Search Results

Ask a specific question about this device

Intended Use

The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller).

The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.

The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.

Indications

Leg Compression

The use of the Kendall SCD SmartFlow Compression System with Sequential, Gradient, Circumferential (SGC) compression is indicated for:

• · Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis.
• · Treatment of pain and swelling related to venous stasis
• · Circulation enhancement

The use of the Kendall SCD SmartFlow Compression System with uniform, posterior compression is indicated for:

· Deep Vein Thrombosis Prophylaxis.

Foot Compression

The use of the Kendall SCD SmartFlow Compression System with foot compression is indicated for:

• · Circulation Enhancement
• · Deep Vein Thrombosis Prophylaxis
• · Edema Acute
• · Edema Chronic
• · Extremity Pain Incident to Trauma or Surgery
• · Leg Ulcers
• · Venous Stasis

The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller).

The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.

The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.

This document is an FDA 510(k) clearance letter for the Kendall SCD SmartFlow Controller and related components. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The letter explicitly states:

• "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...""
• "Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a device performance study report.

Ask a specific question about this device

The SmartFlow™ Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing.

The Catheter will be marketed in the following sizes:
Ventricular Catheter .008 x 7.5mm tip
Ventricular Catheter .008 x 15mm tip
Ventricular Cathcter .021 x 7.5mm tip
Ventricular Catheter .021 x 15mm tip

Each unit will provide for an approximate 23 inch tubing extension.

The provided document is a 510(k) summary for a medical device (MRII MR Compatible Ventricular Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria for a new AI/software device.

Therefore, the information required to populate most sections of the table and answer the subsequent questions is not present in the provided text, as this document describes a traditional medical device submission, not an AI/software device.

However, I can extract information related to the device's technical specifications and the Performance Testing – Bench section, which acts as the "study" proving the device meets certain operational criteria.

Here's a breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test, but phrases like "All samples" and "All Bone Anchors" suggest that specific, likely small, batches of devices/components were tested. The exact number of units per test is not provided.
• Data Provenance: The studies are described as "Bench testing" performed by "MRII, Inc." This indicates the data is from in-vitro (lab/bench) testing of the physical device, not patient data. No country of origin for data is specified beyond the company's location (Irvine, CA, USA). It's prospective in the sense that the tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a traditional device submission focused on physical and material properties, not an AI/software device requiring expert ground truth for classification or detection tasks. The "ground truth" for these tests is based on objective physical measurements and adherence to engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, often for AI performance evaluation. The tests described here are objective bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device, and 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 not an AI/software device. The device's "performance" is its physical function, not an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests is derived from:

• Pre-defined engineering specifications and limits (e.g., specific flow rates, pressure limits, force thresholds).
• Comparative performance against the legally marketed predicate device.
• Objective physical measurements (e.g., fluid volume, pressure, force, visual inspection for damage/leaks).
• Compliance with recognized standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterility).

8. The sample size for the training set

Not applicable. This is not an AI/software device and does not involve training data.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/software device.

Ask a specific question about this device

The SmartFlow® is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.

The SmartFlow® with the Pulse Transmission Coefficient software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures.

The SmartFlow® is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing.

The provided text is a 510(k) summary for the SmartFlow® device, which is a programmable diagnostic computer for evaluating hemodynamic status. It primarily focuses on demonstrating substantial equivalence to previously cleared models. It does not contain information about acceptance criteria, detailed study designs, or specific performance metrics that would allow for a comprehensive response to all the requested points.

However, based on the available information, here's what can be inferred and what is missing:

Summary of Available Information from the Provided Text:

• Device: SmartFlow® with Pulse Transmission Coefficient software.
• Intended Use: To evaluate the hemodynamic status of diseased arteries in coronary and peripheral vasculature in conjunction with pressure measurement devices during diagnostic and interventional procedures.
• Regulatory Status: Class II device (Product Code DQK), cleared via 510(k) process.
• Substantial Equivalence: Claimed against previous SmartFlow® models (K003122 and K012947), with the current model being an improved version that includes calculation of transmission of high-frequency components of the pressure signal and Multiple Lesion case analysis. The FDA concurred with this claim.

Detailed Response to Requested Information (Based on Available Text and Inferences):

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Not specified.	Not specified.

   • Explanation: The document is a 510(k) summary, which typically focuses on substantial equivalence rather than detailed performance study results with predefined acceptance criteria. For devices cleared through 510(k) based on substantial equivalence, the "acceptance criteria" are generally met if the device performs as well as, or better than, the predicate device in its intended use, and does not raise new questions of safety or effectiveness. Specific quantitative acceptance metrics are usually part of a full study report, not necessarily summarized in the 510(k) summary itself unless directly tied to the substantial equivalence claim for a novel feature. The text only states that it is an "improved model" with additional features for calculating pulse transmission coefficient and multiple lesion analysis.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size for Test Set: Not specified.

   • Data Provenance: Not specified. The submitter is from Israel, but the location or nature of any data used for testing (if performed) is not mentioned.

   • Retrospective or Prospective: Not specified.

   • Explanation: As a 510(k) for an improved version of an already cleared device, detailed clinical study data (with test sets and provenance) might not have been required for substantial equivalence, or it might be presented in confidential sections of the full 510(k) submission, not in this public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Number of Experts: Not specified.

   • Qualifications of Experts: Not specified.

   • Explanation: Ground truth establishment information is not present in this document. Given the device's function (calculating physiological parameters like CFR and FFR), ground truth would typically come from invasively measured pressure data, which is considered the clinical standard, rather than expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Adjudication Method: Not specified.

   • Explanation: No information on any adjudication method is provided.

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

   • MRMC Study: Not mentioned.

   • Effect Size: Not applicable as no MRMC study is detailed.

   • Explanation: This device is a diagnostic computer that processes physiological signals (pressure measurements), not an imaging AI that assists human readers in interpreting images. Therefore, a traditional MRMC study as understood in diagnostic imaging is unlikely to be relevant or performed for this type of device. The "AI" in this context refers to the algorithms for calculating hemodynamic parameters, which are presented to the clinician.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Standalone Performance Study: The text implies standalone performance. The device is described as "a tool for measuring coronary and peripheral vasculature hemodynamic status patterns" and performs "software calculations of the CFR and FFR parameters." This suggests the algorithm calculates these values directly from input data. However, a formal "standalone performance" study report (e.g., comparing algorithm output to a reference standard with metrics like accuracy, precision, recall) is not provided in this summary. Instead, the focus is on equivalence.

   • Explanation: The device is the algorithm, providing calculations. The performance would be how accurately those calculations reflect the true physiological state, typically validated against invasively measured data. The summary does not provide details of such a validation study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Type of Ground Truth: Not specified.
   • Inferred Ground Truth: For devices measuring physiological parameters like Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR), the gold standard or ground truth would typically be derived from direct invasive physiological measurements obtained in vivo.

8. The sample size for the training set

   • Sample Size for Training Set: Not specified.

   • Explanation: As an "improved model" of an existing device, it's possible that the core algorithms were developed and validated years prior, and this submission focuses on new features or software updates. Details on training sets are not typically included in 510(k) summaries, especially for updates to existing algorithms.

9. How the ground truth for the training set was established

   • Ground Truth Establishment for Training Set: Not specified.

   • Explanation: Similar to the test set, if a training set was used (e.g., for calibrating the pulse transmission coefficient algorithm), the ground truth would likely involve direct invasive measurements. This information is not in the summary.

Conclusion:

The provided 510(k) summary for the SmartFlow® device is a regulatory document focused on demonstrating substantial equivalence to previously cleared predicate devices. It largely lacks the detailed scientific study information (acceptance criteria, sample sizes, ground truth methodology, expert qualifications, etc.) that would typically be found in a comprehensive clinical trial report or a full 510(k) submission. The FDA's clearance indicates they were satisfied that the device, with its new software features, was substantially equivalent to its predecessors and safe and effective for its stated indications for use, without the need for new, extensive clinical studies detailed in this summary.

Ask a specific question about this device

Florence Medical Ltd. SmartFlow™ is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.

The SmartFlow™ with the Multiple Lesion software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures.

The SmartFlow™ is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing.

The SmartFlow™ may be operated through its touchscreen or through an Infrared receiver port which allows the use of a hand-held remote.

There are two defined accessories for use with the device: Monitor interface for standard medical monitors and hand-held Infrared remote control which activates function keys and acts as a mouse.

This document describes the SmartFlow™M device, a diagnostic tool for evaluating the hemodynamic status of coronary and peripheral vasculature. The information provided is from a 510(k) summary, which is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

Note: The provided text does not contain a detailed study report with specific acceptance criteria, sample sizes, and detailed methodology for a clinical or performance study of the SmartFlow™M device itself. Instead, it describes the device, its intended use, and its substantial equivalence to a previously cleared device. Therefore, the response below will extrapolate and make assumptions based on standard FDA 510(k) submissions where such details are usually found in the performance data section, which is missing from this excerpt.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given 510(k) summary. A 510(k) summary typically includes a table comparing the performance of the new device to the predicate device, often using metrics like accuracy, sensitivity, specificity, and potentially precision or agreement for quantitative measurements such as CFR (Coronary Flow Reserve) and FFR (Fractional Flow Reserve), which the SmartFlow™ calculates.

Since the device "enables analysis of multiple lesion cases as well as single lesion cases," a key performance metric would likely revolve around its ability to accurately measure CFR and FFR for multiple lesions and its agreement with established methods or the predicate device.

Hypothetical Acceptance Criteria (based on common practice in this field, not from the document):

Ask a specific question about this device

Ask a specific question about this device