(308 days)
- Relieves minor muscle aches and pains .
- Relieve muscle spasm
- Temporary Improvement in local circulation
- Temporarily reduces the appearance of cellulite .
The TriActive system utilizes pulsatile vacuum action to achieve massaging results.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, there are no specific acceptance criteria listed, nor is there any reported device performance data from a clinical study. The summary explicitly states:
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Nonclinical Performance Data | Not specified | "none" |
| Clinical Performance Data | Not specified | "none" |
2. Sample Size Used for the Test Set and Data Provenance
Since no clinical or nonclinical performance data was submitted, there is no test set, sample size, or data provenance mentioned in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
As no performance data was provided, there was no ground truth established for a test set, no experts involved, and therefore no qualifications specified.
4. Adjudication Method for the Test Set
With no test set or expert evaluation, there was no adjudication method employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The summary explicitly states "Clinical Performance Data: none."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device, the Cynosure TriActive Therapeutic Massage System, is a physical therapeutic massager, not an AI or algorithm-based device. Therefore, a standalone (algorithm-only) study is not applicable and was not performed.
7. Type of Ground Truth Used
No ground truth was used as no performance data was submitted.
8. Sample Size for the Training Set
Since this is a physical device and no AI/algorithm is involved, there is no training set mentioned or applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, the establishment of ground truth for a training set is not applicable.
Summary of Device Clearance Rationale:
The Cynosure TriActive Therapeutic Massage System received 510(k) clearance based on its substantial equivalence to a legally marketed predicate device (LPG Therapeutic Massager and Vibrator). The FDA concluded that the device is "another safe and effective device for the indications" primarily because it has the "same indications as the predicate device" and utilizes a similar mechanism of action (pulsatile vacuum). The clearance was granted without the submission of new clinical or nonclinical performance data for the TriActive system itself. The assumption is that the safety and effectiveness of the type of device and its intended use had already been established through the predicate device.
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510(k) SUMMARY
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | March 19, 2003 |
| Device Trade Name: | Cynosure TriActive Therapeutic Massage System |
| Common Name: | Therapeutic Massager |
| Classification Name: | Therapeutic Massager21 CFR 890.5660 |
| Equivalent Device: | LPG Therapeutic Massager and Vibrator |
| Device Description: | The TriActive system utilizes pulsatile vacuum action toachieve massaging results. |
| Intended Use: | The TriActive is indicated for minor muscle aches, pain,and spasm. It is also indicated for improvement in localcirculation and reduction in the appearance of cellulite. |
| Comparison: | It has the same indications as the predicate device. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The TriActive Therapeutic Massage System is anothersafe and effective device for the indications. |
| Additional Information: | none |
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Image /page/1/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an image of a bird.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2005
Mr. George Cho Senior Vice President Cynosure. Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824-4145
Re: K030876
Trade/Device Name: Cynosure Triactive Therapeutic Massage System Regulation Number: 21 CFR 890.5500, 21 CFR 890.5660 Regulation Name: Infrared Lamp, Therapeutic massager Regulatory Class:II Product Code: ILY, ISA Dated: December 18, 2003 Received: December 19, 2003
Dear Mr. Cho:
This letter corrects our letter of January 22, 2004 regarding the regulation name, regulatory class and product code of the Cynosure Triactive Therapeutic Massager.
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 enclosurc) to legally marketed predicate devices murketed 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 (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 complics 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 (121
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Page 2 - Mr. George Cho
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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark A. Milkerson
Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Indications for Use
50)(k) Number (if known): K030876
Device Name:
Cynosure TriActive Therapeutic Massage System
Indications For Use:
- Relieves minor muscle aches and pains .
- 1 Relieve muscle spasm
- Temporary Improvement in local circulation 8
- Temporarily reduces the appearance of cellulite .
Prescription Usc (Per 21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (Per 21 CFR 807 Subpan C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ﺎ Division of (-auces , Fran and Neurological Concess KO SUY 510(k) Number
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§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.