(18 days)
The 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.
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 electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece.
One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. 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.
The provided text is a 510(k) summary for the ENCISION AEM Disposable Electrodes and AEM Disposable Handpieces. It describes the device, its intended use, and technological characteristics, and declares substantial equivalence to predicate devices based on non-clinical performance testing.
However, the document does not contain the specific information typically found in a clinical study report regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement for a multi-reader or standalone study. The performance testing mentioned is "bench testing consisting of continuity and capacitance measurements, and compatibility testing."
Therefore, based only on the provided text, I cannot complete the requested tables and descriptions for clinical acceptance criteria and study details. The document is a regulatory submission focused on substantial equivalence to predicate devices through non-clinical testing rather than a detailed report of a clinical efficacy or performance study.
Here's what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
MISSING: The document does not specify quantitative acceptance criteria or detailed reported device performance metrics in the format of a clinical study. The testing was non-clinical.
2. Sample Size Used for the Test Set and Data Provenance
MISSING: No information is provided regarding a "test set" in the context of human data. The testing mentioned is "bench testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
MISSING: No experts for establishing ground truth are mentioned, as the testing was non-clinical bench testing, not a clinical study involving interpretation of data by experts.
4. Adjudication Method for the Test Set
MISSING: No adjudication method is mentioned, as there was no test set involving human data or expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
NO: The document does not describe a MRMC comparative effectiveness study. The testing was non-clinical to confirm safety and effectiveness for substantial equivalence.
6. Standalone Performance Study
NO: The document does not describe a standalone performance study in the context of an algorithm or AI. The performance verified was related to the device's AEM technology and delivery of electrosurgical energy through bench testing.
7. Type of Ground Truth Used
MISSING / NOT APPLICABLE: For bench testing, "ground truth" would relate to engineering specifications and measurements (e.g., continuity, capacitance values) rather than expert consensus, pathology, or outcomes data. These specific "ground truth" details are not provided.
8. Sample Size for the Training Set
MISSING / NOT APPLICABLE: This concept is not relevant to the non-clinical bench testing performed for this device. There is no mention of a "training set" as would be used for AI/ML development.
9. How the Ground Truth for the Training Set Was Established
MISSING / NOT APPLICABLE: Not relevant, as there is no training set mentioned.
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ENCISIGN
K 072-789
510(k) Summary
DATE: 5/19/07
510(k) Submitter: ENCISION INC. 6797 Winchester Circle Boulder, CO 80301 USA Establishment Registration: 1722040 JU7 1 § 2007
Contact Person.
Judith V. King, VP Regulatory Affairs and Quality Assurance Phone: 303-339-6917 Fax: 303-444-2693 e-mail: jking(a 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 Devices:
Electrodes
| Trade, Proprietary or Model Name | Manufacturer |
|---|---|
| Model ES1000 series Monopolar Laparoscopic Electrodes withElectroshield | ENCISION INC. |
| Model 30-6000 series Reusable Monopolar Electrodes | Kirwin Surgical Products |
| Model 8380 series Unipolar Electrodes | Richard Wolf MedicalInstruments Corp. |
| Models SW11100, SW11200, SW11202, SW11300 (Reusable)and SW1220, SW12202, SW12300 (Disposable) ElectrosurgicalPencils | Shining World HealthcareCo., Ltd. |
Handpieces
| Trade, Proprietary or Model Name | Manufacturer |
|---|---|
| Model ES1000 series Monopolar Laparoscopic Electrodes withElectroshield | ENCISION INC. |
| Model ES4000 AEM Cord (AEM Monitor accessory) | ENCISION INC. |
| Model E2508 Disposable Pencil | Valleylab, Inc. |
| Models SW11100, SW11200, SW11202, SW11300 (Reusable)and SW1220, SW12202, SW12300 (Disposable) ElectrosurgicalPencils | Shining World HealthcareCo., Ltd. |
ENCISION 510(k) Notification Summary AEM® Disposable Electrodes and AEM Disposable Handpieces
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ENCISIGN
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 electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece.
One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. 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 【Jse:
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 and AEM Disposable Handpieces incorporate the same technological characteristics as the predicate devices for delivery of the ESU high frequency current, consisting of insulated conductors and shafts with appropriately shaped tips for electrosurgery. The control for ESU Cut and Coag modes on the handswitching handpiece is a switch similar in design and function to the predicate handpiece.
Like the Encision predicate devices, the AFM Disposable Electrodes and AEM Disposable Handpieces include an additional AEM shielding function which diverts stray energy from the shaft of the instrument and is monitored by the Encision AEM Monitor.
Non-clinical Performance Testing:
Performance of the devices' AFM technology and delivery of electrosurgical energy has heen verified by bench testing consisting of continuity and capacitance measurements, and
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ENCISIGN
compatibility testing with a worst case representative electrosurgical generator and the AEM Monitor.
Conclusions:
The AEM Disposable Electrodes and AEM Disposable Handpieces are safe and effective and are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2007
Encision, Inc. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087
Re: K072789
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: II Product Code: GEI Dated: September 28, 2007 Received: October 1, 2007
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 such 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 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); 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. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the word "ENCISION" in all caps. The letters are in a bold, sans-serif font and are black. The "O" in "ENCISION" is replaced by a circular logo with a white curved line running through it. There is a registered trademark symbol to the upper right of the last letter N.
Indications for Use
510(k) Number (if known):
K 072789
Device Name:
AEM Disposable Electrodes and AEM Disposable Handpieces
Indications For Use:
The 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (Part 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)
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number 462289
§ 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.