(223 days)
- O Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV
The device is also indicated for: - O Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, lumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
- O Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
- O Hemostasis: control of bleeding, epilation, telangiectasia.
- O Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis.
- O Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.
The Ellman Surgitron is a compact source of high power RF energy to be employed for a variety of radiosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are activated by push buttons with lights that give the operator feedback of operative status. The power level for each mode is indicated by the front panel digital display, which also identifies the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when fail is displayed. The final output power control is made through foot and/or hand switches. Both monopolar and bipolar electrodes are provided.
The Ellman Surgitron is an electrosurgical unit and accessories device that was evaluated for an expanded indication for use: "non-ablative technique" for the treatment of mild to moderate facial wrinkles and rhytids.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantifiable acceptance criteria (e.g., a specific percentage reduction in wrinkles, a particular safety threshold, or a statistical non-inferiority margin). Instead, it relies on a substantial equivalence argument to a predicate device for its performance.
| Acceptance Criteria (Not explicitly stated, inferred from substantial equivalence) | Reported Device Performance |
|---|---|
| Safety and effectiveness for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV | Studies comparing the subject device to the predicate device demonstrate that the subject device is safe and effective for use in non-ablative procedures such as the treatment of mild to moderate facial wrinkles and rhytids. The device is identical (materials, technology) to the predicate Surgitron device (K013255). The only difference is the addition of the non-ablative indications for use, which are similar to the Thermage ThermaCool device (K040135). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any specific test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for the "studies" mentioned. It merely states that "Studies comparing the subject device to the predicate device" were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for any test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no information about human readers, AI assistance, or effect sizes.
6. Standalone (Algorithm Only) Performance Study
The device described is an electrosurgical unit, a physical medical device, not an algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable in this context.
7. Type of Ground Truth Used
Given that the device is an electrosurgical unit for treating wrinkles, the "ground truth" for its effectiveness would typically involve clinical assessments, such as improvement in wrinkle severity scores (e.g., using standard scales like the Glogau or Fitzpatrick wrinkle scale), photographic evidence of changes, and patient satisfaction. However, the document does not explicitly state the type of ground truth used in the supporting studies. It only broadly claims "safe and effective."
8. Sample Size for the Training Set
The document does not mention a training set sample size. As it is a physical device and not an AI/machine learning model, the concept of a "training set" in that context is not applicable. The device's performance relies on its physical and electrical characteristics.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" with established ground truth is not applicable to this device's submission type (electrosurgical unit, not an AI/ML model). The "studies" likely refer to pre-clinical testing, engineering verification, and potentially clinical trials that demonstrated equivalence to existing predicate devices.
Summary of Study Information:
The provided 510(k) summary relies heavily on demonstrating substantial equivalence to existing predicate devices rather than presenting detailed performance data from a de novo study against specific acceptance criteria.
- Primary Argument: The subject device (Surgitron) is identical in materials and technology to a previously cleared Surgitron (K013255). The only difference is the addition of the "non-ablative technique" for wrinkles, which is similar to the indications for use of another predicate device, Thermage ThermaCool (K040135).
- Performance Data Statement: "Studies comparing the subject device to the predicate device demonstrate that the subject device is safe and effective for use in non-ablative procedures such as the treatment of mild to moderate facial wrinkles and rhytids."
- Lack of Detail: The document is remarkably sparse on specific details regarding these "studies," including methodologies, sample sizes, patient demographics, endpoints, statistical analyses, or the specific "acceptance criteria" met beyond the general claim of "safe and effective" based on substantial equivalence. This level of detail is common in 510(k) summaries where the primary argument is substantial equivalence to a well-understood predicate.
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K 082834
510(k) Summary
Date Prepared [21 CFR 807.92(a)(1)]
. 8/11/08
MAY - 7 2009
Submitter's Information [21 CFR 807.92(a)(1)]
Mr. Rick Epstein President & CEO Ellman International Inc. 3333 Royal Avenue Oceanside, NY 11572.
Telephone: 516-267-6700
The establishment registration number for Ellman International is 2428235.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name
Surgitron
Device Common. Usual. or Classification Names
Electrosurgical Unit and Accessories, Electrosurgical Cutting and Coagulation and Accessories
Classification Panel
Classification of this device is at the discretion of the Center for Devices and Radiological Health (CDRH) and is presumed to be the Division of General, Restorative and Neurological Devices.
Class
Classification: Class II Product Code: GEI, 21 CFR 878.4400
Description of the Device 121 CFR 807.92(a)(4){
The subject device is the same device that was authorized for use under 510(k) premarket notification K013255. The purpose of this submission is to add the indications for use of "non-ablative technique" used for the treatment of mild to moderate facial wrinkles and rhytids.
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K 0 8 2 8 3 4
The Ellman Surgitron is a compact source of high power RF energy to be employed for a variety of radiosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are activated by push buttons with lights that give the operator feedback of operative status.
The power level for each mode is indicated by the front panel digital display, which also identifies the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when fail is displayed. The final output power control is made through foot and/or hand switches. Both monopolar and bipolar electrodes are provided.
The subject device is packaged with the following items:
- o Ellman Surgitron IEC 120 / 4.0 DU Radiofrequency Generator
- o IEC Power Cord
- o Dual Footswitch & Cable
- o IEC Foot controlled Handpiece
- o Bipolar Cable
- o Disposable Neutral Plate
- o Instruction Manual
- o Three Button Fingerswitch Handpiece
Intended Use [21 CFR 807.92(a)(5)]
The device has the following "Indications For Use":
-
o Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV
The device is also indicated for: -
Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
-
o Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage. skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
-
· Hemostasis: control of bleeding, epilation, telangiectasia.
-
o Fulguration: basal cell carcinoma, papilloma, cyst destruction, turnors, verrucae, hemostasis.
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- Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field
(wet or dry), snoring, submucosal palatal shrinkage, traditional
uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage
control, epistaxis treatment and turbinate shrinkage.
082 934
Technological Characteristics [21 CFR 807.92(a)(6)]
Ellman International believes that the subject device is substantially equivalent to the predicate devices.
Performance Data [21 CFR 807.92(b)(1)]
Studies comparing the subject device to the predicate device demonstrate that the subject device is safe and effective for use in non-ablative procedures such as the treatment of mild to moderate facial wrinkles and rhytids.
Predicate Device [21 CFR 807.92(a)(3)1
The predicate devices are as follows:
The device is identical (materials, technology) to the Surgitron device in K013255. The only difference is the addition of the non-ablative indications for use.
The subject device is adding indications for use similar to the Thermage Thermacool device as found in K040135.
Conclusion [21 CFR 807.92(b)(3)]
Based on the aforementioned information, the Ellman International Surgitron, with its expanded "Indication For Use" is safe and effective and substantially equivalent to the identified predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
MAY - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ellman International, Inc. % Mr. Rick Epstein President & CEO 3333 Royal Avenue Oceanside, New York 11572
Re: K082834
Trade/Device Name: Ellman International Non-Ablative Technique for Surgitron IEC Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 24, 2009 Received: April 29, 2009
Dear Mr. Epstein:
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 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 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.
্র---
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Page 2 - Mr. Rick Epstein
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Sincerely yours,
Daniel Krone
Mark N. Melkerson 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): K082834
Device Name: Ellman International Non-Ablative Technique for Surgitron IEC
Indications For Use:
-
O Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV
The device is also indicated for: -
O Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, lumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
-
O Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
-
O Hemostasis: control of bleeding, epilation, telangiectasia.
-
O Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis.
-
O Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Milke Syla formen
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number. K082834
Page 1 of 1
§ 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.