(226 days)
No
The description focuses on the electrosurgical and argon plasma technology, control modes, and safety features, with no mention of AI or ML.
Yes
The device is intended for "argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue," which are medical procedures for treating tissue.
No
The device is described as an Argon Plasma Coagulation unit intended to deliver argon gas for coagulation, ablation, and cutting of tissue. Its function is therapeutic rather than diagnostic.
No
The device description clearly outlines hardware components such as the APC unit, pressure reducer, fastening sets, and the need for connection to an ESU and argon gas source. It also mentions physical accessories like applicators and probes.
Based on the provided information, the Erbe APC 3 with accessories is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue". This is a therapeutic and surgical application performed directly on a living patient's tissue.
- Device Description: The description details how the device works in conjunction with an electrosurgical unit to deliver argon gas and high-frequency current for tissue modification. This is a physical intervention on the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The Erbe APC 3 does not perform any such analysis of bodily specimens.
The device is a surgical tool used for direct treatment of tissue within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.
Product codes
GEI
Device Description
The Erbe Argon Plasma Coagulation Unit Model APC 3 is an APC unit for use in conjunction with an Erbe Electrosurgical Unit (ESU) compatible Model (currently Model VIO® 3). The APC 3 (as well as VIO 3) can be mounted/secured to a cart or on a ceiling mount using fastening sets, i.e. connecting cables and hardware. The APC 3 is connected to an argon gas source via a pressure reducer and connected to the VIO 3 which powers and controls the APC unit. The ESU further provides a touch-screen monitor (i.e., interactive display) with an onscreen tutorial, settings and operational information as well as safety features (i.e., audio and visual error system). When using the APC 3 together with the VIO 3, the user is offered various APC Modes as well as argon-supported Modes which can be adjusted by the physician via effect levels in order to achieve the desired tissue effect. The ESU VIO 3 provides the high-frequency (HF) current required for thermal coagulation. For argon plasma coagulation and ablation, the HF current is applied non-contact to the tissue to be coagulated through ionized and hence electrically conductive argon gas (argon plasma). The argon gas is ionized in the high-frequency electrical field between the electrode of the applicator and the tissue. For argon-assisted cutting, the ESU provides the regular cutting/coagulation Mode while the argon gas provided by the APC 3 circulates the active electrode. This application is with contact to tissue.
Applicators or probes connected to the APC 3 for coagulating tissue via argon plasma and/or for cutting tissue supported by argon gas may be activated via footswitches connected to the ESU or by use of applicators that have an activation finger switch.
The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.
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
Verification/Validation Activities (Including Applied/Certified Standards and Guidance Documents):
FDA Recognized Consensus Standards
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance* *Other versions of this standard were also tested to and certified.
- IEC 60601-1-2 Edition 4.0:2014-02 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests* *Other versions of this standard were also tested to and certified.
- IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surqical accessories* *Other versions of this standard were also tested to and certified
- IEC 62304:2006 + A1:2015 Medical device software - Software life cycle processes
- IEC 62366:2007 + A1:2014 Medical Devices Application Of Usability Engineering To Medical Devices
- IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment Part 1 -. 6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- EN 1041:2008 + A1:2013 Information supplied by the manufacturer of medical . devices
- ISTA 2A:2011 Partial Simulation Performance Test Packaged-Products 150 Ib (68 . kg) or Less
Performance Evaluations/Testing
- Output/Mode Comparison
- Tissue Testing
- Capacitive Coupling (per Standard Number 60601-2-2)
- Accessory Testing
Key results: The proposed Unit has essentially the same principles of operation, technological characteristics, as well as performance characteristics as the predicate APC unit. Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K060484, K083452, K080715, K190823, K992764, K992769, K003462, K013348, K060183, K143306, K183445, K023886
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2019
Erbe Elektromedizin GmbH Julia Weller Specialist Regulatory Affairs Waldhoernlestrasse 17 Tuebingen, 72072 De
Re: K191234
Trade/Device Name: Erbe Argon Plasma Coagulation Unit APC 3 with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: May 3, 2019 Received: May 8, 2019
Dear Julia Weller:
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.
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
1
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 (OS) 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
510(k) Number (if known) K191234
Device Name
Erbe Argon Plasma Coagulation Unit APC 3 with Accessories
Indications for Use (Describe)
The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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3
510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)]
| Submitted By: | Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
72072 Tuebingen
Germany
Tel: 0049-7071-755-0
Fax: 0049-7071-755-179 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Henry Kutz
Specialist Regulatory Affairs |
| Date Prepared: | May 3, 2019 |
| Trade/Proprietary Name: | Erbe APC Unit Model APC 3 with Accessories |
| Common Name: | Argon Plasma Coagulation Unit |
| Classification Name and Code: | Electrosurgical Cutting and Coagulation Device and
Accessories (21 CFR Part 878.4400) |
| Regulatory Class: | II |
| Product Code: | GEI |
| Legally Marketed
Predicate Device: | Erbe VIO APC Model APC 2 with Accessories,
510(k) Number K024047 |
Device Description:
The Erbe Argon Plasma Coagulation Unit Model APC 3 is an APC unit for use in conjunction with an Erbe Electrosurgical Unit (ESU) compatible Model (currently Model VIO® 3). The APC 3 (as well as VIO 3) can be mounted/secured to a cart or on a ceiling mount using fastening sets, i.e. connecting cables and hardware. The APC 3 is connected to an argon gas source via a pressure reducer and connected to the VIO 3 which powers and controls the APC unit. The ESU further provides a touch-screen monitor (i.e., interactive display) with an onscreen tutorial, settings and operational information as well as safety features (i.e., audio and visual error system). When using the APC 3 together with the VIO 3, the user is offered various APC Modes as well as argon-supported Modes which can be adjusted by the physician via effect levels in order to achieve the desired tissue effect. The ESU VIO 3 provides the high-frequency (HF) current required for thermal coagulation. For argon plasma coagulation and ablation, the HF current is applied non-contact to the tissue to be coagulated through ionized and hence electrically conductive argon gas (argon plasma). The argon gas is ionized in the high-frequency electrical field between the electrode of the applicator and the tissue. For argon-assisted cutting, the ESU provides the regular cutting/coagulation Mode while the argon gas provided by the APC 3 circulates the active electrode. This application is with contact to tissue.
Applicators or probes connected to the APC 3 for coagulating tissue via argon plasma and/or for cutting tissue supported by argon gas may be activated via footswitches connected to the ESU or by use of applicators that have an activation finger switch.
The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC
4
user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.
Indications for Use Statement:
The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.
Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):
| Characteristics | Predicate:
Erbe VIO APC Model APC 2 with
Accessories | Proposed:
Erbe APC Unit Model APC 3 with
Accessories |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Erbe Elektromedizin GmbH
(Germany) | Same |
| 510(k) | K024047 | N/A |
| Trade/Proprietary
Name | Erbe VIO APC Model APC 2 with
Accessories | Erbe APC Unit Model APC 3 with
Accessories |
| Indications for Use | The Erbe VIO APC with Accessories
is intended to deliver argon gas for
argon plasma coagulation of tissue
when used in conjunction with a
compatible Erbe VIO Electrosurgical
Generator (ESU) and applicators or
probes. | The Erbe APC 3 with accessories is
intended to deliver argon gas for
argon plasma coagulation and
ablation of tissue as well as argon-
assisted cutting of tissue when used
in conjunction with a compatible
Erbe VIO Electrosurgical Generator
(ESU) and applicators or probes. |
| Prescription or
ОТС | Prescription (Rx) | Same |
| Materials | | |
| Unit | Metal sheet, plastics, wiring, metal
fittings | Same |
| Applicators | Stainless steel, ceramic, plastics,
tungsten, printing color | Same |
| Probes | Stainless steel, ceramic, plastics,
tungsten, glue, silicone | Same |
| Pressure Reducer | Metal, plastic, tubing, metal fittings,
pressure gauge | Same |
| Fastening Sets | N/A | metal, wiring, plastics |
| Technical / Performance Data | | |
| Unit gas flow rate
(adjustable) | 0.1-8 l/min limited by the
respective instrument connected,
adjustable in 0.1 I steps | Same |
| Gas Type Used | Argon 4.8 (99.998% purity) or higher | Same |
| Input/Line | No direct line input / powered
through compatible VIO ESU | Same |
| Protective Circuits | Detection of specific type of
accessory/instruments (e.g.
applicator or probe) through the VIO
ESU | Same |
| Characteristics | Predicate:
Erbe VIO APC Model APC 2 with
Accessories | Proposed:
Erbe APC Unit Model APC 3 with
Accessories |
| Receptacle
Configuration | Up to two sockets.
(one APC/FiAPC socket or two
APC/FiAPC sockets or one
APC/FiAPC socket and one
monopolar/bipolar/
multifunctional socket) | Up to two sockets.
(one FiAPC socket or one FiAPC
socket and one monopolar/ bipolar/
multifunctional socket) |
| Units compatible
with the APC Unit | Erbe ESU Model VIO D and VIO S
series [K060484,K083452 and
K080715] | Erbe ESU Model VIO 3 [K190823 -
pending] |
| Applicators and
Probes compatible
with the APC Unit | APC raspatory handle and tip
[K992764] | N/A |
| | APC applicator [K992769] | N/A |
| | APC handle and applicators
[K003462] | N/A |
| | APCprobe [K013348] | N/A |
| | FiAPC probes [K060183]
HybridAPC probe [K143306] | Same
Same |
| | APCapplicators [K183445] | Same |
| Other compatible
equipment | VIO Cart [K023886] | Same |
| Labeling | APC 2 Unit
- packaging label
- user manual
- service manual | APC 3 Unit
- packaging label
- user manual
- service manual |
| | Applicators and probes - packaging label
- notes on use | Applicators and probes
- packaging label
- notes on use
Note: Compatibility to APC 3 added. |
| | Pressure reducer - packaging label
- notes on use | Pressure reducer
- packaging label
- notes on use
Note: Compatibility to APC 3 added. |
| | N/A | Fastening sets - packaging label |
| | VIO Cart - packaging label
- user manual | VIO Cart
- packaging label
- user manual
Note: Compatibility to APC 3 added. |
| | APC Unit: N/A - no patient contact | Same |
| Biocompatibility | Applicators and probes: direct patient
contact | Same |
| | Pressure reducer and VIO Cart:
N/A - no patient contact | Pressure reducer, VIO Cart and
fastening sets:
N/A - no patient contact |
| Provided condition | APC Unit : non-sterile, reusable | Same |
| | Applicators and probes: sterile,
disposable (single-use) | Same |
| | Pressure reducer and VIO Cart: non-
sterile, reusable | Pressure reducer, VIO Cart and
fastening sets: non-sterile, reusable |
| Shelf Life | Not Applicable for reusable Unit and
Accessories (i.e. pressure reducer
and VIO Cart) | Not Applicable for reusable Unit and
Accessories (i.e. pressure reducer,
VIO Cart and fastening set) |
| Characteristics | Predicate:
Erbe VIO APC Model APC 2 with
Accessories | Proposed:
Erbe APC Unit Model APC 3 with
Accessories |
| | Three (3) years for single use
HybridAPC probe and
APCapplicators and five (5) years for
FiAPC probes. | Same |
5
6
Verification/Validation Activities (Including Applied/Certified Standards and Guidance Documents):
FDA Recognized Consensus Standards
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance* *Other versions of this standard were also tested to and certified.
- IEC 60601-1-2 Edition 4.0:2014-02 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests* *Other versions of this standard were also tested to and certified.
- · IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surqical accessories* *Other versions of this standard were also tested to and certified
- . IEC 62304:2006 + A1:2015 Medical device software - Software life cycle processes
- · IEC 62366:2007 + A1:2014 Medical Devices Application Of Usability Engineering To Medical Devices
- IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment Part 1 -. 6: General requirements for basic safety and essential performance - Collateral standard: Usability
- · ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- EN 1041:2008 + A1:2013 Information supplied by the manufacturer of medical . devices
- ISTA 2A:2011 Partial Simulation Performance Test Packaged-Products 150 Ib (68 . kg) or Less
Performance Evaluations/Testing
- · Output/Mode Comparison
- · Tissue Testing
- · Capacitive Coupling (per Standard Number 60601-2-2)
- · Accessory Testing
Conclusion:
The intended use of the proposed Erbe APC 3 was clarified identifying all functions that may be performed with the Unit when used in combination with a compatible Erbe VIO ESU and applicators or probes. The proposed Unit has essentially the same principles of operation, technological characteristics, as well as performance characteristics as the predicate APC unit. Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate.