(61 days)
No
The device is a simple monopolar electrosurgical electrode and the description does not mention any AI/ML components or functionalities.
Yes
The device is indicated for "coagulation of soft tissue" and its performance studies describe "destruction of sebaceous glands" and "fast relief of inflammation," which are therapeutic actions.
No
Explanation: The device is described as an electrosurgical electrode used for "coagulation of soft tissue" and "destruction of sebaceous glands," which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components (conductive electrode part, insulation coated part, conductive post part) and its function as a physical electrode for delivering radio frequency current. It is 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 is for "coagulation of soft tissue" using radio frequency energy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a monopolar electrosurgical electrode used in conjunction with an electrosurgical device and a neutral electrode plate. This describes a surgical tool used for tissue modification.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies describe animal studies evaluating tissue penetration depth and the effects of the treatment on acne lesions in an animal model. This further supports a therapeutic, rather than diagnostic, application.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool used for direct tissue treatment.
N/A
Intended Use / Indications for Use
The Single Use RF electrode (Needle Type) is a monopolar electrosurgical electrode indicated for coagulation of soft tissue when it used in conjunction with compatible radio frequency electrosurgical device.
Product codes
GEI
Device Description
Single Use RF Electrode (Needle Type) consists of conductive electrode part, insulation coated part and conductive post part. There are several models (Models: GA-B, GA-C, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A) according to the total size and needle electrode part size.
The conductive post of electrode is inserted into the head of the intended handpiece to receive the radio frequency current and delivers the current to a target tissue for coagulation in electrosurgical procedure. This device is a monopolar RF electrosurgical electrode used in conjunction with radio frequency electrosurgical device and a neutral electrode plate which complies with IEC 60601-1 and IEC 60601-2-2. It is intended to be used exclusively with the ESU cleared in K160469, Model: AGNES.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, corium
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
Animal study was conducted to measure the penetration depth and do a macroscopic check on the improvement of acne and histological pathology analyses on the animal model of acne through clinical assessment (photo assessment) and histological evaluation.
- Microscopic assessment
- Macroscopic assessment by dermatologist on damage and safety on the skin surface and inside the corium
- Photo taking with a camera (EOS D3000. Cannon, Tokyo, Japan)
- Check the skin conditions using a folliscope magnifying glass (LeedM, Seoul, Korea)
- Assess reduction of acne lesion using 3 dimensional measuring instrument PRIMOS Pico (GFM, Germany)
- Historical assessment
Extract skin on the rabbit's ear at the end of the test and fix with a 4% paraformaldehyde. Dehydrate with alcohol and xylene by stage and embed with paraffin. Make a fragment of 54m or smaller using a microtome, and remove paraffin with alcohol and xylene again. Dye with hematoxylin & eosin and check the condition of the epidermis and dispersion of sebaceous glands.
This animal study results as the below.
- We checked the depth of skin penetration and discovered that the penetration depth was relatively accurate. For mini pigs, we found distinct coagulation of skin on the area applied with RF.
- In order to make the rabbit's ear model, we conducted intradermal injection of acne bacteria P. acnes and induced oleic acid for 4 weeks. As a result, we found acne lesions such as closed comedos and papules or pustules.
- We selected groups by each grade and conducted the Agnes treatment, and discovered that the sebaceous glands were destroyed and inflammatory cells, papule and pustule on the lesion area were greatly reduced.
- The destruction of sebaceous glands by Agnes killed acne bacteria and induced fast relief of inflammation, and helped quick treatment that it is considered as a valid method to prevent reoccurrence.
The test results are met the performance requirements.
Key Metrics
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2017
Gowoonsesang Cosmetics Co., Ltd. c/o DongHa Lee KMC, Inc. Room No.904, 27,Digital-ro 27 ga-gil, Guro-gu Seoul, Korea 08375
Re: K171707
Trade/Device Name: GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL. GA-W3B. GA-F1A Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: June 13, 2017 Received: June 15, 2017
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. 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 requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Jennifer R. Stevenson -
S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171707
Device Name
Single Use RF electrode (Needle Type)
(Model: GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A)
Indications for Use (Describe)
The Single Use RF electrode (Needle Type) is a monopolar electrosurgical electrode indicated for coagulation of soft tissue when it used in conjunction with compatible radio frequency electrosurgical device.
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
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: July 18, 2017
1. Applicant / Submitter
GOWOONSESANG COSMETICS CO., LTD Address: (Seohyeon-dong, 4, 5F Cocoplaza), 20, Seohyeon-ro 210beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 13591, Korea Tel: +82-31-724-9009 Fax: +82-31-724-9093
2. Submission Contact Person
DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, 08375, Korea Tel: +82-70-8965-5554 Fax: +82-2-2672-0579 Email: dhlee@kmcerti.com
3. Device Information
| Trade Name | GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A,
GA-IL, GA-SL, GA-W3B or GA-F1A | |
|---------------------------|---------------------------------------------------------------------------------|--|
| Common Name | Single Use RF Electrode (Needle Type) | |
| Classification Name | Electrosurgical cutting and coagulation device and accessories | |
| Classification Regulation | 21CFR878.4400 | |
| Device Class | 2 | |
| Product Code | GEI | |
4. Predicate Device
| Manufacturer | Modern Medical Equipment Manufacturing Limited |
|---|---|
| Device Name | Disposable General Electrode |
| 510(k) number | K152059 |
4
5. Description
Single Use RF Electrode (Needle Type) consists of conductive electrode part, insulation coated part and conductive post part. There are several models (Models: GA-B, GA-C, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A) according to the total size and needle electrode part size.
The conductive post of electrode is inserted into the head of the intended handpiece to receive the radio frequency current and delivers the current to a target tissue for coagulation in electrosurgical procedure. This device is a monopolar RF electrosurgical electrode used in conjunction with radio frequency electrosurgical device and a neutral electrode plate which complies with IEC 60601-1 and IEC 60601-2-2. It is intended to be used exclusively with the ESU cleared in K160469, Model: AGNES.
6. Technological Characteristic
The proposed Single Use RF Electrode (Needle Type) is a stainless steel (STS 304) coated by electrical insulation material, p-xylylene dimer C. The conductive electrode part is shaped as needle and the other end as conductive post part is inserted into the intended handpiece to receive the radio frequency current from radio frequency generator.
The conductive electrode part delivers radio frequency current onto a target tissue for coagulation during an electrosurgical procedure. The insulation material prevents accidental conduction of the electrosurgical current from this point to the patient. The construction of proposed electrode and the predicted device is identical. There are no new questions raised regarding to effectiveness and safety.
7. Intended Use / Indication for use
The Single Use RF electrode (Needle Type) is a monopolar electrosurgical electrode indicated for coagulation of soft tissue when it used in conjunction with compatible radio frequency electrosurgical device.
8. Substantial Equivalence
Single Use RF electrode (Needle Type) is substantially equivalent to the predicate device, Disposable General Electrode (K152059) by Modern Medical Equipment Manufacturing Limited. The following comparison table is presented to demonstrate substantial equivalence.
5
| Descriptive Information | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | GOWOONSESANG | |
| COSMETICS CO., LTD. | Modern Medical Equipment | |
| Manufacturing Limited | ||
| Device Name | Single Use RF electrode | |
| (Needle Type) | ||
| (Model: GA-B, GA-C, GA-E, | ||
| GA-I, GA-S, GA-W3A, GA- | ||
| F3A, GA-IL, GA-SL, GA- | ||
| W3B, GA-F1A) | Disposable General Electrode | |
| 510(k) number | K152059 | |
| Product Code | GEI | GEI |
| Regulatory Class | 2 | 2 |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Indications for Use | The Single Use RF electrode | |
| (Needle Type) is a monopolar | ||
| electrosurgical electrode | ||
| indicated for coagulation of soft | ||
| tissue when it used in | ||
| conjunction with compatible | ||
| radio frequency electrosurgical | ||
| device. | The electrode is used to cut and | |
| / or coagulate soft tissues by | ||
| means of high frequency | ||
| electrical current during an | ||
| electrosurgical procedure. | ||
| Prescription or OTC | Prescription | Prescription |
| Monopolar or Bipolar | Monopolar | Monopolar |
| Materials | Stainless Steel (STS 304), | Stainless Steel (Unknown), |
| Insulating Coating | p-xylylene dimer C | Polyolefin Shrink Wrap, Teflon |
| Shrink Wrap or ABS/HIPS | ||
| Single Use or Reusable | Single Use | Single Use |
| Sterilization | EO gas | EO gas |
| Packing | Blister film and Blister paper | Unknown |
| Shelf life | 3 years | Unknown |
8.1 The same between Subject device and Predicate Device.
- Product Code
: The product code of the subject device is GEI. It is the same product code as the predicate device.
6
2) Regulatory Class
: The classification of the subject device is 2 according to the product code, GEI. It is the same classification as the predicate device.
- Indications for Use
: The indications for use of the subject device is indicated for coagulation of soft tissue. It is the same indications for use as the predicate device. In the K152059, the predicate device is indicated to cut and / or coagulate soft tissues by means of high frequency electrical current.
- Prescription Use
: The subject device is a prescription use device. It is the same as the predicate device.
- Principle of operation
: The principle of operation of the subject device is electrosurgical coagulation by means of radio frequency electrical current when it used in conjunction with compatible radio frequency electrosurgical device. It is the same as the predicate device.
- Technical characteristic
: The subject device is a disposable monopolar electrosurgical electrode. It is the same as the predicate device.
- Sterilization.
: The subject device is sterilized by E.O gas. It is the same as the predicate device.
8.2 Difference between Subject device and Predicate Device
- Material
: Raw material of the subject device is stainless, STS 304. Raw material of the predicate device is also stainless but the characteristic is unknown.
- Insulation coating
: Insulation coating material of the subject device is p-xylylene dimer C. The predicate device is coated by insulation materials, Polyolefin Shrink Wrap, Teflon Shrink Wrap or ABS/HIPS
- Packing and shelf life
: The subject device is packed by blister film and blister paper and the shelf life is 3years. Packing and shelf life are unknown.
The subject device has been tested about electrical safety. EMC, bio-compatibility and performance. The packing and shelf life has been verified and validated. The results show that these differences do not raise any problems in the safety and effectiveness.
7
9. Electrical Testing and EMC Testing
The Single Use RF electrode (Needle Type) is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency electrosurgical device.
The electrical and EMC tests were performed with the compatible radio frequency electrosurgical devices (Model: AGNES, Cleared in K160469) in accordance with the FDA recognized standards,
- IEC 60601-1:2005/2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-2:2009, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
- IEC 60601-1-2:2007/2014. Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
The test results are met the electrical safety and EMC requirements.
10. Performance Testing - Nonclinical
-
- RF output
The RF output test were performed with the compatible radio frequency electrosurgical devices (Model: AGNES, Cleared in K160469) in accordance with the FDA recognized standards, Clause 201.11 and 201.12.
- RF output
-
IEC 60601-2-2:2009, Medical electrical equipment Part 2-2: Particular requirements for the । basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
2) Biocompatibility
The biocompatibility tests were performed in accordance with the FDA recognized standards,
- ISO 10993-1:2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- -ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and -
8
skin sensitization.
- ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
3) Sterility
The EO gas sterilization was verified and validated in accordance with the FDA recognized standards
- ISO 11135: 2014, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- -ISO 11138-1:2006, Sterilization of health care products - Biological Indicators - Part 1: General requirements
- -ISO 11138-2: 2006, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- -ISO 10993-7: 2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
4) Packing and Shelf life
The blister packing and the shelf life was verified and validated in accordance with the FDA recognized standards
- ISO 11607-1: 2006. Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- -ISO 116070-2:2006, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980: 2011, Standard guide for accelerated aging of sterile barrier systems for । medical devices.
5) Mechanical retention of detachable active electrodes
The mechanical retention of detachable active electrodes test was performed in accordance with the FDA recognized standard, Clause 201.15.4.1.1 02
- -IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
9
6) Extractable Substance Test
The extractable substance tests were performed about PH, Potassium permanganate-reducible substances, Residue on evaporation, UV spectrum and Heavy metals.
7) Measurement Tolerance Test
The subject device has several models according to different size. The measurement tolerance tests were conducted about the needle length, body length and thickness of the specified different size.
8) Electrical Current Flow Test
The subject device is a monopolar electrosurgical electrode to flow RF current when it used in conjunction with compatible radio frequency electrosurgical device. The electrical current flow test was conducted through a circuit tester.
The test results are met the performance requirements.
11. Performance Testing - Animal
Animal study was conducted to measure the penetration depth and do a macroscopic check on the improvement of acne and histological pathology analyses on the animal model of acne through clinical assessment (photo assessment) and histological evaluation.
1) Microscopic assessment
-
Macroscopic assessment by dermatologist on damage and safety on the skin surface and inside the corium
-
Photo taking with a camera (EOS D3000. Cannon, Tokyo, Japan)
-
Check the skin conditions using a folliscope magnifying glass (LeedM, Seoul, Korea)
-
Assess reduction of acne lesion using 3 dimensional measuring instrument PRIMOS Pico (GFM, Germany)
2) Historical assessment
Extract skin on the rabbit's ear at the end of the test and fix with a 4% paraformaldehyde. Dehydrate with alcohol and xylene by stage and embed with paraffin. Make a fragment of 54m or smaller using a microtome, and remove paraffin with alcohol and xylene again. Dye with
10
hematoxylin & eosin and check the condition of the epidermis and dispersion of sebaceous glands.
This animal study results as the below.
-
We checked the depth of skin penetration and discovered that the penetration depth was relatively accurate. For mini pigs, we found distinct coagulation of skin on the area applied with RF.
-
In order to make the rabbit's ear model, we conducted intradermal injection of acne bacteria P. acnes and induced oleic acid for 4 weeks. As a result, we found acne lesions such as closed comedos and papules or pustules.
-
We selected groups by each grade and conducted the Agnes treatment, and discovered that the sebaceous glands were destroyed and inflammatory cells, papule and pustule on the lesion area were greatly reduced.
-
The destruction of sebaceous glands by Agnes killed acne bacteria and induced fast relief of inflammation, and helped quick treatment that it is considered as a valid method to prevent reoccurrence
12. Conclusion
In comparing between the subject device and the predicate device, there are the same indications for use, prescription use, the principle of operation and technological characteristics (monopolar, single use, raw material). Although there are some different specifications (material, insulation coating, packing and shelf life), the safety and performance test reports are supported to the safety and effectiveness of the subject device. The result of animal study is also supported to thermal effects on tissue and the intended use of the subject device.
In this regard, we conclude that the subject device is substantially equivalent to the predicate device.