(89 days)
No
The summary describes a monopolar electrosurgical instrument and its intended use, focusing on the delivery of energy and mechanical function (scissors). There is no mention of AI, ML, image processing, or any data-driven decision-making process within the device itself. The performance studies are bench tests comparing it to a predicate device, not evaluating algorithmic performance.
Yes
The device delivers electrosurgical energy and is intended for use in laparoscopic procedures on soft tissue, indicating it is used to treat or manage a medical condition.
No
The device is described as an electrosurgical instrument for delivering energy during laparoscopic procedures, not for diagnosis. Its intended use is to perform a surgical action (delivering energy) with scissors inserts, and the performance studies focus on its function as a surgical tool.
No
The device description explicitly mentions "Scissors Inserts" and "Handles," which are physical hardware components used in electrosurgery. The intended use also describes delivering "monopolar electrosurgical energy," which requires hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivering monopolar electrosurgical energy during laparoscopic procedures only." This describes a surgical tool used directly on the patient's tissue, not a device used to examine samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description focuses on the physical design and compatibility with handles and trocars, consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to apply energy to tissue during surgery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
4
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 (subject
device) | Reusable Scissor
(K191612 primary
predicate device) | Comments |
|---------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Scissor Rod | -Thermochromic
indicator on shaft | -No indicator on shaft | None |
| Material | -303 and 17-4 PH
stainless-steel | -420 and 17-4 PH
stainless-steel | Material is identical to
reference predicate
Disposable Scissor
(K191612). |
| Sterilization | -Supplied sterile (E-
beam | -Supplied non-sterile | Sterilization method is
identical to reference
predicate Disposable
Scissor (K191612). |
| Packaging | -Sterile barrier system,
10 per box | -Poly bag, 1 per bag | Packaging
configuration is
identical to reference
predicate Disposable
Scissor (K191612). |
| Cleaning | -Reprocessed for 2
uses | -Reprocessed for up
to 20 uses | No change to cleaning
and steam sterilization
method. |
| Labeling | -Temperature limit
symbol
-Humidity limit symbol
-Sterile symbol
-Do not use damaged
package symbol | -No temperature limit
symbol
-No humidity limit
symbol
-Non-sterile symbol
-No do not use
damaged package
symbol | None |
5
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 and
Trade Name (original device, K191612) | Subject Device Model Number and Trade
Name (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.
6
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 11137-1:2006 | |
| Sterilization 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 11607-1:2006 | |
| Packaging 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 17664:2017 | |
| Processing 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 17665-1:2006 | |
| Sterilization 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 10993-1:2009 | |
| Biological 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 60601-1-2:2014 | |
| Medical 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 60601-2-2:2017 | |
| Medical 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 15223-1:2016 | |
| Medical Devices – Symbols to be | ||
| Used with Medical Device Labels, | ||
| Labelling and Information to be | ||
| Supplied - Part 1: General | ||
| Requirements | The 2X Scissors have associated | |
| labeling in accordance with this | ||
| standard. | ||
| Usability | ANSI/AAMI/IEC 63266-1:2015 | |
| Medical devices - Part 1: Application | ||
| of usability engineering to medical | ||
| devices | The 2X Scissors have been | |
| designed for safe usability in | ||
| accordance with this standard. | ||
| Risk | ||
| management | ANSI/AAMI/ISO 14971:2007 | |
| Medical Devices – Application of Risk | ||
| Management to Medical Devices | Risk management activities for | |
| the 2X Scissors have been | ||
| conducted in accordance with this | ||
| standard. |
7
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 from
thermochromic epoxy, which is non-patient contact. Changes to
stainless steel grade does not affect fundamental design or
reprocessing. |
| Use | Substantially equivalent. The scissor may be reprocessed and used a
second time. No other changes to use. |
8
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.
9
Risk Analysis:
Risk Assessment Summary:
| Change (from
predicate) | Risks | Risk
Category
(see chart
below) | Verification Method / Standard
Used | Acceptance Criteria | Results
(Pass/Fail) |
|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Addition of
indicator | Impossible or difficult
assembly into handle due
to indicator diameter being
too large | C | 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 | C | 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 |
| 2 use scissor | Poor cutting performance
due to dull blade edge | C | 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 |
| Residual Risk:
User may use device after end of life. Risk is mitigated through End of Life Indicators in the Instructions for Use. | | | | | |
| Addition of
indicator | Indicator scraping off | C | 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 |
| Change (from
predicate) | Risks | Risk
Category
(see chart
below) | Verification Method / Standard
Used | Acceptance Criteria | Results
(Pass/Fail) |
| Addition of
indicator | Indicator not attached to
rod due to embrittlement
from E-beam sterilization | C | 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 | C | 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 | C | 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 |
| | | | Visual inspection after max dose
irradiation, environmental
conditioning, aging and ship
testing - same as predicate
ASTM D4169-16, Ship Testing | No visual evidence of
damage (chipping,
cracking,
delamination) to the
indicator passes | 22 of 22 samples
have no visual
evidence chipping,
delamination, or
cracking to the
indicator - Pass |
| Change (from
predicate) | Risks | Risk
Category
(see chart
below) | Verification Method / Standard
Used | Acceptance Criteria | Results
(Pass/Fail) |
| Addition of
indicator | Indicator color does not
permanently change to
orange after cleaning and
autoclaving due to using
incorrect temperature/
humidity in autoclave | C | 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 |
| | Residual Risk:
User may use device if color change does not occur after cleaning and autoclaving. Risk is mitigated in the Sterilization
Cautions in the Instructions for Use. | | | | |
| | Indicator color permanently
changes to orange during
production or processing
(including sterilization) due
to E-beam sterilization | C | Visual inspection of indicator color
change after max dose irradiation
– same as predicate
ISO 11137-1:2006/(R)2010,
Radiation Sterilization | Color changes from
black to orange
passes | 22 of 22 samples
had color change
from black to orange - Pass |
| | Indicator residue contacts
patient | C | 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 | C | 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 |
| Change (from
predicate) | Risks | Risk
Category
(see chart
below) | Verification Method / Standard
Used | Acceptance Criteria | Results
(Pass/Fail) |
| Stainless steel
material
modification
420/17-4PH to
303/17-4PH | Corrosion | C | 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 | C | 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 | |
| Embrittlement, breakage of
assembly, leading to parts
falling off in patient | C | 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 | C | 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 | |
| Change (from
predicate) | Risks | Risk
Category
(see chart
below) | Verification Method / Standard
Used | Acceptance Criteria | Results
(Pass/Fail) |
| Rod diameter
reduction | Impossible or difficult
assembly into handle due
to the rod being bent as a
result of the reduced
diameter for indicator | C | 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 |
| | application | | 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 | C | 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 |
| Reuse
limitation | User misinterprets
indicator's color change as
verification of sterility | C | 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 |
| | | | | Orange color
correctly identified by
Central Processing
personnel | 20 of 20 samples
were correctly
identified as orange-
do not reprocess -
Pass |
| Change (from
predicate) | Risks | Risk
Category
(see chart
below) | Verification Method / Standard
Used | Acceptance Criteria | Results
(Pass/Fail) |
| Reuse
limitation | User does not dispose
insert with orange indicator
after second use | C | 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 |
| | Poor cutting performance
due to dull blade edge | C | 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
passed cut test after
a simulated surgery,
cleaning and
sterilization - Pass |
| Residual Risk:
User may use device after end of life. Risk is mitigated through End of Life Indicators in the Instructions for Use. | | | | | |
10
11
12
13
14
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.