(122 days)
Not Found
No
The summary describes a radiofrequency (RF) energy delivery system for electrocoagulation and hemostasis. It details the hardware components and the mechanism of action (generating heat via micro-needles). There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's functionality. The performance studies focus on electrical safety, EMC, sterilization, and in-vivo tissue effects, not algorithmic performance.
Yes
The device is described as being used in dermatologic and general surgical procedures for electrocoagulation and hemostasis, which are therapeutic medical interventions.
No
The device is described as being used for "electrocoagulation and hemostasis" by delivering RF energy to tissue to generate an electro thermal reaction capable of coagulating tissue. This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a system main body, handpiece, footswitch, and LCD touch screen control panel, and describes the delivery of RF energy through these components.
Based on the provided information, this device 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.
- Device Description: The device delivers RF energy to tissue using micro-needles to generate heat for coagulation. This is a physical interaction with the body, not an in vitro test of a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) outside of the body. The device interacts directly with the patient's tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI, OUH
Device Description
The PINXEL-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 tip being placed in light contact with the tissue and the handpiece being held at right angles to the targettissue. As the RF energy passes through the tissue, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the micro needle tip, the PinXel system creates heat within the target tissue via 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 60501-1-2 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
ISO 11737-2 Sterilization of medical devices --Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
In-Vivo testing was conducted on 3 types of tissue: Liver Kidney and Muscle with results analyzed in a pathology lab. Results showed no instances of unexpected injury.
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). To the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 13, 2018
Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Birmingham, Alabama 35209
Re: K180654
Trade/Device Name: PINXEL-RF system Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: June 13, 2018 Received: June 14, 2018
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 (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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) 510(K) Pending
Device Name
PINXEL-RF System
Indications for Use (Describe)
The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation 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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K180654 Attachment 5 510(K) Summary PINXEL-RF System
This 510(K) Summary of safety and effectiveness for the PINXEL-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, LLC |
|---|---|
| Address: | Rohrer Aesthetics, LLC |
| 105 Citation Court | |
| Birmingham, AL 35209 | |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 — phone |
| mrohrer@rohreraesthetics.com | |
| Preparation Date: | February 17, 2018 |
| Device Trade Name: | PINXEL-RF System |
| Common Name: | Micro-Needle Fractional RF |
| Regulation Name: | Electrosurgical Cutting and Coagulation Device & |
| Acessories | |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI, OUH) |
| Legally Marketed Predicate Device: | |
| 510(K) number: | Secret RF Manufactured by ILOODA CO LTD. |
| K170325 | |
| Regulatory Class: | Class II Prescription Use |
| Description of the PINXEL-RF System: | The PINXEL-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 tip being placed in light contact with the tissue and the | |
| handpiece being held at right angles to the targettissue. As | |
| the RF energy passes through the tissue, it generates an | |
| electro thermal reaction which is capable of coagulating the | |
| tissue. Using the micro needle tip, the PinXel system | |
| creates heat within the target tissue via micro- needles | |
| inserted from the tip. | |
| Intended use of the PINXEL-RF | |
| System | The PINXEL-RF system is intended for use in dermatologic |
| and general surgical procedures for electrocoagulation and | |
| hemostatic. |
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K180654
Attachment 5 510(K) Summary PINXEL-RF System
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 60501-1-2 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
ાડળ 11737-2 Sterilization of medical devices --Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
In-Vivo testing was conducted on 3 types of tissue: Liver Kidney and Muscle with results analyzed in a pathology lab. Results showed no instances of unexpected injury.
Technical Specifications Comparison:
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K180654 Attachment 5 510(K) Summary PINXEL-RF System
| Proposed Device | Predicate Device | |
|---|---|---|
| Model: | PinXel RF Device | Secret |
| Manufacturer: | Rohrer Aesthetics | ILOODA Co Ltd. |
| System Type | BiPolar RF | BiPolar RF |
| Output Energy type: | High Frequency | High Frequency |
| Frequency | 2 MHz | 2 MHz |
| Max.Power | Max 25 W @ 500 ohm | Max 25W @ 500 ohm |
| Total Power delivered | ||
| per treatment | 25W | 25W |
| Power per pin | 25W | 25W |
| RF Duration | 50ms-950ms | 50ms-950ms |
| Tips | MicroNeedle Electrodes | |
| 25 and 64 pins | MicroNeedle Electrodes | |
| 25 and 64 pins | ||
| User interface | 8" Touch LCD Display | Color touch LCD Display |
| Dimensions (including | ||
| Handpiece cable | ||
| hanger | 24 inches x 17 inches x 63 | |
| inches | 7.5 inches x 18.5inches x | |
| 43.5 inches | ||
| (180(W) x 460(D) x 1100 (H)) | ||
| Weight | 8 lbs ( without cart) | 45 kg. (99 pounds) |
| 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 treatment tip design does not raise new or different questions of safety or effectiveness. Furthermore, performance data demonstrate that the subject device is as safe and effective as its predicate device for requested intended use.
Therefore, PINXEL-RF System is substantially equivalent to its predicate device.