(62 days)
Not Found
No
The description focuses on the mechanical and material properties of the device (shape-memory alloy, sequential compression) and mentions pre-programmed control, but does not indicate any adaptive or learning capabilities. The "smart compression technology" appears to refer to the material activation and independent section control, not AI/ML.
Yes
The device is intended for the treatment of conditions like chronic edema, lymphedema, venous insufficiency, and for wound healing, which are therapeutic applications.
No
The device is described as a "wearable compression system" intended for treatment of conditions like chronic edema and lymphedema, and for wound healing, by providing "sequential compression therapy." It does not mention any diagnostic capabilities.
No
The device description explicitly states it consists of a controller and a garment, both of which are hardware components. The garment utilizes active smart compression technology powered by a Nickel Titanium alloy activated by the controller, and the device is powered by a rechargeable battery pack. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Dayspring Lite device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Dayspring Lite Function: The description clearly states that Dayspring Lite is a wearable compression system that applies physical pressure to the affected area (limbs) to treat conditions like edema, lymphedema, and venous insufficiency. It does not involve testing samples from the body.
- Intended Use: The intended use is for applying compression therapy, not for diagnostic testing.
Therefore, Dayspring Lite falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected area (limbs implied by "Compressible Limb Sleeve")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients who are under medical supervision, in a clinic or home setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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
Testing demonstrated that the subject device met all software requirements.
Summary of Performance Testing: The subject device was evaluated based on the following benchtop performance tests.
- Storage and Shelf-Life Stability: 1 Year aging guided by Q10 Theory & ASTM F1980. Status: Completed / Pass
- Transportation Simulation: ASTM D4169. Status: Completed / Pass
- Pressure Verification Testing: Pressure capable of delivering 0-100 mmHg compression pressures. Status: 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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)
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)
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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
Predicate Device
(K210885) | Additional
Predicate Device
(K143185) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Electrical
Requirements | Rechargeable Li-ion
Battery Pack, AC
Charging Adapter | Rechargeable Li-ion
Battery Pack, AC
Charging Adapter | 100-240 VAC
50/60 Hz to AC
Adapter with
output voltage of
12.0V DC and 3.0A |
| Output | Sequential gradient
Pressure | Sequential
calibrated gradient
Pressure | Sequential gradient
Pressure |
| Mechanism of
Action | Exertion of
sequential pressure
to affected area | Exertion of
sequential pressure
to affected area | Exertion of
sequential pressure
to affected area |
| Principles of
Operation | Lithium-ion battery
powered integrated
shape memory alloy
channels creating
compressive
pressure | Lithium-ion battery
powered integrated
shape memory alloy
channels creating
compressive
pressure | Electrically
powered integrated
pneumatic air
channels creating
compressive
pressure |
| Controller
Enclosure Material | All plastic
construction | All plastic
construction | All plastic
construction |
| User Interface | Pushbuttons.
Also available is
Bluetooth Low
Energy (BLE) | Pushbuttons.
Also available is
Bluetooth Low
Energy (BLE) | Pushbuttons
Mobile application
or BLE not
available |
5
| | Module for
communication with
mobile application
on mobile device | Module for
communication
with mobile
application on
mobile device | |
|-------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------|
| Software/Hardware | Analog and digital
electronic with
microprocessor | Analog and digital
electronic with
microprocessor | Analog and digital
electronic with
microprocessor |
| Garment 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 |
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 | |
| Theory & ASTM F1980 | Completed / Pass | |
| Transportation Simulation | ASTM D4169 | Completed / Pass |
| Pressure Verification Testing | Pressure capable of | |
| delivering 0-100 mmHg | ||
| 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
Organization | Standards Title |
|-----------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 60601-1:2005 +
CORR: 1:2006 +
CORR. 2:2007 +
A1:2012 (Edition 3.1) | IEC | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance |
| 60601-1-11:2015 | IEN | Requirements for medical electrical equipment and
medical electrical systems used in the home
healthcare environment |
8
| 60601-1-2:2014
(Edition 4.0) | IEC | Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
disturbances – Requirements and tests |
|---------------------------------|------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 62304:2015
(Edition 1.1) | IEC | Medical devices software –software life cycle
processes |
| 10993-1:2018 | ISO | Biological evaluation of medical devices — Part 1:
Evaluation and testing within a risk management
process |
| 10993-5: 2009 | ISO | Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity |
| 10993-10: 2010 | ISO | Biological evaluation of medical devices - Part 10:
Tests for irritation and skin sensitization |
| D4169-16 | ASTM | Standard Practice for Performance Testing of
Shipping Containers and Systems |
| 14971:2013 | ISO | Medical devices – Application of risk management
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.