(41 days)
The NormaTec Pulse 2.0 and Pulse Pro 2.0 are air pressure massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
The NormaTec Pulse 2.0 and Pulse Pro 2.0 are powered inflatable tube massagers (Product Code "IRP"). They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by the use of an inflatable pressure ouff. The devices are to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.
The user interface on the Pulse Pro 2.0 model is 4.3" color TFT Screen with capacitive sensor (similar to a Smartphone). The user interface on the Pulse 2.0 model is 4.3" color LCD screen with smart switches. There is no difference in function between the two interface technologies, they are offered for marketing differentiation and user preferences. The user interface provides for:
- . Starting and stopping the massage treatment;
- . Adjusting time and intensity (pressure) of the treatment.
In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the Bluetooth app mimics the device interface graphics and buttons. allowing the user to use a compatible Android or iOS phone to control device functions just as if they were using the interface on the device. The app functionality is limited to mimicking the device interface and does not provide or unlock any additional features or alter the therapy provided by the device.
The provided text describes a 510(k) premarket notification for the NormaTec Pulse 2.0 and Pulse Pro 2.0 devices. This type of submission establishes substantial equivalence to a predicate device, rather than performing a de novo study against defined acceptance criteria and performance metrics. Therefore, many of the typical study design questions (like sample size, ground truth, expert adjudication, etc.) are not applicable in the same way they would be for a direct performance study.
Instead, the submission focuses on demonstrating that the new devices are as safe and effective as the predicate device (NormaTec Pulse and Pulse Pro, K160608).
Here's a breakdown of the information that can be extracted, and where the requested information is not explicitly provided due to the nature of a 510(k) submission:
1. Table of acceptance criteria and reported device performance:
Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific acceptance criteria in the traditional sense of a new device performance study with quantitative metrics (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance criteria" here largely revolves around demonstrating equivalence to the predicate device in various aspects.
The table below summarizes the comparison presented in the document, effectively serving as the "performance" of the new device relative to the predicate. Most "reported device performance" aspects are stated as "Same" or "Equivalent" to the predicate.
| Feature / Criterion | Predicate Device (K160608) Performance/Description | Proposed Device (Pulse 2.0, Pulse Pro 2.0) Performance/Description |
|---|---|---|
| Indications for Use | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Same |
| Prescription Use | OTC | Same |
| Manufacturer | NormaTec Industries, LP | Same |
| Intended Use Environment | Clinics, hospital, athlete training, and home environments | Same |
| Power Source(s) | 15 VDC via IEC 60601-1 compliant power supply (100-240 VAC input); Integrated rechargeable battery | Same |
| Software / Firmware Micro-processor Control | Microprocessor | Same |
| Technology | Compressor and valve system that sequentially inflates cells of appliance | Compressor and valve system that sequentially inflates cells of appliance. Bluetooth communication ability. |
| Compliance with Voluntary Standards | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ANSI C63.27-2017. (Complaint with one additional standard) |
| Device Pressure Range | 0-110 mmHg | Same |
| Treatment Time | Stays on until the user turns it off or can be set up to turn off in a range of 10 minutes to continuous | Same |
| Inflation/Deflation Cycle Type | Sequential Gradient, Peristaltic and Pulsing | Same |
| Appliance Contact Surface Material | 200 denier nylon with a polyurethane laminate/extrusion | Same |
| Number of Inflatable appliance segments | 5 or less | Same |
| Weight | 3.6 pounds (incl. battery) | Same |
| Dimensions (W x H x D) | 4" x 5" x 9" | 4.4" x 3.8" x 8.1" |
| Housing Materials and Constructions | Molded ABS enclosure (94V0) | Same |
| Patient contact | Non-conductive appliances | Same |
| Bluetooth Functionality | Not present | Present (Allows use of NormaTec app to control device; app mimics device interface, does not add features or alter therapy). |
| Proprietary/Trade Name | Pulse and Pulse Pro | Pulse 2.0 and Pulse Pro 2.0 |
| Common/Usual Name | Powered inflatable tube massager | Same |
| User Interface (Pulse Pro 2.0) | Not explicitly detailed for predicate, but similar function implied. | 4.3" color TFT Screen with capacitive sensor (similar to a Smartphone). User interface provides for starting/stopping massage, adjusting time/intensity. |
| User Interface (Pulse 2.0) | Not explicitly detailed for predicate, but similar function implied. | 4.3" color LCD screen with smart switches. User interface provides for starting/stopping massage, adjusting time/intensity. |
| Differences between Pulse 2.0 and Pulse Pro 2.0 | Not Applicable | Pulse Pro 2.0 has additional features like "Therapy mode" (Recovery Flush, Rehab), "Custom Settings", "Compliance - Trip meter", "Chronometer Odometer", "Appliance Type selection", "Display Settings Adjustment", and more detailed control over treatment modes and settings compared to the Pulse 2.0 in the provided table. Pulse 2.0 has a basic set of common controls. There is no difference in fundamental function between the two interface technologies. |
2. Sample size used for the test set and the data provenance:
This document describes a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device. It is not a performance study (e.g., clinical trial) that would typically involve a "test set" of patient data in the context of diagnostic or AI device evaluation. The "testing" referred to is likely engineering verification and validation testing to ensure the device performs according to its specifications and is safe, similar to the predicate.
Therefore, information on "sample size used for the test set" and "data provenance (e.g., country of origin, retrospective or prospective)" is not applicable or provided for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As explained above, there is no "test set" in the context of clinical data for ground truth establishment. This is a medical device (massager), not an AI/diagnostic algorithm using image or patient data requiring expert adjudication of ground truth.
Therefore, this information is not applicable or provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as there's no clinical "test set" requiring expert adjudication.
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 device is a physical massager, not an AI diagnostic tool or software-as-a-medical-device (SaMD) that would involve human "readers" or AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this submission is the demonstrated safety and effectiveness of the predicate device, against which the new devices are compared through engineering and design analysis, and compliance with standards.
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI algorithm.
Summary of the study/submission:
The "study" in this context is a 510(k) Premarket Notification designed to demonstrate substantial equivalence of the NormaTec Pulse 2.0 and Pulse Pro 2.0 to a previously cleared predicate device (NormaTec Pulse and Pulse Pro, K160608).
The primary method to "prove" the device meets "acceptance criteria" (which are fundamentally demonstrating equivalence) is through a detailed comparison across various aspects:
- Identical Indications for Use.
- Equivalent Design, Technology, and Principle of Operation. The core mechanism (compressor and valve system inflating cells) is the same. The key difference is the addition of Bluetooth capability for app control, which is argued not to alter therapy or add new features, but merely mimic the existing interface.
- Equivalent Performance and Specifications. This refers to parameters like pressure range, treatment time, inflation/deflation cycles, materials, weight, and dimensions (with minor dimension differences noted but not deemed significant).
- Compliance with relevant standards. The new devices comply with the same standards as the predicate, plus an additional one (ANSI C63.27-2017) related to "Bluetooth communication ability."
- Identical Intended Use Environment and Patient Population.
Verification and Validation activities were performed to establish the performance, functionality, and reliability characteristics of the proposed devices with respect to the predicate, demonstrating that they meet defined requirements and performance claims. These V&V activities constitute the "study" that supports the claim of substantial equivalence. The document does not elaborate on the specifics of these V&V activities (e.g., number of units tested, types of bench tests, clinical subjects if any for general use features), as is typical for 510(k) summaries which focus on summarizing the equivalence rather than detailed study protocols.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).