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 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 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.

AI/ML Overview

The Koya Dayspring is a wearable compression system intended for use in clinic or home settings by medical professionals and patients under medical supervision to increase lymphatic flow in the treatment of various conditions.

Here's an overview of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliant with ISO 10993-1, ISO 10993-5, and ISO 10993-10
Sterilization & Shelf-life	Non-sterile. Accelerated 1-year shelf-life met.
Electrical Safety	Compliant with IEC 60601-1:2012
EMC	Compliant with IEC 60601-1-2:2014
Software Verification/Validation	Compliant with IEC 62304:2015 and FDA Guidance Documents
Transportation Simulation	ASTM D4169 - Completed / Pass
Pressure Verification	Capable of delivering 0-100 mmHg compression pressures - Completed / Pass

2. Sample Size for Test Set and Data Provenance

The provided document does not indicate the use of a "test set" in the context of a clinical study with patients or data. The performance evaluations were primarily based on benchtop testing and assessments of compliance with recognized standards. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) for patient data is not applicable here.

3. Number of Experts and Qualifications for Ground Truth

No experts were explicitly mentioned for establishing ground truth in a clinical or patient data context, as the evaluation was based on benchtop performance testing and compliance with technical standards.

4. Adjudication Method

As there was no clinical study employing human readers or interpretation of medical images/data, an adjudication method (such as 2+1, 3+1) is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported. The submission focuses on device performance through benchtop testing and regulatory compliance, not comparative effectiveness with or without AI assistance for human readers.

6. Standalone (Algorithm Only) Performance

The device is a physical wearable compression system, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The system includes embedded firmware with the ability to connect to a mobile application, but its performance evaluation is centered on the physical device's functions and safety, not an AI algorithm's standalone diagnostic or interpretive capabilities.

7. Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

Compliance with recognized industry standards: e.g., ISO, IEC, ASTM standards for biocompatibility, electrical safety, EMC, software, and mechanical testing.
Benchtop performance measurements: such as pressure verification, demonstrating the device's ability to deliver specified compression ranges.

8. Sample Size for Training Set

The document does not describe a "training set" in the context of machine learning or AI development, as the device is a physical medical device. Software verification and validation were performed, but details of datasets used for training (if any, related to specific software functionalities) are not provided.

9. How Ground Truth for Training Set was Established

Given that the document does not discuss a "training set" for an AI or machine learning model, information on how its ground truth was established is not applicable.

Summary

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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.

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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 (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K210885

Device Name Koya Dayspring

Indications for Use (Describe)

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)

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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: 408 839 5826Fax; 510 217 2340
	E-mail: a.chang@biodesign-rac.com
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:

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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 .

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VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

Feature	Subject Device	Primary PredicateDevice(K193288)	AdditionalPredicate Device(K203178)
Indications for use	The Koya Dayspringsystem is aprescription onlywearablecompression systemthat is intended foruse in a clinic orhome setting bymedicalprofessionals andpatients who areunder medicalsupervision toincrease lymphaticflow in thetreatment of manyconditions such as:• Lymphedema	The KoyaDayspring system isa prescription onlywearablecompression systemthat is intended foruse in a clinic orhome setting bymedicalprofessionals andpatients who areunder medicalsupervision for thetreatment of thefollowing:• Lymphedema• Primarylymphedema	The Flexitouch PlusSystem andgarments for legs,arms, trunk, andchest are intendedfor use by medicalprofessionals andpatients who areunder medicalsupervision toincrease lymphaticflow in thetreatment of manyconditions such as:• Lymphedema• Primarylymphedema• Postmastectomy
	• Primarylymphedema• Post mastectomyedema• Edema followingtrauma andsports injuries• Postimmobilizationedema• Venousinsufficiency• Reducing woundhealing time• Treatment andassistance inhealing stasisdermatitis,venous stasisulcers, or arterialand diabetic legulcers• Lipedema• PhlebolymphedemaThe Dayspringsystem is developedon a wearablecompressiontechnologyplatform, which isdesigned to providemobility forpatients.	• Post mastectomyedema• Edema followingtrauma andsports injuries• Postimmobilizationedema• Venousinsufficiency• Reducing woundhealing timeThe Koya Dayspringsystem is developedon a wearablecompressiontechnologyplatform, which isdesigned to providemobility forpatients.	edema• Edema followingtrauma andsports issues• Postimmobilizationedema• Venousinsufficiency• Reducing wound
ElectricalRequirements	Rechargeable Li-ionBattery Pack, with0.800 A input from90-264 VAC 50/60Hz to AC Adapter,with output voltageof 25.0V DC and3.0A	Rechargeable Li-ionBattery Pack, with1.7A input from100-240 VAC 50/60Hz to AC Adapter,with output voltageof 19.0V DC and3.4A	100-240 VAC50/60 Hz to ACAdapter withoutput voltage of12.0V DC and 3.0A
Output	Sequentialcalibrated gradientPressure	Sequentialcalibrated gradientPressure	Sequentialcalibrated gradientPressure
Mechanism ofAction	Exertion ofsequential pressureto affected area	Exertion ofsequential pressureto affected area	Exertion ofsequential pressureto affected area
Principles ofOperation	Lithium-ion batterypowered integratedshape memory alloychannels creatingcompressivepressure	Lithium-ion batterypowered integratedshape memory alloychannels creatingcompressivepressure	Electricallypowered integratedpneumatic airchannels creatingcompressivepressure
Device TotalPressure 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 sizeand weight	3.4" x 5.2" x 1.5"0.80 lbs	3.2" x 3.6" x 1.79"0.73 lbs	8"x10"x8"6.2 lbs
ControllerEnclosure Material	All plasticconstruction	All plasticconstruction	All plasticconstruction
User Interface	Pushbuttons.Also available isBluetooth LowEnergy (BLE)Module forcommunication withmobile applicationon mobile device	Pushbuttons.Also available isBluetooth LowEnergy (BLE)Module forcommunicationwith mobileapplication onmobile device	PushbuttonsMobile applicationor BLE notavailable
Software/Hardware	Analog and digitalelectronic withmicroprocessor	Analog and digitalelectronic withmicroprocessor	Analog and digitalelectronic withmicroprocessor

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Garment	Image: Garment 1	Image: Garment 2	Image: Garment 3
Garment Material	Nylon fabric withvelcro straps	Nylon fabric withvelcro straps	Nylon fabric withvelcro straps
Stockinette/Liner	Class Ibiocompatibile linerprovided with theunit	Class Ibiocompatibile linerprovided with theunit	Class Ibiocompatibileliner provided withthe unit

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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

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tests.

Performance Study	Overview	Status
Transportation Simulation	ASTM D4169	Completed / Pass
Pressure Verification Testing	Pressure capable ofdelivering 0-100 mmHgcompression 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).

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).