(152 days)
The Reaction™ system is intended for the treatment of the following medical conditions, using the B-contour and F-contour applicators for delivering non thermal RF combined with massage: - relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and - temporary reduction in the appearance of cellulite.
Using the ST applicator for delivering RF, the Reaction™ system is intended for the treatment of relief of minor musele aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
The Reaction™ system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The Reaction™ treatment is indicated for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite
The Reaction™ system provides the treatments using 3 specially-designed applicators that treat various areas of the body, including large and small areas.
The system includes five core modules: the Console, the hand piece, and 3 treatment applicators: B-Contour, F-Contour and ST.
The Reaction™ console houses the following components:
- Power supply
- Hand piece
- Vacuum pump
- RF Generator
- Main CPU
- Display unit
The hand piece allows the operator to adjust the treatment parameters of the RF power and intensity of mechanical vacuum massage.
The applicators incorporate operator panels and are used to adjust the treatment parameters of the RF power and mechanical vacuum manipulation.
The provided text is a 510(k) summary for the Reaction™ System, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than on detailed clinical study results and acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly stated in this document.
However, I can extract the following based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance metrics. The claim of "substantial equivalence" implies that the Reaction™ System's performance characteristics are comparable to those of the predicate devices for the stated indications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated and not a clinical study. The device is seeking clearance based on substantial equivalence to predicate devices for its intended use and performance characteristics. | The Reaction™ System has "the same intended use and the same performance characteristics as the following predicate devices" for each respective application. |
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set or study data is described that would involve a "sample size" in the context of efficacy or performance evaluation for this 510(k) summary. The submission is based on comparison to predicate devices, not on a new clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
4. Adjudication Method:
Not applicable, as no new clinical study data requiring ground truth establishment or expert adjudication is described in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. This 510(k) summary focuses on demonstrating equivalence to existing devices, not on comparing AI-assisted vs. non-AI-assisted human reader performance.
6. Standalone Performance:
Not applicable. The Reaction™ System is a physical device (combining RF technology with mechanical vacuum massage) and does not involve an "algorithm only" or "human-in-the-loop" AI performance as implied by this question. Its performance is inherent to its physical operation.
7. Type of Ground Truth Used:
Not applicable, as no new clinical study requiring ground truth is described. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set:
9. How the Ground Truth for the Training Set Was Established:
Not applicable. The Reaction™ System is not an AI/machine learning device that would involve a training set.
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Image /page/0/Picture/1 description: The image shows the word "VIORA" in a bold, sans-serif font. Above the word is a stylized graphic that resembles a cursive letter or a decorative flourish. The graphic is composed of curved lines that form a loop-like shape, adding a touch of elegance to the overall design.
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510(k) Summary:
Reaction™ System
Company Name: Viora Ltd.
Contact Person: Omri Kessler
COO
Telephone: +972-3-5622248 +972-3-5622247 Fax: E-mail: omri@vioramed.com
Authorized US Agent:
Josef Luzon - CEO Viora Inc. 30 Montgomery Street, Suite 660 Jersey City, NJ 07302
Telephone: (201) 332-4100 Fax: (201) 332-4200 E-mail: josef(@vioramed.com
Date prepared: January 23, 2009
Trade Name: Reaction™ System
Classification name: Laser surgical instrument for use in-general and plastic surgery and in dermatology
Common/usual name: Massager, vacuum, light induced heating
Product Code: NUV, ISA
Regulation No.: 878.4810
Class: II
Panel identification: General and Plastic Surgery Panel.
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090221
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Predicate Device:
VelaShape from Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 510(k) # K071872;
5-2
VelaSmooth, Shaper from Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 510(k) # K050397;
LPG Therapeutic Massager from LPG USA Inc, Fort Lauderdale, Fl, USA, cleared under 510(k) # K990445 and
Description of the device:
The Reaction™ system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The Reaction™ treatment is indicated for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite
The Reaction™ system provides the treatments using 3 specially-designed applicators that treat various areas of the body, including large and small areas.
The system includes five core modules: the Console, the hand piece, and 3 treatment applicators: B-Contour, F-Contour and ST.
The Reaction™ console houses the following components:
- Power supply
- Hand piece
- Vacuum pump
- RF Generator
- Main CPU
- Display unit
The hand piece allows the operator to adjust the treatment parameters of the RF power and intensity of mechanical vacuum massage.
The applicators incorporate operator panels and are used to adjust the treatment parameters of the RF power and mechanical vacuum manipulation.
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K09J221/
Page 3 of 3
Image /page/2/Picture/2 description: The image shows the word "VIORA" in a serif font. Above the word is a stylized graphic that resembles an infinity symbol with a line extending upwards from the left side of the symbol. The text and graphic are in black and white.
Indications for Use:
The Reaction™ system is intended for the treatment of the fellowing medical conditions. using the B-contour and F-contour applicators for delivering non thermal RF combined with massage:
5-3
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relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and
-
temporary reduction in the appearance of cellulite.
Using the ST applicator for delivering RF, the Reaction™ system is intended for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
Substantial Equivalence:
The Reaction 130 System using the B-contour and the F-contour applicators, has the same intended use and the same performance characteristics as the fotlowing predicate devices: VelaShape from Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 510(k) # K071872; VelaSmooth, Shaper from Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 510(k) # K050397 and LPG Therapeutic Massager from LPG USA Inc, Fort Lauderdale, Fl, USA, cleared under 510(k) # K990445.
When using the ST applicator, the Reaction 130 System has the same intended use and the same performance characteristics as the RF application of Cutera CMMCD from Cutera Inc in Brisbane, CA, USA, cleared under 510(k) # K080300 and the following predicate devices: Intelect® SWD 100/ Senior Solutions from Chattanooga Group in Hixson, TN. USA, cleared under 510(k) # K083433 and Auto*Therm® 390, Model ME 390 from Mettler Electronics Corp in Anaheim, CA, USA, cleared under 510(k) # K042554.
The Reaction TM System is therefore substantially equivalent to those devices for each of the intended applications.
Conclusion -
The evaluation of the Reaction " System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUL - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Viora Ltd. % Viora Inc. Mr. Josef Luzon Chief Executive Officer 30 Montgomery Street, Suite 660 Jersey City, New Jersey 07302
Re: K090221
Trade/Device Name: Reaction™ System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: NUV, ISA, ILY Dated: June 18, 2009 Received: June 19, 2009
Dear Mr. Luzon:
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.
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 (reporting of medical
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Page 2 - Mr. Josef Luzon
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
fren Nillson
Mark N.Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Reaction™ System
Indications for Use:
The Reaction™ system is intended for the treatment of the following medical conditions, using the B-contour and F-contour applicators for delivering non thermal RF combined with massage: - relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and - temporary reduction in the appearance of cellulite.
Using the ST applicator for delivering RF, the Reaction™ system is intended for the treatment of relief of minor musele aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
Prescription Use X ાર (Part 21 CFR 801 Subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090221
§ 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.