(30 days)
The device has the following "Indications For Use"
- Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes . I-IV
Accessory handpiece electrode is intended for use with the Ellman Surgitron IEC120 / 4.0 Dual Radio-Frequency generator. The device is considered as an accessory to the RF generator. The generator has been cleared by the FDA under 510(k) K082834 Ellman International Non-Ablative Technique for Surgitron IEC.
The provided text describes a 510(k) submission for a "Non-Ablative Wrinkle Treatment Handpiece," specifically for a change in cleaning/disinfection methods. It does not contain information about clinical studies evaluating the device's performance in treating wrinkles or rhytides, nor does it define performance-based acceptance criteria for such a clinical application.
The sole "study" mentioned is related to the cleaning and disinfection methods of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for Cleaning/Disinfection) | Reported Device Performance |
|---|---|
| Adequate log reduction of inoculated challenge organisms after disinfection. | Successfully achieved "adequate log reduction of inoculated challenge organisms" on test devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text for the disinfection study. The text mentions "test devices" (plural) but does not give a specific number.
- Data Provenance: The study was "successfully executed test protocol as part of this submission" by "Ellman International" and reported by "SGS Protocol # 09A0908673 and demonstrated in SGS Report# 09A0908675." This suggests it was an in-house or contracted laboratory study, likely retrospective to the submission date. The country of origin of the data is not specified, but Ellman International Inc. is located in Oceanside, NY, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The study focuses on microbiological efficacy of disinfection, not clinical outcomes requiring expert interpretation. The "ground truth" here would be the measured reduction of microbial load.
4. Adjudication Method for the Test Set:
- Not applicable as this was a laboratory study of disinfection efficacy; no human subjective assessment for ground truth was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This submission is for a change in cleaning/disinfection methods for an accessory handpiece. No MRMC study was conducted or mentioned for the device's primary clinical indication (wrinkle treatment). The document explicitly states: "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."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical handpiece and not an algorithm. The disinfection study assessed the physical and chemical process.
7. Type of Ground Truth Used:
- For the disinfection study: "Measured reduction of inoculated challenge organisms." This is an objective, quantitative laboratory measurement.
8. Sample Size for the Training Set:
- Not applicable. This submission is about a change to existing instructions for use for a medical device accessory, not the development of a predictive model or algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the reasons stated above.
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K 10 1967
510(K) Summary
Page 1 of 3
Date Prepared [21CFR 807.92(a)(1)] 7/12/2010
Submitter's Information [21CFR 807.92(a)(1)]
AUG1 2 2010
Mr. Jonathan Achenbach Sr. Dir. R&D, Clinical & Regulatory Affairs Ellman International Inc. 333 Royal Ave. Oceanside, NY. 11572 Telephone: 516-267-6744
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)]
Accessory handpiece electrode is intended for use with the Ellman Surgitron IEC120 / 4.0 Dual Radio-Frequency generator. The device is considered as an accessory to the RF generator. The generator has been cleared by the FDA under 510(k) K082834 Ellman International Non-Ablative Technique for Surgitron IEC.
{1}------------------------------------------------
The purpose of this submission is to have the subject device cleared for the following change in Cleaning / Disinfection methods as per the Instructions for Use:
Method:
The Electrode Tip shall be cleaned and disinfected pre and post contact with the patient with an over the counter disinfectant wipe moistened with a full spectrum disinfectant containing a solution of Alkyl dimethyl benzyl ammonium chlorides and Alkyl dimethyl ethylbenzyl ammonium chlorides. The device is to remain wetted by the disinfectant solution for a minimum of 10 (ten) minutes.
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.
Ellman International has shown that the cleaning and disifection method described above is similar to the cleaning and disinfection method provided with ALMA LASERS ACCENT as cleared by K070004 and ALMA LASERS FAMILY OF ACCENT RF SYSTEMS as cleared by K072699.
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 instruction to the existing instructions for use.
The subject device is packaged with the following items:
- IEC 3 Button Reusable Fingerswitch Handpiece ●
- . Pelleve Reusable Electrode
Intended Use [21 CFR 807.92(a)(5)]
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 substantially equivalent to the predicate devices in that they all are similar in technology, function, intended use and method of cleaning and disinfection.
Labels, Labeling [21 CFR XXXX]
Per section "Product Labels"
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Performance Data [21 CFR 807.92(b)(1)]
Page 3 of 3
As defined in SGS Protocol # 09A0908673 and demonstrated in SGS Report# 09A0908675
196
Predicate Devices [21 CFR 807.92(a)(3)(1)]
-
ALMA LASERS LTD:. ACCENT as cleared by K070004 t
KIO -
ALMA LASERS LTD:. ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) . SYSTEMS, MODELS: ACCENT, ACCENT XL as cleared by K072699
-
ELLMAN INTERNATIONAL INC Surgitron, Non-Ablative Technique as cleared by K082834 .
The subject device is substantially equivalent (materials, technology) to the above listed devices.
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/3/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 an abstract image of a stylized human figure, possibly representing a person in motion or a symbol of health and well-being.
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
Re: K101967
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: July 12, 2010 Received: July 13, 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
{4}------------------------------------------------
Page 2 - Mr. Jonathan Achenbach
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/Resourcesfor You/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
Statement
| 510(k) Number (if known): | K 101967 |
|---|---|
| Device Name: | Non-Ablative Wrinkle Treatment Handpiece |
The Device has the following “Indications for Use”:
Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | AUG 1 2 2010 |
|---|---|
| -------------------------------------------------------- | -------------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (per 21 CFR 801.109)
1
OR
Over-The Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101967
§ 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.