ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
K082834 · Ellman Int'L, Inc. · GEI · May 7, 2009 · General, Plastic Surgery
Device Facts
Record ID
K082834
Device Name
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
Applicant
Ellman Int'L, Inc.
Product Code
GEI · General, Plastic Surgery
Decision Date
May 7, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4400
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
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. Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, 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. Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. 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.
Device Story
Surgitron is a compact high-power RF energy generator for radiosurgical procedures; operates via front panel selection of waveforms/power levels; provides feedback via push buttons/lights and digital display; output controlled by foot/hand switches. Uses monopolar and bipolar electrodes to deliver RF energy to tissue. Used in clinical settings by physicians for cutting, coagulation, hemostasis, and non-ablative wrinkle treatment. Device includes self-test/monitoring interlocks to prevent operation during failure. Benefits include precise tissue management and hemorrhage control.
Clinical Evidence
Bench testing only. Studies comparing subject device to predicate demonstrate safety and effectiveness for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
Technological Characteristics
High-power RF energy generator; monopolar and bipolar electrode configurations; front panel digital display for power/status; foot/hand switch controls; self-test/monitoring interlocks. No specific materials or software architecture details provided.
Indications for Use
Indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids in skin phototypes I-IV; also indicated for various surgical cutting, coagulation, hemostasis, and fulguration procedures including snoring, palatal shrinkage, uvulopalatoplasty, myringotomy, epistaxis, turbinate shrinkage, skin incisions, biopsy, and removal of various skin lesions/tumors.
Regulatory Classification
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.
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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:
- o Ellman Surgitron IEC 120 / 4.0 DU K013255
- o Thermage ThermaCool K040135
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.
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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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
