(296 days)
No reference devices were used in this submission.
No
The summary describes a passive electrode pad and does not mention any AI or ML components or functionalities.
No
The device itself is a pad intended to transmit electrical current from other electrical stimulation devices (TENS, EMS), which are therapeutic. The Starly pad is an accessory, not the therapeutic device itself.
No
Explanation: The "Intended Use / Indications for Use" section states that the Starly pad is "intended to transmit current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Transcutaneous Electrical Nerve Stimulation)." This indicates its purpose is therapeutic or stimulatory, not diagnostic.
No
The device description clearly lists physical components like "Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener," indicating it is a hardware device.
Based on the provided information, the Starly pad is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Starly pad is for transmitting electrical current to patient skin for use with electrical stimulation devices (TENS and EMS). This is a therapeutic or physical therapy application, not a diagnostic one.
- Device Description: The description details the physical components of an electrode pad designed for external application to the skin.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical and electrical properties of the pad and its interaction with the skin (biocompatibility, impedance, adhesion, current dispersion), which are relevant to its function as an electrode, not a diagnostic tool.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Starly pad does not fit this definition.
N/A
Intended Use / Indications for Use
Starly pad is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.
Product codes
GXY
Device Description
key device components: The Starly pad consists of Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener.
Principle of operation: Through the electrical conductivity of the material, the current connected to the device is transmitted steadily to the skin surface of the human body.
Mechanism of action: It's allowed electrical stimulation signal output from electrotherapy device is transmitted to the human body through conductive materials of the Starly Pad.
General type of material used: Nonwovens-Polypropylene and Poly(ethylene)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient skin
Indicated Patient Age Range
adults only.
Intended User / Care Setting
OTC (Over-The-Counter) or Prescription use.
Healthcare facility/hospital or, Home.
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 the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the Starly pad was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
The Starly pad is considered tissue contacting for a duration of more than 24 hours and less than 30 days.
Performance testing: The Starly pad had tested below performance refer to the Performance test report.
- Dimensions: Thickness: 2.0mm ± 0.5 mm, Width: 20 mm
300 mm (integers specification only, ±0.5), Length: 20 mm300 mm (integers specification only, ±0.5) - Impedance: 100-300Ω
- Skin adhesion performance: 30 times
- Shelf life (Storage life): 2 years
- Current Dispersion:
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows 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.
March 24, 2023
Shenzhen Xingyuanli Technology Co., Ltd. Tse Adrian Quality manager 4/F, No.1, TianShiDa Industrial Park, No.79 Longwo Road, Kengzi Street, Pingshan New District Zhezhen, Guandong 518110 China
Re: K221589
Trade/Device Name: Starly pad Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: June 1, 2022 Received: June 1, 2022
Dear Tse Adrian:
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
1
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 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,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K221589
Device Name Starly pad
Indications for Use (Describe)
Starly pad is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.
| 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) |
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510(k) Summary
1.1 Submitter Information
- Company: Shenzhen Xingyuanli Technology Co., Ltd. ●
- Address: 4/F, No.1, TianShiDa Industrial Park, No.79 Longwo Road, Kengzi street, Pingshan New District, Shenzhen.
- Phone: +086-15915873605 ●
- Contact: Tse Adrian, Quality Manager
- Mail box: xkxadrian@gmail.com
- Date Prepared: Feb. 20, 2023 ●
1.2 Device Information
- Trade/Device Name: Starly pad
- Common Name: Cutaneous electrode
- Classification requlation: Requlation number: 21 CFR 882.1320 Requlation Description: Cutaneous electrode. Regulation Medical Specialty: Neurology
- Review Panel: Neurology ●
- Product Code: GXY
- Regulation Number: 21 CFR 882.1320
- Device Class: Class II
- Submission number: K221589
- Biocompatibility information: Contact duration categorization of the Starly Pad is Classification B of Intact skin (prolonged - 24h to 30 d); The device is intended for prolonged use over a maximum period of 30 days.
1.3 Predicate Device Information
Predicate Device: ELECTRODES PAD
Manufacturer: Shenzhen Bestpad Technology Development Co., Ltd
510(k) number: K190700
Indication of use:
ELECTRODES PAD is intended to transmit electrical current to patient skin
4
for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
The ELECTRODES PAD is for OTC (Over-The-Counter) or Prescription use. The ELECTRODES PAD is for adults only.
No reference devices were used in this submission.
1.4 Subject Device Description
- Device Identification
key device components: The Starly pad consists of Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener.
Image /page/4/Picture/7 description: The image shows two rectangular, gray, medical electrode pads. Each pad has a small, round, metal connector in the center. The pads are on a clear plastic sheet, and the background is blue.
Fig 1. Entity diagram
5
Image /page/5/Figure/1 description: The image shows a diagram of several layers stacked on top of each other. There are six layers in total, labeled with numbers 1 through 6. Layer 6 is on top and has a grid pattern of dots, while the other layers appear to be solid and vary in shade from light gray to black.
Fig 2. Structure diagram
| No. | Name | Description |
|---|---|---|
| 1 | Insulation backing layer | Insulate current to prevent current leakage |
| 2 | Adhesive layer | Connect the insulation backing layer and carbon film layer |
| 3 | Carbon film | Conduct and distribute treatment current to next layer |
| 4 | Conductive adhesive piece layer | Conduct treatment current to patient |
| 5 | Protective film | Prevent medical adhesive from sticking to dust |
| 6 | Snap fastener | Connect with therapeutic device that releases an electric current |
● Device Characteristics
Patient-contacting material: Conductive adhesive piece layer (Medical conductive gel)
Sterile: The Starly Pad is not supplied sterile and do not require sterilization prior to use.
- Environment of Use:
Healthcare facility/hospital or,
6
Home.
-
Intended user:
Adult only. -
Brief Written Description of the Device:
Principle of operation: Through the electrical conductivity of the material, the current connected to the device is transmitted steadily to the skin surface of the human body.
Mechanism of action: It's allowed electrical stimulation signal output from electrotherapy device is transmitted to the human body through conductive materials of the Starly Pad.
- . Materials of Use
General type of material used: Nonwovens-Polypropylene and Poly(ethylene)
Duration and type of contact: Classification B of Intact skin (prolonged -24h to 30 d);
- Key Performance Specifications/Characteristics of the Device: ●
| Impedance | 100-300Ω |
|---|---|
| Skin adhesion performance | 30 times |
1.5 Indications for Use
Starly pad is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.
7
| Comparison
Items | Subject Device:
Starly pad | Predicate Device:
Electrodes pad
(K190700) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | |
| Classification | GXY
Class II
21 CFR 882.1320 | GXY
Class II
21 CFR 882.1320 |
| Classification
name | Cutaneous electrode | Cutaneous electrode |
| Intended use | Starly pad is intended to
transmit electrical current
to patient skin for use with
legally marketed electrical
stimulation devices, i.e.
TENS (Transcutaneous
Electrical Nerve
Stimulation) and EMS
(Electrical Muscular
Stimulation). The Starly pad
is for OTC (Over-The-
Counter) or Prescription
use. The Starly pad is for
adults only. | ELECTRODES PAD is
intended to transmit
electrical current to
patient skin for use with
legally marketed electrical
stimulation devices, i.e.
TENS (Transcutaneous
Electrical Nerve
Stimulation) and EMS
(Electrical Muscular
Stimulation). The PAD is
for OTC (Over-The-
Counter) or Prescription
use. The PAD is for adults
only. |
| Environment of
Use | For OTC (Over-The-
Counter) or Prescription
use. | For OTC (Over-The-
Counter) or Prescription
use. |
| Contraindications | People allergic to this
ingredient are not
allowed.
Contraindicated on skin | People allergic to this
ingredient are not
allowed.
Contraindicated on skin |
| | wounds. | wounds. |
| Comparison
Statement | The subject device enjoys the same classification and
intended use with the predicate device. | |
| Technological Characteristics | | |
| Principle / Method
of Operation | Through the electrical
conductivity of the
material, the current
connected to the device is
transmitted steadily to the
skin surface of the human
body. | Through the electrical
conductivity of the
material, the current
connected to the device is
transmitted steadily to the
skin surface of the human
body. |
| Structural
composition | Starly pad consists of
nonwovens, conductive
adhesive piece, PET film
and fastener. | It composed of an
insulation backing layer, a
double sides adhesive
tape, conducting film,
hydrogel and plastic film. |
| Shapes | Square flake | Square flake |
| Dimension | Thickness: 2.0mm±0.5mm
Width: 20 mm300 mm300 mm
(integers specification only,
±0.5mm)
Length: 20 mm
(integers specification only,
±0.5mm) | (mm)
Length: 20300300
Width: 20
Height (thickness): 1~20 |
| Impedance | 100-300Ω | number |
|------------------|-----------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Biocompatibility | ISO 10993-5: 2009 | Biological evaluation of
medical devices - Part 5: Tests
for in vitro cytotoxicity | SSMT-R-2021-
01116-01A |
| | ISO 10993-10:
2010 | Biological evaluation of
medical devices - Part 10:
Tests for irritation and skin
sensitization | SSMT-R-2021-
01116-03A
SSMT-R-2021-
01116-02A |
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The Starly pad not composed with any energy storage components and electronic components.
Software Verification and Validation Testing
Not applicable. The Starly pad not composed with any software.
Performance testing
The Starly pad had tested below performance refer to the Performance test report.
| Test item | Test report | Test result |
|---|---|---|
| Dimensions | Thickness: 2.0mm ± 0.5 mm | |
| Width: 20 mm~300 mm (integers | ||
| specification only, ±0.5) | ||
| Length: 20 mm~300 mm (integers | ||
| specification only, ±0.5) | ||
| Impedance | Starly Pad Performance Test Report | 100-300Ω |
| Skin | ||
| adhesion | ||
| performance | 30 times | |
| Shelf life (Storage | ||
| life) | 2 years | |
| Current Dispersion |