(125 days)
AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.
The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.
The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.
The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The material of the molded tip insulation has been changed. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the electrode shaft.
The electrodes snap into the handpiece. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.
The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.
This document is a 510(k) summary for AEM Disposable Electrodes and AEM Disposable Handpieces. It primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in the tip insulation material. Therefore, it does not describe a study proving the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity or specificity.
Instead, the "acceptance criteria" here refer to the requirements for demonstrating the safety and effectiveness of the new material and the devices' continued substantial equivalence. The "study" refers to the non-clinical performance testing conducted to support these claims.
Here's a breakdown of the requested information based on the provided text, acknowledging that some fields may not be directly applicable to this type of submission which focuses on material change and substantial equivalence rather than novel device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (related to material change & substantial equivalence) | Reported Device Performance/Conclusion |
|---|---|
| Biocompatibility of new tip insulation material (per ISO 10993-1) | Suitability of the new material for the tip insulation has been verified by biocompatibility testing per ISO 10993-1. |
| Sterilization validation (per AAMI/ANSI/ISO 11737-1 and -2) | Sterilization Validation has been performed per AAMI/ANSI/ISO 11737-1 and -2. |
| Performance requirements of the device with new tip insulation | The tip insulation material has no effect on the specified performance requirements of the device. |
| Adherence to AEM shielding function | There is no change to the AEM Disposable Electrodes' AEM shielding function which diverts stray energy from the shaft of the instrument and is monitored by the Encision AEM Monitor, via the AEM Handpiece cable. |
| Substantial Equivalence to predicate device | The AEM Disposable Electrodes are safe and effective and are substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the biocompatibility or sterilization validation testing. The document states "Suitability of the new material..." and "Sterilization Validation has been performed...", implying tests were conducted, but specific sample sizes are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or performed by a third-party lab as part of the manufacturer's regulatory submission process. It is non-clinical, likely laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission relies on standardized testing (ISO 10993-1, AAMI/ANSI/ISO 11737-1 and -2) and engineering assessments rather than expert-established ground truth in a clinical or diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.
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 is not an AI-enabled device 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 not an algorithm or AI device. The testing described is for the physical device components and materials.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical testing comprises internationally recognized standards and specifications (ISO 10993-1 for biocompatibility, AAMI/ANSI/ISO 11737-1 and -2 for sterilization validation) which define acceptable parameters for these properties. The device's performance is compared against these predetermined standards.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
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Image /page/0/Picture/0 description: The image shows the word "ENCISION" in a stylized font, with a logo in the middle of the word. To the right of the word is the date "09/07/4" written in handwriting. The word "ENCISION" is in all caps and has a textured, three-dimensional appearance. The logo in the middle of the word appears to be a stylized leaf or organic shape.
AUG 1 7 2009
510(k) Summary
DATE: 7/13/09
510(k) Submitter: ENCISION INC. 6797 Winchester Circle Boulder, CO 80301 USA Establishment Registration: 1722040
Contact Person: Judith V. King, VP Regulatory Affairs and Quality Assurance Phone: 303-339-6917 Fax: 303-444-2693 e-mail: jking@encision.com
Device Name: AEM Disposable Electrodes and AEM Disposable Handpieces
Common name: Device, Electrosurgical, Cutting and Coagulation and Accessories
Classification: CFR Section: 878.4400
Class: II
Product Code: GEI
Predicate Device:
Electrodes
| Trade, Proprietary or Model Name | Manufacturer |
|---|---|
| Model ES0300 series AEM Disposable Electrodes | Encision Inc. |
Handpieces
NA - no change
Description of Devices:
The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.
The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.
The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The material of the molded tip
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insulation has been changed. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the electrode shaft.
The electrodes snap into the handpiece. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.
The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.
Intended Use:
AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.
Technological Characteristics:
The Encision AEM Disposable Electrodes with new tip insulation material incorporates the same technological characteristics as the predicate device for delivery of the ESU high frequency current, consisting of insulated conductors and shafts with appropriately shaped tips for electrosurgery.
There is no change to the AEM Disposable Electrodes' AEM shielding function which diverts stray energy from the shaft of the instrument and is monitored by the Encision AEM Monitor, via the AEM Handpiece cable.
Non-clinical Performance Testing:
The tip insulation material has no effect on the specified performance requirements of the device. There are no industry or international standards that apply to the tip insulation. Suitability of the new material for the tip insulation has been verified by biocompatibility testing per ISO 10993-1. Sterilization Validation has been performed per AAMI/ANSI/ISO 11737-1 and -2.
Conclusions:
The AEM Disposable Electrodes are safe and effective and are substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 7 2009
Encision, Inc. % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K091074
Trade/Device Name: AEM Disposable Electrodes and AEM Disposable Handpieces Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories.
Regulatory Class: Class II
Product Code: GEI
Dated: July 29, 2009
Received: August 5, 2009
Dear Mr. Lehtonen:
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.
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.
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Page 2- Mr. Daniel W. Lehtonen
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/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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AEM Disposable Electrodes and AEM Disposable Handpieces
Indications for Use:
AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Tanner Perry
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091074
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.