(60 days)
Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.
AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.
AEM Single-Use Suction Irrigation Instruments are
• Electrosurgical accessories, which combine
– Classic active electrode functions of cutting and coagulating tissue with monopolar high-frequency electrical energy
– Shape, size and reach to work laparoscopically or endoscopically
– Elimination of stray-energy emission outside surgeon view provided by AEM shielding and monitoring
– Convenience/peace-of-mind provided by product provided clean and sterile from manufacturer to operating room
– Convenience of providing suction or irrigation to the surgical site without having to swap instruments in and out of the cannula
• Used to ablate, remove, resect, and coagulate soft tissue where associated hemostasis and visualization is required
• For use in open, endoscopic, and laparoscopic surgical procedures
The instruments of this submission are configured to support foot-controlled laparoscopic electrosurgery
• Direct connection from instrument tip to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor
• Suction irrigation channel adapted directly to commercially available suction-irrigation valves
• Working length: 32 cm
• Fits within 5.5 mm diameter cannula
The document describes the AEM Single-Use Suction Irrigation Instrument, a device intended to combine electrosurgical functions (cutting and coagulation) with suction and irrigation capabilities during endoscopic and laparoscopic procedures. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared predicate devices, rather than an independent clinical study proving novel performance.
Here's an analysis of the provided information regarding acceptance criteria and the "study" (bench testing in this case) that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrosurgical Performance: Functions of cutting and coagulating tissue with monopolar high-frequency electrical energy, and elimination of stray-energy emission outside surgeon view (AEM technology). | "Electrosurgical application or performance" demonstrated no significant differences from predicate devices. AEM shielding and monitoring are key features. Bench testing characterized essential specifications not covered by equivalent designs and successfully demonstrated no significant effect on primary specifications due to aging and shipping. |
| Suction/Irrigation Performance: Ability to provide suction or irrigation to the surgical site without having to swap instruments. | "Suction/irrigation performance" demonstrated no significant differences from predicate devices. Bench testing characterized essential specifications not covered by equivalent designs and successfully demonstrated no significant effect on primary specifications due to aging and shipping. |
| Biocompatibility: Materials in direct or indirect contact with the patient must be safe. | Biocompatibility of all materials was verified "through analogy with identical materials, processes, and uses from the predicate devices." |
| Sterility: Product must be sterile when delivered and maintain sterility over its shelf life. | Sterilized in shipping boxes on pallets via electron-beam irradiation, in accordance with ANSI-AAMI-ISO 11137-1:2006 guidelines. Shelf life validated for sterility and function for at least one year by accelerated aging, verified by real-time aging. Packaging: individually packaged in Tyvek pouch, then six pouches in a cardboard shipping container. |
| Packaging Integrity/Shelf Life: Packaging must protect the device and maintain sterility for its specified shelf life, and withstand aging and shipping stresses. | Shelf life validated for product and packaging for at least one year by accelerated aging, verified by real-time aging. Extended as data from aging tests demonstrate greater longevity. "use by" date on all boxes and pouches. Bench testing successfully demonstrated no significant effect on primary specifications due to aging (both with accelerated and real-time testing) and shipping drop/shock/vibration. Substantially equivalent to predicate hub sterility (slightly less packaged density for more effective sterilization). |
| Dimensions/Fit: Instrument must fit within a 5.5 mm diameter cannula and have a working length of 32 cm. Connection to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor. Suction irrigation channel adapted to commercially available valves. | Specific description confirms: Working length: 32 cm; Fits within 5.5 mm diameter cannula. Direct connection from instrument tip to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor. Suction irrigation channel adapted directly to commercially available suction-irrigation valves. Bench testing characterized all essential specifications not covered by equivalent designs on production-equivalent units. Electrode shaft and tip, and hub and adapter are identical or substantially equivalent in design, construction, materials, packaging, and sterility to predicate devices. |
| Safety and Effectiveness: Demonstrate acceptable safety and performance outcomes and successful attainment of all essential specifications; no new issues of safety and effectiveness. | "Product testing of subject instruments and direct analogy with predicate device design and materials demonstrates acceptable safety and performance outcomes and successful attainment of all essential specifications for the devices." "There are no significant differences between the subject instruments and their predicate devices which would raise new issues of safety and effectiveness, performance, function or intended use..." Bench testing characterized all essential specifications and demonstrated no significant effect due to aging and shipping. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices or cases in the provided text. The document refers to "production-equivalent units" and "subject instruments" for bench testing. Given this is a 510(k) for substantial equivalence based on bench testing and analogy, a traditional "test set" with a specific number of patient samples is not applicable here.
- Data Provenance: The data comes from bench testing performed internally by Encision, Inc. It is retrospective in the sense that it relies on established data and performance of predicate devices for comparison and analogy. It is not clinical data derived from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is established through engineering and performance specifications validated via bench testing and direct comparison/analogy to predicate devices, not through expert review of patient data.
4. Adjudication Method for the Test Set
- Not applicable. There is no adjudication method described as this is not a study involving human interpretation of results requiring consensus. The verification and validation were performed "in accordance with Design Control requirements per 21 CFR 820.30 and company quality system procedures."
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
- No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument and accessory, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" does not apply.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical electrosurgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)
- The "ground truth" for the performance claims in this 510(k) is based on engineering and performance specifications derived from the predicate devices and industry standards. For biocompatibility, it's analogy to predicate materials. For sterility and shelf life, it's adherence to relevant standards (ANSI-AAMI-ISO 11137-1:2006) and accelerated/real-time aging studies. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient images) was used.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the word "ENCISIGN" in a stylized, outlined font. The letters are bold and have a double-line effect, giving them a three-dimensional appearance. A horizontal line is present beneath the word, adding a subtle emphasis to the text.
510(k) Summary
| Device | AEM® Single-Use Suction Irrigation Instrument | |
|---|---|---|
| Owner | Encision, Inc.6797 Winchester CircleBoulder, CO 80301Phone: (303) 444-2600Fax: (303) 444-2693 | AUG 2 6 2013 |
| Contact | James W. LewisVice President, Regulatory Affairs and Quality Assurance | |
| Date of Summary | 26 June 2013 | |
| DeviceClassification | Trade nameCommon nameClassification | AEM Disposable Suction Irrigation ElectrodeActive suction/irrigation laparoscopic monopolarelectrosurgical electrode with AEM technologyClassification name: Electrosurgical, Cutting &Coagulation & AccessoriesClassification number: 21 CFR 878.4400Product Code: GEIClass: 2FDA Panel: General and Plastic Surgery |
| PrimaryPredicate | Trade NameManufacturerCleared by | AEM Suction Irrigation ElectrodeEncision Inc510(k): K100711 |
| SecondaryPredicate | Trade NameManufacturerCleared by | AEM Disposable Suction Irrigation Electrode andHandsetEncision Inc510(k): K122580 |
Device Description
| Generaldescription | AEM Single-Use Suction Irrigation Instruments are• Electrosurgical accessories, which combine– Classic active electrode functions of cutting and coagulating tissuewith monopolar high-frequency electrical energy– Shape, size and reach to work laparoscopically or endoscopically– Elimination of stray-energy emission outside surgeon viewprovided by AEM shielding and monitoring– Convenience/peace-of-mind provided by product provided cleanand sterile from manufacturer to operating room– Convenience of providing suction or irrigation to the surgical sitewithout having to swap instruments in and out of the cannula |
|---|---|
| Continued on next page |
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510(k) Summary: AEM Single-Use Suction Irrigation Instrument
Device Description (continued)
| Generaldescription(continued) | • Used to ablate, remove, resect, and coagulate soft tissue whereassociated hemostasis and visualization is required• For use in open, endoscopic, and laparoscopic surgical procedures |
|---|---|
| Specificdescription | The instruments of this submission are configured to support foot-controlled laparoscopic electrosurgery• Direct connection from instrument tip to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor• Suction irrigation channel adapted directly to commercially availablesuction-irrigation valves• Working length: 32 cm• Fits within 5.5 mm diameter cannula |
| Intended Use | Sterile, single-patient-use electrosurgical accessories intended toconduct electrosurgical current for cutting and coagulation of tissueand/or to provide suction and irrigation functions to the surgical site.These accessories have applications in general endoscopy andlaparoscopy procedures. |
| AEM instruments incorporate the use of AEM technology and areintended for use with the AEM monitoring system and electrosurgicalgenerators compatible with the AEM system |
Equivalence
Based on operating principles, intended use, technology, safety, and performance; these AEM Disposable Suction Irrigation Instruments are substantially equivalent to the combination of features and construction details of its predicate devices.
| Electrode shaftand tip | Identical to electrode shaft and tip of AEM Disposable SuctionIrrigation Electrode in• Design• Construction• Packaging• Sterility• Materials |
|---|---|
| Hub and adapter | Identical to hub and adapter of AEM Suction Irrigation Electrode in• Design• Construction• Material |
| Substantially equivalent to hub of AEM Disposable SI Electrode insterility (slightly less packaged density for more effective sterilization) |
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510(k) Summary: AEM Single-Use Suction Irrigation Instrument
Bench Testing
Verification and validation tests were performed in accordance with Design Control requirements per 21 CFR 820.30 and company quality system procedures.
Bench testing included
- · Characterizing all essential specifications not covered by equivalent designs on productionequivalent units
- · Successfully demonstrating no significant effect on primary specifications of production units due to
- Aging (both with accelerated and real-time testing)
- Shipping drop/shock/vibration
All testing successfully completed prior to release of product for sale.
Biocompatibility
Biocompatibility of all materials with direct or indirect contact with the patient verified through analogy with identical materials, processes, and uses from the predicate devices.
Sterility / Packaging / Shelf life
| Packaging | • Product individually packaged in Tyvek pouch• Six individual pouches placed in cardboard shipping container |
|---|---|
| Sterilizationmethod | • Sterilized in shipping boxes on pallets• Electron-beam irradiation by qualified contract sterilizer |
| Sterilizationstandard | Sterilized in accordance with ANSI-AAMI-ISO 11137-1:2006 guidelines |
| Aging validation | Shelf life of product and packaging validated for sterility and function• For, at least, one year shelf life by accelerated aging• Verified by real-time aging• Extended as data from aging tests demonstrate greater longevity onthe shelf |
| Shelf-lifecommunication | A "use by" date on all boxes and pouches containing product willindicate validated shelf life of the package |
Conclusion
ে
There are no significant differences between the subject instruments and their predicate devices which would raise new issues of safety and effectiveness, performance, function or intended use with respect to
- · Electrosurgical application or performance
- · Suction/irrigation performance
- · AEM shield and monitoring performance.
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510(k) Summary: AEM Single-Use Suction Irrigation Instrument
Technological similarities between the predicate devices and the proposed device also demonstrate equivalence.
Product testing of subject instruments and direct analogy with predicate device design and materials demonstrates acceptable safety and performance outcomes and successful attainment of all essential specifications for the devices.
AEM Single-Use Suction Irrigation Instruments are substantially equivalent in design, use, construction, and safety and effectiveness to their predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 26, 2013
Encision, Inc. Mr. James W. Lewis Vice President, Regulatory Affairs and Quality Assurance 6797 Winchester Circle Boulder, Colorado 80301
Re: K131949
Trade/Device Name: AEM Disposable Suction Irrigation Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 26, 2013 Received: June 27, 2013
Dear Mr. Lewis:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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
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Page 2 - Mr. James W. Lewis
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/Safetv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S FOR
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AEM® Single-Use Suction Irrigation Instrument Premarket Notification
Section 4 INDICATIONS FOR USE
510(k) Number: K131949
Device Name: AEM Single-Use Suction Irrigation Instrument
Indications for Use:
Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.
AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.
V Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number _ K131949
§ 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.