(137 days)
The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The LUDWIG Electrosurgical System is comprised of the following components:
- . The system's main body, which consists of:
- Touch-screen control/display panel O
- High radio frequency (RF)-generating output component at 0.5, 1 or 2 MHz o
- RF Handpiece for transfer of energy to human tissue O
- Ultrasound Handpiece for visualization of dermis and epidermis O
- Disposable bipolar micro-needle cartridge (electrode) that is inserted into RF o Handpiece and used for coagulation of human tissue
- O Power cord
The LUDWIG Electrosurgical System generates radiofrequency (RF) energy by means of high RF at .5 MHz, 1MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.
The provided text is a 510(k) summary for the LUDWIG Electrosurgical System. It outlines the device's intended use, description, and comparison to predicate devices, referencing various performance data and testing standards. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document discusses non-clinical testing (electrical, biocompatibility, sterility, shelf life, packaging, ultrasound, software verification/validation, and thermal testing) that was completed with the statement "All acceptance criteria were met." However, it does not detail what those specific acceptance criteria were for each test, nor does it provide the results of those tests. More importantly, it is not an AI/ML device but an electrosurgical system, and therefore, the concepts of "test set," "training set," "ground truth," "expert readers," "MRMC study," and "stand-alone performance" as they relate to AI/ML device performance evaluation are not applicable to this document.
Therefore, I cannot fulfill the request as the essential information related to an AI/ML device's acceptance criteria and a study proving it meets them (including sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text. The device is a physical electrosurgical system, not a software algorithm that would require such evaluation methodologies.
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October 16, 2022
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Aesthetics Biomedical Lawrence Rheins Chief Scientific Officer 4602 North 16th Street. Suite 300 Phoenix, Arizona 85016
Re: K221574
Trade/Device Name: LUDWIG Electrosurgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, IYO Dated: September 13, 2022 Received: September 19, 2022
Dear Lawrence Rheins:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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,
for
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
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Indications for Use
K221574
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Device Name
LUDWIG Electrosurgical System
Indications for Use (Describe)
The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Type of Use (Select one or both, as applicable)
| ☒ Transaction Use (11 CFR 201.2, Subpart B) | ☐ Non-Transaction Use (11 CFR 201.2, Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------- |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.
SPONSOR INFORMATION
| Name: | Aesthetics Biomedical |
|---|---|
| Address: | 4602 North 16th Street, Suite 300Phoenix, AZ 85016 U.S.A. |
| Phone: | (800) 726-5029 |
Official Correspondent:
| Name: | Lawrence A. Rheins | ||
|---|---|---|---|
| Address: | Aesthetics Biomedical | ||
| 4602 North 16th Street, Suite 300 | |||
| Phoenix, AZ 85016 | |||
| Phone: | (760)877-5385 | ||
| Email: | lrheins@aestheticsbiomed.com |
FDA Establishment Reg. No.: 3012204368
Date Prepared: October 14, 2022
DEVICE NAME
| Trade Name: | LUDWIG Electrosurgical System |
|---|---|
| Common Name: | Electrosurgical System and Accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Number: | 21 CFR 878.4400 (Class II) |
| Product Code: | GEI, IYO |
| Classification Panel: | General and Plastic Surgery |
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PREDICATE DEVICE
The LUDWIG Electrosureical System is substantially equivalent to the Potenza Device (primary predicate), K192545 and the Genius Device (reference predicate), K180945.
INTENDED USE
The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
DEVICE DESCRIPTION
The LUDWIG Electrosurgical System is comprised of the following components:
- . The system's main body, which consists of:
- Touch-screen control/display panel O
- High radio frequency (RF)-generating output component at 0.5, 1 or 2 MHz o
- RF Handpiece for transfer of energy to human tissue O
- Ultrasound Handpiece for visualization of dermis and epidermis O
- Disposable bipolar micro-needle cartridge (electrode) that is inserted into RF o Handpiece and used for coagulation of human tissue
- O Power cord
The LUDWIG Electrosurgical System generates radiofrequency (RF) energy by means of high RF at .5 MHz, 1MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.
TECHNOLOGICAL CHARACTERISTICS
The LUDWIG Electrosurgical Device and its predicate devices operate in the same manner by applying RF bipolar current via the microneedle electrode assembly to the dermis to produce controlled zones of coagulated collagen at low temperatures without damaging the epidermis layer.
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PERFORMANCE DATA
To establish safety and efficacy of the LUDWIG Electrosurgical System, the following evaluations were completed following the below standards and FDA guidance documents. All acceptance criteria were met:
- Electrical Testing per: ●
- IEC 60601-1:2005/(R)2012, A1:2012 o
- IEC 60601-1-2:2014, Ed. 4.0 o
- IEC 60101-2-2:2017, Ed. 6.0 o
- IEC 60601-1-6:2010 +A1 2013 O
- IEC 62366:2007/AMD 1:2014 o
- Biocompatibility Testing per:
- ISO 10993-1:2009 O
- ISO 10993-5:2009 o
- ISO 10993-10:2010 o
- ISO 10993-11:2017/USP <151> o
- . Sterility Testing:
- The micro-needle cartridge is supplied sterility conforms to a о Sterility Assurance Level (SAL) of 10-6:
- I ISO 11135:2014
- . ISO 11138-7:2019
- I ISO 10993-7:2008
- The micro-needle cartridge is supplied sterility conforms to a о Sterility Assurance Level (SAL) of 10-6:
- Shelf Life and Packaging Testing per:
- ASTM F1980-16 o
- o ASTM F1929-15
- ASTM F88/F88M-15 o
- Ultrasound Testing per:
- IEC 60601-2-37 (Edition 2.1, 2015) o
- IEC 62359 (Edition 2.1 2017-09) o
- Software Verification and Validation Testing: ●
- o FDA's Draft Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued November 4, 2021.
- Thermal Testing:
- o FDA's Guidance for Industry and FDA Staff "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020.
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SUMMARY OF SUBSTANTIAL EQUIVALENCE
The below table summarizes the key elements of the subject device and each predicate device, supporting substantial equivalence:
| Proposed:LUDWIG | Primary Predicate:PotenzaK192545 | Reference Predicate:GeniusK180945 | |
|---|---|---|---|
| Manufacturer | Aesthetics Biomedical, Inc | Jeisys Medical, Inc | Lutronic Corporation |
| Classification | Class II21 CFR §878.4400 | Class II21 CFR §878.4400 | Class II21 CFR §878.4400 |
| Product Code | GEI-Electrosurgical, Cutting &Coagulation & AccessoriesOUH-Skin Resurfacing RfApplicatorIYO-System, Imaging, PulsedEcho, Ultrasonic | GEI- Electrosurgical, Cutting &Coagulation & AccessoriesOUH - Skin Resurfacing RfApplicator | GEI- Electrosurgical, Cutting &Coagulation & Accessories |
| Intended Use | The LUDWIG ElectrosurgicalSystem is intended for use indermatologic and generalsurgical procedures for electro-coagulation and hemostasis. | The POTENZA is intended foruse in dermatologic and generalsurgical procedures forelectrocoagulation andhemostasis. | The LUTRONIC GENIUSRadiofrequency System isintended for use in dermatologicand general surgical proceduresfor electrocoagulation andhemostasis. |
| User Interface | Color Touch Panel | Color Touch Panel | Color Touch Panel |
| ElectricalRequirements | 100-240 VAC, 50-60 HZ | 100-240 VAC, 50-60 HZ | 100-240 VAC, 50-60 HZ |
| RF FEATURES | |||
| Frequency | Radiofrequency: 0.5 MHz,1MHz, 2MHz | Radiofrequency: 1 MHz, 2MHz | Radiofrequency: 0.5MHz |
| Mode | Bipolar | Bipolar and Monopolar | Bipolar |
| Max Power | Max 50W | Max 50W | Max 50W |
| RF ConnectedHandpiece | 1 RF handpiece | 2 RF handpieces | RF handpiece |
| RF NEEDLE FEATURES | |||
| Number ofNeedleCartridges | 6 different electrode tips | 6 different electrode tips | 4 different electrode tips |
| Needle Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle Extension | 0.5 - 4mm (0.1 step) | 0.5 - 4mm (0.1 step) | 0.5 - 3.5mm (0.1 step) |
CONCLUSION
The subject LUDWIG Electrosurgical System has the same intended use and similar indications, technological characteristics, and principles of operation as its primary predicate (K192545) and reference device (K180945). The technological differences between the subject device and its predicate device raise no new issues of safety or effectiveness. Non-clinical and animal testing was conducted to evaluate the performance of subject device in comparison to the predicate devices and results have demonstrated substantial equivalence of the subject device to the predicates in terms of safety and effectiveness for the intended use.
§ 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.