Koya Ripple
Device Facts
| Record ID | K193288 |
|---|---|
| Device Name | Koya Ripple |
| Applicant | Koya, Inc. |
| Product Code | JOW · Cardiovascular |
| Decision Date | Jun 16, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
Koya Dayspring is a wearable compression system for chronic lymphedema treatment; provides mobility via untethered design. Input: programmed controller settings (0-100 mmHg). Operation: controller activates Nickel Titanium (Ni-Ti) shape-memory alloy channels within a garment to exert sequential calibrated gradient pressure. Output: sequential compression to affected limb. Used in clinic or home by patients or medical professionals. Controller is battery-powered (Li-ion); garment includes disposable stockinette liner. Healthcare providers use device to manage edema and wound healing; patient benefits from functional range of motion and mobility during therapy.
Clinical Evidence
No clinical data provided. Substantial equivalence established via benchtop performance testing, including mechanical pressure comparison against predicate, biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), and software verification/validation (IEC 62304).
Technological Characteristics
Wearable compression system using Nickel Titanium (Ni-Ti) shape-memory alloy actuators. Garment: nylon fabric with velcro straps and disposable biocompatible stockinette liner. Controller: microprocessor-based, rechargeable Li-ion battery, 0-100 mmHg pressure range, up to 16 independent sections. Connectivity: Bluetooth Low Energy (BLE) for mobile app communication. Sterilization: non-sterile.
Indications for Use
Indicated for patients with lymphedema, primary lymphedema, post mastectomy edema, edema following trauma/sports injuries, post immobilization edema, venous insufficiency, and for reducing wound healing time. Intended for use by medical professionals and patients under medical supervision in clinic or home settings.
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
- Flexitouch Plus System, Model PD32-G3 (K170216)
Reference Devices
Submission Summary (Full Text)
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June 16, 2020
Koya, Inc. % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K193288
Trade/Device Name: Koya Dayspring Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 19, 2020 Received: May 19, 2020
Dear Robert Packard:
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 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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).
Sincerely,
Fernando Aguel for 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
510(k) Number (if known) K193288
Device Name Koya Dayspring
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span style="text-decoration: underline;">Research Use (Part 21 CFR 361 Subpart B)</span> <span style="padding-left: 20px;">Over-The-Counter Use (21 CFR 361 Subpart C)</span> |
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| <div style="display: flex; align-items: center;"><input checked="true" style="margin-right: 5px;" type="checkbox"/></div> <div style="display: flex; align-items: center;"><input style="margin-right: 5px;" type="checkbox"/></div> |
> Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# K193288 - 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
#### I. SUBMITTER
Koya, Inc. 357 Tehama St., Suite 1 San Francisco, CA, 94103 USA +1.415.851.0337 Fax: N/A Contact Person: Andy Doraiswamy, PhD Date Prepared: February 21, 2020
#### DEVICE II.
| Name of Device: | Koya Dayspring™ |
|------------------------------|--------------------------|
| Classification Name: | Compressible Limb Sleeve |
| Regulation: | 21 CFR § 870.5800 |
| Regulatory Class: | Class II |
| Product Classification Code: | JOW |
#### III. PREDICATE DEVICE
| Predicate Manufacturer: | Tactile Systems Technology, Inc. (dba Tactile Medical) |
|-------------------------|--------------------------------------------------------|
| Predicate Trade Name: | Flexitouch Plus System, Model PD32-G3 |
| Predicate 510(k): | K170216 |
| Reference Device: | K162481 |
#### DEVICE DESCRIPTION IV.
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.
#### INDICATIONS FOR USE V.
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 treatment of the following:
- · Lymphedema
- · Primary lymphedema
- Post mastectomy edema
- · Edema following trauma and sports injuries
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- · Post immobilization edema
- · Venous insufficiency
- Reducing wound healing time
The system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.
### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
A reference device, K162481, was provided to address the concern that the subject device is using a different principle of operation (i.e., shape-memory materials) when compared to the predicate device (i.e., air pressure). The reference device identified uses the same principle as the subject device.
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
| Feature | Subject Device (K193288) | Predicate Device (K170216) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Koya Dayspring system is a<br>prescription only wearable<br>compression system that is<br>intended for use in a clinic or<br>home setting by medical<br>professionals and patients who<br>are under medical supervision for<br>the treatment of the following:<br>• Lymphedema<br>• Primary lymphedema<br>• Post mastectomy edema<br>• Edema following trauma and<br>sports injuries<br>• Post immobilization edema<br>• Venous insufficiency<br>• Reducing wound healing time<br>The Koya Dayspring system is<br>developed on a wearable<br>compression technology<br>platform, which is designed to<br>provide mobility for patients. | The Flexitouch Plus System and<br>garments for legs, arms, trunk,<br>and chest are intended for use by<br>medical professionals and<br>patients who are under medical<br>supervision, for the treatment of<br>many conditions such as:<br>• Lymphedema<br>• Primary lymphedema<br>• Post mastectomy edema<br>• Edema following trauma and<br>sports injuries<br>• Post immobilization edema<br>• Venous insufficiency<br>• Reducing wound healing time<br>• Treatment and assistance in<br>healing stasis dermatitis, venous<br>stasis ulcers, or arterial and<br>diabetic leg ulcers<br>The Flexitouch Plus System and<br>garments for the head and neck<br>are intended for use by medical<br>professionals and patients who<br>are under medical supervision<br>for the treatment of head and |
| | | neck lymphedema. |
| Electrical Requirements | Rechargeable Li-ion Battery<br>Pack, with 1.7A input from 100-240 VAC 50/60 Hz to AC<br>Adapter, with output voltage of 19.0V DC and 3.4A | 100-240 VAC 50/60 Hz to AC<br>Adapter with output voltage of<br>12.0V DC and 3.0A |
| Output | Sequential calibrated gradient<br>Pressure | Sequential calibrated gradient<br>Pressure |
| Mechanism of Action | Exertion of sequential pressure to<br>affected area | Exertion of sequential pressure<br>to affected area |
| Principles of Operation | Lithium-ion battery powered<br>integrated shape memory alloy<br>channels creating compressive<br>pressure | Electrically powered integrated<br>pneumatic air channels creating<br>compressive pressure |
| Device Total Pressure Range | 0-100 mmHg | 0-100 mmHg |
| Controller Unit | Image: Controller Unit 1 | Image: Controller Unit 2 |
| Controller unit size and weight | 3.3" x 3.6" x 0.8"<br>3 lbs | 8"x10"x8"<br>6.2 lbs |
| Controller Enclosure Material | All plastic construction | All plastic construction |
| User Interface | Pushbuttons.<br>Also available is Bluetooth Low<br>Energy (BLE) Module for<br>communication with mobile<br>application on mobile device | Pushbuttons<br>Mobile application or BLE not<br>available |
| Mechanism of Action | Exertion of sequential pressure to<br>affected area | Exertion of sequential pressure<br>to affected area |
| Software/Hardware | Analog and digital electronic<br>with microprocessor | Analog and digital electronic<br>with microprocessor |
| Garment | | |
| Garment Material | Nylon fabric with velcro straps | Nylon fabric with velcro straps |
| Stockinette | Class I biocompatibile liner provided<br>with the unit | Class I biocompatibile liner<br>provided with the unit |
| Chambers/Sections | Up to 16 chambers for the<br>extremity | Up to 16 chambers for the<br>extremity |
| | Short: 12 | Short: 12 |
| | Medium: 14 | Medium: 14 |
| | Long: 16 | Long: 16 |
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### VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
### Sterilization & Shelf-life Testing
Device is non-sterile, and components are unlikely to deteriorate with age with the exception of Li-ion battery. Battery shelf-life and charge/discharge testing data was provided.
## Biocompatibility Testing
The patient contacting portion of the device is the stockinette liner which is a biocompatible, Class 1 device that is marketed in the USA. Since the material comes in contact with intact skin with an exposure duration of less than 24 hours, it was tested to ensure the safety using cytotoxicity study (ISO 10993-5), sensitization study (ISO 10993-10), and irritation study (ISO 10993-10). All results were found to be acceptable and the material found to safe for the intended use.
### Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing included:
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- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, ●
- IEC 60601-1-2 Ed. 4.0
- IEC 60601-1-11 Ed. 2.0 ●
- IEC 62133-2 Ed. 1.0 ●
### Software Verification and Validation Testing
Software verification and validation testing was performed in accordance with IEC 62304 Ed. 1.1. Additional software verification and validation testing was conducted and documentation was provided as recommended by the following FDA Guidance documents for Industry and FDA Staff:
- Guidance for the Content of Premarket Submissions for Software Contained in . Medical Devices
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software . Use in Medical Devices
- Guidance for Industry and Food and Drug Administration Staff Content of ● Premarket Submissions for Management of Cybersecurity in Medical Devices
- Guidance for Industry, FDA Reviewers and Compliance on Postmarket ● Management of Cybersecurity in Medical Devices
### Mechanical and acoustic Testing
A benchtop mechanical testing study was performed to compare the pressure applied by the subject device with the pressure applied by the predicate device. Additionally, transport shipping testing was conducted in accordance with ASTM D4169.
### Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
### Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the Koya Dayspring™ system. Instead, substantial equivalence is based upon benchtop performance testing.
### VIII. CONCLUSIONS
The data included in this submission demonstrates that the Koya Dayspring™ is substantially equivalent to the legally marketed predicate device, Flexitouch Plus® PD32-G3 (K170216).
