(126 days)
ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
The Icoone-h device is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.
lcoone-h Laser is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths:
LED @ 650nm (50Mw) Laser @ 915nm (1W)
The light sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
This FDA 510(k) summary for the ICOONE h device does not include acceptance criteria or a study proving that the device meets those criteria. Instead, it argues for substantial equivalence to predicate devices based on indications for use, technological characteristics, and conformance to safety standards.
Therefore, I cannot provide the requested table or describe a study that proves the device meets acceptance criteria based on the provided text.
However, I can extract information related to the device's characteristics and the basis for its substantial equivalence claim, which may be relevant to regulatory acceptance:
Information available from the provided text:
1. A table of acceptance criteria and the reported device performance:
As stated previously, explicit acceptance criteria and corresponding performance metrics are not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria. The table below summarizes the comparison to predicate devices, which serves as the basis for regulatory acceptance in this context.
| Feature / Characteristic | ICOONE h (Reported Performance/Characteristics) | Predicate Device (K061603 - SmoothShapes) (Reported Performance/Characteristics) | Predicate Device (K053611 - SmoothShapes) (Reported Performance/Characteristics) | Substantial Equivalency Determination |
|---|---|---|---|---|
| Indications for Use | Relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. | Relieves of minor muscle aches and pains, Relieves muscle spasms, Temporary improves local blood circulation, Temporary reduces in appearance of cellulite | Relieves of minor muscle aches and pains, Relieves muscle spasms, Temporary improves local blood circulation, Temporary reduces in appearance of cellulite | Same |
| System Component | Laser, Massage, Suction, Rollers | Laser, Massage, Suction, Rollers | Laser, Massage, Suction, Rollers | Same |
| Mechanical Massage | Yes | Yes | Yes | Same |
| Weight | 191.80 lb (87 kg) | 101.41 lb (46 kg) | 59.52 lb (27 kg) | Different (but similar) |
| Dimension | 37.40x80.71x19.68 inch (95x205x50 cm) | 21.26x23.23x51.97 inch (54x59x132 cm) | 31.47x19.68x13.78 inch (80x50x35 cm) | Different (but similar) |
| Light Emitting Safety | IEC 60825-1: 2007 (in conjunction with IEC 60601-1: 2005), IEC 60601-2-22: 2007 | 21 CFR 1040 | 21 CFR 1040 | Same (FDA accepts equivalency) |
| Electrical Safety | CEI EN 60601-1:2007 /A11: 2012 | IEC/EN 60601-1-1: 1995 | IEC/EN 60601-1-1: 1995 | Same (our device is not a system and IEC 60601-1 is not applicable) |
| EMC | CEI EN 60601-1-2: 2010 | IEC 60601-1-2:1993, 2001 | IEC 60601-1-2:1993, 2001 | Same |
| Patient Contact Material | Handpiece suction rollers | Handpiece suction rollers | Handpiece suction rollers | Same |
| Biocompatibility | Cytotoxicity, irritation, Sensitization (As per requirements) | Unknown | Unknown | (As per requirements) |
| Power Source | 240/110 Vac | 240/110 Vac | 240/110 Vac | Same |
| IR Power | max 1W | max 15W / 915 nm, max 1W / 650 nm | max 1W / 915nm, max 0.5 W / 650 nm | Different (Similar to K053611, Safer than K061603) |
| Infrared Wavelengths | 650nm (LED), 915 nm (LASER) | 650nm (LED), 915 nm (LASER) | 640 nm - 660 nm (LED), 880 nm - 940 nm (LASER) | Same |
| Max. IR Output Energy Density | 26.9 W/m2 | Unknown | Unknown | (Safe and effective) |
| Vacuum | Fractioned | Pulsed | Pulsed | Different (but similar) |
| Treated Area | 3.15x2.36 inch (80x60mm - Robosolo head), 2.36x1.97 inch (60x50mm - Robotwin head) x2, 1.97x1.38 inch (50x35mm - Robomini head), 0.031x0.031 inch (0.8x0.8 mm - Robomicro head with applicator "D"), 0.027x0.91 inch (0.7x23 mm - Robomicro head with applicator "C"), 0.59x1.14 inch (15x29 mm - Robomicro head with applicator "B") | Unknown | 1.57x1.57 inch (40x40mm) | Different (but similar) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states "Clinical tests- brief discussion: Not applicable." This indicates that no clinical studies were performed to establish the device's safety or effectiveness as part of this 510(k) submission. Therefore, there is no test set, sample size, or data provenance to report from this document in this context. The acceptance is based on substantial equivalence to predicate devices, which were assessed through non-clinical technical characteristics and compliance with recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical tests were performed, and therefore, no "ground truth" for a test set was established using experts in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical tests were performed.
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 not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical therapeutic device, not an algorithm, and no standalone performance study was conducted in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical data or ground truth related to patient outcomes or diagnoses were generated for this 510(k) submission. The "ground truth" for regulatory clearance is based on the substantial equivalence argument, particularly alignment with the established safety and efficacy profiles of predicate devices and compliance with relevant safety standards.
8. The sample size for the training set:
Not applicable, as no algorithm or machine learning model was developed or trained for this device.
9. How the ground truth for the training set was established:
Not applicable, as no algorithm or machine learning model was developed or trained for this device.
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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 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.
I-tech Industries Srl % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell. Georgia 30075
January 11, 2019
Re: K182453
Trade/Device Name: ICOONE h (also referred to as ICOONE LASER and ICOONE -h LASER) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NUV Dated: December 7, 2018 Received: December 12, 2018
Dear Jay Mansour:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 medical devices and radiation-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,
Neil R Ogden - Digitally signed by Neil R
S Ogden -S
Date: 2019.01.11 12:08:58
-05'00'
Rinite S Asher MD MBA FAC
For 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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Indications for Use
510(k) Number (if known) K182453
Device Name
ICOONE h (also referred to as ICOONE LASER and ICOONE -h LASER)
Indications for Use (Describe)
ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
| 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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510k Summary
As required by 21 CFR 807.92 (c)
1- Date summary prepared: 1/11/2019
2-Owner/Submitter/Sponsor/Applicant information:
I-Tech Industries S.r.l Via Cicogna 34/B 40068 San Lazzaro Di Savena Bologna Italy
3-Device information:
Common/usual/classification name: Massager, Vacuum, Light Induced Heating
Device name: ICOONE h (also referred to as ICOONE LASER and ICOONE -h LASER)
| FDA 3 letter code | NUV |
|---|---|
| FDA regulation number: 21 CFR | 878.4810 |
| Regulation medical specialty | General & Plastic Surgery |
| Review panel | General & Plastic SurgeryDivision of Surgical Devices (DSD)General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Class | II |
4- Substantial equivalency is claimed against the following predicate device(s):
| 510knumber | Trade or Proprietary or Model Name | Manufacturer | Primary predicate? |
|---|---|---|---|
| K053611 | SmoothShapes | Biocellulase, Inc. | No |
| K061603 | SmoothShapes | Biocellulase, Inc. | Yes |
5- Description of the device:
The Icoone-h device is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.
lcoone-h Laser is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths:
LED @ 650nm (50Mw) Laser @ 915nm (1W)
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The light sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
6- Intended use + indications for use
ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
7- Basis for a determination of substantial equivalency:
-
(a) Indications for use:
The indication for use is identical to the predicates'. -
(b) Technological characteristics:
The technological characteristics are substantially equivalent to the predicate device, meeting the same technical standards.
| Device name | Icoone -h | BiocellulaseSmoothshapes | BiocellulaseSmoothshapes | Substantialequivalency: same ordifferent |
|---|---|---|---|---|
| 510(k) number | TBD | K053611 | K061603 | |
| Systemcomponent | Laser, Massage, Suction, Rollers | Laser, Massage,Suction, Rollers | Laser, Massage,Suction, Rollers | Same |
| Mechanicalmassage | yes | yes | yes | Same |
| Weight | 191.80 lb (87 kg) | 59.52 lb (27 kg) | 101.41 lb (46 kg) | Different (but similar) |
| Dimension | 37.40x80.71x19.68 inch (95x205x50 cm) | 31.47x19.68x13.78inch (80x50x35 cm) | 21.26x23.23x51.97inch (54x59x132 cm) | Different (but similar) |
| Light emittingsafety | IEC 60825-1: 2007 (in conjunction with IEC 60601-1: 2005)IEC 60601-2-22: 2007 | 21 CFR 1040 | 21 CFR 1040 | Same (FDA accepts theequivalency) |
| Electrical Safety | CEI EN 60601-1:2007 /A11: 2012 | IEC/EN 60601-1-1: 1995IEC/EN 60601-1-1: 1995 | IEC/EN 60601-1-1: 1995IEC/EN 60601-1-1: 1995 | Same(our device is not a systemand IEC 60601-1 is notapplicable) |
| EMC | CEI EN 60601-1-2: 2010 | IEC 60601-1-2:1993,2001 | IEC 60601-1-2:1993,2001 | Same |
| Patient contactmaterial | Handpiece suction rollers | Handpiece suctionrollers | Handpiece suctionrollers | Same |
| Biocompatibility | Cytotoxicity, irritation, Sensitization | unknown | unknown | (As per requirements) |
| Indication foruse | Relieves of minor muscle aches and pains, Relieves musclespasms, Temporary improves local blood circulation,Temporary reduces in appearance of cellulite | Relieves of minor muscleaches and pains, Relievesmuscle spasms, Temporaryimproves local bloodcirculation, Temporaryreduces in appearance ofcellulite | Relieves of minor muscleaches and pains, Relievesmuscle spasms, Temporaryimproves local bloodcirculation, Temporaryreduces in appearance ofcellulite | Same |
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| Power Source | 240/110 Vac | 240/110 Vac | 240/110 Vac | Same |
|---|---|---|---|---|
| IR power | max 1W | max 1W / 915nmmax 0.5 W / 650 nm | max 15W / 915 nmmax 1W / 650 nm | Different:Similar to K053611Safer than K061603 |
| Infraredwavelengths | 650nm (LED)915 nm (LASER) | 640 nm - 660 nm (LED)880 nm - 940 nm (LASER) | 650nm (LED)915 nm (LASER) | Same |
| Max. IR outputenergy density | 26.9 W/m2 | unknown | unknown | (safe and effective) |
| Vacuum | Fractioned | Pulsed | Pulsed | Different (but similar) |
| Treated area | 3.15x2.36 inch (80x60mm - Robosolo head)2.36x1.97 inch (60x50mm - Robotwin head) x21.97x1.38 inch (50x35mm - Robomini head)0.031x0.031 inch (0.8x0.8 mm - Robomicro head withapplicator "D")0.027x0.91 inch (0.7x23 mm - Robomicro head withapplicator "C")0.59x1.14 inch (15x29 mm - Robomicro head withapplicator "B") | 1.57x1.57 inch(40x40mm) | unknown | Different (but similar) |
-
(c) Non-clinical tests- brief discussion:
The standards that we comply with (listed above) confirm the safety, fit and effectiveness. -
(d) Clinical tests- brief discussion:
Not applicable. -
(e) Non-clinical and clinical tests- conclusions drawn demonstrating that the device is as safe and as effective, and performs as well as or better than the predicate device(s):
ICOONE h performs as designed, in accordance with requirements. It is as safe and effective as the predicate device(s).
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.