(135 days)
Not Found
No
The description focuses on standard electrosurgical generator functions and safety testing, with no mention of AI or ML capabilities.
Yes
The device is described as an "Electrosurgical Generator" used to "achieve cut or coagulation for the tissue" during surgery, which are therapeutic medical interventions.
No
The device is an electrosurgical generator intended for cutting and coagulating tissue during surgery, not for diagnosing medical conditions.
No
The device description explicitly states it is an "Electrosurgical Generator" and includes components like an "HF generator and accessories," "output Pencil," and is controlled by "foot or hand switch." This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monopolar or bipolar surgery to achieve cut or coagulation for the tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a device that generates high-frequency power transmitted to tissue through an output pencil. This is consistent with an electrosurgical unit used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Electrosurgical Generator 8070 is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
8070 is an Electrosurgical Generator with Monopolar Pure cut, Monopolar Bland Cut, Bipolar function. 8070 consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the output is controlled by foot or hand switch.
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)
To demonstrate safety and effectiveness of the 8070 and to show substantial equivalence to the predicate device (8070), Medrange completed successfully the following non-clinical performance tests:
General Safety Testing: IEC 60601-1:2005+C1+C2+A1:2012 Medical electrical equipment, Part 1 General requirements for basic safety and essential performance
EMC Safety Testing: IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment, Part 1-2 General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances – Requirements and tests
HF Safety Testing: 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
Performance Testing: Applicable parts of FDA Guidance Document “Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”, May 2016
Usability Testing: IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6 General requirements for safety - Collateral Standard: Usability
Key results: The non-clinical test results, such as performance data, electrical safety and electromagnetic compatibility data have demonstrated the 8070 is as safe and effective as the predicate device.
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.
Not Found
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). 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.
September 18, 2020
Medrange Corporation Helen Xie RA Assistant 480 Apollo Street, Suite D. Brea. California 92821
Re: K201224
Trade/Device Name: Electrosurgical Generator and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI. Dated: August 19, 2020 Received: August 19, 2020
Dear Helen Xie:
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201224
Device Name
8070 Electrosurgical Generator and Accessories
Indications for Use (Describe)
The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
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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Image /page/3/Picture/1 description: The image shows the title "510(k) Summary" in a large font. Below the title is a horizontal line, and below the line is the text "Traditional 510(k) Submission" in a smaller font. To the left of the title is a black graphic that resembles a stylized check mark or swoosh.
| Section | |
|---|---|
| Version | 1.1f |
|---|---|
| Pages | 3 |
| Date | September 16, 2020 |
1. Submitter Information
| Company: | Medrange Corporation |
|---|---|
| Address: | Suite D, 480 Apollo Street, Brea CA 92821 |
| Contact: | Helen Xie |
| Phone: | 1(909) 859 - 9055 |
| Email: | hx9055@gmail.com |
2. Device Identification
| Common name: | Electrosurgical Generator and Accessories |
|---|---|
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Trade name: | Accsurg™ Electrosurgical Workstation and Accessories |
| Model: | 8070 |
| Device Class: | Class II |
| Product Code: | GEI |
| 21CFR Regulation Number: | 878.4400 |
3. Predicate Device
Product MB 8010 Electrosurgical Unit 510(K) K102114
4. Device Description
8070 is an Electrosurgical Generator with Monopolar Pure cut, Monopolar Bland Cut, Bipolar function. 8070 consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the output is controlled by foot or hand switch.
5. Indication for use
The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with Monopolar, handpiece and dispersive electrode or bipolar handpiece and footswitches.
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6. Substantial Equivalence Discussion
Technological characteristics
| Device | Subject device | Predicate device |
|---|---|---|
| Manufacturer | Medrange Corporation | Medrange Corporation |
| Model | 8070 | MB 8010 |
| 510(k) Number | K201224 | K102114 |
| Class | II | II |
| Product Code | GEI | GEI |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Mechanism of Action | The device generates high | |
| Frequency current | ||
| 400-600 kHz | The device generates high | |
| Frequency current | ||
| 416-1050 kHz | ||
| System Voltage | 100-240VAC- 50/60Hz | 100-240VAC- 50/60Hz |
| 4 Monopolar Cut Modes | ||
| Max. Power | 320 W (at 300Ω) | 300 W (at 300Ω) |
| Max. Voltage Output | 3800 | 2200 |
| Crest Factor | 1.5-2.5 | 1.8-2.5 |
| Wave Forms | Sinusoidal constant / modulated | |
| Cut / Coag Pulse Phases | Sinusoidal constant / modulated | |
| 8 Monopolar Coagulation Modes | ||
| Max. Power | 120 W (at 500Ω) | 100 W (at 500Ω) |
| Max. Voltage Output | 5800 | 9000 |
| Crest Factor | 4.4-8.7 | 7.0 |
| Wave Forms | Sinusoidal constant / modulated | |
| Cut / Coag Pulse Phases | Sinusoidal constant / modulated | |
| 4 Bipolar Modes | ||
| Max. Power | 240 W (at 100Ω) | 50 W (at 50Ω) |
| Max. Voltage Output | 900 | 280 |
| Crest Factor | 1.7-9 | 1.5-12.1 |
| Wave Forms | Sinusoidal constant / modulated | |
| Pause Phases | Sinusoidal constant / modulated |
5
7. Non-Clinical Performance Data
To demonstrate safety and effectiveness of the 8070 and to show substantial equivalence to the predicate device (8070), Medrange completed successfully the following non-clinical performance tests:
| General Safety Testing | IEC 60601-1:2005+C1+C2+A1:2012 Medical electrical equipment, Part
1
General requirements for basic safety and essential performance |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EMC Safety Testing | IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment, Part
1-2
General requirements for basic safety and essential performance
Collateral Standard: Electromagnetic disturbances – Requirements and
tests |
| HF Safety Testing | 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 |
| Performance Testing | Applicable parts of FDA Guidance Document “Premarket Notification
(510(k)) Submissions for Electrosurgical Devices for General Surgery”,
May 2016 |
| Usability Testing | IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part
1-6
General requirements for safety - Collateral Standard: Usability |
8. Statement of Substantial Equivalence
The 8070 has the same intended use as the 8010, and the same technological characteristics. The non-clinical test results, such as performance data, electrical safety and electromagnetic compatibility data have demonstrated the 8070 is as safe and effective as the predicate device. Therefore it is concluded, that the 8070 fulfills the requirements of a substantially equivalent device and that no new questions of safety and effectiveness were raised.