Nimbl (model PD08-N1)
Device Facts
| Record ID | K234155 |
|---|---|
| Device Name | Nimbl (model PD08-N1) |
| Applicant | Tactile Medical |
| Product Code | JOW · Cardiovascular |
| Decision Date | Jun 21, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing
Device Story
Nimbl (PD08-N1) is a pneumatic compression device for treating chronic edema, lymphedema, venous insufficiency, and wound healing. It consists of a controller, garments, hoses, power adapter, and optional external battery. The controller inflates garment chambers in a pre-programmed distal-to-proximal sequence, creating a pressure gradient (19-60 mmHg) to move excess fluid toward healthy regions while preventing backflow. Used in hospital, clinical, or home settings by patients under medical supervision. The device features Bluetooth connectivity for optional use with a mobile application to log treatment data. Healthcare providers determine appropriate pressure settings. The system benefits patients by facilitating natural fluid absorption and processing by the body.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety and EMC (IEC 60601-1), software verification and validation (IEC 62304), mechanical bench testing (pressure verification, port strength, component life), usability testing, and environment/distribution testing.
Technological Characteristics
Pneumatic compression device; controller with microprocessor; 8-chamber garments (nylon/polyurethane-coated polyester); pressure range 19-60 mmHg; Bluetooth connectivity; power via AC or rechargeable battery. Complies with IEC 60601-1 and IEC 62304. Controller size 8.0" x 5.5" x 2.0"; weight 1.75 lbs.
Indications for Use
Indicated for medical professionals and patients under medical supervision for treatment of chronic edema, lymphedema, venous insufficiency, and wound healing.
Regulatory Classification
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.
Predicate Devices
- Entre (model PD08-U) (K143185)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
June 21, 2024
Tactile Medical % Charmaine Dwyer Managing Director The Tamarack Group-MPLS, LLC 23730 Lawtonka Drive Shorewood. Minnesota 55331
Re: K234155
Nimbl (model PD08-N1) Trade/Device Name: Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: May 22, 2024 Received: May 22, 2024
Dear Charmaine Dwyer:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
# Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
Submission Number (if known)
K234155
Device Name
Nimbl (PD08-N1)
Indications for Use (Describe)
The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing
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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Image /page/3/Picture/1 description: The image shows the logo for Tactile Medical. The word "Tactile" is in a large, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, sans-serif font. The logo is white against a dark blue background. There is a small trademark symbol to the right of the word MEDICAL.
## 510(k) Summary
# Nimbl
Prepared May 1, 2024
#### Submitter
| Manufacturer: | Contact Person: |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Tactile Medical<br>3701 Wayzata Blvd, Suite 300<br>Minneapolis, MN 55416 | Vishal Agarwal, Senior Manager – Quality & Regulatory<br>vagarwal@tactilemedical.com<br>612-800-5535 |
#### Device
| Device Name: | Nimbl (model PD08-N1) |
|--------------------------|--------------------------------------------|
| Common / Usual Name: | Pneumatic compression device |
| Classification Name: | Compressible limb sleeve (21 CFR 870.5800) |
| Product Code | Sleeve, limb, compressible (JOW) |
| Device Regulatory Class: | Class 2 |
#### Predicate
| Device Name: | Entre (model PD08-U) |
|--------------------------------|----------------------|
| Premarket Notification Number: | K143185 |
#### Device Description
The Nimbl system is a pneumatic compression device that delivers intermittent sequential compression treatment to affected extremities for lymphedema, chronic edema, venous insufficiency, and wound healing.
This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Nimbl controller is used to inflate the connected garment chambers in a pre-programmed sequence from the distal end to the proximal end of the patient. The pressure gradient provides higher distal pressures. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal prevent distal backflow. The patient's healthcare provider determines what pressure setting is appropriate for the patient.
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Image /page/4/Picture/1 description: The image shows the logo for Tactile Medical. The logo is set against a blue background. The word "Tactile" is in a large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below it. There is a small white circle to the right of the word "Tactile".
## Indications for Use
The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
- . Chronic edema
- Lymphedema
- . Venous insufficiency
- . Wound healing
The subject and predicate devices have the same intended use and are both prescription devices.
## Comparison of Technological Characteristics with the Predicate Device
The Nimbl device and the predicate Entre device are pneumatic compression devices that utilize the same fundamental technology, mode of action, and principles of operation. They are based on the same basic design, software/firmware, hardware, and materials, and device features are similar. They both require a power source for operation. A high-level comparison is provided below.
| | Nimbl (model PD08-N1) system (subject device) | Entre (model PD08-U) system (predicate device) | Comparison | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Product Type | Pneumatic compression device | Pneumatic compression device | Same | | |
| Components | Controller | Controller | The subject device has the option of battery power supply; the predicate does not have this feature. | | |
| | Garments | Garments | | | |
| | Hoses | Hoses | | | |
| | Power adapter | Power adapter | | | |
| | External battery | | | | |
| Mode of Action | Helps direct and move excess fluid from impaired lymphatic regions to healthy regions, where fluid can be absorbed and processed naturally by the body. | Helps direct and move excess fluid from impaired lymphatic regions to healthy regions, where fluid can be absorbed and processed naturally by the body. | Same | | |
| | Principles of Operation | The controller inflates the connected garment chambers in a pre-programmed sequence from distal to proximal with a pressure gradient that provides high distal pressures. The garment chambers are sequentially inflated, pressure is held, and then all chambers are deflated simultaneously. | The controller inflates the connected garment chambers in a pre-programmed sequence from distal to proximal with a pressure gradient that provides high distal pressures. The garment chambers are sequentially inflated, pressure is held, and then all chambers are deflated simultaneously. | Same | |
| | | Environment of Use | Hospital, clinical, and home settings | Hospital, clinical, and home settings | Same |
| | | | Device Lifetime | 5 years | 5 years |
| | | Controller Size and Weight | 8.0" x 5.5" x 2.0" | 11.0" x 6.0" x 8.0" | The subject device is smaller and weighs less |
| 1.75 lbs | | | 4 lbs | | |
| | | Nimbl (model PD08-N1) system (subject device) | Entre (model PD08-U) system (predicate device) | Comparison | |
| Electrical<br>Requirements | | 100 Vac – 264 VAC, ~50/60 Hz<br>10.9 V rechargeable battery<br>pack | 100 Vac – 240 VAC, ~47/63 Hz | than the predicate, primarily due to its smaller compressor.<br>The subject and predicate devices have similar power requirements. | |
| Controller<br>Enclosure<br>Material | | Plastic | Plastic | Same | |
| User Interface | | Push buttons (silicone pad with carbon puck) | Push buttons (membrane switch) | Same | |
| Wireless<br>Functions | Bluetooth | None | The subject device has Bluetooth capability for optional use with the designated mobile application; the predicate device does not have this feature. | | |
| Software /<br>Hardware Type | Analog and digital electronics with microprocessor | Analog and digital electronics with microprocessor | Same | | |
| Software-<br>Concern Level | Basic Documentation Level | Moderate Level of Concern | Same<br>Minor software updates have been made. | | |
| Pressure Range | 19-60 mmHg | 20-80 mmHg | Similar; upper limit lowered for patient comfort. | | |
| Output<br>Dwell Time | Sequential gradient pressure<br>25 seconds minimum | Sequential gradient pressure<br>25 seconds minimum | Same | | |
| Treatment Time | 1 hour maximum | 1 hour maximum | Same | | |
| Garment<br>Chamber<br>Pressure Control | Pressure based | Pressure based | Same | | |
| Garment-<br>Controller<br>Connections | Optional detachable tether hose and new connectors | No detachable tether hose | The subject device features new connectors on the garment and controller, and an optional tether hose, compared to the predicate. | | |
| Garment Port | New port design | Older port design | Similar; the port snout and base design has been updated. | | |
| Garment<br>Materials | Nylon fabric<br>Polyurethane coated polyester fabric | Nylon fabric<br>Polyurethane coated polyester fabric | Same | | |
| Garment<br>Chambers | 8 | 8 | Same | | |
| | Nimbl (model PD08-N1) system (subject device) | Entre (model PD08-U) system (predicate device) | Comparison | | |
| Device<br>Cleanability | Cleanable using commonly available mild household products and disinfectants. | Cleanable using commonly available mild household products and disinfectants. | Same | | |
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Image /page/5/Picture/1 description: The image shows the logo for Tactile Medical. The word "Tactile" is in a large, bold, sans-serif font, and the word "MEDICAL" is in a smaller, sans-serif font below it. The logo is in a dark blue color, and the background is white. There is a small circle to the right of the word "Tactile".
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Image /page/6/Picture/1 description: The image shows the logo for Tactile Medical. The word "Tactile" is in a large, bold, sans-serif font in a dark blue color. Below the word "Tactile" is the word "MEDICAL" in a smaller, sans-serif font, also in dark blue. There is a small circle above the "i" in "Tactile".
Technological differences, resulting from modifications made to the predicate device, include:
- . Bluetooth connectivity for optional use with the Kylee Mobile App to transfer usage data, supporting user ability to log treatments in the mobile application.
- l an external battery to support portability.
- 트 a smaller controller to support portability.
- 트 garment-controller connection updates to support portability.
These differences do not raise any different questions of safety or effectiveness for the Nimbl system compared to the predicate device.
#### Performance Data
Based on the modifications made to the predicate device, the following types of testing have been completed for the Nimbl device to support the substantial equivalence determination:
- I Electrical safety and electromagnetic compatibility (EMC) testing, following IEC 60601-1 Medical electrical equipment – General requirements for basic safety and essential performance
- Software verification and validation (including cybersecurity), following IEC 62304 Medical device software - Software life cycle processes
- . Mechanical bench testing, including pressure verification, port strength, and component life testing
- " Usability testing
- 트 Environment and distribution testing
The technological comparison and performance testing together demonstrate that Nimbl has a similar safety and effectiveness profile as the predicate device.
#### Conclusion
The Nimbl device is substantially equivalent to the legally marketed predicate device.
