(122 days)
The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
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 target tissue. 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.
The provided document describes the PINXEL-RF System, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating its substantial equivalence to a legally marketed predicate device, the Secret RF by ILOODA CO LTD. The information concerning acceptance criteria and supporting studies is based on this equivalence premise rather than a standalone performance study with specific acceptance thresholds for diagnostic accuracy.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device. The performance data provided is primarily related to safety, electrical standards, and sterilization, along with an in-vivo tissue study.
The criteria for "acceptance" in this context are implicitly met by showing that the PINXEL-RF System performs comparably to the predicate device in terms of technical specifications and does not raise new safety or effectiveness concerns.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (PINXEL-RF System) |
|---|---|---|
| Safety & Essential Performance Electrical Standards | Compliance with IEC 60601-1 | Performed and presumably compliant |
| Electromagnetic Compatibility | Compliance with IEC 60501-1-2 | Performed and presumably compliant |
| High Frequency Surgical Equipment Safety | Compliance with IEC 60601-2-2 | Performed and presumably compliant |
| Sterilization of Medical Devices | Compliance with ISO 11737-2 | Performed and presumably compliant |
| Tissue Injury (In-Vivo) | No instances of unexpected injury | "Results showed no instances of unexpected injury." |
| Technical Specifications (Comparison to Predicate) | Technical specifications are comparable to the predicate device (Secret RF) | Demonstrated comparability in Model, Manufacturer, System Type, Output Energy type, Frequency, Max. Power, Total Power delivered per treatment, Power per pin, RF Duration, Tips, User Interface, Dimensions, Weight, Electrical Rating. Key match: Frequency (2 MHz) and Max. Power (Max 25 W @ 500 ohm). |
1. A table of acceptance criteria and the reported device performance
(See table above)
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- In-Vivo Testing: Not explicitly stated as a numerical sample size but conducted on "3 types of tissue: Liver Kidney and Muscle." The number of individual tissue samples or animals is not specified.
- Other Testing (IEC Standards): Not applicable for a traditional "test set" sample size in the context of diagnostic performance. These are engineering and performance verification tests, typically performed on the device itself.
- Data Provenance: Not explicitly stated. The in-vivo testing results were "analyzed in a pathology lab," but the country of origin or whether it was retrospective or prospective is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- In-Vivo Testing: The document states the results were "analyzed in a pathology lab." It does not specify the number of experts or their qualifications (e.g., "pathologist with X years of experience").
4. Adjudication method for the test set
- In-Vivo Testing: Not specified. It's likely a standard pathology review process, but no specific adjudication method (e.g., 2+1, 3+1 consensus) is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is an electrosurgical system, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device, not a software algorithm. Its performance is inherent in its electrosurgical function.
7. The type of ground truth used
- For In-Vivo Testing: The ground truth was established through pathology analysis of the treated tissue, aiming to assess "unexpected injury."
- For Technical Specifications: The ground truth for comparison was the specifications of the legally marketed predicate device (Secret RF).
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
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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);
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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, LLC105 Citation CourtBirmingham, AL 35209 |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 — phonemrohrer@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, abipolar handpiece with disposable micro-needle typeelectrodes, a footswitch and an LCD touch screen controlpanel |
| The RF energy is delivered to a target tissue using ahandpiece and disposable tip (micro needle electrode tip),the tip being placed in light contact with the tissue and thehandpiece being held at right angles to the targettissue. Asthe RF energy passes through the tissue, it generates anelectro thermal reaction which is capable of coagulating thetissue. Using the micro needle tip, the PinXel systemcreates heat within the target tissue via micro- needlesinserted from the tip. | |
| Intended use of the PINXEL-RFSystem | The PINXEL-RF system is intended for use in dermatologicand general surgical procedures for electrocoagulation andhemostatic. |
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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 deliveredper treatment | 25W | 25W |
| Power per pin | 25W | 25W |
| RF Duration | 50ms-950ms | 50ms-950ms |
| Tips | MicroNeedle Electrodes25 and 64 pins | MicroNeedle Electrodes25 and 64 pins |
| User interface | 8" Touch LCD Display | Color touch LCD Display |
| Dimensions (includingHandpiece cablehanger | 24 inches x 17 inches x 63inches | 7.5 inches x 18.5inches x43.5 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.
§ 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.