(84 days)
No
The description focuses on the mechanical and electrical functions of the device for cutting and sealing tissue, with no mention of AI or ML capabilities.
Yes
The device is described as a surgical instrument used to cut and seal vessels and tissue during surgical procedures, which are therapeutic actions.
No
Explanation: The ENSEAL X1 Tissue Sealers are described as surgical instruments used for cutting and sealing tissue and vessels during procedures. Their function is therapeutic, not to diagnose a condition.
No
The device description clearly outlines a physical surgical instrument with a grip housing, shaft, jaws, knife, and power cord. While it requires a specific generator with software, the device itself is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during surgical procedures to cut, seal, grasp, and dissect tissue and vessels within the body.
- Device Description: The description details a surgical instrument with jaws, a knife, and the ability to deliver bipolar energy for sealing and cutting tissue in vivo.
- Lack of In Vitro Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
Product codes
GEI, HGI
Device Description
The ENSEAL X1 Tissue Sealer instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The ENSEAL X1 Tissue Sealer has a curved jaw and a straight jaw configuration. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue, vascular bundles, 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)
Bench testing and laboratory evaluations were conducted to demonstrate that the ENSEAL X1 Tissue Sealers performed as intended.
Biocompatibility Testing: The biocompatibility of materials used in the ENSEAL X1 Tissue Sealers was evaluated based on ISO 10993-1 and FDA guidance.
Electromagnetic Compatibility and Electrical Safety: Electrical safety and EMC testing were conducted; the system complies with IEC 60601-1-2, IEC 60601-1, and IEC 60601-2-2.
Sterilization/Shelf-Life: Validated to achieve a sterility assurance level of 10-6 using Ethylene Oxide per ISO 11135. Shelf-life is 1-year.
Mechanical Testing: Axial Jaw Retention, Jaw Strength, Hinge Pin Weld Strength, Stress Test were carried out. Results demonstrated ability to perform as well as predicate device.
Bench Testing: Sealed vessel burst test evaluated for substantial equivalence. Evaluation of performance and ability to seal and divide vessels up to 7 mm using porcine arteries. Key results: Data generated met predetermined acceptance criteria.
Acute Animal Testing: Performed in an acute porcine study (2 animals per device) to demonstrate no difference in tissue effects compared to predicate device, evaluating performance and ability to seal and divide vessels up to and including 7 mm. Key results: Demonstrated ability to perform as well as predicate device.
Survival Animal Testing: Performed in a chronic survival study (30-day, 5 animals per device) to demonstrate no difference in tissue effects compared to predicate device, evaluating performance and ability to seal and divide vessels up to and including 7 mm. Key results: Demonstrated ability to perform as well as predicate device.
Clinical Testing: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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November 20, 2017
Ethicon Endo-Surgery, LLC % Ryoji Sakai Manager Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K172580
Trade/Device Name: ENSEAL X1 Tissue Sealers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, HGI Dated: August 25, 2017 Received: August 28, 2017
Dear Ryoji Sakai:
We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good
1
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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K172580
Device Name ENSEAL X1 Tissue Sealers
Indications for Use (Describe)
The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
- Contact Ryoji Sakai Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. Telephone: (513) 337-8586 Email: rsakai3@its.jnj.com
Date Prepared
August 25, 2017
Device Name
Trade Name: ENSEAL® X1 Tissue Sealers Common Name: Electrosurgical Cutting and Coagulating Instruments
Classification Name
- · Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, Product Code GEI)
- · Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HGI)
Regulatory Class
Class II
Predicate Devices
ENSEAL G2 Tissue Sealers initially cleared under K112033 on November 8, 2011 and last cleared under K131435 on October 3, 2013 as part of the ENSEAL Tissue Sealing Devices
Reference Devices
ENSEAL X1 Large Jaw Tissue Sealer cleared under K160554 on September 9, 2016 and K163548 on February 14, 2017
Device Description
The ENSEAL X1 Tissue Sealer instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The ENSEAL X1 Tissue Sealer has a curved jaw and a straight jaw configuration. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar
4
energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.
Indications for Use
The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery,
Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
Technological Characteristics
The ENSEAL® X1 Tissue Sealers are the same as the predicate devices in that they are electrosurgical bipolar vessel sealing instruments used to cut and seal vessels, grasp and dissect tissues during surgery, and utilize the same technology. Differences with the device as compared to the predicate device within this submission include separate energy and cut button, ergonomic differences, jaws configuration (different patient contact materials), steps for use and separate seal and cut functionality.
Performance Data
Bench testing and laboratory evaluations were conducted to demonstrate that the ENSEAL X1 Tissue Sealers performed as intended.
Biocompatibility Testing
The biocompatibility of materials used in the ENSEAL X1 Tissue Sealers was evaluated based on ISO 10993-1: "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" and on FDA guidance "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016.
Electromagnetic Compatibility and Electrical Safety
Electrical safety and EMC testing were conducted on the ENSEAL X1 Tissue Sealers; the system complies with IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-1 and IEC 60601-2-2 for electrical safety.
5
Sterilization/Shelf-Life
The ENSEAL X1 Tissue Sealers were validated to achieve a sterility assurance level of 10th using Ethylene Oxide per ISO 11135. The designated shelf-life for the ENSEAL X1 Tissue Sealers is 1-year.
Mechanical Testing
The following mechanical testing were carried out to verify that the ENSEAL X1 Tissue Sealers performed as expected:
- Axial Jaw Retention ●
- . Jaw Strength
- Hinge Pin Weld Strength ●
- Stress Test .
The results of the mechanical testing demonstrated the ability of the ENSEAL X1 Tissue Sealers to perform as well as the legally identified predicate device.
Bench Testing
Sealed vessel burst test were evaluated for the ENSEAL X1 Tissue Sealers to support substantial equivalence to the predicate device. The bench testing involved evaluation of the devices performance and ability to seal and divide vessels up to 7 mm. Porcine arteries were used in this testing. The maximum and minimum values, standard deviation and the mean were recorded. Data generated from the bench testing met the predetermined acceptance criteria.
Acute Animal Testing
Testing was performed in an acute porcine study with the ENSEAL X1 Tissue Sealers vs. the predicate device to demonstrate that there was no difference in the tissue effects when using the subject device and the predicate device. Moreover, the acute testing involved evaluation of the devices performance and ability to seal and divide vessels up to and including 7 mm. The acute testing was performed in two animals for each device targeting arteries, veins and vessel pedicles less than or equal to 7mm in diameter. The results of the acute study demonstrated the ability of the ENSEAL X1 Tissue Sealers to perform as well as the legally identified predicate device.
Survival Animal Testing
Testing was performed in a chronic survival study with the ENSEAL X1 Tissue Sealers vs. the predicate device to demonstrate that there was no difference in the tissue effects when using the subject device and the predicate device. Moreover, the survival testing involved evaluation of the devices performance and ability to seal and divide vessels up to and including 7 mm. The 30-day survival testing was performed in five animals for each device targeting arteries, veins and vessel pedicles less than or equal to 7mm in diameter. The results of the survival study demonstrated the ability of the ENSEAL X1 Tissue Sealers to perform as well as the legally identified predicate device.
Clinical Testing
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Conclusion
The results of the bench and animal testing performed demonstrate that the ENSEAL X1 Tissue Sealers are substantially equivalent to the identified predicate device.