(117 days)
Not Found
No
The description focuses on standard electrosurgical generator functions controlled by physical buttons and switches, with no mention of AI, ML, or related concepts.
Yes.
The device is used for cutting and coagulation in surgical procedures, which are therapeutic interventions.
No
The device is an electrosurgical generator used for cutting and coagulation in surgical procedures, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines hardware components like a generator, front panel with push buttons and lamps, digital displays, and connections for hand/foot switches and electrodes. It is an electrosurgical generator, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "monopolar cutting and coagulation and bipolar coagulation in surgical procedures." This describes a device used directly on a patient during surgery, not for testing samples outside the body.
- Device Description: The description details an "electrosurgical generator" that performs functions like "pure cut; blend cut, coagulation and bipolar coagulation." These are all procedures performed on living tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is an electrosurgical unit, which is a type of medical device used for surgical procedures.
N/A
Intended Use / Indications for Use
MB8010 Electrosurgical generator is indicated for monopolar cutting and coagulation and bipolar coagulation in surgical procedures and is intended to be used with monopolar handpieces and ground pad or bipolar handpieces and footswitches.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Medrange MB 8010 ESU is an electrosurgical generator with monopolar pure cut; blend cut, coagulation and bipolar coagulation functions which meet surgical demands.
Those functions are achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show status of self-test and monitoring.
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)
Performance testing was performed to ensure that MB 8010 electrosurgical generator functions as intended, and meets design specifications. MB 8010 conforms to ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, IEC60601-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-8, IEC60601-2-2, risk management ISO14971
Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.
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
PDA Conni Divic
SEP 3 0 2010
SECTION 2
510(k) Summary
Received K68
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR. Part 808. Subpart E.Section 807.92
SUBMITTER'S INFORMATION [21CFR 807.92(a)(1)]
NOV 2 2 2010
Medrange Corporation Company: 480 Apollo Street, Suite D Brea, CA 92821 Contact: Mr. Harry Woods Phone: (714) 784.5204 Fax: (714) 255.1531 Email: wuhai@medrange.com
DEVICE IDENTIFICATION [21CFR 807.92(a)(1)]
Trade Name: MB8010 electrosurgical unit Common Name: Electrosurgical cutting and coagulation device and accessories Device Class: Class II
Product Code: GEI
PREDICATE DEVICE INFORMATION [21CFR 807.92(a)(3)] ConMed Excalibur Plus PC Predicate Device1:
Aspen Laboratories Inc. 510(k) number: K953007
Valley lab FX™ Predicate Device2: Valleylab, a Division of Tyco Healthcare LP 510(k) number: K944602
DEVICE DESCRIPTION [21CFR 807.92(a)(4)}
Medrange MB 8010 ESU is an electrosurgical generator with monopolar pure cut; blend cut, coagulation and bipolar coagulation functions which meet surgical demands.
Those functions are achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show status of self-test and monitoring.
1
The final output power control is made through foot or hand switches. Both monopolar and bipolar electrodes are provided. It is designed to comply with international safety standards.
INDICATION FOR USE [21CFR 807.92(a)(5)]
MB8010 Electrosurgical generator is indicated for monopolar cutting and coagulation and bipolar coagulation in surgical procedures and is intended to be used with monopolar handpieces and ground pad or bipolar handpieces and footswitches.
TECHNOLOGICAL CHARACTERISTICS [21CFR 807.92(a)(6)]
Medrange MB8010 ESU has the same intended use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. The MB 8010 is similar in design and function to the predicate devices for the modes of operation and use.
PERFORMANCE DATA AND CONCLUSION [21CFR 807.92(b)]
Performance testing was performed to ensure that MB 8010 electrosurgical generator functions as intended, and meets design specifications. MB 8010 conforms to ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, IEC60601-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-8, IEC60601-2-2, risk management ISO14971
Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medrange Corporation % Mr. Harry Woods 480 Apollo Street, Suite D Brea, California 92821
NOV 2 2 2010
Re: K102114
Trade/Device Name: Medrange Electrosurgical Generator, model MB8010 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 30, 2010 Received: September 30, 2010
Dear Mr. Woods:
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
3
Page 2 - Mr. Harry Woods
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Medical.Devices/Safety/ReportaProblem/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/Industry/default.htm.
Sincerely yours,
For
DEP
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 1
Indication for Use Statement
NOV 2 2 2 2010
510 (k) Number (if know): K102114 Device Name: Medrange MB 8010 Electrosurgical generator
Indications for use:
MB8010 Electrosurgical generator is indicated for monopolar cutting and coagulation and bipolar coagulation in surgical procedures and is intended to be used with monopolar handpieces and ground pad or bipolar handpieces and footswitches.
Prescription Use AND/OR (Part 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisior Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102114