Flexitouch Plus System

• K Number: K203178
• Device Name: Flexitouch Plus System
• Manufacturer: Tactile Systems Technology, Inc. (DBA Tactile Medical)
• Date Cleared: 2020-12-20 ( 55 days)
• Product Code: JOW , PPS
• Regulation Number: 870.5800
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K170216 , K182003

Intended Use

The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as

• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports injuries
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
• Lipedema
• Phlebolymphedema

The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema .

Device Description

The Flexitouch Plus System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. Flexitouch Plus garment chambers inflate sequentially with each chamber inflating before the adjacent distal chamber fully deflates. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal pressure to prevent distal backflow.

AI/ML Overview

The provided text is a 510(k) summary for the Flexitouch Plus System. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the removal of a cancer contraindication. The document explicitly states that no testing was necessary to support substantial equivalence for the Flexitouch Plus system with the cancer contraindication removed.

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria. The submission relies on the existing safety and performance data of the previously cleared primary predicate device (Flexitouch System PD32-G3, K170216).

Here's a breakdown of why the requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission asserts that no new testing was needed because the technological characteristics are the same as the primary predicate device, and the only significant change (removal of a contraindication) aligns with a secondary predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new testing was performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no new testing was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new testing was performed for this submission.
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 pneumatic compression pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pneumatic compression pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new testing was performed for this submission.
8. The sample size for the training set: Not applicable, as no new testing was performed for this submission.
9. How the ground truth for the training set was established: Not applicable, as no new testing was performed for this submission.

In summary, the 510(k) submission for the Flexitouch Plus System PD32-G3 (K203178) does not describe any new studies or testing to establish acceptance criteria or demonstrate performance. It relies on the substantial equivalence principle, stating that the device has the same technological characteristics as its primary predicate and aligns with a secondary predicate regarding the removed contraindication.

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).