(333 days)
Not Found
No
The summary describes a generator that supplies energy to surgical instruments and mentions a touchscreen interface. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation. The performance studies are bench and animal model testing, not related to AI/ML validation.
Yes
The device is described as providing power to instruments used for cutting, sealing, grasping, and dissecting tissue during surgery, which are therapeutic actions.
No
Justification: The device provides radiofrequency power and ultrasonic energy for cutting and sealing vessels and tissue during surgery. It is an energy source for surgical instruments, not a diagnostic tool for identifying a disease or condition.
No
The device description clearly states it is a "Generator G11" that "supplies energy" and has a "receptacle port" and "connectors," indicating it is a hardware device that provides power to surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used during "open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a generator that supplies energy to surgical instruments used for cutting and sealing tissue. This is consistent with a surgical device, not a diagnostic device that analyzes 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 used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on performing surgical actions on the patient's body.
N/A
Intended Use / Indications for Use
The Generator GI I provides radiofrequency power to drive EnSeal® electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue. In addition the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
EnSeal® and Harmonic® instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
Product codes
GEI, HGI, LFL
Device Description
The Ethicon Endo-Surgery Generator G11 supplies energy to EnSeal® electrosurgical instruments and Harmonic ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either EnSeal® or Harmonic® devices. Connectors (one for Harmonic and one for EnSeal® instruments) are used to enable the generator to power currently cleared surgical instruments.
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)
Bench testing and laboratory evaluations in an animal model were conducted to demonstrate that the Generator G11 performs as intended.
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
510(k) Summary
K101990
- Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
- Donovan May Contact Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: (513) 337-7981 Fax: (513) 337-2793 Email: dmay3@its.jnj.com
July 14, 2010 Date Prepared
Device Name Trade Name: Ethicon Endo-Surgery Generator G11 Common Name: Electrosurgical & Ultrasonic Surgical Generator
Classification Names
- · Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, Product Code GEI)
- · Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HGI)
- · Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)
Predicate Devices
- · EnSeal® RF60 Electrosurgical Generator (cleared under K072177 on September 5, 2007 as part of the EnSeal® Vessel Sealing and Hemostasis System)
- · EnSeal® Universal Generator (cleared under K081129 on July 28, 2008 as a system with the EnSeal PowerTip instrument)
- · UltraCision Harmonic® Scalpel Generator 300 (cleared under K002906 on December 15,
- 2000 as part of the UltraCision Harmonic® Scalpel Generator 300 System)
Device Description:
The Ethicon Endo-Surgery Generator G11 supplies energy to EnSeal® electrosurgical instruments and Harmonic ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either EnSeal® or Harmonic® devices. Connectors (one for Harmonic and one for EnSeal® instruments) are used to enable the generator to power currently cleared surgical instruments.
1
Indications for Use:
The Generator G11 provides radiofrequency power to drive EnSeal® electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue. In addition the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
EnSeal® and Harmonic® instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
The differences between the intended use of the subject device and those of the predicate devices do not affect the safety and effectiveness of the subject device when used as labeled for the following reasons:
- · The Generator G11 provides power for the use of both EnSeal electrosurgical and Harmonic ultrasonic surgical open and laparoscopic surgical instruments. The predicate devices referenced are only able to provide power for one of these surgical instrument : types.
- · The predicate devices were each submitted as part of a surgical system thus the Indications for Use statements included in the submissions associated with them did not contain indications specific to the function of the generators except for those in the labeling. These differences do not alter the intended surgical effects of the subject device from that of the predicate devices.
Technological Characteristics: The Ethicon Endo-Surgery Generator G11 incorporates the technological characteristics of the predicate devices in a single surgical generator but allows for a greater range of power, voltage, current, and frequency for both the EnSeal electrosurgical and Harmonic ultrasonic surgical modes. A touchscreen user interface has been incorporated to provide the user with information, control, and feedback during use.
Performance Data: Bench testing and laboratory evaluations in an animal model were conducted to demonstrate that the Generator G11 performs as intended.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Mr. Donovan May Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
JUN 1 3 2011
Re: K101990
Trade Name: Generator G11 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL, HGI Dated: June 1, 2011 Received: June 2, 2011
Dear Mr. May:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nevers forrewed your bother is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent 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 r ou may are see of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 or uny 1 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
3
Page 2 - Mr. Donovan May
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/MedicalDevices/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.
Euis D. Keith
for 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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Indications for Use
510(k) Number (if known): K101990
Device Name: Generator G11
Indications for Use:
The Generator GI I provides radiofrequency power to drive EnSeal® electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue. In addition the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
EnSeal® and Harmonic® instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
KIO 990 510(k) Number ________________________________________________________________________________________________________________________________________________________________