(402 days)
Not Found
No
The description focuses on the RF technology and a simple temperature sensor for safety, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for the relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation, which are therapeutic indications.
No
The device is intended for therapeutic purposes (relief of pain, spasm, and improved blood circulation) rather than for diagnosing a condition.
No
The device description explicitly mentions hardware components such as an RF handpiece, electrode cable, power adapter, and a main body, indicating it is a physical device with software control, not a software-only device.
Based on the provided information, the Apollo Duet (RF Mode) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation. This is a therapeutic use, applied directly to the patient's body.
- Device Description: The device uses Radio-frequency (RF) energy applied through a handpiece with electrodes. This is a physical therapy modality, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Apollo Duet's function and intended use clearly fall outside this definition.
N/A
Intended Use / Indications for Use
Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
Device Description
Apollo Duet has RF handpiece attached to the main body, and consists of an electrode cable and a power adapter.
This equipment has RF mode, which is the main function, RF mode is a mode in which Radio-frequency is output in a bipolar method. An RF handpiece is used, and a high frequency is output through 4ea RF handpiece electrodes. In addition, the RF handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 45 C
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults requiring treatment as specified in the indication for use
Intended User / Care Setting
Hospital or Clinic 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)
Bench tests were conducted to verify that the proposed device met all design specifications.
Ex-vivo testing was performed to compare RF ablation thermal effects of subject device and predicate device on porcine abdominal skin tissue.
Skin temperature was measured when using the subject device on 6 healthy volunteers, including 3 people of light skin and 3 people of dark skin, with a thermographic camera at the irradiated areas on the skin.
Safety testing results demonstrated that the proposed device complies with the following standards:
- Basic safety and essential performance of the Apollo Duet is tested and evaluated according to the IEC 60601-1:2005, AMD1:2012.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014.
- Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories is tested and evaluated according to the IEC 60601-2-2:2017.
- Particular requirements for the basic safety and essential performance of nerve and muscle stimulators is tested and evaluated according to the IEC 60601-2-10:2012/A1:2016.
- Risk management was recorded by referring to ISO 14971:2019.
- Usability was documented by referring to IEC 60601-1-6:2010(Third Edition) + A1:2013.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2022
Weero Co. Eunice Cho Quality Management Representative A605 VentureValley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea
Re: K212253
Trade/Device Name: Apollo Duet (Model : APD-4000) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: July 15, 2021 Received: July 19, 2021
Dear Eunice Cho:
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
1
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 (OS) 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,
for
Colin K. Chen, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212253
Device Name Apollo Duet (Model name: APD-4000)
Indications for Use (Describe)
Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
| 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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3
K212253 Exhibit 5
Date of Summary Preparation: August. 23, 2022
-
- Submitter and US Official Correspondent Submitter : WEERO Co. Address: A605 VentureValley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea Telephone No.: +82-31-5182-8588
| Official Correspondent: Eunice cho | |
|---|---|
| Correspondent: | WEERO Co. |
| Address: | A605 VentureValley II, 142-10, Saneop-ro 156beon-gil, |
| Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea | |
| Telephone No.: | +82-31-5182-8588 |
| Email: | eunice@weeroweero.com |
| 2. | Device Information | |
|---|---|---|
| Trade/Device Name: | Apollo Duet | |
| Regulation Name: | Electrosurgical cutting and coagulation device and | |
| accessories | ||
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories | |
| Product Code: | GEI, PBX | |
| Device Class: | Class II per regulation 21CFR878.4400 |
- Predicate Device(Equivalent Legally Marketed Device) 3.
| Manufacturer: | InMode Ltd. |
|---|---|
| Device Name: | InMode RF Pro System |
| 510(k) Number: | K210492 |
| Classification: | Electrosurgical, Cutting & Coagulation & Accessories |
| : GEI, | |
| Massager, Vacuum, Radio Frequency Induced Heat: PBX | |
| Massager, Therapeutic, Electric: ISA, | |
| Massager, Vacuum, Light Induced Heating: NUV | |
| Class II per regulation 21CFR878.4400. |
-
- Description of the Device
Apollo Duet has RF handpiece attached to the main body, and consists of an electrode cable and a power adapter.
- Description of the Device
This equipment has RF mode, which is the main function, RF mode is a mode in which Radio-frequency is output in a bipolar method. An RF handpiece is used, and a high frequency is output through 4ea RF handpiece electrodes. In addition, the RF handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 45 C
-
- Indications for use (intended use) Apollo duet (RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
4
| Apollo Duet |
|---|
| 510(k) Summary |
Substantial equivalence chart 7.
| Name | Proposed device | Predicate device |
|---|---|---|
| Device Name | Apollo Duet (RF Mode) | InMode RF Pro System |
| (Applicator: Forma) | ||
| Product Code | ||
| Class | GEI | |
| Class II | GEI | |
| Class II | ||
| Manufacturer | WEERO Co. | InMode Ltd. |
| 510(k) No. | K212253 | K210492 |
| Indications | ||
| for use | Apollo duet(RF Mode) is intended for | |
| relief of minor muscle aches and pain, | ||
| relief of muscle spasm, and temporary | ||
| improvement of local blood circulation. | The InMode RF Pro System with the | |
| Non-invasive RF Applicators employs | ||
| RF energy for various applications: | ||
| i-Forma, Forma (Plus), Plus (Plus Plus) | ||
| and Plus90 for relief of minor muscle | ||
| aches and pain, relief of muscle spasm, | ||
| and temporary improvement of local | ||
| blood circulation. | ||
| Target Population | Adults requiring treatment as | |
| specified in the indication for use | Adults requiring treatment as | |
| specified in the indication for use | ||
| Environment Used | Hospital or Clinic setting | Hospital or Clinic setting |
| Input Power | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz |
| Energy Used | (Non-invasive) Bipolar RF | (Non-invasive) Bipolar RF |
| Maximal | ||
| RF output power | 40[W] | Forma: 50[W] |
| RF Frequency | 1MHz | 1MHz |
| Biocompatibility | Materials are biocompatible. | Materials are biocompatible. |
| Sterility | NA | NA |
| Reprocessing | Applicator to be reprocessed in | |
| accordance with user manual | ||
| instructions. | Applicator to be reprocessed in | |
| accordance with user manual | ||
| instructions. |
The proposed device uses similar or identical technology as the predicate devices and has same intended uses. Based upon the predicted overall performance characteristics for the Apollo Duet, WEERO Co. believes that no significant differences in usage of its underlying technological principles between Apollo Duet and the predicate devices.
5
Apollo Duet
510(k) Summary
8. Software / Cybersecurity
The Apollo Duet software design and development follows FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".
The Apollo Duet cybersecurity follows FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Device:.
9. Electrical Safety, Electromagnetic Compatibility Testing & Performance Data
Bench tests were conducted to verify that the proposed device met all design specifications.
Ex-vivo testing was performed to compare RF ablation thermal effects of subject device and predicate device on porcine abdominal skin tissue.
Skin temperature was measured when using the subject device on 6 healthy volunteers, including 3 people of light skin and 3 people of dark skin, with a thermographic camera at the irradiated areas on the skin.
Safety testing results demonstrated that the proposed device complies with the following standards:
- Basic safety and essential performance of the Apollo Duet is tested and evaluated according to the IEC 60601-1:2005, AMD1:2012.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014.
- Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories is tested and evaluated according to the IEC 60601-2-2:2017.
- Particular requirements for the basic safety and essential performance of nerve and muscle stimulators is tested and evaluated according to the IEC 60601-2-10:2012/A1:2016.
- Risk management was recorded by referring to ISO 14971:2019.
- Usability was documented by referring to IEC 60601-1-6:2010(Third Edition) + A1:2013.
- Biocompatibility
| Part | Material | Patient Contact | Duration of
Contact by
ISO 10993-1 | Bio-
compatibility |
|-------------|---------------|-----------------|------------------------------------------|-----------------------|
| Electrode | SUS 304 | Intact Skin | Limited
(