(63 days)
Not Found
No
The document describes a standard electrosurgical generator with various modes and a touch screen interface. There is no mention of AI, ML, or any features that would suggest the use of such technologies for decision-making, image analysis, or adaptive control beyond basic feedback loops inherent in electrosurgical devices.
No.
Therapeutic devices are used to treat or cure diseases or conditions. This device is used for cutting and coagulation of soft tissue and ligation of vessels, which are surgical procedures, not treatments in themselves.
No
The device description and intended use state that the electrosurgical generator is used for cutting and coagulation of soft tissue and ligation of vessels, which are therapeutic actions, not diagnostic ones.
No
The device is an electrosurgical generator, which is a piece of hardware that generates high-frequency current and supports ultrasonic instruments for cutting and coagulation of tissue. While it has a touch screen GUI, the core function is hardware-based energy delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulation of soft tissue and for ligation of vessels" using high frequency current and supporting ultrasonic instruments. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical generator that delivers energy for tissue manipulation. It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Using reagents or assays
The device is an electrosurgical generator used in surgical procedures. IVD devices are used to perform tests on samples outside of the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.
The electrosurgical generator is intended to be used in the following medical fields:
- · Open surgery
- · Laparoscopic surgery, including single-site surgery
- · Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
Product codes
GEI
Device Description
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different high frequency monopolar and bipolar cutting and coagulation modes with a maximum output power of 320 W, as well as capability to power the existing Olympus ultrasonic THUNDERBEAT and SONICBEAT devices via a redesigned HYBRID ULTRASONIC socket and four new modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy. The maximum RF output power for the THUNDERBEAT mode is 110 W.
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of soft tissue in open surgery, laparoscopic surgery (including single-site surgery), endoscopic surgery and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.
The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) as well as the power switch (on/off), six output sockets and one neutral electrode socket.
The touch screen GUI displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the menu in order to edit settings/procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to access user-defined settings and procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician in an adequate medical environment
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)
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility testing: Not required as ESG-410 and foot switches do not come into direct or indirect patient contact.
- Electrical safety and electromagnetic compatibility (EMC): Complies with recognized standards.
- Thermal Safety: Complies with recognized standards.
- Clinical and animal Studies: Not necessary to prove equivalence. Determination was based on non-clinical bench testing.
- Software: Software validation activities performed in accordance with FDA Guidance. Device software is considered "Major Level of Concern". Off-the-shelf software and cybersecurity considerations were also followed.
- Performance Bench Testing: Demonstrated substantial equivalence through performance and validation tests incorporating the same range of waveform outputs and power levels as predicates. Waveforms and tissue effects were directly compared. Bench testing supports the claim of substantial equivalence.
- Non-clinical (electrical, dimensional, functional, stability) tests were conducted.
- Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety were conducted.
- Testing of equivalence was performed in comparison to the predicate devices in relevant aspects associated with usability, tissue effects, and thermal effects.
- Key results:
- Vessel Burst Pressure: The burst pressure in vessels (veins and arteries) of test article (subject device) is higher than or not statistically significantly different from those of control groups.
- Thermal Spread: The thermal spread in vessels of test article (subject device) is smaller than or not statistically significantly different from those of control groups.
- Comparable tissue effects could be achieved for applicable modes of operation with applicable tissue types.
- Reprocessing: Required cleaning, disinfecting and drying procedures are described in the instructions for use.
- Usability and user interface were also assessed according to the risk management plan, based on Olympus predecessor product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2023
Olympus Winter & Ibe GmbH % Mr. Dolan Mills Program Manager, Regulatory Affairs Olympus Surgical Tech. America; Gyrus ACMI, Inc. 800 West Park Drive Westborough, Massachusetts 01581
Re: K231777 Trade/Device Name: ESG-410 (Models: WA91327U, WA91327W)
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 16, 2023 Received: June 16, 2023
Dear Mr. Mills:
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 medical devices and radiation-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,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.08.18
09:21:24 -04'00'
Mark Trumbore, 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
510(k) Number (if known) K231777
Device Name ESG-410 (Models: WA91327U, WA91327W)
Indications for Use (Describe)
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.
The electrosurgical generator is intended to be used in the following medical fields:
- · Open surgery
- · Laparoscopic surgery, including single-site surgery
- · Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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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3
2 510(k) Summary
2.1 General Information
| Applicant: | Olympus Winter & Ibe GmbH
Kuehnstrasse 61
22045 Hamburg
Germany |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 9610773 |
| Manufacturer: | Olympus Winter & Ibe GmbH
Berlin Facility
Rheinstrasse 8
14513 Teltow
Germany
Establishment Registration Number: 3003724334 |
| 510(k) Correspondent: | Mr. Dolan Mills
Program Manager, Regulatory Affairs
Olympus Surgical Tech. America
Gyrus ACMI, Inc.
800 West Park Drive
Westborough, MA 01581
Phone: (901) 355-0007
Email: dolan.mills@olympus.com
Establishment Registration Number: 3003790304 |
| Date prepared: | Aug 15, 2023 |
2.2 Device Identification
| Tradename: | ESG-410 (Models: WA91327U, WA91327W) |
|---|---|
| Footswitch Model numbers: | WA91311W, WA91321W |
| Classification Number: | 21 CFR 878.4400 |
| Classification name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Product code: | GEI |
| Regulatory class: | Class II |
| Review Panel: | General & Plastic Surgery |
4
2.3 Predicate Device
The electrosurgical generator ESG-410 and accessories are considered substantially equivalent to the following legally marketed devices:
| Predicate Device | Manufacturer | 510(k) No. | |
|---|---|---|---|
| Primary Predicate | Electrosurgical Generator | ||
| ESG-410 and Accessories | Olympus Winter & Ibe | ||
| GmbH | K203277 | ||
| Secondary Predicate | Olympus ULTRASONIC | ||
| BIPOLAR GENERATOR | |||
| USG-410 | OLYMPUS MEDICAL | ||
| SYSTEMS | K211838 |
Table 2.1: Identification of predicate device
2.4 Product Description
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different high frequency monopolar and bipolar cutting and coagulation modes with a maximum output power of 320 W, as well as capability to power the existing Olympus ultrasonic THUNDERBEAT and SONICBEAT devices via a redesigned HYBRID ULTRASONIC socket and four new modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy. The maximum RF output power for the THUNDERBEAT mode is 110 W.
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of soft tissue in open surgery, laparoscopic surgery (including single-site surgery), endoscopic surgery and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.
The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) as well as the power switch (on/off), six output sockets and one neutral electrode socket.
The touch screen GUI displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the menu in order to edit settings/procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to access user-defined settings and procedures.
It is compliant with FDA recognized consensus safety standards as listed in section 2.8.8 below.
2.5 Indications for Use
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.
5
The electrosurgical generator is intended to be used in the following medical fields:
- . Open surgerv
- Laparoscopic surgery, including single-site surgery .
- Endoscopic surgery ●
Only for use by a qualified physician in an adequate medical environment.
2.6 Technological Characteristics
The subject ESG-410 has an equivalent intended use and technological characteristics as the primary predicate device ESG-410 (K203277).
Various instruments can be connected to the two monopolar sockets or one bipolar socket as well as to the two universal sockets. In addition, dedicated Olympus instruments or Olympus cables can be connected to the two universal sockets with instrument recognition.
The basic design philosophy of the User Interface (UI) and GUI flow chart concept is equivalent. Compared to the predicate ESG-410 (K203277), the ESG-410 subject to this submission offers four additional output modes which are equivalent to the modes in the secondary predicate device USG-410 (K211838). Furthermore, the GUI of 2 existing modes from the primary predicate (K203277) adds level 1-5 as an alternative to the existing power/effect settings. The new level concept does not exceed the predicate power/effect settings. It provides another option to deliver an easy setup for users to account for user preference.
The capability to connect THUNDERBEAT and SONICBEAT devices via the HYBRID ULTRASONIC socket is equivalent to the function provided by the secondary predicate device USG-410 (K211838).
2.6.1 Output modes in comparison to the primary predicate device ESG-410
The range of bipolar and monopolar output waveforms and the power levels are identical in comparison to the predicate ESG-410 electrosurgical generator, K203277.
2.6.2 Output modes in comparison to the secondary predicate device USG-410
The range of ultrasonic and high frequency output waveforms and the power levels are equivalent in comparison to the secondary predicate USG-410 electrosurgical generator, K211838.
2.7 Substantial Equivalence
Substantial equivalence is demonstrated by acknowledged verification/validation methodologies. The subject devices have equivalent technology, performance, dimensions, and materials. The differences from the primary predicate device ESG-410 (K203277) are:
- One HYBRID ULTRASONIC socket, compared to one Surgisaber socket ●
- . The GUI is modified to support the four new modes.
6
- The GUI is modified to integrate the new level concept of two modes.
- . Intelligent Tissue Monitoring (ITM) is provided for two modes used in conjunction with THUNDERBEAT and SONICBEAT devices to detect small impedance changes of ultrasonic vibrations, so that the electrosurgical generator is able to automatically stop the output after the target tissue is divided.
To support the additionally implemented HYBRID ULTRASONIC socket and the additional four modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy, a secondary predicate device has been selected. Substantial equivalence for the secondary predicate device is demonstrated by acknowledged verification/ validation methodologies. The secondary predicate device has equivalent technology and performance in respect to the compared modes.
There have been no changes to the technological characteristics or intended use of the predicate devices since its clearance.
The intended use for the subject device in comparison to the primary predicate ESG-410 (K203277) is complemented by the ability to support ultrasonic instruments by way of the secondary predicate USG-410 (K211838). The indication wording differences do not represent an extension of the indications for use but add clarity to the indications for use that are already covered by the predicates.
| Items of
Comparison | Subject device:
ESG-410 and
accessories | Primary Predicate
Device: ESG-410
and accessories
(K203277) | Secondary
Predicate
device:
USG-410
(K211838) | Evaluation
of
differences |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Device Name | Electrosurgical
Generator ESG-
410 and
Accessories | Electrosurgical
Generator ESG-
410 and
Accessories | USG-410
Ultrasonic Bipolar
Generator | Same |
| Regulation
Specialty | General &
Plastic Surgery | General & Plastic
Surgery | General & Plastic
Surgery | Identical |
| Device
Classification
Name | Electrosurgical
cutting and
coagulation
device and
accessories | Electrosurgical
cutting and
coagulation device
and accessories | Electrosurgical
cutting and
coagulation
device and
accessories | Identical |
| Intended Use/
Indications for
Use | Intended for
cutting and
coagulation of
soft tissue and
for ligation of
vessels.
Open
surgery | Intended for cutting
and coagulation of
tissue:
Open surgeryLaparoscopic
surgery | Intended for
open,
laparoscopic
(including single-
site surgery), and
endoscopic
surgery to cut
(dissect) or | Same in total |
The basic compatibility testing and electrical testing demonstrate equivalence.
7
| Items of
Comparison | Subject device:
ESG-410 and
accessories | Primary Predicate
Device: ESG-410
and accessories
(K203277) | Secondary
Predicate
device:
USG-410
(K211838) | Evaluation
of
differences |
|------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------|
| | Laparoscopic surgery,
including single-site
surgery Endoscopic surgery | Endoscopic surgery | coagulate soft
tissue or to ligate
(seal and cut)
vessels. | |
2.8 Performance Data
The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.
All data was prepared in accordance with the FDA guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020. The guidance was followed for all relevant sections.
2.8.1 Biocompatibility testing
The ESG-410 and foot switches do not come into direct or indirect patient contact. Therefore, biocompatibility evaluation and testing according to ISO 10993-1 is not required.
2.8.2 Electrical safety and electromagnetic compatibility (EMC)
The design of the ESG-410 complies with recognized standards as listed in section 2.8.8 below.
The FDA quidance, Electromagnetic Compatibility (EMC) of Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued June 6, 2022, has been followed.
2.8.3 Thermal Safety
The design of the ESG-410 complies with recognized standards as listed in section 2.8.8 below.
2.8.4 Clinical and animal Studies
Clinical and animal studies were not necessary to prove equivalence.
This determination was based on the test results obtained during the non-clinical bench testing, which confirmed:
i. Vessel Burst Pressure: The burst pressure in vessels (veins and arteries) of test article (subject device) is higher than or not statistically significantly different from those of control groups.
8
ii. Thermal Spread: The thermal spread in vessels of test article (subject device) is smaller than or not statistically significantly different from those of control groups.
2.8.5 Software
The subject ESG-410 generator contains software. The software validation activities were performed in accordance with the FDA Guidance. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The device software is considered a "Major Level of Concern". Furthermore, the FDA Guidance, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff", issued January 11, 2002 was followed.
As parts of the software are off-the-shelf software. The guidance "Off-The-Shelf Software Use in Medical Devices" Guidance for Industry and Food and Drug Administration Staff, issued on September 27, 2019, was taken into account for the relevant sections.
To fulfill the requirements with regard to cybersecurity the FDA Guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 02, 2014" was followed. Cybersecurity is documented according to AAMI TIR57 "Principles for medical device security - Risk management", 2016. The wired foot switches which are subject to this submission do not contain software.
2.8.6 Performance Bench Testing
To demonstrate substantial equivalence the following aspects were considered within the verification and validation versus the predicate devices:
-
- Performance and validation tests incorporated the same range of waveform outputs and power levels.
-
- During the validation testing the waveforms and tissue effects were compared directly between the subject and predicate devices.
Bench testing supports the claim of substantial equivalence to the predicate devices. The validation plan specifies modes, instruments and test protocols/plans for tissue effects and electrical waveforms. Beside tissue effects, the waveforms of the generators were compared. For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms.
The following non-clinical and preclinical tests were conducted:
-
- non-clinical (electrical, dimensional, functional, stability),
-
- preclinical (simulated use) evaluation and testing of tissue effects and thermal safety
Non-clinical: Basic safety and performance testing was performed in accordance with IEC standards. In addition, verification and comparison bench studies were conducted to evaluate the functional performance.
Testing of equivalence was performed in comparison to the predicate devices in relevant aspects associated with usability, tissue effects, and thermal effects.
9
These comprehensive validation bench tests support equivalence to the predicate devices. Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with applicable tissue types.
Usability and user interface were also assessed according to the risk management plan. The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable.
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2019.
2.8.7 Reprocessing
Required cleaning, disinfecting and drying procedures are described in the instructions for use.
10
2.8.8 Applied standards
| Standard No. | Standard Title | FDA-
Recognition
no + date |
|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| AAMI/ANSI/ES
60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012
(Cons. Text) [Incl.
AMD2:2021] | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD)
[Including Amendment 2 (2021)] | 19-46
05/30/2022 |
| ANSI/AAMI/ES
60601-
1:2005/(R)2012 and
C1:2009/(R)2012
and,
A2:2010/(R)2012
(Consolidated Text) | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD) | 19-4
07/09/2014
(foot switches) |
| ANSI/AAMI/IEC
60601-1-2:2014
[including AMD
1:2021] | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests [including Amendment 1 (2021)] | 19-36
12/21/2020 |
| ANSI/AAMI/IEC
60601-1-8:2006 and
A1:2012 [Including
AMD 2:2021] | Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential
performance - Collateral Standard: General
requirements, tests and guidance for alarm
systems in medical electrical equipment and
medical electrical systems [Including
Amendment 2 (2021)] | 5-131
12/21/2020 |
| 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 | 6-389
06/07/2021 |
| IEC
62304
Edition 1.1 2015-06
CONSOLIDATED
VERSION | Medical device software - Software life cycle
processes | 13-79
01/14/2019 |
| IEC
60601-1-6
Edition 3.2:
2020-07
CONSOLIDATED
VERSION | Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability | 5-132
12/21/2020 |
| IEC 62366-1 Edition
1.1 2020-06
CONSOLIDATED
VERSION | Medical devices - Part 1: Application of
usability engineering to medical devices | 5-129
07/06/2020 |
| Standard No. | Standard Title | FDA-
Recognition
no + date |
| ISO 14971 Third
Edition 2019-12 | Medical devices – Application of risk
management to medical devices | 5-125
12/23/2019 |
| ASTM D4169-22 | Standard Practice for Performance Testing of
Shipping Containers and Systems | 14-576
05/30/2022 |
| ASTM D4332-14 | Standard Practice for Conditioning Containers,
Packages, or Packaging Components for
Testing | 5-99
04/04/2016 |
11
Table 2.2: Applied standards
2.9 Conclusion
The performance data support the safety of the devices and demonstrate that the subject devices comply with the recognized standards as specified.
In summary, we believe the ESG-410 and accessories are substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The ESG-410 and accessories raise no new concerns of safety or effectiveness when compared to the predicate devices.