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510(k) Data Aggregation
(30 days)
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:
- Hypervascular tumors
- Blood vessels to occlude blood flow for controlling bleeding/hemostasis in the peripheral vasculature
The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood vessel to block blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.
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(241 days)
The Arctx Cool Catheter Set is a thermal regulating device, intended to: connect to a Blanketrol III Hyper-Hypothermia System to control patient temperature, allow enteral administration of fluids, and provide gastric decompression and suctioning.
The ACC Set is comprised of the Arctx Catheter and the Arctx Extension Line.
The ACC Set is intended to cool or warm a patient's temperature for up to 72 hours when connected to a commercial external thermal regulating system, provide gastric decompression and suctioning, and allow enteral administration of fluids. The Arctx Catheter is inserted through the nasopharynx, past the oropharynx and into the esophagus and stomach/duodenum where two lumens deliver cooled or heated water in a closed circuit, from a commercial thermal regulating system to control patient temperature. The circulating water does not contact the patient.
A third catheter lumen enables gastric suction and decompression as well as enteral administration of fluids.
The Arctx Catheter is made of standard medical-grade thermoplastic elastomers. It is a single-use, disposable, non-implantable device. The ACC Set has a quick-connect system that allows the Arctx Catheter to be easily disconnected from the Arctx Extension Line while the catheter remains in place. The quick-connect system allows the patient to move around freely for bathroom breaks, and other medical procedures outside the hospital room. The Arctx Catheter connects to the external thermal regulating system via the Arctx Extension Line.
The ACC Set is intended to be used with the Gentherm Medical Blanketrol III System, model #233. The Blanketrol III System supplies temperature-controlled water through a connector conduit to the ACC Set. An accessory temperature probe interfaces with the Blanketrol and the patient to measure patient temperature, which is displayed on the Blanketrol III System control panel. The Blanketrol III System controls water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control, and includes a circulating pump, heater, and refrigeration system.
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(219 days)
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing and cardiac disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only.
The SANSA device records and stores ECG recording for up to 10 hours of wear time which can be displayed in the software portal for manual annotation and analysis. The SANSA does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm and is not intended for pacemaker analysis.
The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only. The SANSA™ device records and stores ECG recording for up to 10 hours of wear time which can be displayed in the software portal for manual annotation and analysis. The SANSA™ does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm and is not intended for pacemaker analysis.
The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Sleep/Wake), and ECG. The following summary metrics are calculated: sansa-Apnea Hypopnea Index (sAHI) and Total Sleep Time (TST).
Recorded data are uploaded to a software portal where physiological tracings are made available for review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study.
Here's a breakdown of the acceptance criteria and the study information for the SANSA HSAT device, based on the provided FDA 510(k) clearance letter:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are primarily found on Page 9 of the document, under the "Performance" section within "Table 1: Device Comparison."
| Performance Metric | Acceptance Criteria / Predicate Performance (K202359) | Reported Device Performance (SANSA HSAT) | Comparison |
|---|---|---|---|
| Heart Rate (Arms) | No Heart Rate Analysis (Predicate) | ≤ 3 bpm (range 30-250 bpm) | N/A |
| SpO2 (Arms) | Does not collect SpO2 (Predicate) | ≤ 3% (range 70-100%) | N/A |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15) - Sensitivity | Not applicable (Predicate does not diagnose OSA) | 88.2% | N/A |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15) - Specificity | Not applicable (Predicate does not diagnose OSA) | 87.3% | N/A |
| ECG Recording Accuracy: Frequency Response | 0.67 Hz to 40 Hz | 0.67 Hz to 40 Hz | Identical |
| ECG Recording Accuracy: Input Impedance | >10 MΩ | >10 MΩ | Identical |
| ECG Recording Accuracy: Gain Accuracy | Maximum amplitude error ±10% | Maximum amplitude error ±10% | Identical |
| ECG Recording Accuracy: Gain Stability | <3% over a 24-hour period | <3% over a 24-hour period | Identical |
| ECG Recording Accuracy: Timing Accuracy | <30 seconds | <30 seconds | Identical |
Note: For Heart Rate, SpO2, and OSA diagnosis metrics, the predicate device (iRhythm Zio Monitor) does not provide these analyses or collect SpO2. Therefore, the "acceptance criteria" for these aspects are implicitly met by the absence of safety/effectiveness concerns with the SANSA HSAT's reported performance, which aligns with its intended use in sleep apnea evaluation. The ECG recording accuracy metrics are directly comparable and are identical between the subject device and the predicate.
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly state the sample size used for the clinical performance validation of the SANSA HSAT's ECG, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions:
- Sample Size: Not specified.
- Data Provenance: Not specified (country/retrospective/prospective).
For the Aid to Diagnosis of OSA, a sensitivity of 88.2% and specificity of 87.3% are reported. The document does not provide the sample size or provenance for this particular study, but it was leveraged from a previous clearance (K244027).
3. Number of Experts and Qualifications for Ground Truth - Test Set
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set specifically for the ECG clinical performance validation.
For the "Aid to Diagnosis of Moderate to Severe OSA", the percentages suggest a comparison against a diagnostic standard, which would typically involve expert interpretation, but the details are not provided in this document.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size related to human reader improvement with or without AI assistance. The SANSA device explicitly states it "does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm." (Pages 4 and 5).
6. Standalone Performance Study
Yes, a standalone performance study was done for the SANSA HSAT's ECG:
- Study Type: "Sansa ECG clinical performance was validated through comparison to a simultaneously collected reference standard Holter monitor." (Page 11)
- Performance: "Clinically acceptable performance was demonstrated through qualitative and quantitative analysis of the ECG signal." (Page 11)
The reported sensitivity and specificity for OSA diagnosis (Page 9) also represent standalone algorithm performance.
7. Type of Ground Truth Used
- For ECG Clinical Performance: "simultaneously collected reference standard Holter monitor." (Page 11)
- For Aid to Diagnosis of OSA (reported sensitivity/specificity): While not explicitly stated, the context of "Aid to Diagnosis" for Sleep Apnea typically implies comparison to a polysomnography (PSG) study, which is the gold standard, interpreted by sleep specialists. This data was "leveraged from previous clearance."
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for a training set. This is consistent with the statement that the device does not provide automated analysis of the ECG and explicitly states that it is not intended for use with a 3rd party automated algorithm. While the device uses "AI/ML components" for other signals (Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging), the training set size for these components is not detailed in this document.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established. Given the focus on manual annotation and analysis for ECG, and the lack of detail on the AI/ML components for other signals, this information is not present in the clearance letter.
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(90 days)
Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
The Telescope™ Guide Extension Catheter is a single-lumen rapid exchange catheter designed to act as an extension to a traditional guide catheter. The Telescope™ Guide Extension Catheter is intended to be used with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
The Telescope™ Guide Extension Catheter device is 150cm in length and consists of a hydrophilic-coated single-lumen distal guide segment connected to a stainless-steel polytetrafluoroethylene (PTFE) coated proximal pushwire.
The device is offered in two sizes 6F and 7F, with a hub at the proximal end of the pushwire that is used for device identification.
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(30 days)
The Seguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.
The Seguin Annuloplasty Ring (SARP) is a semi-rigid or semi-flexible annuloplasty ring designed to support mitral valve repair. The ring is constructed from a polyethylene core covered by a knitted polyester sewing cuff. The Seguin Ring is sterilized by EO sterilization and supplied sterile. The Seguin ring is offered in sizes 24-40mm in increments of 2 mm.
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(29 days)
The ClotTriever Thrombectomy System is indicated for:
- The non-surgical removal of thrombi and emboli from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).
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(168 days)
The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.
The VenAir system is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism. The product consists of the pump, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation.
The VenAir system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow this manual to check the error code and action as advised.
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(28 days)
Visions® PV.014P RX Digital IVUS Catheter:
The Visions® PV.014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in the cerebral vessels.
The Visions® PV.014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Visions® PV .018 Digital IVUS Catheter:
The Visions® PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
The Visions® PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The Visions® PV .014P RX Digital IVUS Catheter and the Visions® PV .018 PV .018 Digital IVUS Catheter are being bundled into one submission per FDA Guidance for Industry: Bundling Multiple Devices or Multiple Indications in a Single Submission, June 2007 (FDA-2003-D-0376), as the two catheters share the same indications for use, FDA classification product codes, and technological characteristics, and part of the same product line of catheters.
Visions® PV .014P RX Digital IVUS Catheter
The Visions® PV .014P RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.
The Visions® PV .014P RX Digital IVUS Catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The Visions® PV .014P RX Digital IVUS Catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.
Visions® PV .018 Digital IVUS Catheter
The Visions® PV .018 Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.
The Visions® PV .018 Digital IVUS Catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The Visions® PV .018 Digital IVUS Catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.
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(180 days)
The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the arm cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use.
The blood pressure monitor is a fully automatic, non-invasive upper arm measurement device using oscillometric methodology to measure systolic pressure, diastolic pressure and pulse rate. The device features an inflatable cuff that wraps around the arm, with a built-in pressure sensor and transducer that analyze arterial pulsations to determine blood pressure values. Measurement results are clearly displayed on the LCD screen.
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(64 days)
The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.
The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.
The LumiGuide system consists of the following primary devices:
The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.
The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.
The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.
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