(403 days)
The INFINI Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
The INFINI Radiofrequency System includes the system main body, a handpiece equipped with disposable handpiece tips, footswitch, and an LCD touch screen control panel. The RF energy is delivered using disposable handpiece tip. The radiofrequency energy is delivered to the target tissue using a handpiece and disposable 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 MFR tip (Microneedle Fractional RF) the INFINI Radiofrequency System creates heat within the target dermal tissue via microneedles inserted from the MFR tip.
The INFINI Radiofrequency System is intended for use in electrocoagulation and hemostasis in dermatologic and general surgical procedures, and for the percutaneous treatment of facial wrinkles.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or numerical performance metrics for the INFINI Radiofrequency System in a clear table format. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria Category | Description | Reported Device Performance (Summary) |
|---|---|---|
| Safety | The device must demonstrate safe operation, including electrical and mechanical safety. It should also demonstrate that it delivers radiofrequency energy without causing unintended damage to surrounding tissues. | Bench testing, electrical and mechanical safety testing were performed. In an in vivo micropig model, it was demonstrated that the INFINI Radiofrequency System delivered radiofrequency energy at a depth in the dermis without causing any electrothermal damage to the epidermis. Non-clinical tests established substantial equivalence to the predicate device in terms of safety. |
| Effectiveness (General) | The device must be effective for its stated indications: electrocoagulation, hemostasis, and percutaneous treatment of facial wrinkles. Effectiveness is primarily demonstrated through substantial equivalence to a legally marketed predicate device. | The INFINI Radiofrequency System was determined to be substantially equivalent to the Primaeva Medical Miratone System (K082391) in terms of intended use, principles of operation, target population, and energy source. Clinical trials established substantial equivalence for the percutaneous treatment of facial wrinkles. |
| Effectiveness (Histology) | The device should produce similar histological effects (e.g., thermal coagulation zones) in target tissue as the predicate device when used for similar applications. | Histologically, the controlled creation of dermally located thermal coagulation zones by the INFINI System was shown to be substantially equivalent to the thermal coagulation zones by the predicate device. |
| Technological Equivalence | The device's technological characteristics should be similar to those of the predicate device, ensuring similar performance and safety profiles. This includes aspects like energy source, delivery method, and operating principles. | The INFINI Radiofrequency System is stated to be substantially equivalent to the predicate device in technological characteristics, such as intended use, principles of operation, target population, and energy source. Both are bipolar radiofrequency systems with delivery methods through optical fibers and handpieces, and both employ bipolar microneedle electrode systems. Any differences were deemed to have no significant influence on safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific numerical sample size (number of human subjects or cases) used for the clinical trials or the in vivo animal model. It mentions "clinical trials, conducted in two study centers" and "an in vivo micropig model."
- Data Provenance:
- Clinical Trials: "conducted in two study centers." The country of origin is not specified, but the submitter is Lutronic Corporation from the Republic of Korea, and the contact person is in the US. It is common for clinical trials for 510(k) submissions to include sites in the US or other regions with established clinical research infrastructure. The nature of the study (retrospective or prospective) is not explicitly stated, but clinical trials for demonstrating substantial equivalence are typically prospective.
- Micropig Model: "an in vivo micropig model" is mentioned, indicating an animal study. This is a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Histologically, the controlled creation of dermally located thermal coagulation zones by the INFINI System was shown to be substantially equivalent to the thermal coagulation zones by the predicate device." This implies histological assessment by pathologists or qualified personnel, but no specific numbers or qualifications are given.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set, as might be seen in diagnostic image analysis studies. The assessment of substantial equivalence appears to be based on the overall findings from the clinical trials and histological analyses comparing the new device to the predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, or at least not described in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human readers interpret images with and without AI assistance. The INFINI Radiofrequency System is a therapeutic device.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable in the typical sense for this device. The INFINI Radiofrequency System is a physical medical device that delivers energy, not a standalone AI algorithm that performs a diagnostic or prognostic task without human intervention. Its performance is inherent in its operation and effect on tissue, guided by a human operator. The "performance data" describes the device's ability to achieve its intended biophysical effects.
7. Type of Ground Truth Used
- Clinical Effectiveness (Facial Wrinkles): This would likely involve clinical assessments of wrinkle reduction, potentially using standardized scales or objective measurements, though not explicitly detailed. The "ground truth" here is the observed clinical improvement of facial wrinkles, as assessed in the clinical trials, demonstrating equivalence to the predicate.
- Histology: The ground truth for histological assessment was the physical observation and characterization of thermal coagulation zones in tissue samples, examined under a microscope by qualified personnel (presumably pathologists). This is a form of pathology ground truth.
- Safety: Ground truth for safety would be the absence of adverse events or unexpected tissue damage, as observed in both the animal model and clinical trials.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as the INFINI Radiofrequency System is not an AI/ML algorithm that learns from data. It is a physical device.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this device in the context of AI/ML. The device's design and operating parameters are based on scientific and engineering principles of radiofrequency energy delivery, not on machine learning from a dataset.
{0}------------------------------------------------
K121481
510(k) Summary for the Lutronic Corporation INFINI Radiofrequency System
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
General Information
Submitter:
Lutronic Corporation 219 Sowon-ro, Haengsin-dong, Deogyang-gu, Goyang-si. Gyeonggi-do, 410-722 Republic of Korea
Contact Person
Jhung Won Vojir, Ph.D. Global Regulatory Officer Lutronic, Inc. Six Neshaminy Interplex, Suite 100 Trevose, PA 19053 ivojir@lutronic.com Tele: 215-205-2219 FAX: 609-488-6958
Summary Preparation Date: June 11, 2013
Names
Trade Name:
INFINI Radiofrequency System
Electrosurgical, cutting & coagulation device Classification Name: & accessories Product Code: GEI Panel: General and Plastic Surgery
Predicate Devices
The INFINI Radiofrequency System is substantially equivalent to the Primaeva Medical Miratone System (K082391).
Device Description
The INFINI Radiofrequency System includes the system main body, a handpiece equipped with disposable handpiece tips, footswitch, and an LCD touch screen control panel. The RF energy is delivered using disposable handpiece tip. The radiofrequency energy is delivered to the target tissue using a handpiece and
Page 1 of 2
{1}------------------------------------------------
disposable 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 MFR tip (Microneedle Fractional RF) the INFINI Radiofrequency System creates heat within the target dermal tissue via microneedles inserted from the MFR tip.
Intended Use
The INFINI Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
Technological Characteristics
The INFINI Radiofrequency System is substantially equivalent to the predicate device in technological characteristics, such as intended use, principles of operation, target population, and energy source. The INFINI Radiofrequency System and the predicate device are both bipolar radiofrequency systems, with delivery methods through optical fibers and handpieces. Both the INFINI Radiofrequency System and the predicate system are minimally invasive radiofrequency devices employing bipolar microneedle electrode systems.
Performance Data:
Non-clinical tests of the INFINI Radiofrequency System included bench testing, histology, electrical and mechanical safety testing. Using an in vivo micropig model. it was demonstrated that the INFINI Radiofrequency System delivered radiofrequency energy at a depth in the dermis without causing any electrothermal damage to the epidermis. Clinical trials, conducted in two study centers, established the substantial equivalence of the INFINI Radiofreqency System to the predicate device for the percutaneous treatment of facial wrinkles. Histologically, the controlled creation of dermally located thermal coagulation zones by the INFINI System was shown to be substantially equivalent to the thermal coagulation zones by the predicate device. Therefore, non-clinical and clinical tests established the substantial equivalence of INFINI Radiofrequency System to the predicate device, Primaeva Medical Miratone System (K082391).
Summary:
The intended use of the INFINI Radiofrequency System is virtually identical to the intended use of the predicate devices and the technological characteristics of the INFINI Radiofrequency System are similar to the technological characteristics of the predicate device. Any differences between the INFINI Radiofrequency System and the predicate device have no significant influence on safety or effectiveness of the INFINI Radiofrequency System. Therefore, the INFINI Radiofrequency System is substantially equivalent to the predicate system.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract design of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2013
Lutronic, Inc. c/o Jhung Won Vojir, Ph.D. Global Regulatory Officer Six Neshaminy Interplex, Suite 100 Trevose, PA 19053
Re: K121481
Trade/Device Name: INFINI Radiofrequency System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 11, 2013 Received: June 13, 2013
Dear Ms. Vojir:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{3}------------------------------------------------
Page 2 - Jhung Won Vojir
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.hum.
Sincerely yours,
For
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
.
K121481 510(k) Number (if known):
NFINI Radiofrequency System Device Name:
Indications for Use:
The INFINI Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
Joshua C. Nipper -S
(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K121481
§ 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.