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510(k) Data Aggregation
(71 days)
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: • amputations (minor) • angioplasty/stent failure • arteriopathic wounds . graft failure . intermittent claudication . ischemia . night pain . rest pain . small vessel disease ● ulcers.
The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (IC-BAP-DL, applicant device) is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf. The device consists of an AC-powered pump, inflatable garments, and interconnection tubing. In operation, the device is attached via the interconnection tubing to sleeves or garments containing discrete inflatable chambers, which are applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations or use with garments or sleeves from other manufacturers. The pump design provides intermittent, rapid impulse pressurization to the chambers. Inflation and deflation cvcles are requlated by a two-section valve, turned by the valve motor at three rpm. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off using information from the pressure sensor. When the garments are inflated. they compress the blood vessels in the foot and calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. Pressure is pre-set at the factory to 120 mmHg, and the compressor is capable of no more pressure than 150 mmHq, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP/DOWN soft key arrows. An LED panel displays the set pressure and display "0" during the deflation cycle. Foot/calf garments are connected and are available in a range of sizes. The garments contain discrete, interconnected and segmented inflatable chambers, providing a single inflation chamber for the foot and two inflation chambers for the calf. Garments are supplied nonsterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. The device is intended for home use. and instructions are provided for the patient to attach the garments and perform therapy after physician prescription and patient orientation and education. The user interface consists of a soft keypad and UP/DOWN pressure adjustment soft kev arrows. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump and the valve motor. The pump sends air through the 2-section valve, which turns and sends air to the two bilateral output ports, filling first the foot and then the calf garments. As the valve continues to rotate the air is released from all chambers at once and the garments deflate. The cvcle repeats three times per minute and default treatment time is one hour, controlled by an internal timer on the PCB.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance data that the device is tested against before release. However, it does not explicitly state quantitative acceptance criteria for each parameter other than the displayed pressure accuracy. Instead, it emphasizes comparable inflation cycle profiles to the predicate device.
| Parameter | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Electrical Leakage | Must meet performance specifications | Tested and meets all performance specifications |
| Pressure Adjustment | Must meet performance specifications | Tested and meets all performance specifications |
| Inflation Pressure in each segment | Must meet performance specifications | Tested and meets all performance specifications |
| Air Pressure Display Accuracy | $\pm 10$ mmHg of sleeve pressure, pressure set point displayed on LED | Tested and meets all performance specifications |
| Inflation/Deflation Cycle Times | Must meet performance specifications | Tested and meets all performance specifications; demonstrable comparable inflation cycle profiles (rise times, inflation pressures, deflation times and cycle times) to predicate device. |
2. Sample Size for Test Set and Data Provenance:
The document explicitly states: "Before being released every device is tested and must meet all performance specifications." This implies that the sample size for the test set is n=1 (each individual device manufactured).
The data provenance is prospective manufacturing quality control testing. The country of origin for the data is not specified, but given the US regulatory context, it would likely be where the devices are manufactured or tested.
3. Number of Experts used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable in this context. The "ground truth" here is based on the device's technical specifications and engineering measurements, not clinical expert consensus. The testing described is functional testing against engineering requirements.
4. Adjudication Method for the Test Set:
This information is not applicable. The functional testing described is a direct measurement against defined specifications, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The study focuses purely on the device's functional equivalence to its predicate, not its clinical effectiveness against human readers or other treatments.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone performance evaluation was conducted. The "Performance Data" section describes "functional testing" performed on "every device" before release, which includes objective measurements like electrical leakage, pressure adjustment, inflation pressure, air pressure display accuracy, and inflation/deflation cycle times. This is a standalone evaluation of the device's physical and functional characteristics.
7. Type of Ground Truth Used:
The ground truth used for the device's performance evaluation is based on engineering specifications and pre-defined performance parameters for the device itself and its predicate. This includes measurements against expected pressure levels, timing, and electrical safety standards.
8. Sample Size for the Training Set:
This information is not applicable. The device described is a mechanical/electronic medical device with a pre-defined and tested operational logic, not a machine learning or AI-based system that requires a "training set" in the conventional sense. Its "training" is in its design and manufacturing process.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated above.
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(45 days)
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
The BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:
- Amputations (minor)
- Angioplasty / stent failure
- Arteriopathic wounds
- Graft failure
- Intermittent claudication
- Ischemia
- Night pain
- Rest pain
- Small vessel disease
- Ulcers
The BioArterial Plus Arterial Blood Flow Enhancement System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The AC-powered device for consists of a pump, inflatable garments, and interconnection tubina. In operation, the device is attached via interconnect tubina to sleeves or garments containing discrete inflatable chambers applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations. Garments are available in a unique anatomical configuration, providing a single inflation chamber for the foot, and a single inflation chamber for the calf. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners support a wide range of anatomy sizes. The device is intended for home use.
Here's an analysis of the acceptance criteria and supporting study for the "BioArterial Plus Arterial Blood Flow Enhancement System" based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The product meets its specifications. | "Performance testing was performed and assures that the product meets its specifications." |
| Inflation cycle profiles (risetimes, cycle times, and inflation pressures) are similar to predicate devices. | "Bench testing was performed, comparing the inflation cycle profiles of the product to the predicate devices. The results of the testing demonstrate similar risetimes (time required to reach pressure), cycle times (total inflated and deflated times within a cycle), and inflation pressures." |
| The device is substantially equivalent to predicate devices, and does not raise any new questions of safety or effectiveness. (This is a regulatory acceptance criterion for 510(k) clearance). | "Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices in terms of features, functionality, and bench comparisonal testing, the manufacturer believes that the BioArterial Pius Arterial Blood Flow Enhancement System is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness." The FDA's 510(k) clearance letter (K072666) confirms this by stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
Study Details from the Provided Document:
- Sample size used for the test set and the data provenance:
The document does not specify a sample size or data provenance for human subject testing. The "Performance Data" section only mentions "bench testing." - Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring expert ground truth. - Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring adjudication. - 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:
This information is not applicable. The device is an "Arterial Blood Flow Enhancement System" and not an AI-powered diagnostic or interpretive device that would involve human readers or MRMC studies. - If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device (pump and garments) for enhancing blood flow, not an algorithm. - The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench testing, the "ground truth" used was the specifications and performance profiles of the predicate devices. The testing aimed to show similarity to these established devices rather than a biological or clinical ground truth in the traditional sense. - The sample size for the training set:
This information is not applicable as there is no mention of a "training set" for an algorithm or AI model within this 510(k) submission. The performance assessment was based on bench testing of the physical device. - How the ground truth for the training set was established:
This information is not applicable for the reasons stated above (no training set for an algorithm).
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