(28 days)
Not Found
No
The description focuses on the electrothermal mechanism of action and does not mention any AI/ML components or functions.
No.
A therapeutic device is one that treats a disease or condition, and this device is intended for electrocoagulation and hemostasis, which are surgical procedures, not treatments in themselves.
No
The device description and intended use state that it is used for electrocoagulation and hemostasis, which are therapeutic procedures, not diagnostic ones. It generates an electrothermal reaction to coagulate tissue.
No
The device description clearly outlines physical hardware components including a system main body, handpiece, electrodes, footswitch, and LCD touch screen, which are integral to the device's function of delivering RF energy.
Based on the provided information, the PiXel8-RF system is not an IVD (In Vitro Diagnostic).
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 diagnostic test performed on a sample taken from the body.
- Device Description: The device description details a system that delivers RF energy via micro-needles to create heat within tissue for coagulation. This is a physical interaction with the tissue, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for surgical procedures involving tissue modification, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
Product codes (comma separated list FDA assigned to the subject device)
GEI, OUH
Device Description
The Pixel8-RF System includes the system main body, a bipolar handpiece with disposable micro-needle type electrodes, a footswitch and an LCD touch screen control panel.
The RF Energy is delivered to a target tissue using a handpiece and disposable tip (micro needle electrode tip), the being placed in light contact with the tissue and the handpiece being held at right angles to the target tissue. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The Pixel8-RF System creates heat within the target tissue using micro-needles inserted from the tip.
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)
The following performance data was provided in support of the substantial equivalence determination:
IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance
IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-2 Medical electrical equipment part 2: particular requirements for the basic safety and essential performance of high frequency surgical equipment
In-Vivo testing was conducted on 3 types of tissue: Liver, Kidney and Muscle with results analyzed in a pathology lab. Results showed measurable thermal damage and no instances of unexpected injury.
Results of Clinical Study: No clinical study was conducted to support this 510K submission.
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.
Pixel8-RF (K180654)
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.
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 25, 2023
Rohrer Aesthetics Mark Rohrer President 105 Citation Court Homewood, Alabama 35209
Re: K233147
Trade/Device Name: PiXel8-RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: September 27, 2023 Received: September 27, 2023
Dear Mark Rohrer:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.10.25 08:03:32 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233147
Device Name PiXel8-RF
Indications for Use (Describe)
The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
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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4
This 510(K) Summary of safety and effectiveness for the PIXEL8-RF System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Rohrer Aesthetics |
|---|---|
| Address: | Rohrer Aesthetics |
| 105 Citation Court | |
| Birmingham, AL 35209 | |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 – phone |
| mrohrer@rohreraesthetics.com | |
| Preparation Date: | September 18, 2023 |
| Type of Submission: | Special 510K |
| Device Trade Name: | Pixel8-RF System |
| Common Name: | Micro-Needle Fractional RF |
| Regulation Name: | Electrosurgical Cutting and Coagulation Device |
| 79-GEI | |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, OUH |
| LegallyMarketed | |
| Predicate Device(s): | Pixel8-RF (K180654) |
| Description of the | |
| PIXEL8-RF System: | The Pixel8-RF System includes the system main body, a bipolar |
| handpiece with disposable micro-needle type electrodes, a | |
| footswitch and an LCD touch screen control panel. | |
| The RF Energy is delivered to a target tissue using a handpiece | |
| and disposable tip (micro needle electrode tip), the being placed | |
| in light contact with the tissue and the handpiece being held at | |
| right angles to the target tissue. As the RF energy passes | |
| through the tissue, it generates an electrothermal reaction | |
| which is capable of coagulating the tissue. The Pixel8-RF System |
5
510(K) Summary PiXel8-RF System
creates heat within the target tissue using micro-needles inserted from the tip.
- Intended use of the The PIXEL8-RF system is intended for use in dermatologic and PIXEL8-RF System general surgical procedures for electrocoagulation and hemostatis.
- Performance Data: The following performance data was provided in support of the substantial equivalence determination:
IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance
IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-2 Medical electrical equipment part 2: particular requirements for the basic safety and essential performance of high frequency surgical equipment
In-Vivo testing was conducted on 3 types of tissue: Liver, Kidney and Muscle with results analyzed in a pathology lab. Results showed measurable thermal damage and no instances of unexpected injury.
Results of Clinical Study: No clinical study was conducted to support this 510K submission.
Technical Specifications Comparison:
6
510(K) Summary PiXel8-RF System
| | PiXel8 RF System
(Subject Device) | Pinxel RF System
(Predicate Device)
K180654 |
|----------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Model | Pixel8 RF System | Pinxel RF System |
| Manufacturer | Rohrer Aesthetics | Rohrer Aesthetics |
| System Type | BiPolar RF | BiPolar RF |
| Output Energy Type | High Frequency | High Frequency |
| Frequency | 4 MHz | 2 MHz |
| Max Power | Max 25 W@ 500 ohm | Max 25 W @ 500 ohm |
| Total RF Treatment
Level | Up to 20 (Max power 25 W) | Up to 20 (Max power 25W) |
| RF Duration | 50 ms – 950ms | 50ms - 950ms |
| Tips | MicroNeedle Electrodes
25, 49 and 64 pins | MicroNeedle Electrodes
25 and 64 pins |
| User interface | 8" Touch LCD Display | Color touch LCD Display |
| System cooling | Air cooling | Air cooling |
| Dimensions (including
Handpiece cable
hanger | 24 inches x 17 inches x 63
inches | 24 inches x 17 inches x 63
inches) |
| Weight | 8 lbs (without cart) | 8 lbs (without cart) |
| Electrical rating | Single phase 110 - 230VAC, 60-
60Hz Power consumption:
500VA (Fuse: 250V/6.3A) | Single phase 110 - 230VAC, 60-
60Hz Power consumption:
500VA (Fuse: 250V/6.3A) |
Conclusion:
The difference in the frequency does not raise new or different questions of safety or effectiveness. The performance data demonstrate that the subject device is as safe and effective as its predicate device for the intended use. Therefore, the PiXel8-RF system is substantially equivalent to its predicate device.