The i-lipo™ Ultra Vacuum Massage System is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The i-lipo™ Ultra Treatment Pads and Probes are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.
The i-lipo™ Ultra System consists of a main unit, and applied parts (massage head with rollers and various laser diode cluster probes and pads). The Main Unit contains the mains input, fuses, power supply, pump, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The massage head, and cluster probes and pads, which are placed against the patients skin, contain the rollers, and Laser diodes, Laser light provides topical heating which increases tissue temperature, and the rollers in combination with the vacuum mechanically manipulate the tissue.
The provided text describes a 510(k) submission for the Chromogenex Technologies Limited i-lipo™ Ultra System. However, it does not contain the detailed information requested regarding specific acceptance criteria, study design parameters (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or comprehensive performance results.
The document states:
- Clinical Testing: "Skin temperature measurements were made to support the performance of pads and probes as thermal heating systems for pain relief." This is the only mention of a "study" related to performance. It doesn't elaborate on the specifics of this study, its results, or how these results relate to predefined acceptance criteria.
- Non-Clinical Testing: Safety testing was to be carried out to various IEC, UL, and CSA standards (e.g., IEC 60601-1, IEC 60601-2-22, CSA C22.2, IEC 60601-1-2) for electrical safety and electromagnetic compatibility. These are standards for device safety, not device performance against specific clinical efficacy claims or acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Skin temperature measurements were made to support performance as thermal heating systems for pain relief. (No specific values or metrics provided.) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (implicitly clinical data, but no country or retrospective/prospective status).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified, as there is no mention of ground truth established by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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 study was mentioned. The device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a physical medical device, not an algorithm. Standalone performance as typically described for AI/software is not relevant. The device itself operates "standalone" in its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "skin temperature measurements," the implicit ground truth would be the temperature measurements themselves, considered direct evidence of heating. For other indications like pain relief, muscle spasms, blood circulation, and cellulite reduction, the document only mentions "support the performance" but does not detail how efficacy was measured or validated against a ground truth.
8. The sample size for the training set:
- Not applicable/Not specified as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Not applicable/Not specified as no training set for an algorithm is mentioned.
Summary of Device and Study Information:
- Device Name: i-lipo™ Ultra System
- Intended Use: Temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
- Key Finding from Document: The device appears to have obtained 510(k) clearance based on substantial equivalence to predicate devices and non-clinical testing for safety (electrical, EMC) and limited clinical support for performance via skin temperature measurements. The document does not provide details of a rigorous clinical trial with defined acceptance criteria for efficacy or comprehensive performance data for each indicated use. The FDA letter confirms the 510(k) clearance based on substantial equivalence.
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Chromogenex Technologies Limited - i-lipo™ Ultra -Traditional 510(k) Application May 2010
510(k) Summary
SEP 1 7 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K0101366
Submitter: A.
Chromogenex Technologies Limited Units 1-2 Heol Rhosyn Parc Dafen Llanelli Carmarthenshire SA14 8QG nk
Phone: +44 (0) 1554 755444 Fax: +44 (0) 1554 755333
Contact: Mr Peter R Bevan (Quality Manager)
Date Prepared: May 2010
B. Device Names:
Classification name Common/usual name Proprietary name
Massager, vacuum, Light Induced Heating Massager / shaper i-lipo™ Ultra System
C. Predicate Devices:
Biocellulase Smoothshapes - K061603 Meridian Co. Ltd Lapex BCS - K081962
D. Device Description:
The i-lipo™ Ultra System consists of a main unit, and applied parts (massage head with rollers and various laser diode cluster probes and pads). The Main Unit contains the mains input, fuses, power supply, purmp, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The massage head, and cluster probes and pads, which are placed against the patients skin, contain the rollers, and Laser diodes, Laser light provides topical heating which increases tissue temperature, and the rollers in combination with the vacuum mechanically manipulate the tissue.
Intended Use: ﻧﻨﺎ
The Chromogenex Technologies Limited i-lipo™ Ultra Vacuum Massage System is indicated for the temporary relief of minor muscle aches and pain, temporary relief of
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Chromogenex Technologies Limited - i-lipo™ Ultra -Traditional 510(k) Application May 2010
muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
The i-lipo™ Ultra Treatment Pads and Probes are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.
F. Comparison with the Predicate Devices:
The i-lipo™ Ultra is substantially equivalent to the predicates with respect to intended use and technological characteristics.
G. Clinical Testing
. 4
Skin temperature measurements were made to support the performance of pads and probes as thermal heating systems for pain relief.
H. Non Clinical Testing
Safety testing is to be carried out to IEC and UL 60601-1 Medical Electrical Equipment Part 1 - General Requirements for Safety; Collateral Standard : Safety Requirements for Medical Electrical Systems, IEC 60601-2-22 Specification for diagnostic and therapeutic laser equipment, CSA C22.2 Canadian Electrical code Part II, and IEC 60601-1-2 - Collateral Standard : Electromagnetic Compatibility.
1. Conclusion
Based on the technological characteristics and the non clinical testing, the i-lipo™ Ultra is substantially equivalent to the above names predicate devices, for the intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three arms or wings extending upwards.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Chromogenex Technologies, Ltd. % Mr. Peter R. Bevan Units 1 & 2 Heol Rhosyn Parc Dafen Carmarthenshire SA14 8QG United Kingdom
Re: K101366
Trade/Device Name: i-lipo" Ultra System 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, ILY Dated: September 13, 2010 Received: September 15, 2010
Dear Mr. Bevan:
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.
SEP 1 7 2010
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Page 2 - Mr. Peter R. Bevan
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Poto thimón
Mark N. Me Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Chromogenex Technologies Limited - i-lipo™ Ultra -Traditional 510(k) Application May 2010
Indications for Use
510(k) Number (if known): K 101366
Device Name: _ i-lipo™ Ultra System
SEP 1 7 2010
Indications for use:
The i-lipo™ Ultra - Vacuum Massage System - is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
The i-lipo™ Ultra -Treatment Pads and Probes - are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil RP Ogden for man
Division Size 800
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101366
§ 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.