(29 days)
Not Found
No
The summary describes a mechanical compression system controlled by a programmed shape-memory alloy and a controller. There is no mention of AI or ML in the device description, intended use, or performance studies. The "smart compression technology" appears to refer to the programmable nature of the Ni-Ti alloy, not AI/ML.
Yes
The device is intended to treat various medical conditions such as lymphedema, venous insufficiency, and ulcers by increasing lymphatic flow and providing compression therapy.
No
The device is described as a wearable compression system intended for increasing lymphatic flow and treating various conditions, not for identifying or assessing a medical condition.
No
The device description clearly outlines hardware components including a controller, garment with active smart compression technology using a shape-memory alloy, and a rechargeable Lithium-ion battery pack. The performance studies also include testing for electrical safety, EMC, and mechanical properties, which are relevant to hardware.
Based on the provided information, the Koya Dayspring system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "wearable compression system" used to "increase lymphatic flow in the treatment of many conditions." This describes a therapeutic device that acts directly on the patient's body.
- Device Description: The description details a physical system consisting of a controller and garment that applies compression. This is consistent with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Koya Dayspring system does not fit this description. It is a therapeutic device that applies physical compression to treat medical conditions.
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. The garment is powered by an active smart compression technology that is calibrated, instantacting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by the controller. A liner is worn as an accessory under the device to prevent direct patient contact with the garment. 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected area (limbs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients who are under medical supervision / 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 cumulativeuse. The patient-contacting material consists of a circular knit liner made of a hydrophilic nylon fiber and is commonly used for compression liner applications. The surface contacting material described has been evaluated for biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Results demonstrated that the subject device was 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 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 thatthe 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 Postmarket Management of Cybersecurity in Medical Devices
Mechanical Testing:
- 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 Koya Dayspring system. Instead,substantial equivalence is based upon benchtop performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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.
April 23, 2021
Koya Medical, Inc. % Alex Chang Regulatory Affairs Consultant BioDesign Regulatory Services, LLC 16185 Los Gatos Blvd. Los Gatos, California 95032
Re: K210885
Trade/Device Name: Dayspring Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 22, 2021 Received: March 25, 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/cdrl/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.
1
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 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,
Claire L. Hambright -S
for Nicole Gillette Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210885
Device Name Koya 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | Alex Chang | ||
| Regulatory Consultant | |||
| Phone: 408 839 5826 | |||
| Fax; 510 217 2340 | |||
| E-mail: a.chang@biodesign-rac.com | |||
| DATE PREPARED: | April 21, 2021 | ||
| II. DEVICE: | |||
| TRADE NAME: | DAYSPRING | ||
| CLASSIFICATION NAME: | COMPRESSIBLE LIMB SLEEVE | ||
| DEVICE CLASSIFICATION: | CLASS II | ||
| PRODUCT CODE: | JOW | ||
| III. PREDICATE DEVICES: | |||
| Primary Predicate | |||
| Manufacturer: | Koya Medical, Inc. | ||
| Trade Name: | Koya Dayspring | ||
| 510(k): | K193288 | ||
| Additional Predicate | |||
| Manufacturer: | Tactile Systems Technology, Inc. | ||
| Trade Name: | Flexitouch Plus System (PD32-G3) | ||
| 510(k): | K203178 |
IV. DEVICE DESCRIPTION:
The Dayspring system consists of two main components: a controller and garment. The garment is powered by an active smart compression technology that is calibrated, instantacting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by the controller. A liner is worn as an accessory under the device to prevent direct patient contact with the garment. The garment is wrapped around the patient's
4
affected area so that the device fits snugly. The device has up to 14 independently controlled sections in each limb. 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.
V: INDICATIONSFORUSE:
The Dayspring system is a prescription only wearable compression system thatis 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 treatmentof 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.
Differences in the indications from the cleared primary predicate device (K193288): With the addition of the lower extremity garments, the Dayspring System, which provides a range of 0 - 100 mmHg of active compression, can now allow for the treatment of the following new indications (conditions):
- Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or ● arterial and diabetic leg ulcers
- Lipedema ●
- Phlebolymphedema .
5
VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
| Feature | Subject Device | Primary Predicate
Device
(K193288) | Additional
Predicate Device
(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 | 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
treatment of the
following:
• Lymphedema
• Primary
lymphedema | 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 |
| | • 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
• Phlebolymphede
ma
The Dayspring
system is developed
on a wearable
compression
technology
platform, which is
designed to provide
mobility for
patients. | • 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. | edema
• Edema following
trauma and
sports issues
• Post
immobilization
edema
• Venous
insufficiency
• Reducing wound
|
| 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
1.7A input from
100-240 VAC 50/60
Hz to AC Adapter,
with output voltage
of 19.0V DC and
3.4A | 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: White controller unit | Image: Black controller unit | Image: White controller unit with screen |
| Controller unit size
and weight | 3.4" x 5.2" x 1.5"
0.80 lbs | 3.2" x 3.6" x 1.79"
0.73 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 |
6
7
8
| Garment | Image: Garment 1 | Image: Garment 2 | Image: Garment 3 |
|---|---|---|---|
| Garment Material | Nylon fabric with | ||
| velcro straps | Nylon fabric with | ||
| velcro straps | Nylon fabric with | ||
| velcro straps | |||
| Stockinette/Liner | Class I | ||
| biocompatibile liner | |||
| provided with the | |||
| unit | Class I | ||
| biocompatibile liner | |||
| provided with the | |||
| unit | Class I | ||
| biocompatibile | |||
| liner provided with | |||
| the unit |
9
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 cumulativeuse. The patient-contacting material consists of a circular knit liner made of a hydrophilic nylon fiber and is commonly used for compression liner applications. The surface contacting material described has been evaluated for biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Results demonstrated that the subject device was 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 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 thatthe 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 Postmarket . Management of Cybersecurity in Medical Devices
Mechanical Testing
The subject device was also evaluated based on the following additional benchtop performance
10
tests.
| Performance Study | Overview | Status |
|---|---|---|
| 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 Koya Dayspring system. Instead,substantial equivalence is based upon benchtop performance testing.
VIII.CONCLUSION:
The data included in this submission demonstrate thatthe modified Koya Dayspring™ is substantially equivalent to the cleared primary predicate device, the Koya Dayspring™ (K193288).