Dayspring Lite

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September 21, 2021 Koya Medical, Inc. % Alex Chang Regulatory Affairs Consultant BioDesign Regulatory Services, LLC 16185 Los Gatos Blvd. Los Gatos, California 95032 ## Re: K212287 Trade/Device Name: Dayspring Lite Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 23, 2021 Received: August 24, 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/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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, Nicole Gillette Assistant Director (Acting) 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212287 Device Name Dayspring Lite Dayspring Lite Indications for Use (Describe) Dayspring Lite 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 conditions: - · Chronic edema - · Lymphedema - · Venous insufficiency - · Wound healing Dayspring Lite 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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ # 1. 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 5826 | | | Fax; 510 217 2340 | | | E-mail: a.chang@biodesign-rac.com | | DATE PREPARED: | Aug 20, 2021 | | II. DEVICE: | | | TRADE NAME: | DAYSPRING LITE | | CLASSIFICATION NAME: | COMPRESSIBLE LIMB SLEEVE (21 CFR 870.5800) | | DEVICE CLASSIFICATION: | CLASS II | | PRODUCT CODE: | JOW | | III. PREDICATE DEVICES: | K143185, K210885 | # IV. DEVICE DESCRIPTION: Dayspring Lite consists of two main components: a controller and garment. The garment is powered by an active smart compression technology that is instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Tì) shape-memory alloy that is activated by the controller. A liner is worn as an accessory under the device 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 up to 14 independently controlled sections in each limb. The controller is pre-programmed to provide sequential compression therapy to the affected area. 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. {4}------------------------------------------------ #### V: INDICATION FOR USE: Dayspring Lite 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 conditions: - . Chronic edema - . Lymphedema - Venous insufficiency . - Wound healing Dayspring Lite is developed on a wearable compression technology platform, which is designed to provide mobility for patients. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE #### DEVICE: | Feature | Subject Device | Primary<br>Predicate Device<br>(K210885) | Additional<br>Predicate Device<br>(K143185) | |----------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Electrical<br>Requirements | Rechargeable Li-ion<br>Battery Pack, AC<br>Charging Adapter | Rechargeable Li-ion<br>Battery Pack, AC<br>Charging Adapter | 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 gradient<br>Pressure | Sequential<br>calibrated gradient<br>Pressure | Sequential 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 | | 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) | Pushbuttons.<br>Also available is<br>Bluetooth Low<br>Energy (BLE) | Pushbuttons<br>Mobile application<br>or BLE not<br>available | {5}------------------------------------------------ | | Module for<br>communication with<br>mobile application<br>on mobile device | Module for<br>communication<br>with mobile<br>application on<br>mobile device | | |-------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------| | 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 | | 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>biocompatible liner<br>provided with the<br>unit | Class I<br>biocompatible liner<br>provided with the<br>unit | Class I<br>biocompatible liner<br>provided with the<br>unit | ## 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 cumulative use. The surface contacting material described was previously evaluated for biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. #### Sterilization 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 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. {6}------------------------------------------------ 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 Post market . Management of Cybersecurity in Medical Devices In accordance with IEC 62304:2015 and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the following software lifecycle documentation has been developed. Testing demonstrated that the subject device met all software requirements. | Document | Status | |--------------------------------------------|------------------| | Software Development Plan | Completed | | Software Requirements Specifications (SRS) | Completed | | Software Design Specification (SDS) | Completed | | Off-the-Shelf Software Management | Completed | | Software Configuration Management | Completed | | Software Architecture | Completed | | Cybersecurity Analysis | Completed | | Software Coding Standard | Completed | | Traceability Analysis | Completed | | Software Verification and Validation | Completed / Pass | #### Summary of Performance Testing The subject device was evaluated based on the following benchtop performance tests. {7}------------------------------------------------ | Performance Study | Overview | Status | |----------------------------------|------------------------------------------------------------------------|------------------| | Storage and Shelf-Life Stability | 1 Year aging guided by Q10<br>Theory & ASTM F1980 | Completed / Pass | | Transportation Simulation | ASTM D4169 | Completed / Pass | | Pressure Verification Testing | Pressure capable of<br>delivering 0-100 mmHg<br>compression pressures. | Completed / Pass | ## Packaging, Shelf Life and Transport Stability Testing The subject device was packaged in a corrugated shipper. The packaging configuration was evaluated based on ASTM D4169. Prior to running the transit simulation, the test sample underwent 1 year accelerated aging based on ASTM F1980 - Standard Guide for Accelerated Aging of Medical Device Packages and was subjected to environmental conditioning to confirm shelf-life stability. Post-simulation, functional testing of the subject device was performed and showed that it continued to meet all functional specifications. # Benchtop Pressure Testing Benchtop pressure testing was performed to verify the pressure range applied by the subject device was equivalent to pressure applied by the K143185 and K210885 predicate systems. #### Test Summary The subject device has been investigated and tested against and complies with the following voluntary standards: | Standards | Standards<br>Organization | Standards Title | |-----------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------| | 60601-1:2005 +<br>CORR: 1:2006 +<br>CORR. 2:2007 +<br>A1:2012 (Edition 3.1) | IEC | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance | | 60601-1-11:2015 | IEN | Requirements for medical electrical equipment and<br>medical electrical systems used in the home<br>healthcare environment | {8}------------------------------------------------ | 60601-1-2:2014<br>(Edition 4.0) | IEC | Medical electrical equipment – Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic<br>disturbances – Requirements and tests | |---------------------------------|------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 62304:2015<br>(Edition 1.1) | IEC | Medical devices software –software life cycle<br>processes | | 10993-1:2018 | ISO | Biological evaluation of medical devices — Part 1:<br>Evaluation and testing within a risk management<br>process | | 10993-5: 2009 | ISO | Biological evaluation of medical devices - Part 5:<br>Tests for in vitro cytotoxicity | | 10993-10: 2010 | ISO | Biological evaluation of medical devices - Part 10:<br>Tests for irritation and skin sensitization | | D4169-16 | ASTM | Standard Practice for Performance Testing of<br>Shipping Containers and Systems | | 14971:2013 | ISO | Medical devices – Application of risk management<br>to medical devices | Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests. # 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 Lite. Instead, substantial equivalence is based upon benchtop performance testing. #### VIII. CONCLUSION: The data included in this submission demonstrates that Dayspring Lite is substantially equivalent to the cleared and marketed primary predicate for its intended use.