(355 days)
JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
JETT Medical II is a portable medical device designed for non-ablative treatment of wrinkles and rhytids. The device works on the physical principle of a sequence of DC microcurrents, which are generated by electrically or battery powered generator and that are transmited to the patient skin through indifferent conductive gel. Patient loop is formed by pairing the handpiece with one of flat applicators with the grounding electrode (cylinder or disposable). Device consists of the standard package and optional accessories.
The provided FDA 510(k) summary for the JETT Medical II device does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) study report. This document describes an electrosurgical device for non-ablative treatment of facial wrinkles, not an AI software.
Therefore, I cannot extract the specific information requested regarding acceptance criteria and study details for an AI-powered device, as the document focuses on the substantial equivalence of a hardware device to a predicate device based on non-clinical and a single clinical study of its performance.
Based on the provided text, here's what can be inferred about the device and its testing, though it's not an AI/SaMD study:
The device is the JETT Medical II, an electrosurgical device.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria for "device performance" in the way one would for an AI diagnostic. Instead, it describes acceptance of substantial equivalence to a predicate device (Pelleve GlideSafe Non-Ablative Wrinkle Treatment System (K102698)) based on:
- Non-clinical testing: Demonstrating compliance with various standards related to electrical safety, electromagnetic compatibility, software (general medical device software, not AI-specific), biocompatibility, sterilization, risk management, and usability.
- Bench testing: Specifically, "Skin temperature during treatment."
- Clinical testing: A study to demonstrate safety and effectiveness for its intended use.
Acceptance Criteria Mentioned (Implicit based on testing and comparison):
| Criterion Type | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance/Findings |
|---|---|---|
| Intended Use/Indications | Same as predicate (non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV). | Identical: JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV. |
| Principle of Operation | Similar thermal effect on tissue despite energy type difference. | Similar (justified): JETT Medical II uses DC current; Predicate uses AC current (RF). The document states: "thermal effects on tissue are identical which does not introduce new questions of safety and effectiveness." This was further supported by a "substantial equivalence test" measuring thermal effect. |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6. | Complies: "The JETT Medical II electrical safety and electromagnetic compatibility has been evaluated and found to be in compliance with..." listed IEC standards. |
| Software | Compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304. | Complies: "The JETT Medical II software testing was performed and found to be in compliance with..." listed FDA guidance and IEC standard. (Note: This refers to general medical device software, not specific AI/ML software.) |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 for patient-contacting components (flat applicators, cylinder electrode). | Complies: "The patient-contacting components... comply with..." listed ISO standards. |
| Sterilization | Compliance with ISO 17665-1 for patient-contacting components (flat applicators). | Complies: "Sterilization... has been found to be in compliance with..." ISO 17665-1. "Sterilization is performed according to validated procedure (SAL= 10-6) stated in the Instruction of use." |
| Risk Management | Compliance with ISO 14971. | Complies: "Risk analysis for JETT Medical II has been evaluated and found to comply with..." ISO 14971. |
| Usability | Compliance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices," IEC 62366-1, and IEC 60601-1-6. | Complies: "The JETT Medical II usability has been evaluated and found to comply with..." listed FDA guidance and IEC standards. |
| Bench Testing (Skin Temp.) | Skin temperature during treatment should not exceed 42°C. Demonstrate temperature rise with application. | Meets Criterion: "The highest temperature of 41.3 was measured at the highest intensity with a flat applicator 20 mm. The temperature never increased above 42°C." "The results showed that the temperature rise is quite well provable... The increase was in almost all cases linear." |
| Clinical Effectiveness | Lower bound of 95% confidence interval of the response rate (≥ 1 point improvement on FWCS from baseline at 3-month follow-up after last treatment) in the JPM II test treatment group (RRTST) is greater than 0.75. | Met Criterion (Implied by Conclusion): The conclusion states "non-clinical and clinical tests have shown that JETT Medical II is substantially equivalent in terms of safety and effectiveness." The specific response rate is not provided, only the acceptance threshold. |
| Clinical Safety | Demonstrated safety for intended use. | Demonstrated (Implied by Conclusion): No adverse events or safety concerns are mentioned, and the conclusion affirms safety. The bench testing on skin temperature also supports safety. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a separate "test set" in the context of an AI/ML study.
- For the clinical study: The document states "A prospective, multi-center, non-randomized, evaluator-blinded study was provided as clinical evidence... The study population consists of subjects who have wrinkles mild to moderate in severity as specified by the Fitzpatrick wrinkle classification system (FWCS) with Fitzpatrick skin scale I-IV." The number of subjects (sample size) is not provided.
- Data provenance:
- Country of origin: Not specified, but it is a "multi-center" study.
- Retrospective or prospective: Prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/provided as the "ground truth" for this device's clinical study is "improvement of ≥ 1 point on the FWCS from baseline." This is an objective measurement or clinical assessment, not AI-driven ground truth expert labeling. The study was "evaluator-blinded," implying human evaluators, but their number and specific qualifications are not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/provided in the context of AI ground truth. The "evaluator-blinded" nature suggests that the assessment of wrinkle improvement was done by clinical evaluators who were unaware of treatment assignment, but no specific adjudication method for their assessments is detailed.
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:
Not applicable. This device is a treatment device, not an AI diagnostic/imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware treatment device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the clinical study was defined by the primary effectiveness endpoint: "an improvement of ≥ 1 point on the FWCS from baseline at the 3-month follow-up after the last treatment." This is a clinical assessment/outcomes data based on the Fitzpatrick Wrinkle Classification System (FWCS).
8. The sample size for the training set:
Not applicable. This is a hardware device; there is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" for an AI model.
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January 22, 2025
COMPEX, spol, s.r.o. Rob Packard Palackeho trida 924/105 Brno. 612 00 Czech Republic
Re: K240311
Trade/Device Name: JETT Medical II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 13, 2024 Received: December 13, 2024
Dear Rob Packard:
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 (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" (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).
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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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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 medical devices and radiation-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).
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Digitally signed by Long H. Long H. Chen -S Chen -S Chen -S
Date: 2025.01.22 08:10:04 -05'00'
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
Submission Number (if known)
Device Name
JETT Medical II
Indications for Use (Describe)
JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
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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K240311
510(k) SUMMARY
SUBMITTER INFORMATION - 807.92(a)(1) l.
Name: COMPEX, spol. s r.o. Adress: Palackeho trida 924/105, Brno, Czech Republic Postal code: 612 00
Contact Person: Rob Packard Date Prepared: January 21, 2025
II. DEVICE - 807.92(a)(2)
| Name of Device: | JETT Medical II |
|---|---|
| Classification Name: | Electrosurgical Cutting & Coagulation Device |
| Regulation: | 21 CFR §878.4400 |
| Regulatory Class: | Class II |
| Product Classification Code: | GEI |
III. PREDICATE DEVICE - 807.92(a)(3)
| Predicate Manufacturer: | Ellman International |
|---|---|
| Predicate Trade Name: | Pelleve GlideSafe Non-Ablative Wrinkle Treatment System |
| Predicate 510(k): | K102698 |
| Classification Name: | Electrosurgical Cutting & Coagulation Device |
| Regulation: | 21 CFR §878.4400 |
| Regulatory Class: | Class II |
| Product Classification Code: | GEI |
No reference devices were used in this submission.
DEVICE DESCRIPTION - 807.92(a)(4) IV.
JETT Medical II is a portable medical device designed for non-ablative treatment of wrinkles and rhytids. The device works on the physical principle of a sequence of DC microcurrents, which are generated by electrically or battery powered generator and that are transmited to the patient skin through indifferent conductive gel. Patient loop is formed by pairing the handpiece with one of flat applicators with the grounding electrode (cylinder or disposable).
Device consists of the standard package and optional accessories:
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| • Disposable electrode |
|---|
| • Curly connection cable for disposable electrodes |
| • Connection cable for cylinder electrode |
| • Extension cable for power supply |
| • Power supply unit |
| • Foot switch |
| • Rechargeable battery |
| Optional accessories |
| • Pen III/S |
| • Flat applicator 3 mm S |
| • Flat applicator 5 mm S |
| • Flat applicator 10 mm S |
| • Flat applicator 20 mm S |
INTENDED USE/INDICATIONS FOR USE - 807.92(a)(5) V.
JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
TECHNOLOGICAL COMPARISON - 807.92(a)(6) VI.
Comparison of the JETT Medical II and the predicate device shows the technological characteristics of the subject device and currently marketed predicate device. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.
| JETT Medical II | Pelleve GlideSafe Non-AblativeTreatment(K102698) | Comparison | |
|---|---|---|---|
| Regulation name | Electrosurgical, cutting andcoagulation device andaccessories | Electrosurgical, cutting andcoagulation device andaccessories | Identical |
| Regulationnumber | 21 CFR 878.4400 | 21 CFR 878.4400 | Identical |
| Regulatory Class | II | II | Identical |
| Product Code | GEI | GEI | Identical |
| Rx/OTC | Prescription | Prescription | Identical |
| Indications forUse | JETT Medical II is intendedfor non-ablative treatmentof mild to moderate facialwrinkles and rhytids forskin phototypes I-IV. | Non-ablative treatment ofmild to moderate facialwrinkles and rhytides forskin phototypes I-IV. | Identical |
| Principle ofoperation | Application of heat to thetissue by DC current. | Application of heat to thetissue with RF energy. | Identical |
| Interface | Touch screen user appliedinterface to program andset the controls for thepatient application; thereare hand-pieces utilized todeliver the treatment. | Buttons and knobs on theunit; there is a hand-pieceutilized to deliver thetreatment. | Similar. |
| Treatment | Non-ablative | Non-ablative | Identical |
| Energy type | Direct current (DC) | Alternating current (AC)with 4MHz (radiofrequency) | Different, but difference has noinfluence on intended use -thermal effects on tissue areidentical which does not introducenew questions of safety andeffectiveness (Refer to Vol18_Bench Substantial EquivalenceTest for difference in Energysource). Safety of subject device issupported by Electrical safety andEMC according to IEC 60601-1, IEC60601-1-2 |
| Modality | Monopolar | Monopolar, bipolar | Identical, monopolar modality ofpredicate is used for our intendeduse |
| Device Activation | Using footswitch | Using a hand or footswitchbased on user preference | Similar |
| Treatment Modes | Multiple treatment levels | Multiple treatment levels | Identical |
| Supply PowerInput | 100-240 V47-63 Hz | 110-250 V50/60 Hz | Similar, supply power input of thesubject device is covered by thepredicate which does notintroduce new questions of safetyand effectiveness. Safety ofsubject device is supported byElectrical safety and EMCaccording to IEC 60601-1, IEC60601-1-2 |
| Output Frequency | N/A | 4 MHz | Different, because subject deviceuses DC, while predicate uses AC.The difference has no influence onprinciple of operation which doesnot introduce new questions ofsafety and effectiveness. Safety ofsubject device is supported byElectrical safety and EMCaccording to IEC 60601-1, IEC60601-1-2 |
| Max. PowerOutput | 4.4 W | 120 W | Different, max power output ofthe subject device is covered bythe predicate. Predicate has wideruse, but performance for non-ablative treatment is comparableto performance of subject devicewhich does not introduce newquestions of safety andeffectiveness. Safety of subjectdevice is supported by Electricalsafety and EMC according to IEC60601-1, IEC 60601-1-2 |
| OperatingTemperature | 5°C to 40°C | 10°C to 40°C | Similar. Operating temperaturemostly overlaps with predicatedevice. |
| OperatingHumidity | 30-70% | 30-75% | Similar |
| TreatmenttemperatureRange | < 42°C | 39°C to 42°C | Similar |
| PowerLevelAdjustableviaApplicator | No, Via central console. | No, Via central console. | Similar |
| SystemComponents | System consists ofelectrosurgical unit withgenerator and controlconsole, handpieces, flatapplicators, cables,grounding electrodes,power supply, footswitchand rechargeable battery. | Rf generator, handpieces,footswitch, fingerswitch,cables, neutral plates,disposable electrodes, | Different, but difference has noinfluence on intended use. Fortreatment only handpieces withapplicator are use which does notintroduce new questions of safetyand effectiveness. Safety ofsubject device is supported byElectrical safety and EMCaccording to IEC 60601-1, IEC60601-1-2, biocompatibilityaccording to 10993-1 and tissuetesting |
| Handpiece | Pen IIIPen III/S | GlideSafe™ Handpiece | Similar, the Pen of the subjectdevice is similar as Handpiece ofpredicate - deliver energy fromgenerator to the patient's skinwhich does not introduce newquestions of safety andeffectiveness |
| Neutral electrode | Yes | Yes | Identical |
| MaterialofNeutral Electrode | Cylinder electrode(reusable): aluminum alloyHurev electrode(disposable): ProtectiveLiner (Polyethyleneterephthalate), Hydrogel,Conductive Film (Carbon),Backing Material(Polyester non-wovenfabric), Sensor (Ag/AgClcoated 20% glass-filledABS), Snap (SUS304),Leadwire (PVC jacketCarbon wire) | The effective electrodes aretwo aluminum oilconductors, covered by ahydrogel conductiveadhesive (disposable) | Different, but difference in neutralelectrodes does not affect thepatient connection for thetreatment which does notintroduce new questions of safetyand effectiveness. Safety issupported by biocompatibilityaccording to ISO 10993-1 |
| Applicator | Yes (reusable) | Yes (reusable) - inseparablepart of handpiece | Identical |
| Applicatormaterial | aluminum alloy | Gold-plated brass | Different, but difference has noinfluence on intended use,because emitting energy fromapplicator to tissues which doesnot introduce new questions ofsafety and effectiveness.Moreover, applicator is sterilizedbefore first and after eachtreatment. Safety is supported bybiocompatibility according to ISO10993-1 |
| Size in diameters | applicators with diameter3/5/10/20 mm | Applicators with diameter7.5/10/15/20 mm | Similar, size is covered bypredicate |
| Applicator Weightwith pen | <100g | <100g | Identical |
| SystemDimensions | 27.5 x 12.5 x 18.5 cm | 24cm x18cm x 42cm | Similar |
| System weight | Approx. 1.7 kg | 26 lb (11.8 kg) | Subject device weighs muchlighter than predicate, whichmakes it easier to carry ifnecessary. |
| Sterilization | Steam sterilization (at134°C for 3 min, dryingtime is 27 min) | N/A | Different, but difference has noinfluence on intended use whichdoes not introduce new questionsof safety and effectiveness.Sterilization is performedaccording to validated procedure(SAL= 10-6) stated in theInstruction of use. |
| PerformanceTesting | Complies with IEC 60601-1,IEC 60601-1-2 | Complies with IEC 60601-1,IEC 60601-1-2 | Identical |
Comparison of all characteristics is given in the following table.
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VII. NON-CLINICAL TESTING - 807.92(b)(1)
Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the JETT Medical II compared to the predicate device. Non-clinical testing has demonstrated that the JETT Medical II complies with standards and requirements and it is substantially equivalent to the predicate device.
Electrical safetv and electromaanetic compatibility (EMC)
The JETT Medical II electrical safety and electromagnetic compatibility has been evaluated and found to be in compliance with:
- . IEC 60601-1:2005 + A1:2012 + A11:2011 + A12:2014 + AC:2014-07+COR3:2022, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014+AMD1:2020, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbance Requirements and tests
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION: Medical electrical equipment ● Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6:2010 + A1:2015+AMD2:2020, Medical electrical equipment - Part 1- 6: General requirements for basic safety and essential performance - Collateral standard: Usability
Software
The JETT Medical II software testing was performed and found to be in compliance with:
- FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket . Submissions for Software Contained in Medical Devices"
- IEC 62304 Ed. 1.1 2015-06 CONSOLIDATED VERSION, Medical device software - Software lifecycle processes
Biocompatibility
The patient-contacting components of the device are flat applicators and cylinder electrode and the biocompatibility of these components comply with:
- FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical . devices - Part 1: Evaluation and testing within a risk management process
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- ISO 10993-1:2018, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within risk management process.
- ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro ● cytotoxicity,
- ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for irritation ● and delayed-type hypersensitivity
Sterilization
Sterilization of the patient-contacting components of the device (flat applicators) of JETT Medical II has been found to be in compliance with:
- ISO 17665-1:2006, Sterilization of health care products Moist heat Part 1: Requirements . for the development, validation and routine control of a sterilization process for medical devices
Risk management
Risk analysis for JETT Medical II has been evaluated and found to comply with:
- . ISO 14971:2019 Medical devices – Application of risk management to medical devices
Usability
The JETT Medical II usability has been evaluated and found to comply with:
- . FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices
- . IEC 62366-1:2015+AMD1:2020Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
- IEC 60601-1-6:2010 + A1:2015+AMD2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Bench testing - Skin temperature during treatment
Bench test was performed to ensure that the JETT Medical II performs as intended and meets design specifications.
The results showed that the temperature rise is quite well provable as after the application of the device at different intensities the temperature of skin was higher than the initial temperature. The temperature also rose with higher intensities. The increase was in almost all cases linear.
The highest temperature of 41.3 was measured at the highest intensity with a flat applicator 20 mm. The temperature never increased above 42°C.
Based on these results we can state that the device in its normal function and while adhering to treatment protocols is safe for the patient.
Substantial Equivalence - Test to assess differences in Energy source between subject device and predicate device
The energy source of the subject device is different from the predicate device (DC vs AC with radiofrequency). As is the supply power output frequency, max. output power). A substantial equivalence test was conducted to demonstrate that thermal effect of DC and RF is the same. The substantial equivalence test showed that the subject device is at least, as safe and equally efficient to the predicate device, that at similar intensity settings the delivered energy is similar to that of the predicate. Therefore this technological difference does not raise new questions of safety or effectiveness.
Animal testing
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No animal test was performed.
VIII. CLINICAL TESTING - 807.92(b)(2)
A prospective, multi-center, non-randomized, evaluator-blinded study was provided as clinical evidence of the safety and effectiveness of the device. The clinical evidence was presented as a single-arm analysis for the JPM II test treatment group (RRTST). The study population consists of subjects who have wrinkles mild to moderate in severity as specified by the Fitzpatrick wrinkle classification system (FWCS) with Fitzpatrick skin scale I-IV. The primary effectiveness endpoint is defined as an improvement of ≥ 1 point on the FWCS from baseline at the 3-month follow-up after the last treatment. The lower bound of 95% confidence interval of the response rate in the JPM II test treatment group (RRTST) is greater than the pre-defined threshold of 0.75.
IX. Conclusion - 807.92(b)(3)
The subject device JETT Medical II has the same intended use/indication for use. Despite the technological differences, non-clinical and clinical tests have shown that JETT Medical II is substantially equivalent in terms of safety and effectiveness to the predicate device and the differences do not raise any new or different questions of safety and effectiveness.
§ 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.