |
| Torqueability | The guidewire shall transmit rotation from the proximal end to the distal tip to allow users to select branches of the vasculature and reach the target location. | Pass |
| Torque Strength | Device shall not fail under expected torsional input when distal end is unable to move/rotate. | Pass |
| Tip Flexibility | Tip of guidewire shall not cause vessel damage; defined by ability to buckle to reduce contact pressure and prevent perforation. | Pass |
| Tensile Strength and Tip Pull | Guidewire shall withstand tensile forces expected in clinical use without breaking. | Pass |
| Kink Resistance | Guidewire shall be able to traverse through clinically relevant bends without kinking. | Pass |
| Coating Integrity | Coating shall remain intact during clinical use. | Pass |
| Coating Lubricity | Coating shall be lubricious to reduce frictional forces for navigation. | Pass |
| Particulate Evaluation | Guidewire shall not generate particles at a level greater than the range generated by the predicate. | Pass |
| Corrosion Resistance | Guidewire shall not corrode from time of manufacture through its shelf life. | Pass |
| Radiopacity | Opacity to x-ray shall allow physicians to visualize guidewire under fluoroscopy. | Pass |
| Simulated Use | Guidewire must be able to reach anatomical locations and deliver catheters and other interventional devices used in common neurovascular procedures. | Pass |
| Cytotoxicity | Test article extracts must yield grade 2 or lower. | Pass, Noncytotoxic |
| Sensitization | Overall pattern, intensity, duration, character of reactions compared to control conditions. | Pass, Nonsensitizer |
| Irritation or Intracutaneous Reactivity | Difference between test extract mean score and corresponding control mean score ≤1. | Pass, Nonirritating |
| Acute Systemic Toxicity | None of the animals treated with test article extracts must show significantly greater biological reactivity than control-treated animals. | Pass, Non-toxic (acute systemic) |
| Material Mediated Pyrogenicity | Test article extract must yield |
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