(202 days)
The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision for the following:
- Lymphedema
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sports injuries
- Post immobilization edema
- Venous insufficiency
- Reducing wound healing time
The Koya Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.
The Koya Dayspring™ system is powered by an active smart compression technology that is calibrated, instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by a controller system. A disposable stockinette is worn as an accessory under the device to prevent direct patient contact with the device is wrapped around the patient's arm so that the device fits snugly. The device has up to 16 independently controlled sections in each arm. The controller can be programmed to provide sequential compression therapy to the affected area over a range of 0-100 mmHg. The device is powered by a rechargeable Lithium-ion battery pack. The device was developed to provide patients with untethered access and a functional range of motion and mobility while treating chronic lymphedema.
The Koya Dayspring is a wearable compression system intended for lymphedema and related conditions. The FDA determined it to be substantially equivalent to the Flexitouch Plus System.
No specific acceptance criteria related to a study of device performance for diagnostic use (like sensitivity, specificity, accuracy) are mentioned in this document. The provided information focuses on engineering and regulatory testing to ensure device safety and functional equivalence to a predicate device, rather than a clinical performance study with defined acceptance criteria for diagnostic efficacy.
Here's a breakdown of the studies conducted, as per the provided text, and how they contribute to demonstrating the device's acceptability:
1. A table of acceptance criteria and the reported device performance
As stated above, this document does not present clinical performance data against acceptance criteria for diagnostic outputs. Instead, it describes engineering and safety testing.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization & Shelf-life Testing | Components should not deteriorate; battery shelf-life adequate. | Device non-sterile, components unlikely to deteriorate with age (except Li-ion battery). Battery shelf-life and charge/discharge testing data provided and found acceptable (implied). |
| Biocompatibility Testing (Stockinette Liner) | Safe for intact skin contact ( |
§ 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).