(18 days)
Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV
Non-ablative treatment of mild to moderate facial wrinkles for skin phototypes I-IV
The purpose of this submission is to modify the Cleaning / Disinfection methods of the Non-Ablative Wrinkle Treatment Handpiece cleared as Ellman Non-Ablative Wrinkle Treatment Handpiece under K101967. The device is identical to the device cleared under K101967 Ellman International Non-Ablative Wrinkle Treatment Handpiece except for the modified Cleaning/Disinfection method.
This 510(k) summary describes a modification to a medical device, specifically changes to its cleaning and disinfection methods, rather than an AI-powered diagnostic or treatment device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types, are not applicable in this context.
The document discusses the device's cleaning and disinfection methods and a study conducted to demonstrate their effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieves adequate log reduction of inoculated challenge organisms on test devices with the proposed cleaning/disinfection method. | "Ellman International has presented a successfully executed test protocol... to demonstrate that the methods described above achieve an adequate log reduction of inoculated challenge organisms on the test devices." |
| Provides an effective alternate cleaning and disinfection to the existing instructions for use. | "Ellman International has presented substantial evidence to support the claims made in method above to provide an effective alternate cleaning and disinfection to the existing instructions for use." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (e.g., number of test devices or samples) for the test set used in the cleaning/disinfection study. The data provenance is described as "test protocol as part of this submission" and "SGS Protocol # 09A1006547 and demonstrated in SGS Report# 09A1006548," indicating an internal or contracted laboratory study rather than clinical data from a specific country or retrospective/prospective collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is a laboratory test of cleaning and disinfection efficacy, not an assessment of diagnostic performance requiring expert interpretation.
4. Adjudication method for the test set
Not applicable. This is a laboratory test, not a diagnostic assessment with human readers.
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-powered 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 medical device for non-ablative wrinkle treatment, not an algorithm. The study focuses on the efficacy of a cleaning and disinfection protocol.
7. The type of ground truth used
For the cleaning and disinfection study, the "ground truth" would be the direct measurement of bacterial/microbial reduction on the test devices after applying the proposed method. This is laboratory-derived quantitative data, not expert consensus, pathology, or outcomes data in the typical sense of AI-driven diagnostics.
8. The sample size for the training set
Not applicable. This document describes a traditional medical device and its cleaning protocol validation, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, the ground truth establishment is irrelevant in this context.
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510(K) Summary
102368
Page 1, 2
Date Prepared [21CFR 807.92(a)(1)] 8/19/2010
Submitter's Information [21CFR 807.92(a)(1)]
Mr. Jonathan Achenbach Sr. Dir. R&D, Clinical & Regulatory Affairs Ellman International Inc. 333 Royal Ave. Oceanside, NY. 11572 Telephone: 516-594-3333
SEP. 0'7 2010
The establishment registration number for Ellman International is 2428235
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name
Non-Ablative Wrinkle Treatment Handpiece
Device common, usual or Classification Names
Device: Electrosurgical, cutting & coagulation & accessories
Regulation Description: Electro surgical cutting and coagulation device and accessories
Class
Classification: Class II Product Code: GEI
Device Description [21 CFR 807.92(a)(4)]
The purpose of this submission is to modify the Cleaning / Disinfection methods of the Non-Ablative Wrinkle Treatment Handpiece cleared as Ellman Non-Ablative Wrinkle Treatment Handpiece under K101967. The device is identical to the device cleared under K101967 Ellman International Non-Ablative Wrinkle Treatment Handpiece except for the modified Cleaning/Disinfection method.
The proposed method is:
Method:
Disinfect Handpiece and Cable prior to and after each procedure by wiping exterior surfaces with a lint free cloth soaked in liquid solution containing 70% Isopropyl Alcohol. Ensure surface
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remains wet for at least 5 minutes. An additional application of 70% Isopropyl Alcohol should be applied if the surface appears dry during the 5 minute period.
Ellman International has presented a successfully executed test protocol as part of this submission to demonstrate that the methods described above achieve an adequate log reduction of inoculated challenge organisms on the test devices.
Further to this, Ellman International has presented substantial evidence to support the claims made in method above to provide an effective alternate cleaning and disinfection to the existing instructions for use.
Intended Use [21 CFR 807.92(a)(5)}
:
ﺮ ﺍ
The device has the following "Indications For Use"
- Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin . phototypes I-IV
Technological Characteristics [21 CFR 807.92(a)(6)}
Ellman International maintains that the subject device is identical to the predicate device except for the modified cleaning and disinfection method.
Labels, Labeling [21 CFR XXXX]
Per section "Product Labels"
Performance Data [21 CFR 807.92(b)(1)]
As defined in SGS Protocol # 09A1006547 and demonstrated in SGS Report# 09A1006548
Predicate Devices [21 CFR 807.92(a)(3)(1)|
The device is substantially equivalent to the Non-Ablative Wrinkle Treatment Handpiece cleared as Ellman Non-Ablative Wrinkle Treatment Handpiece under K101967.
Consideration for Special 510(k) Status
In accordance with the FDA guidance document: The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance Attachment 2, Ellman Internal maintains that this change in the cleaning and disinfection method is a "Device Modification" and therefore requests that the FDA considers it as such.
As there are no technological, structural, design or intended use changes for the subject device, Ellman International believes that no further data or clinical study is required to support the position that the device is safe and effective to use with the changes delineated in the instructions for 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" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ellman International, Inc. % Mr. Jonathan Achenbach Sr. Director R & D. Clinical And Regulatory Affairs 3333 Royal Avenue Oceanside, New York 11572
SEP 0 7 2010
Re: K102368
Trade/Device Name: Non-Ablative Wrinkle Treatment Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 19, 2010 Received: August 20, 2010
Dear Mr. Achenbach:
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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Page 2 - Mr. Jonathan Achenbach
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/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.
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" Statement
KI 02368 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SEP 0 7 2010
Device Name: _________ Non-Ablative Wrinkle Treatment Handpiece
The Device has the following "Indications for Use":
Non-ablative treatment of mild to moderate facial wrinkles for skin phototypes I-IV
Prescription Use X (per 21 CFR 801.109)
ない
OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
Division Sign-(ft)
(Division Sign Division of Surgeal. Orthopedic, and Restorative را vices
510(k) Number K102368
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.