(21 days)
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: lymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectorny lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves (Product Code "JOW"). They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered by an external IEC 60601-1 Power Supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.
The provided text describes a 510(k) premarket notification for the NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 devices. It focuses on demonstrating substantial equivalence to existing predicate devices (NormaTec PCD-B and NormaTec PCD-T K161346) rather than proving de novo acceptance criteria for an AI/ML medical device through a performance study.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.
The provided text concerns a device that applies pressure to extremities for therapeutic purposes, which falls under physical therapy or rehabilitation, not an AI/ML imaging or diagnostic device. The "AI" mentioned is simply a mobile application that mimics the physical device's user interface via Bluetooth, not an artificial intelligence algorithm that performs analysis or makes decisions.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
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AI/ML Device Context: The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are compressible limb sleeves. Their core function is mechanical (applying pressure). The "Bluetooth capability" and "NormaTec app" are described as solely mimicking the device's physical interface ("does not provide or unlock any additional features or alter the therapy provided by the device"). This indicates the device does not employ AI/ML for analysis, diagnosis, or treatment planning that would require performance criteria as typically assessed for AI/ML medical devices.
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Regulatory Pathway: The document is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device. This pathway typically relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through comparisons and non-clinical testing (e.g., electrical safety, EMC, performance verification), not necessarily extensive clinical performance studies comparing diagnostic accuracy or AI algorithm performance.
Therefore, the specific information requested in the prompt (acceptance criteria for AI/ML performance, ground truth, expert opinions, MRMC studies, etc.) is not applicable to or present in this 510(k) submission, as it pertains to a different type of medical device and regulatory evidence.
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December 21, 2018
NormaTec Industries, LP % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
Re: K183328
Trade/Device Name: Pulse Rx 2.0, Pulse Pro Rx 2.0 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: November 27, 2018 Received: November 30, 2018
Dear Mark Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Fernando Aguel Fernando Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K183328
Device Name Pulse Rx 2.0, Pulse Pro Rx 2.0
Indications for Use (Describe)
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: Iymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectorny lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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NormaTec Industries, LP
| 480 Pleasant StreetSuite A200Watertown MA 02472 | Tel – 800.355.0960Fax - 866.279.2579 |
|---|---|
| Official Contact: | Albert G Sanford, Quality Systems and Regulatory Manager |
| Proprietary or TradeName: | Pulse Rx 2.0 and Pulse Pro Rx 2.0 |
| Common/Usual Name: | Compressible limb sleeve |
| Classification Code andName: | 21 CFR 870.5800 Compressible Limb SleeveProduct Code: JOWClass II |
| Device Name: | Pulse Rx 2.0, and Pulse Rx 2.0 |
| Predicate Device: | K161346 – NormaTec PCD-B and NormaTec PCD-T |
Device Description
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves (Product Code "JOW"). They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered by an external IEC 60601-1 Power Supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.
The user interface on the Pulse Pro Rx 2.0 model is 4.3" color TFT Screen with capacitive sensor (similar to a Smartphone). The user interface on the Pulse Rx 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.
Intended User
Rx Only
Patient Population
Adults
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Indications for Use
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves 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
Intended Use Environment:
Home, hospital, and other healthcare settings.
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Table 5.1 – Table of Device Comparisons and Differences
| Predicate Devices | Proposed New Devices | Comment | |
|---|---|---|---|
| Model Name510(k) Number | NormaTec PCD-B and NormaTec PCD-T 510(k) K161346 | NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 510(k) TBD | N/A |
| Manufacturer | NormaTec Industries, LP | Same | N/A |
| Prescriptive | Yes | Same | N/A |
| Indications for use | The NormaTec PCD-B and PCD-T arecompressible limb sleeves intended toapply pressure to the extremities to treatLymphedema and other edematousconditions, 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 | Same | N/A |
| Intended UseEnvironment | Home, hospital, and other healthcaresettings. | Same | N/A |
| Power Source(s) | 15 VDC via an IEC 60601-1compliant power supply (100- 240 VACinput).Optional internal battery. | 15 VDC via an IEC 60601-1compliant power supply (100- 240 VACinput).Integrated rechargeable battery | N/A |
| Predicate Devices | Proposed New Devices | Comment | |
| Software / FirmwareMicro-processorControl | Microprocessor | Same | N/A |
| Technology | Compressor and valve system thatsequentially inflates cells of appliance | Compressor and valve system thatsequentially inflates cells of appliance.Bluetooth communication ability. | Proposed devices incorporate a certifiedBluetooth module to allow using aNormaTec app as a user interface. |
| Compliance withVoluntary 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. | The proposed devices comply with oneadditional standard: ANSI C63.27-2017 |
| Device PressureRange | Same | Same | N/A |
| Treatment Time | Stays on until the user turns it off or canbe set up to turn off in a range of 10 to175 minutes | Stays on until the user turns it off or canbe set up to turn off in a range of 10minutes to continuous | N/A |
| Inflation/DeflationCycle Type | Sequential Gradient, Peristaltic andPulsing | Same | N/A |
| Appliance ContactSurface Material | 200 denier nylon with a polyurethanelaminate/extrusion | Same | N/A |
| Number of Inflatableappliance segments | 5 or less | Same | N/A |
| Weight | 3.6 pounds (incl. battery) | Same | N/A |
| Dimensions(W x H x D) | 4" x 5" x 9" | 4.4" x 3.8" x 8.1" | N/A |
| Housing Materialsand Constructions | Molded ABS enclosure (94V0) | Same | N/A |
| Patient contact | Non-conductive appliances | Same | N/A |
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Premarket Notification 510(k) Section 5 – 510(k) Summary
NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0
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Differences Between Models
| Characteristic | Pulse Rx 2.0 | Pulse Pro Rx 2.0 |
|---|---|---|
| Power On - The system recalls and displays the last used settings for: | ||
| Treatment time | X | X |
| Treatment mode | X | X |
| Therapy mode | ||
| Rehab mode - Recalls zone focus | X | X |
| Custom - recalls all settings | ||
| Recovery Flush | ||
| Appliance Type | N/A | X |
| Power Level | X | X |
| Number of zones | X | X |
| Rest time | X | X |
| Time | ||
| Add time | ||
| Before treatment | X | X |
| During treatment | ||
| Decrease time | ||
| Before treatment | X | X |
| During treatment | ||
| Continuous mode | X | X |
| Counter | ||
| Count down - 1 second increments | X | X |
| Count up (continuous mode) - 1 second increments | ||
| Compliance - Trip meter - reset by User | N/A | X |
| Chronometer Odometer - cannot be reset by User | X | X |
| Pressure | ||
| Increase level | ||
| Before treatment | X | X |
| During treatment | ||
| Decrease level | ||
| Before treatment | X | X |
| During treatment |
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| Section 5 - 510(k) Summary | |
|---|---|
| Characteristic | Pulse Rx 2.0 | Pulse Pro Rx 2.0 |
|---|---|---|
| Treatment Mode – Can ONLY be changed before treatment begins | ||
| NormaTec Pulse | X | X |
| Sequential | X | X |
| Rest Time | ||
| View or change rest time – before treatment | X | X |
| # of Zones | ||
| Change number of zones – before treatment | X | X |
| Treatment | ||
| Starting | X | X |
| Pause | X | X |
| Un-pause | X | X |
| End – If timer reaches 0:0000, treatment will continue until Rest periodis reached. The user is given options to either:Add timeContinue until cycle is finishedQuit | X | X |
| Remote operation via Bluetooth app | X | X |
| Battery Charging | ||
| Displays battery level | X | X |
| Displays when battery is charging | X | X |
| Power off | ||
| No treatment in process | X | X |
| Treatment is process | X | X |
| Appliance type | ||
| Select appliance – boot, arm, hipNOTE: If hip appliance is selected, treatment mode defaults to 2-zonetreatment | X | X |
| Therapy Mode | ||
| Recovery FlushPreset NormaTec PULSE time / PULSE pressure valuesAppliance type applicable - boot, arm, hip | N/A | X |
| RehabPreset NormaTec PULSE time / PULSE pressure valuesLeg appliance – Foot/ankle, calf, knee, lower quad, upper quadArm appliance – Hand/wrist, forearm, elbow, bicep, shoulderHip appliance - Quadriceps, hip | N/A | X |
| Characteristic | Pulse Rx 2.0 | Pulse Pro Rx 2.0 |
| Custom SettingsAllows user to program NormaTec PULSE pressure and time values foreach zonePressure range – 30-110 mmHg, user can select in 10 mmHgincrementsTime range - 15 seconds to 4 minutes, user can select in 15 secondincrements | N/A | X |
| Display Settings Adjustment | ||
| Brightness controls | N/A | X |
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Determination of Substantial Equivalence
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are substantially equivalent to currently marketed and cleared devices NormaTec PCD-B and NormaTec PCD-T 510(k) K161346 because:
Indications for Use
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 indications for use are identical to the predicate device, NormaTec PCD-B and NormaTec PCD-T 510(k) K161346.
Prescriptive
The NormaTec Pulse Rx 2.0, Pulse Pro Rx 2.0, and the predicate (K161346) are Rx devices.
Design, Technology, and Principle of Operation
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 have equivalent design and features when compared to the predicate and have the equivalent technology to the predicate. NormaTec PCD-B and NormaTec PCD-T 510(k) K161346.
The proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. 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.
Performance and Specifications
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 have equivalent specifications of performance when compared to the predicate. NormaTec PCD-B and PCD-T 510(k) K161346.
Compliance with Standards
The predicate devices are compliant with AAM ANSI ES60601-1-2, and IEC 60601-1-11.
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 comply with AAMI ANSI ES60601-1. IEC 60601-1-2. IEC 60601-1-11, and ANSI C63.27-2017.
Materials
The patient-contacting materials of the Pulse Rx 2.0 and Pulse Pro Rx 2.0 are the inflatable appliances that are identical to the predicate, NormaTec PCD-B and PCD-T 510(k) K161346.
Intended Use Environment
Home, hospital, and other healthcare settings, which are identical to the predicate.
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Features
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 have equivalent features when compared to the predicate, NormaTec PCD-B and PCD-T 510(k) K161346.
Conclusion
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are substantially equivalent to the predicate, NormaTec PCD-B and PCD-T 510(k) K161346 in:
- Patient population, .
- Environment of use, .
- Technology characteristics, .
- . Materials,
- Specifications / performance, and .
- . Compliance with international standards.
The inclusion of the Bluetooth capability and associated app does not affect the proposed devices and the predicate. The app functions only as an alternative user interface. No additional features are provided or unlocked by the app. Nor is the therapy provided by the devices affected by using the app.
Other minor differences as detailed in the substantial equivalence table do not raise questions of safety and effectiveness.
Indications for Use
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 Indications for Use and Contraindications are identical to the predicate device, NormaTec PCD-T and NormaTec PCD-B 510(k) K161346.
Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 with respect to the predicate were performed. Testing performed demonstrated that the proposed devices meet defined requirements and performance claims.
§ 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).