(30 days)
The NormaTec PCD-T and NormaTec PCD-B are intended to apply pressure to the extremities to treat:
Lymphedema and other edematous conditions, including
- Congenital lymphedema (Millroy's disease, lymphedema praecox, ●
- and lymphedema tarda) ●
- Post-mastectomy lymphedema
- Post-infection lymphedema ●
- Post-traumatic lymphedema .
- . Post-surgical lymphedema
- Post-radiation-treatment lymphedema .
- Venous insufficiency .
- Venous stasis ulceration ●
and to prevent:
Deep Vein Thrombosis
The NormaTec PCD-T and PCD-B are designed to provide noninvasive air compression therapy for the treatment of lymphedema, venous insufficiency, other edemas, and venous stasis ulceration and to prevent deep venous thrombosis.
They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.
The NormaTec PCD-T and PCD-B consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.
The inflatable leg and arm "appliances" and the plastic air tubing are of the same general design and constructions as those cleared in the predicate NormaTec PCD (K013436) the materials are identical. The hip appliance is identical to that in NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608 and uses identical materials. Additionally, the air compressor, valve control are similar to the predicate NormaTec PCD (and are identical to the NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608)
The user interface on the PCD-T model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the PCD-B model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.
The provided document is a 510(k) summary for the NormaTec PCD-T and NormaTec PCD-B devices. This type of regulatory submission seeks to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for device performance studies, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone performance, training set details) is generally not part of a 510(k) submission unless the device introduces new technology or indications for use that differ significantly from the predicate.
In this specific document, the manufacturer relies on a comparison to a predicate device (NormaTec PCD, K013436) and a reference device (NormaTec Pulse and Pulse Pro, K160608) to establish substantial equivalence. Performance testing mentioned is primarily bench testing and compliance with electrical safety and electromagnetic compatibility standards.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance studies in the way you might expect for a novel device proving efficacy. Instead, the "performance" is largely demonstrated by showing substantial equivalence to the predicate device and compliance with relevant safety standards.
The closest we get to "reported device performance" in relation to acceptance criteria is the statement under "Performance Testing": "The device has been tested to ensure that it all requirements have been met, this includes:
- Testing of all controls
- Testing of all indicators
- Testing of battery state indicators
- Testing of performance
- Testing of hazard mitigations"
However, no specific performance metrics (e.g., pressure accuracy, cycle timing accuracy with defined thresholds) or the results against them are provided in this summary. The "acceptance criteria" here implicitly refers to the device functioning as intended and matching the performance characteristics of the predicate, as well as meeting the requirements of the standards listed.
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 applicable/not provided. The performance testing described is bench testing, not a study involving human subjects or collected data sets in the typical sense.
- Data Provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/not provided. "Ground truth" is typically established in clinical or diagnostic studies. For these devices, the "ground truth" for demonstrating substantial equivalence is the predicate device's established safety and performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not provided. No clinical test set requiring expert adjudication is described.
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/not provided. This is not an AI-enabled diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/not provided. This is a physical medical device (compressible limb sleeve), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this 510(k) submission, the "ground truth" for regulatory clearance is the substantial equivalence to the predicate device, which has already been deemed safe and effective for its intended uses. The performance testing focuses on ensuring the new device operates similarly and meets safety standards.
8. The sample size for the training set
Not applicable/not provided. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable/not provided.
Summary of what was included and relevant for a 510(k) submission:
-
Predicate Device Comparison Table (Pages 7-8): This is the core of the substantial equivalence argument. It directly compares the new devices (PCD-T and PCD-B) to the predicate device (PCD K013436) across several attributes, including:
- Indications for Use (Identical)
- Contraindications (Identical)
- Prescriptive (Identical)
- Power Source (New devices have optional integrated battery)
- Software/Firmware/Microprocessor Control (Same control technology)
- Technology (Identical compressor and valve system)
- Compliance with Voluntary Standards (New devices comply with updated standards and a home use standard)
- Device Pressure range (Identical)
- Treatment Time (New devices have added ability to time treatment)
- Inflation/deflation cycle type (Identical)
- Appliance contact surface material (Identical)
- Number of Inflatable appliance segments (Identical)
- Weight and Dimensions (Similar, new devices are lighter/smaller)
- Housing Materials and Constructions (Similar)
- Patient contact (Identical)
- Appliances (New devices use leg/arm appliances from K013436 and hip appliance from K160608)
-
Performance Testing (Page 9):
- Bench Testing: Described as ensuring "all requirements have been met," including controls, indicators, battery state, overall performance, and hazard mitigations. No specific quantitative criteria or results are provided in this summary.
- Standards Compliance:
- AAMI / ANSI ES60601-1:2005 (Medical electrical equipment - basic safety and essential performance)
- IEC 60601-1-2: 2007 (Electromagnetic Compatibility)
- IEC 60601-1-11: 2010 (Home healthcare environment)
-
No Animal Testing or Clinical Testing was performed.
The conclusion explicitly states "The NormaTec PCD-T and PCD-B are substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness." This statement, along with the detailed comparison table and standards compliance, forms the basis of the "proof" that the device meets the implicit acceptance criteria for a 510(k) clearance.
§ 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).