(30 days)
The medi pneumatic compression system (pcs) - brio is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
-Lymphedema
-Venous stasis ulcers
-Venous insufficiency
-Peripheral edema
The device is intended for home, and hospital use
The medi pneumatic compression system (pcs) – brio (Model 651) system consists of a medi pcs pump device a medi pcs air inflatable sleeve with air hose and connectors. The pump device, air hose, and sleeves are all non-sterile and single patient use.
The medi pcs brio (Model 651) device is an intermittent mechanical gradient compression pump that includes a pressure control unit (PCU) with two connection points for air inflatable sleeves with air hose and connectors, a power switch and a wall power connection for standard 125v AC Power. The PCU provides compression with short cycles of pneumatic pressure applied in short, steady cycles. The air compressor distributes calibrated gradient pressure through a series of regulators to original compression sleeves containing either 6 or 8 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs brio (Model 651) is a basic model and is adjustable and limits the different treatment pressures and treatment times according to physician prescription.
The medi pcs brio (Model 651), air hose and sleeves together may only be distributed, sold and operated as a prescribed device. The device must be operated only with a new, original manufacturer limb sleeves, and all pads that are non-sterile, single patient use.
The medi pcs brio (Model 651) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs brio (Model 651)) device, air hoses and air inflatable sleeves together may only be distributed, sold and operated as a prescribed device.
The provided text describes the medi pneumatic compression system (pcs) - brio (Model 651), a Class II medical device intended for treating lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema. The submission is a 510(k) premarket notification, which means the manufacturer is asserting the device is substantially equivalent to a legally marketed predicate device, the CircuFlow 5200 Series Sequential Compression Device (K101523).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the performance tests conducted to demonstrate that the new device is as safe and effective as the predicate device. Unlike a clinical trial with predefined statistical endpoints for efficacy, a 510(k) submission relies on demonstrating substantial equivalence, often through bench testing, adherence to recognized standards, and comparison of technological characteristics.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are typically defined by the performance specifications of the device itself and the recognized standards it claims to meet. The "reported device performance" is the result of the bench testing demonstrating adherence to these specifications and standards.
| Acceptance Criteria (Derived from device specifications & standards) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility: Meet ISO 10993 requirements for cytotoxicity, sensitization, and irritation for prolonged skin contact. | Nylon 210D material (used for sleeves) passed Cytotoxicity, Sensitization, and Irritation studies according to AAMI / ANSI / ISO 10993-1, 10993-5, and 10993-10, and GLP (21 CFR Part 58). |
| Electrical Safety: Conform to general requirements for basic safety and essential performance. | Conforms to ANSI/AAMI 60601-1. |
| Electrical Safety (Collateral Standard): Conform to collateral standard for electrical safety. | Conforms to ANSI/AAMI 60601-1-11. |
| Electromagnetic Compatibility (EMC): Meet EMC requirements and tests. | Conforms to IEC 60601-1-2. |
| Software Verification and Validation: Conform to standard for medical device software (moderate concern level). | Conforms to IEC 62304:2006. |
| Bench Performance: Meet specifications for various operational parameters. | Inflation and Deflation Time Performance: Assured to meet product specifications. |
| Treatment Time Performance: Assured to meet product specifications. | |
| Pressure Performance: Assured to meet product specifications. | |
| Burst Pressure Performance: Assured to meet product specifications. | |
| Pressure Gradient Performance: Assured to meet product specifications. | |
| Software Integration (GUI Navigation): Assure proper navigation. | GUI Navigation Performance demonstrated to meet specifications. |
| Software Integration (Pressure Calibration): Assure proper pressure calibration. | Pressure Calibration Performance demonstrated to meet specifications. |
| Safety (Errors & Alarm): Assure proper error and alarm functionality. | Errors & Alarm Performance demonstrated to meet specifications. |
| Substantial Equivalence: Demonstrate similar technical and performance characteristics to the predicate device and not raise new safety/effectiveness issues. | Concluded to be substantially equivalent to the CircuFlow 5200 (K101523) based on shared intended use, safety and performance testing results, compliance with standards, and comparison of features and characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text details bench testing and biocompatibility testing. For these types of tests, "sample size" doesn't typically refer to patient data or a clinical test set in the same way it would for a clinical efficacy study.
- Biocompatibility Testing: The "test article" was Nylon 210D, which is a material. The "sample size" would relate to the number of material samples subjected to the cytotoxicity, sensitization, and irritation assays. The specific number of samples tested is not provided in the text.
- Bench Performance Testing: The "sample size" would refer to the number of medi pcs brio (Model 651) devices or components tested. This information is not specified in the document.
- Data Provenance: The data is from laboratory and bench testing conducted by the manufacturer, not from patient data or clinical studies. Therefore, there's no country of origin for clinical data, nor is it retrospective or prospective in that sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is typically relevant for studies involving human interpretation (e.g., medical imaging). Since this submission primarily involves bench and material testing, there's no mention of "experts" establishing ground truth in this context. The "ground truth" for these tests is established by the defined specifications and standards (e.g., a specific pressure reading, a cytotoxicity level).
4. Adjudication Method for the Test Set
As the evaluation primarily consists of objective bench and material testing against predefined criteria and standards, an "adjudication method" involving multiple human reviewers (like 2+1 or 3+1) is not applicable or mentioned. The tests produce measurable results that are compared directly to the specified acceptance criteria.
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
This type of study is not mentioned and is not applicable to the medi pneumatic compression system. This device is not an AI-based diagnostic or assistive reading tool. The submission is for a physical medical device (a pump and sleeves) for compression therapy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is also not applicable. The medi pneumatic compression system is a physical device, not an algorithm. Its "performance" is its mechanical function (pressure delivery, cycle times, safety features), not an algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed can be characterized as:
- Engineering Specifications: For inflation/deflation time, pressure ranges, cycle times, treatment times, and burst pressure, the ground truth is the device's design specifications and performance limits.
- Standard Compliance: For biocompatibility, electrical safety, EMC, and software, the ground truth is defined by the specific requirements and limits set forth in the international and national standards (e.g., ISO 10993, ANSI/AAMI 60601 series, IEC 62304).
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This device is not an AI/machine learning product that requires training data. The "training" in this context would refer to internal development and refinement of the device's design, manufacturing processes, and software, rather than a separate dataset for model training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, this question is not applicable.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).