(127 days)
Prevention of Deep Vein Thrombosis (DVT)
Enhancement of venous & arterial circulation
Prevention of venous stasis
Assist healing of cutaneous ulcers
Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
Reduction of compartmental pressures
The Flowtron Foot Garment is a wrap around foot garment comprising of a bladder and surrounding material intended to apply cyclic compression to the foot to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT).
The Flowtron Foot Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Foot Garment in a cyclic manner.
Flowtron Foot Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps.
The provided text describes a 510(k) premarket notification for "Flowtron Foot Garments – Sterile" (K122330). The core of the submission is to demonstrate substantial equivalence to a predicate device (K965153, Huntleigh FP5000 System, Model FP5000), with the primary difference being the sterility of the new device.
Therefore, the acceptance criteria and the study that proves the device meets them are focused on demonstrating that the sterility process makes the sterile garments safe and effective, and that they perform identically to the non-sterile predicate.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in a table format for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is deemed acceptable if it is identical to the predicate except for the sterility aspect, and the sterility process itself is validated.
| Acceptance Criteria Category | Specific Criteria (Inferred from Text) | Reported Device Performance (from text) |
|---|---|---|
| Performance (Non-Sterility Aspects) | Identical to Foot Garments in predicate device (K965153) in materials, construction, and overall performance. | "The Flowtron Foot Garments - Sterile and the Foot Garments included in the predicate device clearance are identical in all respects including materials, construction, performance and indications for use." |
| Indications for Use | Identical to Foot Garments in predicate device (K965153). | "The Flowtron Foot Garments - Sterile and the Foot Garments included in the predicate device clearance are identical in all respects including... indications for use." |
| Sterility | Sterility processing in accordance with ISO 11135; Validation of sterility processing and shelf-life stability. | "Sterile garments being processed using Ethylene Oxide in accordance with ISO 11135." "Full details of the validation of sterility processing and shelf life stability have been submitted for sterile garments." "Issues raised by the sterilisation process have been addressed in the validation process and these demonstrate that the sterile Foot Garments remain safe and effective." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical performance data for the device's therapeutic function (e.g., DVT prevention efficacy). The performance is established by direct comparison and equivalence to the predicate.
For the sterility validation, which is the primary novelty of this submission, the document states: "Full details of the validation of sterility processing and shelf life stability have been submitted for sterile garments." However, it does not provide the sample size, data provenance, or whether the study was retrospective or prospective. Given it's a validation of a manufacturing process (sterilization and shelf life), it would typically be a prospective, controlled study performed by the manufacturer, ArjoHuntleigh AB, located in Sweden.
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. This device submission relies on substantial equivalence to a previously cleared device and validation of a manufacturing process (sterilization). There is no "ground truth" derived from expert consensus on clinical images or patient outcomes for this particular submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no clinical "test set" requiring expert adjudication mentioned in the document.
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 medical garment for compression therapy, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is primarily established by:
- Predicate Device Performance: The established safety and effectiveness of the existing non-sterile Flowtron Foot Garments (K965153).
- Sterilization Standards: Adherence to recognized international standards for sterilization (ISO 11135) and subsequent validation of that process.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" in the context of this device submission, as it's not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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).