(433 days)
No
The summary describes a standard RF electro-coagulation device and does not mention any AI or ML components or functionalities.
Yes
The device is described as an electro-coagulation and hemostasis device used in dermatological and general surgical procedures, which directly treats tissue, aligning with the definition of a therapeutic device.
No
The device is described as being used for "electro-coagulation and hemostasis" in "dermatologic and general surgical procedures," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly lists hardware components such as a system main body, handpieces, electrodes, footswitch, and an LCD touch screen control panel, indicating it is not software-only.
Based on the provided information, the ACUTRON device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures for electro-coagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on the patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details how the device delivers RF energy to tissue using a handpiece and micro-needle electrodes to create heat and coagulate tissue. This is a physical interaction with the body, not an analysis of a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The ACUTRON is clearly described as a surgical device used for tissue modification through electro-coagulation.
N/A
Intended Use / Indications for Use
ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
ACUTRON is High Frequency(=Radio Frequency, RF) includes the system main body, a handpieces with single-use micro-needle type electrodes, footswitch and an LCD touch screen control panel.
The RF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue.
Using the micro needle tip, the ACUTRON creates heat within the target dermal tissue via micro-needles inserted from the tip.
The ACUTRON is consists of ;
-
- Main unit
-
- Smartcure handpiece(FDA cleared K182355)
-
- Monopolar type micro-needle electrodes(FDA cleared K182355)
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)
Design verification process were performed following risk assessment to verify that no new questions of safety and effectiveness have been raised due to the modifications introduced.
Biocompatibility testing:
The patient contact components and materials are identical to the predicate device. The biocompatibility is being leveraged from the predicate device.
Non Clinical testing:
IEC 60601-1: 2005, AMD 1: 2012 Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2: 2014 Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2: 2017 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories.
Animal testing:
Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces, the predicate device.
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.
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2022
ILOODA Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Ste 610 Houston, Texas 77054
Re: K211000
Trade/Device Name: Acutron Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 4, 2022 Received: April 11, 2022
Dear Dave Kim:
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 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 top ic. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211000
Device Name ACUTRON
Indications for Use (Describe)
ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation 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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3
510(k) Summary K211000
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Date 510k summary prepared: July 6, 2022
I. SUBMITTER
| Submitter's Name : | Ilooda Co.,Ltd |
|---|---|
| Submitter's HQ Address: | 120, Jangan-ro 458 Beon-gil, Jangan-Gu, |
| Suwon-Si Gyeonggi do, KOREA, 16200 | |
| Submitter's Telephone: | +82-31- 210-1622 |
| Contact person: | Yun-Jung HA (yjha@ilooda.com) / RD Manager |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| Address: | 7505 Fannin St. Ste 610, Houston, TX 77054 |
| Telephone: | +713-467-2607 |
| DEVICE | |
| Trade/proprietary name: | ACUTRON |
| Common or Usual Name: | Micro-needle RF system |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI) |
| Regulatory Class: | Class II |
| Prescription Use. |
4
PREDICATE DEVICE
| Device Manufacturer: | ILOODA CO.,LTD |
|---|---|
| Device Name: | Secret RF Smartcure Applicator |
| 510(k) Number: | K182355 |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI, OUH) |
| Regulatory Class: | Class II |
REFERENCE DEVICE
| Device Manufacturer: | ILOODA CO., LTD |
|---|---|
| Trade/proprietary name: | Secret RF |
| Common or Usual Name: | Micro-needle Fractional RF |
| 510K number: | K170325 |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI, OUH) |
| Regulatory Class: | Class II |
These devices have not been subject to a design-related recall.
II. DEVICE DESCRIPTION
ACUTRON is High Frequency(=Radio Frequency, RF) includes the system main body, a handpieces with single-use micro-needle type electrodes, footswitch and an LCD touch screen control panel.
The RF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue.
Using the micro needle tip, the ACUTRON creates heat within the target dermal tissue via micro-needles inserted from the tip.
The ACUTRON is consists of ;
-
- Main unit
-
- Smartcure handpiece(FDA cleared K182355)
-
- Monopolar type micro-needle electrodes(FDA cleared K182355)
5
INDICATIONS FOR USE: IV.
ACUTRON is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE V.
| Proposed Device | Predicate Device | Remark | ||
|---|---|---|---|---|
| ACUTRON | ||||
| (K211000) | Secret RF Smartcure | |||
| applicator (K182355) | ||||
| Indications for use | ACUTRON is intended | |||
| for use in dermatologic and | ||||
| general surgical procedures | ||||
| for electro-coagulation and | ||||
| hemostasis. | Secret RF Smartcure | |||
| applicator is intended for | ||||
| use in dermatologic and | ||||
| general surgical procedures | ||||
| for electro-coagulation and | ||||
| hemostasis | ||||
| Handpieces | Image: Handpiece | Image: Handpiece | Same | |
| Handpiece | ||||
| material | Aluminum | Aluminum | Same | |
| Patient return | ||||
| electrode | All-in-one connection with | |||
| Patient plate connector. | ||||
| The handpiece and the counter | ||||
| plate connector are connected to | ||||
| one connector of the main body | ||||
| and do not affect the safety or | ||||
| effectiveness performance. | The electrode handpiece | |||
| and the patient plate are | ||||
| separate. | Same | |||
| Frequency | $2MHz \pm 10%$ | $2MHz \pm 10%$ | Same | |
| Output Power | $0.1W ~ 45W at 500\Omega$ | $0.1W ~ 45W at 500\Omega$ | Same | |
| Treatment time | 10~15min | |||
| (recommended) | 10~15min | |||
| (recommended) | Same | |||
| With Connected | ||||
| Needle electrodes | MTR-AC series | Same | ||
| MTR-AC-01, MTR-AC-04, MTR-AC-27G | Same | |||
| Body | PC(Polycarbonate) | PC(Polycarbonate) | Same | |
| Needle | ||||
| material needle | Stainless Steel 304 + | |||
| Perylene coating | Stainless Steel 304 + | |||
| Perylene coating | Same |
6
| Electrode Needle Specification | ||||||||
|---|---|---|---|---|---|---|---|---|
| Model name | ACUTRON (K211000) | Secret RF Smartcure applicator (K182355) | ||||||
| 510(k)number | K211000 | K182355 | ||||||
| Model name of electrode | MTR | |||||||
| AC-27G | MTR | |||||||
| AC-01 | MTR | |||||||
| AC-04 | MTR | |||||||
| AC-27G | MTR | |||||||
| AC-01 | MTR | |||||||
| AC-04 | Same | |||||||
| Configuration | Body + Needle | Body + Needle | Same | |||||
| Physical | ||||||||
| SPEC. | Total length (mm) | 40 | 20 | 20 | 40 | 20 | 20 | Same |
| Needle(tip) Diameter | $Ø$ 0.4 | $Ø$ 0.25 | $Ø$ 0.25 | $Ø$ 0.4 | $Ø$ 0.25 | $Ø$ 0.25 | Same | |
| Needle(tip) Length(mm) | 3.0 | 2.5 | 1.5 | 3.0 | 2.5 | 1.5 | Same | |
| Needle(tip) Unit | 1 | 1 | 4 | 1 | 1 | 4 | Same | |
| Patient | ||||||||
| Contacting | ||||||||
| Materials | Body (indirect) | Polycarbonate | Polycarbonate | Same | ||||
| Needle | Stainless steel 304 + | |||||||
| Perylene coating | Stainless steel 304 + | |||||||
| Perylene coating | ||||||||
| Output power | Max 45W | Max 45W | Same | |||||
| Type and operation mode | Monopolar (Normal mode) | Monopolar (SC mode) | Same | |||||
| Single Use | Single use | Single use | Same | |||||
| Sterilization method | E.O gas | E.O gas | Same |
| Proposed device | Reference device | Remark | |
|---|---|---|---|
| Model name | ACUTRON | SecretRF | |
| Manufacturer | ILOODA CO.,LTD | ILOODA CO.,LTD | |
| 510(k)number | K211000 | K170325 | |
| Intended use | ACUTRON is intended | ||
| for use in dermatologic and | |||
| general surgical procedures | |||
| for electro-coagulation and | |||
| hemostasis. | SECRET RF is intended for | ||
| use in dermatologic and | |||
| general surgical procedures for | |||
| electro-coagulation and | |||
| hemostasis | Same | ||
| Rated voltage | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | |
| User interface | Color touch Panel | Color touch Panel | Same |
| Dimension(mm) | Main unit : | ||
| 274(W)x187(D)x291(H) | Main unit : | ||
| 180(W)x460(D)x1100(H) | |||
| Delivery system | Monopolar handpieces + | ||
| Micro needle electrodes | Monopolar handpiece + Micro | ||
| needle electrodes | Same |
7
| Mode of operation | Monopolar mode (Normal mode) | Monopolar (SC mode) | Same monopolar |
|---|---|---|---|
| Method of activation | Footswitch | Footswitch | Same |
| Output energy type | High frequency | High frequency | Same |
| Frequency | 2MHz ± 10% | 2MHz ± 10% | Same |
| Max power | Max 45W at 500Ω | Max 45W at 500Ω | Same |
ACUTRON has the same technical specifications and same indications for use as those of the predicate device and the reference device.
The main differences are:
- Change in the dimension of the device -
- Change in GUI design -
-
- Main unit(RF console)
-
ACUTRON has been specifically designed for the Secret RF Smartcure applicator handpieces, the predicate device (K182355) and identical operating specifications compared with the Secret RF system, the reference device (K170325). Electrical and mechanical safety and performance of ACUTRON electrosurgical system have been verified according to international standards.
-
- Handpiece
ACUTRON handpieces include the identical handpiece needles cleared for the predicate device, Smartcure Applicator (K182355). Therefore, ACUTRON handpieces are subject to the same biocompatibility, sterilization, cleaning, shelf-life performance validation testing for the Smartcure Applicator handpieces, the predicate device, K182355.
- Handpiece
VI. PERFORMANCE DATA
Design verification process were performed following risk assessment to verify that no new questions of safety and effectiveness have been raised due to the modifications
8
introduced.
Biocompatibility testing:
The patient contact components and materials are identical to the predicate device. The biocompatibility is being leveraged from the predicate device.
Non Clinical testing:
IEC 60601-1: 2005, AMD 1: 2012 Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2: 2014 Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2: 2017 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories.
Animal testing:
Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces, the predicate device.
VII. CONCLUSIONS
There are no significant differences between ACUTRON and the predicate device and the reference device.
The proposed device does not raise any additional questions regarding safety and effectiveness. ACUTRON has the same indication of use and shares the same technological characteristics as the predicate devices.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the opinion of Ilooda Co, Ltd. that ACUTRON is substantially equivalent in comparison with the predicate device and the reference device as described herein.