NORMATEC PCD

• K Number: K013436
• Device Name: NORMATEC PCD
• Manufacturer: NORMATEC, INC.
• Date Cleared: 2001-12-21 ( 66 days)
• Product Code: JOW
• Regulation Number: 870.5800
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K935998 , K830577 , K915637 , K810338 , K911853

Intended Use

The NormaTec PCD is intended to be used to apply pressure to the extremities. The NormaTec PCD is indicated for use in the treatment of: 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 the prevention of: Deep Vein Thrombosis

Device Description

The NormaTec PCD is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics. Both NormaTec's PCD and its predicates are intended to apply pressure to the extremities to treat edematous states like lymphedema, and to prevent deep vein thrombosis. NormaTec's PCD has very similar components as its predicate devices and very similar principles of operation. Each device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, control of pressure applied cyclically and simultaneous treatment of two limbs, if necessary. Like the predicates, pressure is pulsed to the affected limb for a specified period of time, followed by a rest period, according to the physician's prescription.

AI/ML Overview

The NormaTec PCD is a noninvasive pneumatic compression device.

1. Acceptance Criteria and Reported Device Performance:

   Test Type	Acceptance Criteria	Reported Device Performance
   Electromagnetic Interference	Not specified	"functioned as intended"
   Burst Testing	Not specified	"functioned as intended"
   Safety Testing	Not specified	"functioned as intended"
   Quality Assurance Testing	Not specified	"functioned as intended"

2. Sample Size and Data Provenance:

   • No specific sample size for a test set is mentioned. The document only states that the device "underwent electromagnetic interference testing, burst testing, safety testing and quality assurance testing."
   • Data provenance is not specified. The studies were likely conducted internally by NormaTec, Inc.

3. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. The document describes engineering and safety tests, not clinical studies involving expert interpretation of medical data.

4. Adjudication Method:

   • Not applicable. This was not a study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence to predicate devices and basic engineering/safety performance.

6. Standalone Performance Study:

   • The "Performance Data" section describes direct testing of the device itself ("The NormaTec PCD underwent..."). This can be considered a standalone assessment of the device's basic operational performance and safety characteristics.

7. Type of Ground Truth Used:

   • The "ground truth" for the engineering and safety tests would have been predefined engineering specifications, safety standards, and functional requirements for pneumatic compression devices. For instance, "burst testing" implies a standard for pressure resistance.

8. Sample Size for Training Set:

   • Not applicable. This is not a machine learning or AI-based device, so there is no training set mentioned.

9. How Ground Truth for Training Set was Established:

   • Not applicable, as there is no training set for this device.

Regulation Number and Section

§ 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).