(89 days)
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
The AEM enTouch® 2X Scissors Inserts are designed for use with the ES8000 / ES8200 series AEM enTouch® Handles. All scissors will fit through standard 5.5mm trocars.
The provided document is an FDA 510(k) Premarket Notification for the Encision AEM enTouch® 2X Scissor. It details the device, its intended use, design changes from a predicate device, and the testing conducted to demonstrate substantial equivalence.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the device's validation is presented in the "Risk Analysis: Risk Assessment Summary" table (pages 9-10). This table directly lists the changes from the predicate device, associated risks, verification methods, acceptance criteria, and results.
| Change (from Predicate) | Risk | Verification Method / Standard Used | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|---|
| Addition of Indicator | Impossible or difficult assembly into handle due to indicator diameter being too large | Direct Measurement (Calipers) - same as predicate | Diameter of indicator is less than diameter of rod passes | 22 of 22 samples have indicator diameters less than their rod diameters - Pass |
| Rod actuation force is too high due to the indicator diameter being too large | Handle with insert mechanical actuation - same as predicate; ISO 7741:1986/(R)2017, Scissor Test Methods | No binding or impaired mechanical function passes | 22 of 22 samples have no binding or mechanical functional impairments - Pass | |
| Indicator scraping off | Visual inspection under magnification during mechanical testing - same as predicate; ISO 10993-1:2009/(R)2013, Biocompatibility | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence of chipping, delamination or cracking to the indicator - Pass | |
| Indicator not attached to rod due to embrittlement from E-beam sterilization | Visual inspection after E-beam sterilization - same as predicate; ISO 11137-1:2006/(R)2010, Radiation Sterilization | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence of chipping, delamination or cracking to the indicator - Pass | |
| Indicator not attached to rod due to damage during cleaning and sterilization at the hospital | Visual inspection after cleaning and sterilization - same as predicate; ISO 17664:2017, Cleaning; ISO 17665-1:2006/(R)2013, Steam Sterilization | No damage to the epoxy region passes | 22 of 22 samples have no damage to the epoxy region - Pass | |
| Indicator delaminates from the rod or cracks due to damage from shipping or use | Visual inspection after ship testing - same as predicate; ASTM D4169-16, Ship Testing | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence chipping, delamination, or cracking to the indicator - Pass | |
| Indicator color does not permanently change to orange after cleaning and autoclaving | Visual inspection of indicator color change after environmental conditioning - same as predicate; ISO 11607-1:2006/(R)2010, Sterile Barrier Systems | Color changes from black to orange passes | 22 or 22 samples had color change from black to orange - Pass | |
| Indicator residue contacts patient | Visual inspection under magnification during mechanical testing - same as predicate; ISO 10993-1:2009/(R)2013, Biocompatibility | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence of chipping, delamination, or cracking to the indicator - Pass | |
| Indicator changes to orange during transportation/storage due to product being exposed to extreme temperature/humidity | Visual inspection after max dose irradiation, environmental conditioning, aging and ship testing - same as predicate; ASTM D4169-16, Ship Testing | Indicator remains black after ship testing | 22 of 22 samples have remained black after ship testing - Pass | |
| 2-Use Scissor | Poor cutting performance due to dull blade edge | Cut test simulation after simulated use and reprocessing – same as predicate; ISO 7741:1986/(R)2017, Scissor Test Methods; ASTM F1079-87, Surgical Scissors | After a single simulated surgery followed by cleaning and sterilization, shall pass cut test | 15 of 15 samples pass cut test after a simulated surgery, cleaning and sterilization - Pass |
| User misinterprets indicator's color change as verification of sterility | Correct Use of device based on indicator color and labeling in Quick Use Guide instructions (when received from OR); IEC 62366-1:2015, Medical Device Usability | Black color is correctly identified by Central Processing personnel | 20 of 20 samples were correctly identified as black - Ok to reprocess - Pass | |
| User does not dispose insert with orange indicator after second use | Correct Use of device based on indicator color and labeling in Quick Use Guide instructions (when received from OR); IEC 62366-1:2015, Medical Device Usability | Orange color correctly identified by Central Processing personnel | 20 of 20 samples were correctly identified as orange - do not reprocess - Pass | |
| Stainless Steel Material Modification | Corrosion | Visual inspection after max dose irradiation, environmental conditioning, aging and ship testing - same as predicate; ASTM A967-17, Stainless Steel Passivation | No visual evidence of corrosion or rust | 22 of 22 samples have no evidence of corrosion or rust - Pass |
| Embrittlement, breakage of assembly, leading to loss of function | Pouch drop testing IEC 60601-1 after max dose irradiation, environmental conditioning, aging and ship testing - same as predicate; IEC 60601-1 edition 3.1, Electrical Safety | No bend in the rod | 22 of 22 samples have no bend in their rod - Pass | |
| Intermittent power output at the tip | Direct measurement (resistance - multimeter) - same as predicate; IEC 60601-1 edition 3.1, Electrical Safety | Resistance is less than 5 ohms | 22 of 22 samples have a resistance less than 5 ohms - Pass | |
| Rod Diameter Reduction | Impossible or difficult assembly into handle due to the rod being bent as a result of the reduced diameter for indicator application | Handle with insert mechanical actuation - same as predicate; IEC 60601-1 edition 3.1, Electrical Safety | Any difficulty with actuation is a failure | 22 of 22 samples do not have any difficulty with actuation - Pass |
| (Continued) Rod bend | Straightness inspection - same as predicate; ASTM F2819-10, Rod Straightness; ASTM D4169-16, Ship Testing | Rod gap meets straightness requirement | 22 of 22 Samples have a rod gap that meets straightness requirement - Pass | |
| Sterility Process Change | Instrument becomes non-sterile during shipping | Instrument packaging sterile barrier seal integrity testing; ISO 11607-2:2019, Sterile Barrier System; ASTM F2096-11, Seal Integrity Bubble Test | The insert and sterile barrier shall withstand ship testing, with minimal cosmetic damage. After ship testing, the insert shall remain functional. The sterile barrier shall maintain product sterility | 22 of 22 samples maintained a sterile barrier after ship testing - Pass |
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for the various tests are explicitly stated in the "Risk Assessment Summary" table:
- 22 samples for most mechanical, visual, and material integrity tests (e.g., indicator diameter, actuation force, indicator scraping, embrittlement, etc.).
- 15 samples for cutting performance tests.
- 20 samples for usability/indicator interpretation tests by Central Processing personnel.
Data Provenance: The document indicates that all testing was "bench testing" (page 8). This implies the data were collected in a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in the context of clinical use, as these were all bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not explicitly addressed in the provided document. The ground truth for this device's performance is established through adherence to recognized industry standards (e.g., ISO, ASTM) and internal design control procedures. For the "Usability" tests (Correct Use of device based on indicator color), it mentions "Central Processing personnel," implying trained individuals are the evaluators, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus). The tests are based on objective measurements (e.g., calipers, multimeter, visual inspection against criteria) or adherence to pass/fail benchmarks from recognized standards. For the usability tests regarding indicator color interpretation, it implies direct observation of correct identification rather than a consensus process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed. The document explicitly states: "No animal or clinical testing is required" (page 8). This is a bench-tested device with minor modifications from a predicate, demonstrating substantial equivalence through engineering and laboratory tests, not comparative clinical performance or human reader studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable to this device. The Encision AEM enTouch® 2X Scissor is a surgical instrument, not an AI/algorithm-based diagnostic or therapeutic system. Its performance is inherent to its physical design and material properties, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for proving device performance is primarily objective engineering measurements, adherence to established international and domestic standards (ISO, ASTM, IEC), and internal design control procedures. These tests aim to ensure the device meets predefined physical, mechanical, electrical, and functional specifications, as well as sterility and biocompatibility requirements. For the "user interpretation" aspect of the indicator, the ground truth is simply the correct identification of the color (black for reprocess, orange for dispose).
8. Sample Size for the Training Set
This question is not applicable. Since this device is not an AI/machine learning system, there is no concept of a "training set" for an algorithm. The testing described focuses on validating the physical and functional aspects of the manufactured device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied for this device, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
July 15, 2020
Encision Inc. Pete Geary VP Operations 6797 Winchester Circle Boulder, Colorado 80260
Re: K201018
Trade/Device Name: Encision AEM enTouch 2X Scissor Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 17, 2020 Received: June 19, 2020
Dear Pete Geary:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K201018
Device Name
Encision AEM (Active Electrode Monitoring) enTouch® 2X Scissor
Indications for Use (Describe)
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the logo for Encision. The logo features the word "ENCISION" in green, with an orange circle containing white lines to the right of the word. Below the word is the phrase "DELIVERING ENERGY SAFELY" in a smaller font.
K201018 510(k) Summary
Device: Encision AEM (Active Electrode Monitoring) enTouch® 2X Scissor
Owner: Encision Inc.
- Contact: Pete Geary VP Operations 6797 Winchester Circle Boulder, CO, 80301, USA 303-444-2600 pgeary@encision.com
Submission Date: 14 July 2020
Subject Device:
| Trade Name | AEM enTouch® 2X Scissors |
|---|---|
| Model Number | ES0201, ES0201-45, ES0202, ES0202-45 |
| Common Name | Monopolar laparoscopic accessory |
| Regulation Name | Electrosurgical, Cutting & Coagulation, Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Device Class | 2 |
| Review Panel | General and Plastic Surgery |
Primary Predicate Device:
| Trade Name | ES000X, Reusable Scissor |
|---|---|
| Regulation Name | Electrosurgical, Cutting & Coagulation, Accessories |
| Manufacturer | Encision Inc. |
| 510(k) Number | K191612 |
Reference Predicate Device:
| Trade Name | ES01XX, Disposable Scissor |
|---|---|
| Regulation Name | Electrosurgical, Cutting & Coagulation, Accessories |
| Manufacturer | Encision Inc. |
| 510(k) Number | K191612 |
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Special 510(k) Decision:
The 2X Scissor is a modified version of the AEM Reusable Scissor, which was FDA cleared on K191612.
The change adds a thermochromic indicator to the scissor that allows the user to reprocess the device for one more use, supplies the device sterile and changes the stainless-steel materials. This is a change from the Reusable Scissor, which is supplied non-sterile. The 2X Scissor is supplied sterile with a black indicator. It can be reprocessed for one further use via the same validated method as the AEM Reusable Scissor. The indicator changes color from black to orange following steam sterilization. The indicator is non-patient contact. The materials are changed from 420 SS and 17-4 PH SS to 303 SS and 17-4 PH SS. No changes have been made to the fundamental design. The changes to the device can be evaluated using wellestablished methods.
The changes are summarized below:
| Change | 2X Scissor (subjectdevice) | Reusable Scissor(K191612 primarypredicate device) | Comments |
|---|---|---|---|
| Scissor Rod | -Thermochromicindicator on shaft | -No indicator on shaft | None |
| Material | -303 and 17-4 PHstainless-steel | -420 and 17-4 PHstainless-steel | Material is identical toreference predicateDisposable Scissor(K191612). |
| Sterilization | -Supplied sterile (E-beam | -Supplied non-sterile | Sterilization method isidentical to referencepredicate DisposableScissor (K191612). |
| Packaging | -Sterile barrier system,10 per box | -Poly bag, 1 per bag | Packagingconfiguration isidentical to referencepredicate DisposableScissor (K191612). |
| Cleaning | -Reprocessed for 2uses | -Reprocessed for upto 20 uses | No change to cleaningand steam sterilizationmethod. |
| Labeling | -Temperature limitsymbol-Humidity limit symbol-Sterile symbol-Do not use damagedpackage symbol | -No temperature limitsymbol-No humidity limitsymbol-Non-sterile symbol-No do not usedamaged packagesymbol | None |
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Image /page/5/Picture/0 description: The image shows the word "ENCISION" in a bold, sans-serif font. The letters are all capitalized and black. To the right of the letters is a stylized graphic of a circle with two curved lines running through it. A small registered trademark symbol is located to the upper right of the last letter.
Device Description:
2X Scissor Insert – ES02XX Series
The AEM enTouch® 2X Scissors Inserts are designed for use with the ES8000 / ES8200 series AEM enTouch® Handles. All scissors will fit through standard 5.5mm trocars.
Model Numbers and Trade Names:
| Predicate Device Model Number andTrade Name (original device, K191612) | Subject Device Model Number and TradeName (modified device, K201018) |
|---|---|
| ES0001, AEM® Curved Scissors, 1/2"Insert, 35cm | ES0201, AEM enTouch® 2X Scissor, 1/2", 35cm |
| ES0001-45, AEM® Curved Scissors, 1/2"Insert, 45cm | ES0201-45, AEM enTouch® 2X Scissor, 1/2",45cm |
| ES0002, AEM® Curved Scissors, 3/4"Insert, 35cm | ES0202, AEM enTouch® 2X Scissor, 3/4", 35cm |
| ES0002-45, AEM® Curved Scissors, 3/4"Insert, 45cm | ES0202-45, AEM enTouch® 2X Scissor, 3/4",45cm |
Indications for Use:
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only.
AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.
Scissors Inserts are intended for use on soft tissue only.
Sterility/Packaging:
This product is supplied sterile per ANSI/AAMI/ISO 11137-1:2006 and ANSI/AAMI/ISO 11607-1:2006. The product is sterilized using E-beam sterilization to achieve 10-6 SAL. Product is packaged in a Tyvek mylar pouch (10 pouches in a box) with a 1.5 year shelf life in the sterile packaging.
The product may be cleaned and steam sterilized for one more use per ANSI/AAMI/ISO 17664:2017 and ANSI/AAMI/ISO 17665-1:2006. The product is cleaned using manual, automatic or combined manual/automatic cleaning methods. Product is sterilized through Prevac steam sterilization using FDA-cleared sterile wraps to achieve 10-8 SAL. After steam sterilization product may be used one additional time before end of life conditions are met.
Biocompatibility:
All patient contact materials are biocompatible. Material testing demonstrates conformance with ANSI/AAMI/ISO 10993-1:2009, 4th edition. Gap analysis 05927 demonstrates that testing to a previous revision of the standard is consistent with the current recognized revision of ISO 10993-1. The product is not made with natural rubber latex.
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Standards:
The AEM enTouch® 2X Scissors have been tested to show conformity to the following FDA recognized standards:
| Topic | Standard Used | Application |
|---|---|---|
| E-beam sterilization | ANSI/AAMI/ISO 11137-1:2006Sterilization of Health Care Products – Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices | The 2X Scissors are sterilized to 10-6 SAL using E-beam sterilization in accordance with this standard. |
| Sterile packaging | ANSI/AAMI/ISO 11607-1:2006Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems | The 2X Scissors are packaged with a sterile barrier system in accordance with this standard. |
| Reprocessing – cleaning and sterilization | ANSI/AAMI/ISO 17664:2017Processing of Health Care Products – Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices | The 2X Scissors are reprocessed for one more use in accordance with this standard |
| Reprocessing – steam sterilization | ANSI/AAMI/ISO 17665-1:2006Sterilization of Health Care Products – Moist Heat – Part 1: Requirements for the Development, Validation and Routing Control of a Sterilization Process for Medical Devices | The 2X Scissors are reprocessed to 10-6 SAL using steam sterilization in accordance with this standard. |
| Biocompatibility | ANSI/AAMI/ISO 10993-1:2009Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | All patient-contact materials for the 2X Scissors have been tested for biocompatibility in accordance with this standard. |
| Electromagnetic compatibility | ANSI/AAMI/IEC 60601-1-2:2014Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance. Collateral Standard. Electromagnetic Compatibility. Requirements and Tests | The AEM® Monitoring System in which these scissors are an accessory has been tested for electromagnetic compatibility in accordance with this standard. |
| Electrical safety | ANSI/AAMI/IEC 60601-2-2:2017Medical Electrical Equipment – Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories | The AEM® Monitoring System in which these scissors are an accessory has been tested for electrical safety in accordance with this standard. |
| Topic | Standard Used | Application |
| Labeling | ANSI/AAMI/ISO 15223-1:2016Medical Devices – Symbols to beUsed with Medical Device Labels,Labelling and Information to beSupplied - Part 1: GeneralRequirements | The 2X Scissors have associatedlabeling in accordance with thisstandard. |
| Usability | ANSI/AAMI/IEC 63266-1:2015Medical devices - Part 1: Applicationof usability engineering to medicaldevices | The 2X Scissors have beendesigned for safe usability inaccordance with this standard. |
| Riskmanagement | ANSI/AAMI/ISO 14971:2007Medical Devices – Application of RiskManagement to Medical Devices | Risk management activities forthe 2X Scissors have beenconducted in accordance with thisstandard. |
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Technoloqical Characteristics:
The technological characteristics of the subject device are identical to the Reusable Scissor with regards to fundamental design, operating principle, use, compatibility and reprocessing method. The differences between the subject and predicate device are:
- The addition of a thermochromic indicator on the shaft of the insert, which changes color ● from black to orange as a result of steam sterilization following the first use of the device. The rod diameter is reduced where the indicator is applied. The indicator is a non-patient contact material and biocompatible.
- The scissor is made with 303 and 17-4 PH stainless-steel materials. ●
- The scissor is provided sterile to 10-6 SAL. ●
- The scissor may be reprocessed and reused only once.
Equivalence:
The subject device is substantially equivalent to the predicate device, as there is no change to the Indications for Use, Operating Principle, Patient Contact Materials, Fundamental Technology, Performance and EMC. The differences between the subject and predicate device are the addition of a thermochromic indicator on the insert shaft, supplying the device sterile and the stainless-steel material. The indicator is for reference only and does not raise new concerns of safety or effectiveness.
| Topic | Subject Device (this submission) compared to Predicate Device(K191612) |
|---|---|
| Intended Use | No change to Intended Use. |
| Operating Principle | No change to Operating Principle. |
| Materials | Substantially equivalent. Addition of indicator made fromthermochromic epoxy, which is non-patient contact. Changes tostainless steel grade does not affect fundamental design orreprocessing. |
| Use | Substantially equivalent. The scissor may be reprocessed and used asecond time. No other changes to use. |
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Image /page/8/Picture/0 description: The image shows the word "ENCISION" in a stylized, bold, sans-serif font. The "O" in "ENCISION" is replaced by a circular graphic with curved lines inside, resembling a stylized eye or a lens. A small registration mark is present to the upper right of the word.
| Topic | Subject Device (this submission) compared to Predicate Device (K191612) |
|---|---|
| Technology | Substantially equivalent. Addition of thermochromic indicator that changes color to show the insert can be used one more time. No change to fundamental technology. |
| Sterilization | Substantially equivalent. The scissor is provided sterile to 10-6 SAL following E-beam sterilization. It can be cleaned and steam sterilized for one more use via the same validated method as the Reusable Scissor. |
| Performance | No change to Performance. |
| Storage & Transportation | Substantially equivalent. The scissor has storage temperature and humidity limits so that the indicator does not change color in the sterile packaging. No change to safety or effectiveness. |
| EMC | No change to EMC or Electrical Safety. The AEM System in which the scissor is an accessory has been tested. |
Bench Testing:
All testing required per design control procedures was conducted using bench testing. Performance analysis has shown the Encision AEM enTouch® 2X Scissors to perform as intended and as well as the predicate device under the same and/or similar conditions. The subject device has been tested with settings set equal to those seen in typical procedures where these devices would be indicated for use. The requirements for electrodes function in the AEM Monitoring System have not changed from the original 510(k) submissions. The tests conducted show that the changes since the original 510(k) submissions demonstrate conformity to the original internal and regulatory requirements. No differences have been observed between the performance of the predicate devices and the device subject of this 510(k) Notification submission.
No animal or clinical testing is required.
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Risk Analysis:
Risk Assessment Summary:
| Change (frompredicate) | Risks | RiskCategory(see chartbelow) | Verification Method / StandardUsed | Acceptance Criteria | Results(Pass/Fail) |
|---|---|---|---|---|---|
| Addition ofindicator | Impossible or difficultassembly into handle dueto indicator diameter beingtoo large | C | Direct Measurement (Calipers) -same as predicate | Diameter of indicatoris less than diameterof rod passes | 22 of 22 sampleshave indicatordiameters less thantheir rod diameters -Pass |
| Rod actuation force is toohigh due to the indicatordiameter being too large | C | Handle with insert mechanicalactuation - same as predicateISO 7741:1986/(R)2017, ScissorTest Methods | No binding orimpaired mechanicalfunction passes | 22 of 22 sampleshave no binding ormechanicalfunctionalimpairments - Pass | |
| 2 use scissor | Poor cutting performancedue to dull blade edge | C | Cut test simulation after simulateduse and reprocessing – same aspredicateISO 7741:1986/(R)2017, ScissorTest MethodsASTM F1079-87, SurgicalScissors | After a singlesimulated surgeryfollowed by cleaningand sterilization, shallpass cut test | 15 of 15 samplespass cut test after asimulated surgery,cleaning andsterilization - Pass |
| Residual Risk:User may use device after end of life. Risk is mitigated through End of Life Indicators in the Instructions for Use. | |||||
| Addition ofindicator | Indicator scraping off | C | Visual inspection undermagnification during mechanicaltesting - same as predicateISO 10993-1:2009/(R)2013,Biocompatibility | No visual evidence ofchipping,delamination, orcracking to theindicator passes | 22 of 22 sampleshave no visualevidence ofchipping,delamination orcracking to theindicator - Pass |
| Change (frompredicate) | Risks | RiskCategory(see chartbelow) | Verification Method / StandardUsed | Acceptance Criteria | Results(Pass/Fail) |
| Addition ofindicator | Indicator not attached torod due to embrittlementfrom E-beam sterilization | C | Visual inspection after E-beamsterilization - same as predicateISO 11137-1:2006/(R)2010,Radiation Sterilization | No visual evidence ofchipping,delamination, orcracking to theindicator passes | 22 of 22 sampleshave no visualevidence ofchipping,delamination orcracking to theindicator - Pass |
| Indicator not attached torod due to damage duringcleaning and sterilization atthe hospital | C | Visual inspection after cleaningand sterilization - same aspredicateISO 17664:2017, CleaningISO 17665-1:2006/(R)2013,Steam Sterilization | No damage to theepoxy region passes | 22 of 22 sampleshave no damage tothe epoxy region -Pass | |
| Indicator delaminates fromthe rod or cracks due todamage from shipping oruse | C | Visual inspection after ship testing- same as predicateASTM D4169-16, Ship Testing | No visual evidence ofchipping,delamination, orcracking to theindicator passes | 22 of 22 sampleshave no visualevidence chipping,delamination, orcracking to theindicator - Pass | |
| Visual inspection after max doseirradiation, environmentalconditioning, aging and shiptesting - same as predicateASTM D4169-16, Ship Testing | No visual evidence ofdamage (chipping,cracking,delamination) to theindicator passes | 22 of 22 sampleshave no visualevidence chipping,delamination, orcracking to theindicator - Pass | |||
| Change (frompredicate) | Risks | RiskCategory(see chartbelow) | Verification Method / StandardUsed | Acceptance Criteria | Results(Pass/Fail) |
| Addition ofindicator | Indicator color does notpermanently change toorange after cleaning andautoclaving due to usingincorrect temperature/humidity in autoclave | C | Visual inspection of indicator colorchange after environmentalconditioning - same as predicateISO 11607-1:2006/(R)2010, SterileBarrier Systems | Color changes fromblack to orangepasses | 22 or 22 sampleshad color changefrom black to orange- Pass |
| Residual Risk:User may use device if color change does not occur after cleaning and autoclaving. Risk is mitigated in the SterilizationCautions in the Instructions for Use. | |||||
| Indicator color permanentlychanges to orange duringproduction or processing(including sterilization) dueto E-beam sterilization | C | Visual inspection of indicator colorchange after max dose irradiation– same as predicateISO 11137-1:2006/(R)2010,Radiation Sterilization | Color changes fromblack to orangepasses | 22 of 22 sampleshad color changefrom black to orange- Pass | |
| Indicator residue contactspatient | C | Visual inspection undermagnification during mechanicaltesting - same as predicateISO 10993-1:2009/(R)2013,Biocompatibility | No visual evidence ofchipping,delamination, orcracking to theindicator passes | 22 of 22 sampleshave no visualevidence ofchipping,delamination, orcracking to theindicator - Pass | |
| Indicator changes to orangeduringtransportation/storage dueto product being exposed toextreme temperature/humidity | C | Visual inspection after max doseirradiation, environmentalconditioning, aging and shiptesting - same as predicateASTM D4169-16, Ship Testing | Indicator remainsblack after shiptesting | 22 of 22 sampleshave remained blackafter ship testing -Pass | |
| Change (frompredicate) | Risks | RiskCategory(see chartbelow) | Verification Method / StandardUsed | Acceptance Criteria | Results(Pass/Fail) |
| Stainless steelmaterialmodification420/17-4PH to303/17-4PH | Corrosion | C | Visual inspection after max doseirradiation, environmentalconditioning, aging and shiptesting - same as predicateASTM A967-17, Stainless SteelPassivation | No visual evidence ofcorrosion or rust | 22 of 22 sampleshave no evidence ofcorrosion or rust -Pass |
| Embrittlement, breakage ofassembly, leading to loss offunction | C | Pouch drop testing IEC 60601-1after max dose irradiation,environmental conditioning, agingand ship testing - same aspredicateIEC 60601-1 edition 3.1, ElectricalSafety | No bend in the rod | 22 of 22 sampleshave no bend intheir rod - Pass | |
| Embrittlement, breakage ofassembly, leading to partsfalling off in patient | C | Pouch drop testing IEC 60601-1after max dose irradiation,environmental conditioning, agingand ship testing - same aspredicateIEC 60601-1 edition 3.1, ElectricalSafety | No bend in the rod | 22 of 22 sampleshave no bend intheir rod - Pass | |
| Intermittent power output atthe tip | C | Direct measurement (resistance -multimeter) - same as predicate.IEC 60601-1 edition 3.1, ElectricalSafety | Resistance is lessthan 5 ohms | 22 of 22 sampleshave a resistanceless than 5 ohms -Pass | |
| Change (frompredicate) | Risks | RiskCategory(see chartbelow) | Verification Method / StandardUsed | Acceptance Criteria | Results(Pass/Fail) |
| Rod diameterreduction | Impossible or difficultassembly into handle dueto the rod being bent as aresult of the reduceddiameter for indicator | C | Handle with insert mechanicalactuation - same as predicateIEC 60601-1 edition 3.1, ElectricalSafety | Any difficulty withactuation is a failure | 22 of 22 samples donot have anydifficulty withactuation - Pass |
| application | Straightness inspection - same aspredicateASTM F2819-10, RodStraightnessASTM D4169-16, Ship Testing | Rod gap meetsstraightnessrequirement | 22 of 22 Sampleshave a rod gap thatmeets straightnessrequirement - Pass | ||
| Sterilityprocesschange | Instrument becomes non-sterile during shipping | C | Instrument packaging sterilebarrier seal integrity testingISO 11607-2:2019, Sterile BarrierSystemASTM F2096-11, Seal IntegrityBubble Test | The insert and sterilebarrier shallwithstand shiptesting, with minimalcosmetic damage.After ship testing, theinsert shall remainfunctional. Thesterile barrier shallmaintain productsterility | 22 of 22 samplesmaintained a sterilebarrier after shiptesting - Pass |
| Reuselimitation | User misinterpretsindicator's color change asverification of sterility | C | Correct Use of device based onindicator color and labeling inQuick Use Guide instructions(when received from OR)IEC 62366-1:2015, Medical DeviceUsability | Black color iscorrectly identified byCentral Processingpersonnel | 20 of 20 sampleswere correctlyidentified as black-Ok to reprocess -Pass |
| Orange colorcorrectly identified byCentral Processingpersonnel | 20 of 20 sampleswere correctlyidentified as orange-do not reprocess -Pass | ||||
| Change (frompredicate) | Risks | RiskCategory(see chartbelow) | Verification Method / StandardUsed | Acceptance Criteria | Results(Pass/Fail) |
| Reuselimitation | User does not disposeinsert with orange indicatorafter second use | C | Correct Use of device based onindicator color and labeling inQuick Use Guide instructions(when received from OR)IEC 62366-1:2015, Medical DeviceUsability | Orange colorcorrectly identified byCentral Processingpersonnel | 20 of 20 sampleswere correctlyidentified as orange-do not reprocess -Pass |
| Poor cutting performancedue to dull blade edge | C | Cut test simulation after simulateduse and reprocessing - same aspredicateISO 7741:1986/(R)2017, ScissorTest MethodsASTM F1079-87, SurgicalScissors | After a singlesimulated surgeryfollowed by cleaningand sterilization, shallpass cut test. | 15 of 15 samplespassed cut test aftera simulated surgery,cleaning andsterilization - Pass | |
| Residual Risk:User may use device after end of life. Risk is mitigated through End of Life Indicators in the Instructions for Use. |
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Equivalence Conclusion:
The AEM enTouch® 2X Scissor design changes do not introduce new safety or effectiveness concerns. The modification made do not affect the fundamental technological design of there is no change to the Intended Use. Therefore, the subject device is substantially equivalent to the predicate device.
§ 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.