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K Number
K221574
Device Name
LUDWIG Electrosurgical Device
Manufacturer
Aesthetics Biomedical
Date Cleared
2022-10-16

(137 days)

Product Code
GEIIYOOUH
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
More Information

K192545

K180945

No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard electrosurgical and ultrasound technology. The performance studies listed are standard electrical, biocompatibility, sterility, shelf life, ultrasound, and software verification/validation tests, with no mention of AI/ML specific performance metrics or studies.

Yes
The device is used for electrocoagulation and hemostasis in dermatologic and general surgical procedures, which are therapeutic interventions.

No
The device is intended for electrocoagulation and hemostasis in dermatologic and general surgical procedures, which are therapeutic actions, not diagnostic ones. Although it has an Ultrasound Handpiece for visualization, its primary function as described is to generate RF energy for tissue coagulation.

No

The device description explicitly lists multiple hardware components including a main body, touch-screen control/display panel, RF-generating output component, RF Handpiece, Ultrasound Handpiece, disposable bipolar micro-needle cartridge, and power cord. The performance studies also include extensive testing of electrical, biocompatibility, sterility, shelf life, packaging, and thermal aspects, which are all related to hardware components. While software verification and validation are mentioned, the device is clearly not solely software.

Based on the provided information, the LUDWIG Electrosurgical System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for "dermatologic and general surgical procedures for electrocoagulation 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 device generates and delivers RF energy to tissue for coagulation. While it includes an Ultrasound Handpiece for visualization, its primary function is to apply energy to the body, not to analyze a biological sample.
  • Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The LUDWIG system does not perform this function.

Therefore, the LUDWIG Electrosurgical System is a therapeutic/surgical device, not an IVD.

N/A

Intended Use / Indications for Use

The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Product codes

GEI, IYO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Dermis and epidermis.

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)

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 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
  • 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K192545

Reference Device(s)

K180945

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

October 16, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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

2

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 300
Phoenix, 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

4

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.

5

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 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
  • 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.

6

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:
Potenza
K192545 | Reference Predicate:
Genius
K180945 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Aesthetics Biomedical, Inc | Jeisys Medical, Inc | Lutronic Corporation |
| Classification | Class II
21 CFR §878.4400 | Class II
21 CFR §878.4400 | Class II
21 CFR §878.4400 |
| Product Code | GEI-Electrosurgical, Cutting &
Coagulation & Accessories
OUH-Skin Resurfacing Rf
Applicator
IYO-System, Imaging, Pulsed
Echo, Ultrasonic | GEI- Electrosurgical, Cutting &
Coagulation & Accessories
OUH - Skin Resurfacing Rf
Applicator | GEI- Electrosurgical, Cutting &
Coagulation & Accessories |
| Intended Use | The LUDWIG Electrosurgical
System is intended for use in
dermatologic and general
surgical procedures for electro-
coagulation and hemostasis. | The POTENZA is intended for
use in dermatologic and general
surgical procedures for
electrocoagulation and
hemostasis. | The LUTRONIC GENIUS
Radiofrequency System is
intended for use in dermatologic
and general surgical procedures
for electrocoagulation and
hemostasis. |
| User Interface | Color Touch Panel | Color Touch Panel | Color Touch Panel |
| Electrical
Requirements | 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 Connected
Handpiece | 1 RF handpiece | 2 RF handpieces | RF handpiece |
| RF NEEDLE FEATURES | | | |
| Number of
Needle
Cartridges | 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.