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

Device Description

The Dayspring system consists of two main components: a controller and garment is powered by an active smart compression technology that is calibrated, instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Tì) shape-memory alloy the controller. A liner or lite weight clothing is worn under the garment to prevent direct patient contact with the garment is wrapped around the patient's affected area so that the device fits snugly. The device has independently controlled sections in each limb. The controller can be programmed to provide graduated 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 Medical Dayspring system is a prescription-only wearable compression system. The provided text describes the regulatory filing and testing performed for this device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided input:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance related to its therapeutic indications (e.g., specific reductions in lymphedema volume). Instead, the performance evaluations focus on safety, functionality, and manufacturing quality. The reported performance confirms compliance with established standards and successful benchtop testing.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility of patient-contacting materials	Compliant to ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Shelf stability / Non-deterioration of components over time	Accelerated shelf-life testing performed and supports shelf stability.
Electrical safety and electromagnetic compatibility (EMC)	Compliant to IEC 60601-1:2012, IEC 60601-1-11:2015, and IEC 60601-1-2:2014.
Software quality and safety (for embedded firmware and mobile app)	Software lifecycle planning, documentation, and verification testing performed per IEC 62304:2015 and FDA guidance documents. Moderate level of concern addressed.
Robustness of packaging and transportation	ASTM D4169 completed and passed.
Pressure delivery capability (0-100 mmHg)	Pressure Verification Testing completed and passed, capable of delivering 0-100 mmHg.

2. Sample size used for the test set and the data provenance:

The document mentions benchtop performance tests, which typically do not involve human subjects as a "test set" in the clinical sense. Instead, the "samples" are the device units or components themselves. No specific sample sizes for these benchtop tests are provided in the summary.

Provenance: This is not applicable in the context of benchtop testing as described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the testing described is primarily technical and regulatory compliance-focused, rather than involving expert assessment of diagnostic accuracy or treatment efficacy against a "ground truth" derived from expert consensus.

4. Adjudication method for the test set:

This is not applicable as the described testing does not involve subjective human interpretation or a need for adjudication methods like 2+1 or 3+1. The tests are objective measurements against defined standards.

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:

This is not applicable. The device (Dayspring) is a compression system for various lymphedema-related conditions, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this device description.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The Dayspring device is a physical medical device (a compressible limb sleeve with a controller), not an algorithm or AI system for standalone performance evaluation in the described context.

7. The type of ground truth used:

For the performance data provided:

Benchtop Tests (Biocompatibility, Shelf-life, Electrical Safety, EMC, Packaging, Pressure Verification): The "ground truth" is defined by international and national standards (e.g., ISO 10993 series, IEC 60601 series, ASTM D4169) and the device's own design specifications (e.g., delivering 0-100 mmHg pressure). These are objective, measurable criteria.
Software Verification and Validation: The "ground truth" is established by software design specifications, requirements, and compliance with standards such as IEC 62304:2015 and relevant FDA guidance documents for software in medical devices.

8. The sample size for the training set:

This is not applicable. The description focuses on regulatory submission and direct performance testing of a physical device. There is no mention of a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

This is not applicable for the same reasons as #8.

Summary

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January 4, 2024

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

Re: K223228

Trade/Device Name: Dayspring Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 1, 2023 Received: May 2, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,

Eric E. Richardson -S

for Nicole Gillette 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) K223228

Device Name 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K223228

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 USAEstablishment Registration: 3017424826
CONTACT:	Jarren BaldwinVP Operations & TechnologyP: 415 851 0337E-mail: jarren@koyamedical.com
DATE PREPARED:	May 1 2023
II. DEVICE:
TRADE NAME:	DAYSPRING
CLASSIFICATION NAME:	SLEEVE, LIMB, COMPRESSIBLE
DEVICE CLASSIFICATION:	CLASS II
PRODUCT CODE:	JOW
III. PREDICATE DEVICES:
Primary PredicateManufacture:Trade Name:510(k):	Koya Medical IncDayspringK210885
Secondary PredicateManufacture:Trade Name:510(k):	Tactile System TechnologyFlexitouch Plus System (PD32-G3)K203178

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IV. DEVICE DESCRIPTION:

V: INDICATIONS FOR USE:

The 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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

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VII. PERFORMANČE DATA:

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

Biocompatibility Testing

The subject device contains the addition of an abdominal garment that consists of a static and active compression wrap that is placed over lite-weight clothing. The arm and leg garments evaluated in previous 510(k) applications are applied over patient-contacting circular-knit liners that have been evaluated for biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Previous applications submitted for the Dayspring system demonstrated that all patient contacting material is 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 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 that the 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 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

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Mechanical Testing

The subject device was evaluated based on the following benchtop performance tests.

Performance Study	Overview	Status
Packaging Transportation Simulation	ASTM D4169	Completed / Pass
Pressure Verification Testing	Pressure capable of delivering 0-100 mmHg 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 Dayspring system. Instead, substantial equivalence is based upon benchtop performance testing.

VIII. CONCLUSION:

The data included in this submission demonstrates that the modified Dayspring is substantially equivalent to the primary predicate device, Dayspring (K210885).

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).

Feature	Subject Device	Primary Predicate(K210885)	Additional Predicate(K203178)
Indications for use	The Koya Dayspringsystem is a prescriptiononly wearablecompression system thatis intended for use in aclinic or home setting bymedical professionals andpatients who are undermedical supervision toincrease lymphatic flowin the treatment of manyconditions such as:• Lymphedema• Primarylymphedema• Post mastectomyedema• Edema followingtrauma and sportsinjuries• Post immobilizationedema• Venousinsufficiency• Reducing woundhealing time• Treatment andassistance inhealing stasisdermatitis, venousstasis ulcers, orarterial and diabeticleg ulcers• Lipedema• PhlebolymphedemaThe Dayspring system isdeveloped on a wearablecompression technologyplatform, which isdesigned to providemobility for patients.	The Koya Dayspringsystem is a prescriptiononly wearablecompression system thatis intended for use in aclinic or home setting bymedical professionals andpatients who are undermedical supervision toincrease lymphatic flow inthe treatment of manyconditions such as:• Lymphedema• Primarylymphedema• Post mastectomyedema• Edema followingtrauma and sportsinjuries• Postimmobilizationedema• Venousinsufficiency• Reducing woundhealing time• Treatment andassistance in healingstasis dermatitis.venous stasis ulcers,or arterial anddiabetic leg ulcers• Lipedema• PhlebolymphedemaThe Dayspring system isdeveloped on a wearablecompression technologyplatform, which isdesigned to providemobility for patients.	The Flexitouch PlusSystem and garmentsfor legs, arms, trunk,and chest are intendedfor use by medicalprofessionals andpatients who are undermedical supervision toincrease lymphatic flowin the treatment ofmany conditions suchas:• Lymphedema• Primarylymphedema• Post mastectomyedema• Edema followingtrauma and sportsissues• Postimmobilizationedema• Venousinsufficiency• Reducing woundhealing time• Treatment andassistance inhealing stasisdermatitis, venousstasis ulcers,arterial ulcers, anddiabetic legulcers• Lipedema• PhlebolymphedemaThe Flexitouch PlusSystem and garmentsfor the head and neckare intended for use bymedical professionalsand patients who are

			under supervision forthe treatment of headand neck lymphedema.
Electrical Requirements	Rechargeable Li-ionBattery Pack, with 0.800A input from 90-264VAC 50/60 Hz to ACAdapter, with outputvoltage of 25.0V DC and3.0A	Rechargeable Li-ionBattery Pack, with 0.800A input from 90-264 VAC50/60 Hz to AC Adapter,with output voltage of25.0V DC and 3.0A	100-240 VAC 50/60 Hzto AC Adapter withoutput voltage of 12.0VDC and 3.0A
Output	Sequential calibratedgradient Pressure	Sequential calibratedgradient Pressure	Sequential calibratedgradient Pressure
Mechanism of Action	Exertion of sequentialpressure to affected area	Exertion of sequentialpressure to affected area	Exertion of sequentialpressure to affected area
Principles of Operation	Lithium-ion batterypowered integrated shapememory alloy channelscreating compressivepressure	Lithium-ion batterypowered integrated shapememory alloy channelscreating compressivepressure	Electrically poweredintegrated pneumatic airchannels creatingcompressive pressure
Device Total PressureRange	0-100 mmHg	0-100 mmHg	0-100 mmHg
Controller Unit	Image: Controller Unit	Image: Controller Unit	Image: Controller Unit
Controller unit size andweight	3.4" x 5.2" x 1.5"0.80 lbs	3.4" x 5.2" x 1.5"0.80 lbs	8"x10"x8"6.2 lbs
Controller EnclosureMaterial	All plastic construction	All plastic construction	All plastic construction
User Interface	Pushbuttons.Also available isBluetooth Low Energy(BLE) Module forcommunication withmobile application onmobile device	Pushbuttons.Also available isBluetooth Low Energy(BLE) Module forcommunication withmobile application onmobile device	PushbuttonsMobile application orBLE not available
Software/Hardware	Analog and digitalelectronic withmicroprocessor	Analog and digitalelectronic withmicroprocessor	Analog and digitalelectronic withmicroprocessor
Appliances	Upper Extremity (Arm) Lower Extremity (Leg + Abdomen)	Upper Extremity (Arm) Lower Extremity (Leg)	Upper Extremity (Arm + Chest) Lower Extremity (Leg + Abdomen) Head and Neck
Appliance Material	Nylon fabric with velcro straps	Nylon fabric with velcro straps	Nylon fabric with velcro straps
Stockinette/Liner	Class I biocompatible liner provided with the unit	Class I biocompatible liner provided with the unit	Class I biocompatible liner provided with the unit