(465 days)
The Buzz Facial Toning System is an Over-The-Counter handheld device indicated for cosmetic use.
The Buzz Facial Toning System is a TENS device that applies an electrical current to electrodes on a person's skin for aesthetic purposes.
The provided 510(k) summary for "The Buzz Facial Toning System" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Here's why and what can be extracted from the document:
Why the requested information is largely absent:
- Substantial Equivalence Pathway: This 510(k) application is based on substantial equivalence to existing predicate devices (K011935, K040871, K072260, K070217, K070250, K071573). This pathway typically does not require new clinical performance studies to demonstrate safety and effectiveness if the device is sufficiently similar to legally marketed devices.
- "Cosmetic Use" Indication: The device is indicated for "cosmetic use." Devices for cosmetic purposes often have less rigorous performance study requirements compared to devices making medical claims (e.g., treating a disease, diagnosing a condition).
- Explicitly Stated "N/A" for Performance Testing: The document explicitly states "N/A" (Not Applicable) for "Performance Testing - Bench," "Performance Testing - Animal," and "Performance Testing - Clinical." This confirms that specific performance studies, as one might expect for a new medical claim or a device not relying on substantial equivalence for performance, were not conducted or submitted.
Despite the lack of a traditional performance study, I will structure the answer based on your request, explaining why certain sections are empty and what little information is available.
Acceptance Criteria and Study for The Buzz Facial Toning System
The 510(k) summary for "The Buzz Facial Toning System" does not present specific acceptance criteria or a dedicated study to prove the device meets these criteria in terms of performance for its stated cosmetic indication. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Criteria: No specific performance criteria (e.g., metrics for "facial toning," improvement in skin appearance) are defined or measured in this submission. | Performance (via Substantial Equivalence): The manufacturer states, "The Buzz Facial Toning System employs the same indications for use and technological characteristics, including design materials, and power output as the predicates listed on the chart specifically K011935 Salton's Rejuvenique... The manufacturer believes that no significant differences exist between the device and the predicates listed in Section 3." This implies that its performance is considered equivalent to the predicates, which are already legally marketed for similar cosmetic uses. |
| Safety Criteria: Biocompatibility of patient contact materials. | Safety (via Biocompatibility Review): Patient contact materials (stainless steel nodules, ABS plastic body, Collagen Conductive Gel) were reviewed. Stainless steel and ABS plastic are "well known and considered safe." The Collagen Conductive Gel was determined to be "the same material, follows the same manufacturing process, is the same chemical composition, and has the same body contact as the legally marketed predicate device, Dezac, Conductive Gel, K022006 and therefore Biocompatibility Requirements are met." |
| Electrical/Mechanical Safety: Compliance with relevant standards. | Electrical/Mechanical Safety: "EN Standards testing reports are attached." (The specific standards and results are not detailed in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No dedicated clinical or performance test set was used, as performance was established through substantial equivalence.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. There was no clinical study requiring expert assessment for ground truth establishment.
4. Adjudication Method
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not conducted. The submission specifically states "Performance Testing - Clinical - N/A."
6. Standalone Performance Study (Algorithm Only)
- No. A standalone performance study was not conducted for the device. The device is a physical TENS device, not an algorithm, and its performance was not evaluated independently of human use in a specific study within this submission.
7. Type of Ground Truth Used
- Not applicable for performance. The "ground truth" for the device's marketability and safety was based on the regulatory precedent of the predicate devices a.k.a. Substantial Equivalence. For biocompatibility, the ground truth was the established safety of the materials and a legally marketed predicate conductive gel.
8. Sample Size for the Training Set
- Not applicable. As no new performance study was conducted, there was no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable.
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DEC - 9 2011
510(k) SUMMARY K 102494
DAKA Industrial LTD.
Device: The Buzz Facial Toning System
1. General Information
Date Prepared: November 1, 2011
Submitter: AEGIS Regulatory, Inc. 1131 Anthem View Lane Knoxville, TN 37922 Tel.: (865) 982-5552 Fax: (865) 381-1808 Contact: Robert T. Wagner Email: bob@fdalistingconsultants.com
On Behalf of: DAKA Industrial Limited. Dali District, Qingxi Town Dongguan City, Guangdong Province Tel.: 86- 769- 8730- 9666 Fax: 86-769- 8731- 4119 Contact: Lawrence Chan Email: sannychi@newford.com
2. Names and Code
Device Proprietary Name: The Buzz Facial Toning System
Classification Name: TENS Device for aesthetic use.
Classification Code: NFO, Class II
Indications: Indicated for cosmetic use.
3. Predicate Devices
- a. K011935 -Salton Inc- Rejuvenique
- b. K040871-FaceMaster of Beverly Hills- Facemaster
- c. K072260-Carol Cole Company- Nuface
- d. K070217 -Neuro Resource Group-Interx 1000
- e. K070250- Isomers Lab-Nutritone Facial System
- f. K071573- Fatrotek SRL- Rugalift
Please see attached Predicate Chart
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4. Device Description
The Buzz Facial Toning System is a TENS device that applies an electrical current to electrodes on a person's skin for aesthetic purposes. ા
5. Substantial Equivalence
The Buzz Facial Toning System employs the same indications for use and technological characteristics, including design materials, and power output as the predicates listed on the chart specifically K011935 Salton's Rejuvenique. Therefore substantial equivalency is requested.
6. Biocompatibility
The patient contact materials in the Beauty Buzz device are stainless steel . nodules, body of the device and the Collagen Conductive Gel.
The nodules in contact with the face are stainless steel and the body is constructed of ABS plastic and are the same materials used in predicate devices. The biocompatibility of these products are well known and considered safe when in contact with healthy skin.
A review of the Biocompatibility decision is shown on the "General Program Memorandum - #G95-1, Attachment C, Biocompatibility Flow Chart for the Selection of Toxicity Tests for 510(k)s." Please see the following page. Following the Biocompatibility flowchart, the Beauty Buzz Collagen Conductive Gel is the same material, follows the same manufacturing process, is the same chemical composition, and has the same body contact as the legally marketed predicate device, Dezac, Conductive Gel, K022006 and therefore Biocompatibility Requirements are met.
7. Indications for Use / Intended Use
The Buzz Facial Toning System is an Over-The-Counter handheld device indicated for cosmetic use.
8. Performance Data
Taking into consideration the statement in "5. Substantial Equivalency" above, after an analysis of the safety, indications and intended uses,
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performance, features, technological properties and methods of operation. The manufacturer believes that no significant differences exist between the device and the predicates listed in Section 3 (on attached chart).
OTC variance is requested.
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Software Validation - Report follows
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Sterilization / Use - N/A
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Electromagnetic Compatibility and Electrical, Mechanical and Thermal Safety - EN Standards testing reports are attached.
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Performance Testing - Bench - N/A
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Performance Testing - Animal - N/A
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Performance Testing - Clinical - N/A
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is rendered in blue. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DAKA Industrial Limited c/o Mr. Robert T. Wagner Chief Executive Officer AEGIS Regulatory, Inc. 1131 Anthem View Lane Knoxville, TN 37922
JUN - 1 2012
Re: K102494
Trade/Device Name: Beauty Buzz Facial Toning System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NFO Received: November 28, 2011
Dear Mr. Wagner:
This letter corrects our substantially equivalent letter of December 9, 2011.
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.
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
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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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
510(k) Number: K102494
Device Name: Beauty Buzz Facial Toning System
Indications for Use:
The Beauty Buzz Facial Toning System is indicated for cosmetic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ (Per 21 CFR 801.109) Over-The-Counter Use__X_ (Optional Format 1-2-96)
R
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102494
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).