(106 days)
Not Found
No
The summary describes a standard electrosurgical generator with software control, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
Yes
The device is described as a "Bipolar Coagulator" intended for use in surgery to generate electrical power for bipolar instruments, which are used for coagulation, a therapeutic process.
No
The device is described as an electrosurgical generator intended for use in surgery to generate electrical power for coagulation (e.g., stopping bleeding by denaturing proteins). It does not collect or analyze data to diagnose a medical condition.
No
The device description explicitly states it is an electrosurgical generator with electrical components housed within an enclosure, and it connects to instruments via a cord and is activated by a foot control. While it mentions a "software based program," this software drives the hardware components of the generator, making it a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate electrical power for bipolar instruments used in surgery for coagulation. This is a therapeutic/surgical function performed directly on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description details an electrosurgical generator that delivers high-frequency electrical current for coagulation. This is a surgical tool, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely focused on performing a surgical procedure.
N/A
Intended Use / Indications for Use
Aesculap's Bipolar Coagulator (GN160) is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Aesculap's Bipolar HF Device is a non-sterile, reusable electrosurgical generator capable of generating high frequency electrical current, driven through a software based program, for coaqulation with existing Aesculap bioolar instruments (e.g. forceps). It is equipped with a bipolar outlet. The device is fitted with a universal power adapter for mains voltages 100-120V and 220-240V. All software and electrical components are housed within a combination metallic and thermoplastic enclosure. A bipolar cord connects the instruments to the unit. The unit is activated by means of a foot control.
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
surgery
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)
No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. The Aesculap Bipolar HF Device conforms to the following IEC standards:
- IEC 60601-1: Medical electrical equipment - Part 1: General requirement for safety, ●
- IEC 60601-2-2: Medical electrical equipment - Part 2: Particular requirements for the safety . of high frequency surgical equipment,
- . IEC 60601-1-2: Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility EMC Requirements and Tests.
- IEC 62304: Medical device software Software life cycle process .
Testing results demonstrate that the Aesculap Bipolar HF Device is safe and effective. No clinical testing was performed.
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.
Aesculap Bipolar Coagulator (K952524), Wolf Model 2352 {K945914}, Vallevlabs Force FZ (K953195), Vallevlabs Forcetriad (K102913)
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
P4
B. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN 2 8 2011
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Aesculap Bipolar High Frequency (HF) Device June 13, 2011
Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 CONTACT Lisa M. Boyle, Sr. RA Specialist 800-258-1946 x 5274 (phone) 610-791-6882 (fax) lisa.bovle@aesculap.com TRADE NAME: Aesculap Bipolar High Frequency (HF) Device COMMON NAME: Bipolar HF Electrosurgical Unit CLASS. NAME: Electrosurgical, Cutting & Coagulation & Accessories (GEI) REG. NUMBER: 878.4400 (Class II)
SUBSTANTIAL EQUIVALENCE
The Aesculap Bipolar HF Device as described in this premarket notification is substantially equivalent to the following predicate devices:
Aesculap Bipolar Coagulator (K952524) .
DEVICE DESCRIPTION
Aesculap's Bipolar HF Device is a non-sterile, reusable electrosurgical generator capable of generating high frequency electrical current, driven through a software based program, for coaqulation with existing Aesculap bioolar instruments (e.g. forceps). It is equipped with a bipolar outlet. The device is fitted with a universal power adapter for mains voltages 100-120V and 220-240V. All software and electrical components are housed within a combination metallic and thermoplastic enclosure. A bipolar cord connects the instruments to the unit. The unit is activated by means of a foot control.
INDICATIONS FOR USE
Aesculab's Bipolar Coagulator (GN160) is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are use in Neurosurgery, ENT surgery, urology, laparoscopy and plastic surgery.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Bipolar HF Device described in this premarket notification share similar features and functions such as intended use, labeling, and basic operating principles to the following predicate devices: Aesculap Bipolar Coaqulator (K952524), Wolf Model 2352 (K945914), Valleylabs Force FZ (K953195), and the Valleylabs Forcetriad (K102913).
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Testing of the subject device was found to be similar in performance to the previously cleared device with similar indications.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. The Aesculap Bipolar HF Device conforms to the following IEC standards:
- IEC 60601-1: Medical electrical equipment - Part 1: General requirement for safety, ●
- IEC 60601-2-2: Medical electrical equipment - Part 2: Particular requirements for the safety . of high frequency surgical equipment,
- . IEC 60601-1-2: Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility EMC Requirements and Tests.
- IEC 62304: Medical device software Software life cycle process .
Testing results demonstrate that the Aesculap Bipolar HF Device is safe and effective. No clinical testing was performed.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap, Inc. % Ms. Lisa M. Boyle Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
JUN 28 2011
Re: K110695
Trade/Device Name: Bipolar HF Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 15, 2011 Received: June 16, 2011
Dear Ms. Boyle:
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
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Page 2 - Ms. Lisa M. Boyle
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11118800.html 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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Premarket Notification
Aesculap Bipolar HF Device (GN160)
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
KII 0695 510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Aesculap Bipolar HF Device
Indications for Use:
Aesculap's Bipolar Coagulator (GN160) is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
| Prescription Use | X | and/or Over-the-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110695