(189 days)
Cutting: Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures; Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures; Hemostasis: Control of Bleeding, Epilation, Telangicctasia; Bipolar: Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)
The @llman Surgitron Radiolase II is a high frequency, medium power output electrosurgical medical device. The design is similar to currently marketed electrosurgical generators and provides the essential operational modes that are most often used in medium power electrosurgical applications. The unit consists of both a nominal 50 Watt maximum output power in monopolar mode and a nominal 55 Watt maximum output power in bipolar mode, providing the capability of precision cutting, coagulation, and hemostasis in a four megacycle frequency electrical current. The unit is designed to comply with the international safety standards.
Here's a breakdown of the acceptance criteria and study information for the ellman Surgitron Radiolase II device, based on the provided 510(k) summary:
This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically does not contain detailed primary study results, acceptance criteria, or comprehensive performance data as would be found in a full clinical study report. Instead, it focuses on demonstrating equivalence to existing devices.
Therefore, the information provided below will be based on what can be inferred from the 510(k) submission, particularly the comparison to predicate devices, rather than explicit statements of acceptance criteria and a detailed study proving performance against them.
Acceptance Criteria and Reported Device Performance
Note: The 510(k) summary does not explicitly state "acceptance criteria" in the typical sense of quantitative performance targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and safety standards. The reported device performance is described by its technical specifications and capabilities, which are compared directly to the predicate devices.
| Feature / Acceptance Criteria (Implicit) | Reported Device Performance (ellman SURGITRON RADIOLASE II) |
|---|---|
| Intended Use (Substantially Equivalent to Predicates) | Monopolar and/or Bipolar Electrosurgical Cutting, Blended Cutting and Coagulation, and Hemostasis. (Specific indications listed: Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures, Papilloma Keloids, Verrucae, Basal Cell Carcinoma, Fistulas, Epithelioma, ENT procedures, Control of Bleeding, Epilation, Telangiectasia.) |
| Monopolar Output Power (Equivalent or within acceptable range of Predicates) | 50 Watts |
| Bipolar Output Power (Equivalent or within acceptable range of Predicates) | 55 Watts |
| Output Waveforms (Similar to Predicates) | Monopolar and Bipolar - 4.0 MHz Sine-wave shaped, Fully Rectified, Partially Rectified. |
| Compliance with Safety Standards (Meeting or exceeding Predicate standards) | IEC 60601-1, 60601-2-2, BS 5724-1, Requirements of the Medical Device Directive 93/42/EEC. |
| Delivery System Configuration (Comparable to Predicates) | Monopolar and Bipolar Capability |
| Software Presence (Comparable to Predicates) | Device does not contain software. |
Study Information (Based on 510(k) Submission)
1. Sample size used for the test set and the data provenance:
- Test Set: Not applicable for this type of submission. A 510(k) premarket notification primarily relies on a comparison of technological characteristics and intended use to predicate devices, rather than a new clinical study with a "test set" in the sense of clinical data. The submission indicates that the "indications for use is identical to the Surgitron as a preamendment device".
- Data Provenance: The document does not describe specific clinical data or a test set. The provenance of the comparison data is the existing specifications and regulatory clearances of the predicate devices: ellman Surgitron Radiolase (K992382) and ellman Surgitron 4.0 Dual RF/120 IEC (K013225).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with human-established ground truth in this 510(k) submission. Ground truth would be derived from the established safety and effectiveness of the predicate devices.
3. Adjudication method for the test set:
- Not applicable, as no human expert adjudication of a test set is described.
4. 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:
- No. This device is an electrosurgical unit, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. Therefore, an MRMC study is not relevant here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical electrosurgical unit. It does not contain an algorithm or AI component.
6. The type of ground truth used:
- For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of legally marketed predicate devices, as determined by the FDA's original clearance of those devices. This includes adherence to recognized performance standards (e.g., IEC 60601-1, 60601-2-2).
7. The sample size for the training set:
- Not applicable. The device does not contain software or AI that would require a "training set."
8. How the ground truth for the training set was established:
- Not applicable, as no training set exists for this device.
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APR 7 2005
Image /page/0/Figure/1 description: The image shows the logo for Ellman International, Inc. The word "ellman" is in a large, outlined font. To the right of "ellman" is the phrase "international, inc." in a smaller, solid font.
established 1959
ellman Surgitron Radiolase II
510(k) Summar 04211
- Submitter name and address:
Dr. Jon. C. Garito President @lliman international 3333 Royal Avenue Oceanside, New York 11572-3625
Page 1 9 ②
2. Device name and classification:
Surgitron Radiolase II 2.1 Device Name: Class II device, 21 CFR 878.4400 2.2 Classification:
3. Description of the device:
The @llman Surgitron Radiolase II is a high frequency, medium power output electrosurgical medical device. The design is similar to currently marketed electrosurgical generators and provides the essential operational modes that are most often used in medium power electrosurgical applications. The unit consists of both a nominal 50 Watt maximum output power in monopolar mode and a nominal 55 Watt maximum output power in bipolar mode, providing the capability of precision cutting, coagulation, and hemostasis in a four megacycle frequency electrical current. The unit is designed to comply with the international safety standards.
4. The intended use/indication for use of the device:
- 4.1 Cutting
Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures
4.2 Blended Cutting and Coagulation
Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures
-
4.3 Hemostasis
Control of Bleeding, Epilation, Telangiectasia -
4.4 Bipolar
Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)
Page 1 of 2
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Image /page/1/Picture/0 description: The image shows the text "ellman international, inc.". The word "ellman" is written in a large, outlined font. The words "international, inc." are written in a smaller, solid font to the right of "ellman".
established 1959
5. Identification to predicate devices
5.1.Sugitron Radiolase with general use indication K992382 5.2 Surgitron 4.0 Dual RF/120 IEC with general use indication K013225
Page 2 of 2
6. Summary of the technological characteristics of the new device in comparison to the predicate devices.
| FEATURE | ellmanSURGITRONRADIOLASE II(New Application Device ) | ellmanSURGITRONRADIOLASEK992382 PREDICATE | ellmanSURGITRON4.0 Dual RF/120 IECK013225 PREDICATE |
|---|---|---|---|
| Indications For Use | Monopolar and /or BipolarElectrosurgical Cutting,Blended Cutting andCoagulation, andHemostasisRefer to Page 5 for morespecific indications for use | Monopolar- covers allindications for use as theSurgitron Radiolase IIdevice.Refer to Exhibit D | Monopolar-covers manyindications for use listedfor Surgitron Radiolase IIdevice.Bipolar- covers allindications of use listedfor Surgitron Radiolase IIdevice.Refer to Exhibit D |
| Design Specification | IEC 60601-1 and60601-2-2Requirementrs of theMedical Device Directive93/42/EEC | Same As New Device | UL544 andIEC 601-2-2 |
| Enclosure Size(inches) | 10.3" wide x 4.5" highx 10.5" deep | 7.0" wide x 4.3" highx 9.0" deep | 9.3" wide x 5.0" highx 13.5" deep |
| Output Energy | Monopolar - 50 WattsBipolar - 55 Watts | Monopolar- 50 Watts | Monopolar - 120 WattsBipolar - 120 Watts |
| Output Waveform (s) | Monopolar and Bipolar-4.0 MHz Sine-waveshaped, Fully Rectified,Partially Rectified. | Monopolar- 4.0 MHzSine-wave shaped, FullyRectified, PartiallyRectified. | Monopolar- 4.0 MHzSine-wave shaped, FullyRectified, PartiallyRectifiedBipolar- 1.7 MHz withmodulated waveform. |
| Software | Device does not containsoftware | Device does not containsoftware | Device containsoperational software |
| Standards Met | IEC 60601-1, 60601-2-2BS 5724-1 | IEC 60601-1, 60601-2-2BS 5724: Section 2.2UL2601 | IEC 601-1, 601-2-2BS 5724: Section 2.2UL2601 |
| Delivery system andconfiguration | Monopolar and Bipolar | Monopolar | Monopolar and Bipolar |
| Biocompatibility Test | Not applicable | Not applicable | Not applicable |
| Sterilization Method(s) | Not applicable | Not applicable | Not applicable |
Substantial equivalence ﺎﺀ - - ﺍ 1 01 . .
Page 2 of 2
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APR 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Garito Ellman International, Inc. 3333 Royal Avenue Oceanside, New York 11572-3625
Re: K042710
Trade/Device Name: Surgitron Radiolase II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 10, 2005 Received: February 11, 2005
Dear Mr. Garito:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your become 310(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the enorosary to regary to regars and the Medical Device Amendments, or to commerce prof to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). allu Cosmete 71ct (11ct) that do not requesabject to the general controls provisions of the Act. The 1 ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (36€ doove) inrols. Existing major regulations affecting your device FDA It inay be subject to ston additional Communisms, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Featur regular regularing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I DTC 3 issuantes or our device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally Federal Statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set and CrK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic a forth in the quality systems (QD) regations (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jon Garito
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to oogin mains of substantial equivalence of your device to a legally premarket notification: "The PDF interlight for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice 10. Jour acon 2011 276-0120 . Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on Journer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet and odress http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
$\pi$
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| international, inc.established 1959 | |
|---|---|
| 510(k) Premarket Notification | |
| @Wiman internationalpage 5Surgitron Radiolase II - General Surgery Use | |
| 510(k) Number K042710 | |
| SURGITRON RADIOLASE IIDevice Name: | |
| Indication For Use: is idendical to the Surgitron as a preamendment device such as: | |
| * Cutting | |
| Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, | |
| Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures,Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures | |
| * Blended Cutting and Coagulation | |
| Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, | |
| Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures | |
| * Hemostasis | |
| Control of Bleeding, Epilation, Telangicctasia | |
| * Bipolar | |
| Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or | |
| Dry) | |
| Prescription UseOver-The- Counter UseOR | |
| (Per 21 CFR 801.109)(Optional Format 1-2-96) | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGEIF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| storative100%. | |
ﺍﻷﻓﺮﻳﻘﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
3333 Royal Avenue
Oceanside, NY 11572-3625 U.S.A.
Tel: (800) 835-5355 • (516) 594-333 www.ellman.co!
710
§ 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.