Dayspring

K210885 · Koya Medical, Inc. · JOW · Apr 23, 2021 · Cardiovascular

Device Facts

• Record ID: K210885
• Device Name: Dayspring
• Applicant: Koya Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Special
• 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 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 Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

Device Story

Dayspring is a wearable compression system for lymphedema and related conditions. It consists of a controller and a garment with up to 14 independently controlled sections. The system uses Nickel Titanium (Ni-Ti) shape-memory alloy channels, powered by a rechargeable Lithium-ion battery, to exert sequential, calibrated gradient pressure (0-100 mmHg) on the affected limb. A biocompatible liner is worn under the garment. Operated by patients or clinicians in home or clinic settings, the device provides mobility during therapy. The controller manages compression sequences; it includes a Bluetooth Low Energy (BLE) module for communication with a mobile application. The output is sequential compression, which aids lymphatic flow and wound healing. The device is designed to be untethered, allowing functional range of motion for the patient.

Clinical Evidence

No clinical data. Substantial equivalence is based on benchtop performance testing, including pressure verification (0-100 mmHg), transportation simulation (ASTM D4169), electrical safety/EMC (IEC 60601-1, 60601-1-11, 60601-1-2), and biocompatibility (ISO 10993-1, 5, 10).

Technological Characteristics

Wearable compression system using Nickel Titanium (Ni-Ti) shape-memory alloy channels. Powered by rechargeable Lithium-ion battery. Provides sequential gradient pressure (0-100 mmHg). Garment made of nylon fabric with velcro straps; includes biocompatible liner. Controller features microprocessor, pushbuttons, and BLE connectivity. Compliant with IEC 60601-1, IEC 60601-1-11, and IEC 60601-2. Non-sterile.

Indications for Use

Indicated for patients requiring increased lymphatic flow for treatment of lymphedema (primary/post-mastectomy), edema (post-trauma/sports injury/immobilization), venous insufficiency, wound healing, stasis dermatitis, venous/arterial/diabetic leg ulcers, lipedema, and phlebolymphedema. For use by medical professionals or 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

• Koya Dayspring (K193288)
• Flexitouch Plus System (PD32-G3) (K203178)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2021

Koya Medical, Inc. % Alex Chang Regulatory Affairs Consultant BioDesign Regulatory Services, LLC 16185 Los Gatos Blvd. Los Gatos, California 95032

Re: K210885

Trade/Device Name: Dayspring Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 22, 2021 Received: March 25, 2021

Dear Alex Chang:

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/cdrl/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.

{1}------------------------------------------------

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 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 (QS) 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 [phone] or 301-796-7100).

Sincerely,

Claire L. Hambright -S

for Nicole Gillette Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known) K210885

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 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 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| I.SUBMITTER: | Koya Medical, Inc. | | |
|-------------------------|------------------------------------------|--|--|
| | 2461 Peralta St. Oakland CA 94607 USA | | |
| | Establishment Registration: 3017424826 | | |
| CONTACT: | Alex Chang | | |
| | Regulatory Consultant | | |
| | Phone: [phone]<br>Fax; 510 217 2340 | | |
| | E-mail: [e-mail] | | |
| DATE PREPARED: | April 21, 2021 | | |
| II. DEVICE: | | | |
| TRADE NAME: | DAYSPRING | | |
| CLASSIFICATION NAME: | COMPRESSIBLE LIMB SLEEVE | | |
| DEVICE CLASSIFICATION: | CLASS II | | |
| PRODUCT CODE: | JOW | | |
| III. PREDICATE DEVICES: | | | |
| Primary Predicate | | | |
| Manufacturer: | Koya Medical, Inc. | | |
| Trade Name: | Koya Dayspring | | |
| 510(k): | K193288 | | |
| Additional Predicate | | | |
| Manufacturer: | Tactile Systems Technology, Inc. | | |
| Trade Name: | Flexitouch Plus System (PD32-G3) | | |
| 510(k): | K203178 | | |

#### IV. DEVICE DESCRIPTION:

The Dayspring system consists of two main components: a controller and garment. The garment is powered by an active smart compression technology that is calibrated, instantacting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by the controller. A liner is worn as an accessory under the device to prevent direct patient contact with the garment. The garment is wrapped around the patient's

{4}------------------------------------------------

affected area so that the device fits snugly. The device has up to 14 independently controlled sections in each limb. 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.

# V: INDICATIONSFORUSE:

The Dayspring system is a prescription only wearable compression system thatis intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatmentof 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 Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

Differences in the indications from the cleared primary predicate device (K193288): With the addition of the lower extremity garments, the Dayspring System, which provides a range of 0 - 100 mmHg of active compression, can now allow for the treatment of the following new indications (conditions):

- Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or ● arterial and diabetic leg ulcers
- Lipedema ●
- Phlebolymphedema .

{5}------------------------------------------------

# VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

| Feature | Subject Device | Primary Predicate<br>Device<br>(K193288) | Additional<br>Predicate Device<br>(K203178) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Koya Dayspring<br>system is a<br>prescription only<br>wearable<br>compression system<br>that is intended for<br>use in a clinic or<br>home setting by<br>medical<br>professionals and<br>patients who are<br>under medical<br>supervision to<br>increase lymphatic<br>flow in the<br>treatment of many<br>conditions such as:<br>• Lymphedema | The Koya<br>Dayspring system is<br>a prescription only<br>wearable<br>compression system<br>that is intended for<br>use in a clinic or<br>home setting by<br>medical<br>professionals and<br>patients who are<br>under medical<br>supervision for the<br>treatment of the<br>following:<br>• Lymphedema<br>• Primary<br>lymphedema | The Flexitouch Plus<br>System and<br>garments for legs,<br>arms, trunk, and<br>chest are intended<br>for use by medical<br>professionals and<br>patients who are<br>under medical<br>supervision to<br>increase lymphatic<br>flow in the<br>treatment of many<br>conditions such as:<br>• Lymphedema<br>• Primary<br>lymphedema<br>• Post<br>mastectomy |
| | • Primary<br>lymphedema<br>• Post mastectomy<br>edema<br>• Edema following<br>trauma and<br>sports injuries<br>• Post<br>immobilization<br>edema<br>• Venous<br>insufficiency<br>• Reducing wound<br>healing time<br>• Treatment and<br>assistance in<br>healing stasis<br>dermatitis,<br>venous stasis<br>ulcers, or arterial<br>and diabetic leg<br>ulcers<br>• Lipedema<br>• Phlebolymphede<br>ma<br>The Dayspring<br>system is developed<br>on a wearable<br>compression<br>technology<br>platform, which is<br>designed to provide<br>mobility for<br>patients. | • Post mastectomy<br>edema<br>• Edema following<br>trauma and<br>sports injuries<br>• Post<br>immobilization<br>edema<br>• Venous<br>insufficiency<br>• Reducing wound<br>healing time<br>The Koya Dayspring<br>system is developed<br>on a wearable<br>compression<br>technology<br>platform, which is<br>designed to provide<br>mobility for<br>patients. | edema<br>• Edema following<br>trauma and<br>sports issues<br>• Post<br>immobilization<br>edema<br>• Venous<br>insufficiency<br>• Reducing wound<br> |
| Electrical<br>Requirements | Rechargeable Li-ion<br>Battery Pack, with<br>0.800 A input from<br>90-264 VAC 50/60<br>Hz to AC Adapter,<br>with output voltage<br>of 25.0V DC and<br>3.0A | Rechargeable Li-ion<br>Battery Pack, with<br>1.7A input from<br>100-240 VAC 50/60<br>Hz to AC Adapter,<br>with output voltage<br>of 19.0V DC and<br>3.4A | 100-240 VAC<br>50/60 Hz to AC<br>Adapter with<br>output voltage of<br>12.0V DC and 3.0A |
| Output | Sequential<br>calibrated gradient<br>Pressure | Sequential<br>calibrated gradient<br>Pressure | Sequential<br>calibrated gradient<br>Pressure |
| Mechanism of<br>Action | Exertion of<br>sequential pressure<br>to affected area | Exertion of<br>sequential pressure<br>to affected area | Exertion of<br>sequential pressure<br>to affected area |
| Principles of<br>Operation | Lithium-ion battery<br>powered integrated<br>shape memory alloy<br>channels creating<br>compressive<br>pressure | Lithium-ion battery<br>powered integrated<br>shape memory alloy<br>channels creating<br>compressive<br>pressure | Electrically<br>powered integrated<br>pneumatic air<br>channels creating<br>compressive<br>pressure |
| Device Total<br>Pressure Range | 0-100 mmHg | 0-100 mmHg | 0-100 mmHg |
| Controller Unit | Image: White controller unit | Image: Black controller unit | Image: White controller unit with screen |
| Controller unit size<br>and weight | 3.4" x 5.2" x 1.5"<br>0.80 lbs | 3.2" x 3.6" x 1.79"<br>0.73 lbs | 8"x10"x8"<br>6.2 lbs |
| Controller<br>Enclosure Material | All plastic<br>construction | All plastic<br>construction | All plastic<br>construction |
| User Interface | Pushbuttons.<br>Also available is<br>Bluetooth Low<br>Energy (BLE)<br>Module for<br>communication with<br>mobile application<br>on mobile device | Pushbuttons.<br>Also available is<br>Bluetooth Low<br>Energy (BLE)<br>Module for<br>communication<br>with mobile<br>application on<br>mobile device | Pushbuttons<br>Mobile application<br>or BLE not<br>available |
| Software/Hardware | Analog and digital<br>electronic with<br>microprocessor | Analog and digital<br>electronic with<br>microprocessor | Analog and digital<br>electronic with<br>microprocessor |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

| Garment | Image: Garment 1 | Image: Garment 2 | Image: Garment 3 |
|-------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| Garment Material | Nylon fabric with<br>velcro straps | Nylon fabric with<br>velcro straps | Nylon fabric with<br>velcro straps |
| Stockinette/Liner | Class I<br>biocompatibile liner<br>provided with the<br>unit | Class I<br>biocompatibile liner<br>provided with the<br>unit | Class I<br>biocompatibile<br>liner provided with<br>the unit |

{9}------------------------------------------------

#### VII. PERFORMANCE DATA:

The following performance data were provided in support of substantial equivalence determination.

#### Biocompatibility Testing

The subject device is considered a surface contacting device with prolonged exposure duration considering potential cumulativeuse. The patient-contacting material consists of a circular knit liner made of a hydrophilic nylon fiber and is commonly used for compression liner applications. The surface contacting material described has been evaluated for biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Results demonstrated that the subject device was compliant to all applicable biocompatibility safety standards.

#### Sterilization & Shelf-life Testing

The subject device is non-sterile, and components are unlikely to deteriorate with age. Accelerated 1-year accelerated shelf life testing was performed and shown to support shelf stability.

## Electrical Safety and Electromagnetic Compatibility (EMC)

The subject device was evaluated based on the following applicable performance and safety standards: IEC 60601-1:2012,IEC 60601-1-11:2015 and IEC 60601-1-2:2014. Results demonstrated thatthe subject device was compliant to all applicable performance and safety standards.

#### Software Verification and Validation Testing

The subject device includes embedded firmware in the controller which has the ability to connect with custom software installed on a mobile device. The system software exhibits a moderate level of concern.

Software lifecycle planning and documentation as well verification and validation testing were performed in accordance with IEC 62304:2015 and 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 Testing

The subject device was also evaluated based on the following additional benchtop performance

{10}------------------------------------------------

tests.

| Performance Study | Overview | Status |
|-------------------------------|------------------------------------------------------------------------|------------------|
| Transportation Simulation | ASTM D4169 | Completed / Pass |
| Pressure Verification Testing | Pressure capable of<br>delivering 0-100 mmHg<br>compression pressures. | Completed / Pass |

## Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

## Clinical Study

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.CONCLUSION:

The data included in this submission demonstrate thatthe modified Koya Dayspring™ is substantially equivalent to the cleared primary predicate device, the Koya Dayspring™ (K193288).