(27 days)
No
The 510(k) summary describes a standard RF electrosurgical device and does not mention any AI or ML components or functionalities.
No.
The device is used for electrocoagulation and hemostasis, which are surgical procedures rather than therapeutic in nature.
No
The device description indicates that AGNES is an RF electrosurgical device used for electrocoagulation and hemostasis, which are treatment procedures, not diagnostic ones.
No
The device description explicitly lists hardware components such as an LCD screen, radiofrequency generator, SMPS, footswitch, and hand-piece, indicating it is a hardware device with software control, not a software-only medical device.
Based on the provided information, the AGNES device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocoagulation and hemostasis in dermatological and general surgical procedures." This describes a therapeutic or surgical intervention performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an "RF electrosurgical device" with components like a generator, hand-piece, and electrodes. These are tools used for surgical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any features or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or assays typically used in IVD testing
In summary, the AGNES device is an electrosurgical device used for therapeutic purposes during surgery, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI, KCW
Device Description
AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a footswitch, a hand-piece, FDA cleared Single use needle type RF electrodes (K171707) and FDA cleared Disposable neutral electrode pad (K102372).
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
Not Found
Intended User / Care Setting
Not Found
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)
Software (firmware) of the device controls the initialization function about the button. The modified function was verified and validated. The software verification and validation results show that this change does not raise any problems in the safety and effectiveness.
Software (firmware) of the device controls output setting such as output power levels and operating time. The output settings were verified and validated. Software verification and validation results include RF outputs performance result.
IEC 60601-2-2 test also was conducted for the changes. The Software verification and validation results and IEC 60601-2-2 test results show that this change does not raise any problems in the safety and effectiveness.
The new foot switch was certified by UL (E240199) and evaluated in accordance with IEC 60601-1 by TUV.
For the changes (modification), software verification and validation activities have been conducted and the reports were prepared in accordance with "FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
The tests were performed in accordance with the FDA recognized standard, IEC 60601-2-2, Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 24, 2019
Agnes Medical Co., Ltd % Dongha Lee Regulatory Affairs Consultant KMC, Inc. Room No. 904, 27 Digital-ro 27ga-gil, Guro-gu Seoul. Korea 08375
Re: K192728
Trade/Device Name: Agnes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, KCW Dated: September 24, 2019 Received: September 27, 2019
Dear Dongha Lee:
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,
Long Chen, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name AGNES
Indications for Use (Describe)
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
| 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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K192728 page 1 of 4
510(k) Summary
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: September 24, 2019
1. Applicant / Submitter
AGNES MEDICAL CO., LTD
Address: (Seohyeon-dong, 4, 5F Cocoplaza), 20, Seohyeon-ro 210beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea (Postal code: 13591) Tel : +82-31-8020-9702 Fax : +82-31-701-5162
2. Submission Contact Person
DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, Korea Tel : +82-70-8965-5554 Fax : +82-2-2672-0579 Email: dhlee@kmcerti.com
3. Device Information
- Trade Name: AGNES
- Common Name: RF Electrosurgical Device
- Classification Name: Electrosurgical cutting and coagulation device and accessories
- Classification Product Code and Regulation: GEI, 21CFR 878.4400
- Subsequent Product Code and Regulation: KCW, 21CFR878.5350
- Device Class: 2
4. Legally Marketed (Existing) Device
- Trade Name: AGNES (K160469)
5. Description
AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a footswitch, a hand-piece, FDA cleared Single use needle type RF electrodes (K171707) and FDA cleared Disposable neutral electrode pad (K102372).
6. Indication for use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
4
7. Comparison of the modified device to the cleared device
The following comparison table is presented to demonstrate substantial equivalence.
| Descriptive Information | Cleared Device | Modified Device | |
|---|---|---|---|
| Manufacturer | GOWOONSESANG | ||
| COSMETICS CO., LTD | AGNES MEDICAL CO., LTD | ||
| Device Name | AGNES | The same (No change) | |
| 510(k) number | K160469 | - | |
| Classification Product Code / | |||
| Regulatory Number | GEI / 878.4400 | The same (No change) | |
| Subsequent Product Code | KCW / 878.5350 | The same (No change) | |
| Regulatory Class | 2 | The same (No change) | |
| Indications for Use | AGNES is indicated for use in | ||
| dermatological and general | |||
| surgical procedures for | |||
| electrocoagulation and | |||
| hemostasis. | The same (No change) | ||
| Prescription or OTC | Prescription | The same (No change) | |
| Operation | The device uses RF energy | ||
| delivered through micro | |||
| needle electrode to apply heat | |||
| to target tissue for | |||
| coagulating. | The same (No change) | ||
| Electrosurgical | |||
| Unit (ESU) | LCD power | ||
| button | When the mains switch is | ||
| turned on and the LCD power | |||
| button is touched for 1 second, | |||
| the device starts booting. | LCD power button is used for | ||
| initialization (1 level output | |||
| power, 100ms and 0 count) of | |||
| the device. | |||
| Booting is automatically | |||
| started after the mains switch | |||
| is turned on. | |||
| Monopolar or | |||
| Bipolar | Monopolar | The same (No change) | |
| Temperature | |||
| sensors | None | The same (No change) | |
| Impedance | |||
| monitor | None | The same (No change) | |
| Continuity | |||
| monitor | Checking the connection | ||
| between the neutral electrode | |||
| and the electrosurgical unit. | The same (No change) | ||
| Electrode | |||
| monitor | Provide a camera to monitor | ||
| the electrode coating condition | |||
| and shape before using by the | |||
| user. | The same (No change) | ||
| Waveform | Oscillating rectangular wave | The same (No change) | |
| Output | |||
| frequency | 1MHz | The same (No change) | |
| Output | |||
| operating time | Min 50ms / Max 1,000ms | Min 50ms / Max 2,000ms | |
| Output power | |||
| levels | 10 levels | ||
| (2 to 46 W) | 25 levels | ||
| (2 to 46 W) | |||
| Max. | |||
| output | |||
| power | 46 W at 200 ohm | The same (No change) | |
| Max. | |||
| output | |||
| voltage | 104V | The same (No change) | |
| Dimensions | 290mm(W)x455mm(L)x271.7 | ||
| mm(H) | The same (No change) | ||
| Weight | 5.8Kg | The same (No change) | |
| Power Input | 100-250VAC, 50-60Hz | The same (No change) | |
| Active accessory | |||
| (RF Electrode) | FDA Approval | 510(k) cleared by FDA | |
| (K171707) | The same (No change) | ||
| Neutral | |||
| electrode | |||
| pad | FDA Approval | 510(k) cleared | |
| by | |||
| FDA | |||
| (K102372) | The same (No change) | ||
| Functions | For emitting RF energy into | ||
| electrode. | The same (No change) | ||
| Miscellaneous | |||
| accessory | |||
| (Foot switch) | Performance | ||
| Specifications | Single pole, single throw | The same (No change) | |
| Physical | |||
| Specification | Single pedal, IPX6 | Single pedal, IPX8 |
5
Justification of the Changes
- Manufacturer Name
Manufacturer name is changed from GOWOONSESANG COSMETICS CO., LTD to AGNES MEDICAL CO., LTD. Manufacturer organization and address is not changed. Only name is changed.
The facility information (manufacturer name) of FDA database (FURLS, DRLM) was updated to AGNES MEDICAL CO., LTD via DRLM.
The user manual and product label is revised in accordance with changed manufacturer name, AGNES MEDICAL Co Ltd.
2) LCD power button
In the cleared device, LCD power button was used for booting the device. When the mains switch is turned on and the LCD power button is touched for 1 second, the device starts booting.
In the modified device, the button is used for initialization (1 level output power, 100ms and 0 count) of the device. Whenever user wants to set the device to initialization (1 level output power, 100ms and 0 count), it is achieved by touching the button. Booting is automatically started after the mains switch is turned on.
Software (firmware) of the device controls the initialization function about the button. The modified function was verified and validated. The software verification and validation results show that this change does not raise any problems in the safety and effectiveness.
6
3) Output power levels and operating time
Output power is subdivided from 10 levels to 25 levels. The maximum output power is not changed. Operating time is changed from Max 1,000ms to Max 2,000ms.
Software (firmware) of the device controls output setting such as output power levels and operating time. The output settings were verified and validated. Software verification and validation results include RF outputs performance result.
IEC 60601-2-2 test also was conducted for the changes.
The Software verification and validation results and IEC 60601-2-2 test results show that this change does not raise any problems in the safety and effectiveness.
4) Foot switch
Foot switch is changed. The mechanism and physical specification is not changed except to IP degree. The new foot switch has IPX8 which is the more suitable for against water.
The new foot switch was certified by UL (E240199) and evaluated in accordance with IEC 60601-1 by TUV.
8. Software
The software is a firmware to control the RF electrosurgical device, AGNES.
For the changes (modification), software verification and validation activities have been conducted and the reports were prepared in accordance with "FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
9. Performance Testing - Nonclinical
- RF output power testing
The tests were performed in accordance with the FDA recognized standard, IEC 60601-2-2, Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
10. Conclusion
The major consideration such as intended use and principle of operation is not changed. The changes (modifications) of the device were verified and validated, and the results are supported that the device still maintain safety and effectiveness.
In this regard, we conclude that the modified device is substantially equivalent to the legally marketed device.