(443 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description or performance studies. The "smart compression technology" appears to refer to the use of a shape-memory alloy and programmable control, not AI/ML.
Yes.
The device is intended for use in the treatment of various medical conditions such as lymphedema, venous insufficiency, and ulcers, all of which aim to improve a patient's health and well-being.
No
The Koya Dayspring system is described as a wearable compression system intended for treatment of various conditions, not for diagnosis. Its components and functions are related to delivering therapy (compression) rather than gathering information to identify a medical condition.
No
The device description explicitly states it consists of two main components: a controller and a garment, and mentions hardware components like a Nickel Titanium (Ni-Ti) shape-memory alloy and a rechargeable Lithium-ion battery pack. It also includes performance studies related to electrical safety, EMC, and mechanical testing, which are indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a wearable compression system used to treat various conditions by increasing lymphatic flow. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical system with a controller and garment that applies compression. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Performance Studies: The performance studies listed focus on biocompatibility, sterilization, electrical safety, software validation, and mechanical testing. These are typical tests for a medical device, but not for an IVD which would involve analytical and clinical performance studies related to diagnostic accuracy.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
In summary, the Koya Dayspring system is a therapeutic medical device used for physical treatment, not an in vitro diagnostic device used for diagnosing conditions by analyzing samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Extremity (Arm), Lower Extremity (Leg + Abdomen)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as: 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
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
Mechanical Testing:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
1
Page
2
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
2
Indications for Use
510(k) Number (if known) K223228
Device Name Dayspring
Indications for Use (Describe)
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.
| 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) |
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
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: | Jarren Baldwin
VP Operations & Technology
P: 415 851 0337
E-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 Predicate
Manufacture:
Trade Name:
510(k): | Koya Medical Inc
Dayspring
K210885 |
| Secondary Predicate
Manufacture:
Trade Name:
510(k): | Tactile System Technology
Flexitouch Plus System (PD32-G3)
K203178 |
4
IV. 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.
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.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
| Feature | Subject Device | Primary Predicate
(K210885) | Additional Predicate
(K203178) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | 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. | 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. | The Flexitouch Plus
System and garments
for legs, arms, trunk,
and chest are intended
for use 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
issues
• Post
immobilization
edema
• Venous
insufficiency
• Reducing wound
healing time
• Treatment and
assistance in
healing stasis
dermatitis, venous
stasis ulcers,
arterial ulcers, and
diabetic leg
ulcers
• Lipedema
• Phlebolymphedema
The Flexitouch Plus
System and garments
for the head and neck
are intended for use by
medical professionals
and patients who are |
| | | | |
| | | | under supervision for
the treatment of head
and neck lymphedema. |
| Electrical Requirements | Rechargeable Li-ion
Battery Pack, with 0.800
A input from 90-264
VAC 50/60 Hz to AC
Adapter, with output
voltage of 25.0V DC and
3.0A | Rechargeable Li-ion
Battery Pack, with 0.800
A input from 90-264 VAC
50/60 Hz to AC Adapter,
with output voltage of
25.0V DC and 3.0A | 100-240 VAC 50/60 Hz
to AC Adapter with
output voltage of 12.0V
DC and 3.0A |
| Output | Sequential calibrated
gradient Pressure | Sequential calibrated
gradient Pressure | Sequential calibrated
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 |
| Device Total Pressure
Range | 0-100 mmHg | 0-100 mmHg | 0-100 mmHg |
| Controller Unit | Image: Controller Unit | Image: Controller Unit | Image: Controller Unit |
| Controller unit size and
weight | 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 Enclosure
Material | All plastic construction | All plastic construction | All plastic construction |
| User Interface | Pushbuttons.
Also available is
Bluetooth Low Energy
(BLE) Module for
communication with
mobile application on
mobile device | Pushbuttons.
Also available is
Bluetooth Low Energy
(BLE) Module for
communication with
mobile application on
mobile device | Pushbuttons
Mobile application or
BLE not available |
| Software/Hardware | Analog and digital
electronic with
microprocessor | Analog and digital
electronic with
microprocessor | Analog and digital
electronic with
microprocessor |
| 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 |
6
7
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
8
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).