(433 days)
ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
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 ; 1) Main unit 2) Smartcure handpiece(FDA cleared K182355) 3) Monopolar type micro-needle electrodes(FDA cleared K182355)
The provided text is a 510(k) summary for the ACUTRON device, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing details of new clinical or standalone performance studies with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies are not available in the provided text.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary asserts substantial equivalence based on technical specifications and leveraging performance data from predicate devices, rather than presenting new acceptance criteria and a study demonstrating performance against those criteria.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. No new "test set" in the context of a clinical performance study (e.g., diagnostic accuracy) is described. The performance data is primarily "leveraged" from predicate devices and non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. As no new clinical performance study with a test set requiring expert ground truth establishment is detailed, this information is absent.
4. Adjudication method for the test set
Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The device is an electrosurgical unit, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The ACUTRON is a medical device (electrosurgical unit), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The document describes non-clinical testing of the device itself (electrical and mechanical safety, EMC).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided for a new clinical study. For the animal testing and biocompatibility, the assumption is that established scientific methods and reference standards would be used, but specific "ground truth" for a performance endpoint is not detailed. The document mentions "Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces, the predicate device." This implies histology was used as a reference for the predicate, but specific details for ACUTRON are not given beyond leveraging.
8. The sample size for the training set
Not applicable/Not provided. This device is hardware for electrosurgery, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable/Not provided.
Summary of available information related to performance/testing:
The document focuses on demonstrating substantial equivalence to existing predicate devices (Secret RF Smartcure applicator K182355 and Secret RF K170325). The performance data cited is primarily in the form of non-clinical testing and leveraging existing data from the predicate devices.
Non-clinical testing performed for ACUTRON:
- Biocompatibility testing: Leveraged from the predicate device as patient contact components and materials are identical.
- IEC 60601-1: 2005, AMD 1: 2012: General Requirements for basic safety and essential performance of Medical Electrical Equipment. (The requirements were fulfilled).
- IEC 60601-1-2: 2014: General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility). (The requirements were fulfilled).
- IEC 60601-2-2: 2017: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories. (The requirements were fulfilled).
- Animal testing: Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces (predicate device).
Conclusion from the document:
The manufacturer concludes that "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." This substantial equivalence argument is based on the shared technical specifications and leveraging the performance and safety data of the predicate devices.
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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.
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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
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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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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. |
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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)
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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 Smartcureapplicator (K182355) | |||
| Indications for use | ACUTRON is intendedfor use in dermatologic andgeneral surgical proceduresfor electro-coagulation andhemostasis. | Secret RF Smartcureapplicator is intended foruse in dermatologic andgeneral surgical proceduresfor electro-coagulation andhemostasis | ||
| Handpieces | Image: Handpiece | Image: Handpiece | Same | |
| Handpiecematerial | Aluminum | Aluminum | Same | |
| Patient returnelectrode | All-in-one connection withPatient plate connector.The handpiece and the counterplate connector are connected toone connector of the main bodyand do not affect the safety oreffectiveness performance. | The electrode handpieceand the patient plate areseparate. | 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 ConnectedNeedle electrodes | MTR-AC series | Same | ||
| MTR-AC-01, MTR-AC-04, MTR-AC-27G | Same | |||
| Body | PC(Polycarbonate) | PC(Polycarbonate) | Same | |
| Needlematerial needle | Stainless Steel 304 +Perylene coating | Stainless Steel 304 +Perylene coating | Same |
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| Electrode Needle Specification | ||||||||
|---|---|---|---|---|---|---|---|---|
| Model name | ACUTRON (K211000) | Secret RF Smartcure applicator (K182355) | ||||||
| 510(k)number | K211000 | K182355 | ||||||
| Model name of electrode | MTRAC-27G | MTRAC-01 | MTRAC-04 | MTRAC-27G | MTRAC-01 | MTRAC-04 | Same | |
| Configuration | Body + Needle | Body + Needle | Same | |||||
| PhysicalSPEC. | 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 | |
| PatientContactingMaterials | 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 intendedfor use in dermatologic andgeneral surgical proceduresfor electro-coagulation andhemostasis. | SECRET RF is intended foruse in dermatologic andgeneral surgical procedures forelectro-coagulation andhemostasis | 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 + Microneedle electrodes | Same |
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| 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
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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.
§ 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.