(355 days)
Not Found
No
The document describes a device that uses DC microcurrents for treatment and does not mention any AI or ML components in its description, performance studies, or key metrics.
Yes
The device is intended for the "non-ablative treatment of mild to moderate facial wrinkles and rhytids," which is a therapeutic purpose.
No
The device is intended for non-ablative treatment of facial wrinkles and rhytids, not for diagnosis.
No
The device description explicitly states it is a "portable medical device" that works on the physical principle of generating and transmitting DC microcurrents through hardware components like a generator, handpiece, applicators, and grounding electrode. This indicates it is a hardware device, not software-only.
Based on the provided information, the JETT Medical II device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "non-ablative treatment of mild to moderate facial wrinkles and rhytids." This describes a therapeutic treatment applied directly to the patient's skin.
- Device Description: The device description explains how it works by applying "DC microcurrents" to the patient's skin. This is a physical treatment method.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. The JETT Medical II is a device that directly treats a condition on the body.
N/A
Intended Use / Indications for Use
JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
Product codes
GEI
Device Description
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:
• 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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.
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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).
1
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).
2
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
3
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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4
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:
5
| • 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-
Ablative
Treatment
(K102698) | Comparison |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation name | Electrosurgical, cutting and
coagulation device and
accessories | Electrosurgical, cutting and
coagulation device and
accessories | Identical |
| Regulation
number | 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 for
Use | JETT Medical II is intended
for non-ablative treatment
of mild to moderate facial
wrinkles and rhytids for
skin phototypes I-IV. | Non-ablative treatment of
mild to moderate facial
wrinkles and rhytides for
skin phototypes I-IV. | Identical |
| Principle of
operation | Application of heat to the
tissue by DC current. | Application of heat to the
tissue with RF energy. | Identical |
| Interface | Touch screen user applied
interface to program and
set the controls for the
patient application; there
are hand-pieces utilized to
deliver the treatment. | Buttons and knobs on the
unit; there is a hand-piece
utilized to deliver the
treatment. | Similar. |
| Treatment | Non-ablative | Non-ablative | Identical |
| Energy type | Direct current (DC) | Alternating current (AC)
with 4MHz (radiofrequency) | Different, but difference has no
influence on intended use -
thermal effects on tissue are
identical which does not introduce
new questions of safety and
effectiveness (Refer to Vol
18_Bench Substantial Equivalence
Test for difference in Energy
source). Safety of subject device is
supported by Electrical safety and
EMC according to IEC 60601-1, IEC
60601-1-2 |
| Modality | Monopolar | Monopolar, bipolar | Identical, monopolar modality of
predicate is used for our intended
use |
| Device Activation | Using footswitch | Using a hand or footswitch
based on user preference | Similar |
| Treatment Modes | Multiple treatment levels | Multiple treatment levels | Identical |
| Supply Power
Input | 100-240 V
47-63 Hz | 110-250 V
50/60 Hz | Similar, supply power input of the
subject device is covered by the
predicate which does not
introduce new questions of safety
and effectiveness. Safety of
subject device is supported by
Electrical safety and EMC
according to IEC 60601-1, IEC
60601-1-2 |
| Output Frequency | N/A | 4 MHz | Different, because subject device
uses DC, while predicate uses AC.
The difference has no influence on
principle of operation which does
not introduce new questions of
safety and effectiveness. Safety of
subject device is supported by
Electrical safety and EMC
according to IEC 60601-1, IEC
60601-1-2 |
| Max. Power
Output | 4.4 W | 120 W | Different, max power output of
the subject device is covered by
the predicate. Predicate has wider
use, but performance for non-
ablative treatment is comparable
to performance of subject device
which does not introduce new
questions of safety and
effectiveness. Safety of subject
device is supported by Electrical
safety and EMC according to IEC
60601-1, IEC 60601-1-2 |
| Operating
Temperature | 5°C to 40°C | 10°C to 40°C | Similar. Operating temperature
mostly overlaps with predicate
device. |
| Operating
Humidity | 30-70% | 30-75% | Similar |
| | | | |
| Treatment
temperature
Range |