(316 days)
No
The description focuses on the physical components and electrical function of an electrosurgical attachment, with no mention of AI or ML.
Yes.
The device is intended for coagulation and cutting of soft tissue, which are therapeutic medical procedures.
No
The device is an electrosurgical attachment used for coagulation and cutting of soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states the device is an "electrode tip, made of stainless steel," which is a physical hardware component. The performance studies also focus on physical, mechanical, and biocompatibility tests of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation and cutting of soft tissue" using electrosurgical energy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is an "electrode tip" that delivers high-frequency energy to tissue. This is a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely interventional.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ACE Monopolar Attachment is intended to be used with the compatible ERBE Monopolar Disposable Electrosurgical Pencil (model: No.20190-109) for coagulation and cutting of soft tissue when used in conjunction with compatible ERBE Electrosurgical Generator (ESU) Systems.
Product codes
GEI
Device Description
The ACE Monopolar Attachment is used with compatible ERBE Electrosurgical Generator (ESU) Systems which deliver High Frequency (HF) energy through the electrode tip of the ACE Monopolar Attachment for coagulation and cutting of soft tissue. The ACE Monopolar Attachment is an electrode tip, made of stainless steel, and compatible with marketed plastic insulation handle. The compatible ERBE Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie receptacle. The Monopolar Attachment is provided single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
A series of preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the ACE Monopolar Attachment. The safety tests were conducted in vitro and in vivo in accordance with ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISO 10993-5: 2003, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10:2002/Amd. 1:2006(E), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1, IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995, IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3), IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories, ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and ASTM D7334-08 Standard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement.
The Performance Tests were conducted on the subject device and the predicate device for the ex vivo test and mechanical test items listed below:
Ex vivo test: Arcing Test, Charring Test, Thermal Spread Test
Mechanical test: Dropping Test, Pulling Test
All the test results demonstrate the safety and performance of ACE Monopolar Attachment meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the ACE Monopolar Attachment is substantially equivalent to the predicate devices.
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
BioEconeer Inc. 510(k) Notification
5.4
ACE Monopolar Attachment
AUG 1 3 2
K123061
510(k) Summary
5.1 Type of Submission: Traditional
5.2 Preparation Date: Sep 28, 2012
5.3 Revised Date: August 09 , 2013
Submitter: BioEconeer Inc. Address: 10355 Norwich Avenue, Cupertino, CA 95014, U.S.A Phone: +886-989-103981 Fax: 408-252-6996 Contact: Tony ChaoFu Chang Establishment Registration Number: N/A
ર્સ્ટ Identification of the Device:
| Proprietary/Trade name: | ACE Monopolar Attachment |
|---|---|
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Device Classification: | II |
| Regulation Number: | 878.4400 |
| Panel: | General & Plastic Surgery |
| Product Code: | GEI |
5.6 Identification of the Predicate Device:
| Predicate Device Name: | GEIGER DISPOSABLE ELECTROSURGICAL | |
|---|---|---|
| ELECTRODE | ||
| Manufacturer: | GEIGER MEDICAL TECHNOLOGIES, INC. | |
| 510(k) Number or Clearance Information: | K994075 |
1
ACE Monopolar Attachment
5.7 Intended Use and Indications for Use of the subject device.
The ACE Monopolar Attachment is intended to be used with the compatible ERBE Monopolar Disposable Electrosurgical Pencil (model: No.20190-109) for coagulation and cutting of soft tissue when used in conjunction with compatible ERBE Electrosurgical Generator (ESU) Systems.
5.8 Device Description
The ACE Monopolar Attachment is used with compatible ERBE Electrosurgical Generator (ESU) Systems which deliver High Frequency (HF) energy through the electrode tip of the ACE Monopolar Attachment for coagulation and cutting of soft tissue. The ACE Monopolar Attachment is an electrode tip, made of stainless steel, and compatible with marketed plastic insulation handle. The compatible ERBE Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie receptacle. The Monopolar Attachment is provided single-use.
5.9 Non-clinical Testing
A series of preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the ACE Monopolar Attachment. The safety tests were conducted in vitro and in vivo in accordance with ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISO 10993-5: 2003, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10:2002/Amd. 1:2006(E), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1, IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995, IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3), IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories, ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and ASTM D7334-08 Standard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement.
2
BioEconeer Inc. 510(k) Notification ACE Monopolar Attachment
The Performance Tests were conducted on the subject device and the predicate device for the ex vivo test and mechanical test items listed below:
Ex vivo test: Arcing Test, Charring Test, Thermal Spread Test Mechanical test: Dropping Test, Pulling Test
All the test results demonstrate the safety and performance of ACE Monopolar Attachment meets the requirements of its pre-defined acceptance criteria and intended uses.
5.10Safety and Effectiveness
.
The results of the non-clinical testing demonstrate that the ACE Monopolar Attachment is substantially equivalent to the predicate devices.
5.11Substantial Equivalence Determination
The ACE Monopolar Attachment submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared GEIGER Disposable Electrosurgical Electrode which is the subject of K994075. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | Predicate Device
(GEIGER Disposable
Electrosurgical Electrode) | Proposed Device
(ACE Monopolar Attachment) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarity | | |
| Classification | Class II | Class II |
| Code or Federal Regulations | 878.4400 | 878.4400 |
| Prescription Medical
Devices | YES | YES |
| Intended Use | The Geiger Disposable
Electrosurgical Electrode is
intended to be utilized for basic
non-sterile electrosurgical
procedures. Examples of non-sterile
procedures include the removal of | The ACE Monopolar
Attachment is intended to be
used with the compatible ERBE
Monopolar Disposable
Electrosurgical Pencil (model:
No.20190-109) for coagulation |
3
BioEconeer Inc. 5 10(k) Notification
ACE Monopolar Attachment
| | | moles, warts and skin tags. The
electrodes are a standard 3/32" in
diameter and will fit the majority of
electrosurgical generators and
handpieces in the marketplace. | and cutting of soft tissue when
used in conjunction with
compatible ERBE
Electrosurgical Generator (ESU)
Systems. |
|------------------------------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Material of electrode tip | | Stainless Steel | Stainless Steel |
| Dimension | | Shaft: 3/32" | Shaft: φ 2.35mm |
| Safety Standards | | ISO 10993-1
ISO 10993-5
ISO 10993-10
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2
ISO 11137-2
ASTM D7334-08 | ISO 10993-1
ISO 10993-5
ISO 10993-10
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2
ISO 11137-2
ASTM D7334-08 |
| Performance Standards | | Not applicable | Not applicable |
| Comparative
Performance
Test Items | Ex vivo | Arcing Test
Charring Test
Thermal Spread Test | |
| | Mechanical | Dropping Test | |
| | | Pulling Test | |
| Differences | | | |
| Material of insulation | | polystyrene | Nylon |
| Sterilization | | non-sterile | Gamma irradiation (Single Use) |
The differences between the subject device and predicate device are on the material of insulation and sterilization. The subject device has tested on safety and performance tests and the test results were complied with the test requests. Therefore, the differences of subject device and predicate device didn't raise any problems of safety or effectiveness. The ACE Monopolar Attachment is substantially equivalent to the predicate device in design, operation, intended use, method of preparation, and performance claims.
4
BioEconeer Inc. 5 10(k) Notification ACE Monopolar Attachment
5.12Conclusion
After analyzing bench tests. electrical safety testing data, it can be concluded that ACE Monopolar Attachment is substantially equivalent to the predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BioEconeer Incorporated % Michael Lee President AcmeBiotechs Company, Ltd. No.45, Minsheng Road, Danshui District New Taipei City, Taiwan 251
August 13, 2013
Re: K123061
Trade/Device Name: ACE Monopolar Attachment Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 19, 2013 Received: July 26, 2013
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Michael Lee
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Image /page/6/Picture/7 description: The image shows the name "Peter De Rumm -S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The letters "D" and "R" have a decorative pattern within them, adding a unique visual element to the text. The overall impression is clean and legible, with a touch of artistic flair in the letter design.
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
BioEconeer Inc. 510(k) Notification ACE Monopolar Attachment 510(k) Number:K123061
Indications for Use
510(k) Number (if known): K123061
Device Name: ACE Monopolar Attachment
Indications for Use:
The ACE Monopolar Attachment is intended to be used with the compatible ERBE Monopolar Disposable Electrosurgical Pencil (model: No.20190-109) for coagulation and cutting of soft tissue when used in conjunction with compatible ERBE Electrosurgical Generator (ESU) Systems.
Prescription Use _ X (Pari 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Page I of __
| DSD-DIVISION SIGN-OFF | Joshua C. Nipper - |
|---|---|
| Division of Surgical Devices | S |
| 510(k) Number: K123061 |