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 Description

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.

AI/ML Overview

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 (<24 hrs exposure): non-cytotoxic, non-sensitizing, non-irritating.	Passed cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10) studies. All results acceptable, material safe for intended use.
Electrical Safety and Electromagnetic Compatibility (EMC)	Compliance with relevant electrical safety and EMC standards.	Adheres to 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	Compliance with software development and cybersecurity guidelines.	Performed in accordance with IEC 62304 Ed. 1.1 and relevant FDA Guidance documents.
Mechanical and Acoustic Testing	Applied pressure comparable to predicate device; transport integrity maintained.	Benchtop mechanical testing showed comparable pressure to predicate device. Transport shipping testing conducted in accordance with ASTM D4169.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes benchtop engineering and safety tests, not clinical studies involving patient data.
For biocompatibility, electrical safety, software V&V, and mechanical testing, the "sample size" would refer to the number of devices or components tested. This specific number is not provided in the summary.
Data provenance is not specified, but these are typically prospective engineering tests conducted in a lab setting rather than clinical data from a specific country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no "ground truth" for diagnostic purposes or clinical interpretation by experts was established in the context of this submission. The tests performed are objective engineering measures (e.g., pressure output, electrical safety, material biocompatibility).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no expert review or adjudication of a test set for diagnostic performance.

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

A MRMC comparative effectiveness study was not done. This device is a therapeutic compression system, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the Koya Dayspring is a physical medical device delivering compression therapy, not an algorithm, and its performance is assessed directly through its physical output and safety features.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the engineering and safety tests, the "ground truth" is defined by established engineering standards, biocompatibility requirements, and direct physical measurements (e.g., actual pressure output compared to expected output, current leakage within limits, material cytotoxicity results). There is no "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense for these types of tests.

8. The sample size for the training set

This is not applicable. The Koya Dayspring is not an AI/ML device that requires a training set of data for an algorithm.

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

This is not applicable as there is no training set for this device.

Summary

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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)

· 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)
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Research Use (Part 21 CFR 361 Subpart B) Over-The-Counter Use (21 CFR 361 Subpart C)

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.

INDICATIONS FOR USE V.

· 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 aprescription only wearablecompression system that isintended for use in a clinic orhome setting by medicalprofessionals and patients whoare under medical supervision forthe treatment of the following:• Lymphedema• Primary lymphedema• Post mastectomy edema• Edema following trauma andsports injuries• Post immobilization edema• Venous insufficiency• Reducing wound healing timeThe Koya Dayspring system isdeveloped on a wearablecompression technologyplatform, which is designed toprovide mobility for patients.	The Flexitouch Plus System andgarments for legs, arms, trunk,and chest are intended for use bymedical professionals andpatients who are under medicalsupervision, for the treatment ofmany conditions such as:• Lymphedema• Primary lymphedema• Post mastectomy edema• Edema following trauma andsports injuries• Post immobilization edema• Venous insufficiency• Reducing wound healing time• Treatment and assistance inhealing stasis dermatitis, venousstasis ulcers, or arterial anddiabetic leg ulcersThe Flexitouch Plus System andgarments for the head and neckare intended for use by medicalprofessionals and patients whoare under medical supervisionfor the treatment of head and
		neck lymphedema.
Electrical Requirements	Rechargeable Li-ion BatteryPack, with 1.7A input from 100-240 VAC 50/60 Hz to ACAdapter, with output voltage of 19.0V DC and 3.4A	100-240 VAC 50/60 Hz to ACAdapter with output voltage of12.0V DC and 3.0A
Output	Sequential calibrated gradientPressure	Sequential calibrated gradientPressure
Mechanism of Action	Exertion of sequential pressure toaffected area	Exertion of sequential pressureto affected area
Principles of Operation	Lithium-ion battery poweredintegrated shape memory alloychannels creating compressivepressure	Electrically powered integratedpneumatic air channels creatingcompressive 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"3 lbs	8"x10"x8"6.2 lbs
Controller Enclosure Material	All plastic construction	All plastic construction
User Interface	Pushbuttons.Also available is Bluetooth LowEnergy (BLE) Module forcommunication with mobileapplication on mobile device	PushbuttonsMobile application or BLE notavailable
Mechanism of Action	Exertion of sequential pressure toaffected area	Exertion of sequential pressureto affected area
Software/Hardware	Analog and digital electronicwith microprocessor	Analog and digital electronicwith microprocessor
Garment
Garment Material	Nylon fabric with velcro straps	Nylon fabric with velcro straps
Stockinette	Class I biocompatibile liner providedwith the unit	Class I biocompatibile linerprovided with the unit
Chambers/Sections	Up to 16 chambers for theextremity	Up to 16 chambers for theextremity
	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).

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).