(275 days)
No
The summary describes a bipolar electrosurgical instrument for cutting and sealing tissue and vessels. There is no mention of AI or ML in the intended use, device description, or performance studies. The device relies on electrosurgical energy and mechanical action.
No.
Therapeutic devices are generally considered to be those that treat a disease or condition. While this device is used in surgery, which is a form of treatment, its primary function is to cut and seal tissue during surgical procedures, not to directly treat a disease or medical condition itself. It's a surgical tool that facilitates treatment.
No
The device is described as a surgical instrument used to cut and seal vessels and tissue during surgical procedures, not to diagnose conditions.
No
The device is a bipolar electrosurgical instrument with physical components (grip housing, shaft, jaws, knife, power cord) and is used in conjunction with a separate hardware generator. While it relies on software in the generator, the device itself is a physical instrument.
Based on the provided information, the ENSEAL X1 Tissue Sealers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that 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 within the body.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens outside of the body, such as blood, urine, or tissue samples, which is the defining characteristic of an IVD.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ENSEAL X1 Tissue Sealers are surgical tools used directly on tissue 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, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tisue 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 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 (comma separated list FDA assigned to the subject device)
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 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. 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
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 including acute and 30-day chronic survival studies were conducted to demonstrate that the ENSEAL X1 Tissue Sealer performs as intended.
Biocompatibility testing: The biocompatibility of materials used in the ENSEAL X1 Tissue Sealers were 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.
Sterilization/Shelf-Life: The ENSEAL X1 Tissue Sealers were validated to achieve a sterility assurance level of 10-6 using Ethylene Oxide per ISO 11135. The designated shelf-life for the ENSEAL X1 Tissue Sealer is 5-years.
Mechanical Testing: The following mechanical testing were carried out to verify that the ENSEAL X1 Tissue Sealers performed as expected:
- Axial Jaw Retention Strength
- Compression System Stress Test
- Hinge Pin Weld Strength
The results of the mechanical testing demonstrated the ability of the ENSEAL X1 Tissue Sealers to perform as expected and risks associated with mechanical failures is minimized.
Bench Testing: Sealed vessel burst pressure test was 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 left and right burst 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 versus the predicate device to investigate differences 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 four 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.
Chronic/ Survival Animal Testing: Testing was performed in a chronic survival study with the ENSEAL X1 Tissue Sealers vs. the predicate device to investigate differences in the tissue effects between 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 (±2) day survival testing was performed in ten 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 historical performance of the legally identified 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): 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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 22, 2021
Ethicon Endo-Surgery, LLC % Kweku Biney Senior Regulary Affairs Program Lead Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K201066
Trade/Device Name: ENSEAL X1 Tissue Sealers, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealers, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealers, Curved Jaw, 45 cm Shaft Length Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 17, 2020 Received: December 21, 2020
Dear Kweku Biney:
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/cdrl/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.
1
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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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
2
Indications for Use
510(k) Number (if known) K201066
Device Name
ENSEAL® X1 Tissue Sealers, Curved Jaw, 25 cm shaft length ENSEAL® X1 Tissue Sealers, Curved Jaw, 37 cm shaft length ENSEAL® X1 Tissue Sealers, Curved Jaw, 45 cm shaft length
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, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tisue 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 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Page 1 of 5
510(k) Summary
Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact Kweku Biney Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3135 Email: kbiney@its.jnj.com
Date Prepared January 21, 2021
Device Name
Trade Name: ENSEAL® X1 Tissue Sealers, Curved Jaw, 25 cm shaft length ENSEAL® X1 Tissue Sealers, Curved Jaw, 37 cm shaft length ENSEAL® X1 Tissue Sealers, Curved Jaw, 45 cm shaft length
Common Name: Electrosurgical Cutting and Coagulating Instruments
Note: The name ENSEAL X1 Tissue Sealer(s) as used in this submission refers to the curved jaw version of the device on the ENSEAL X1 platform.
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 Device
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 Device
ENSEAL X1 Tissue Sealer cleared under K172580 on November 20, 2017. ENSEAL X1 Tissue Sealer cleared under K172580 on November 20, 2017. The K172580 submission included both straight and curved jaw versions of the device.
4
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 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. 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.
Indication 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, 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 device 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.
| Characteristic/
Specification | ENSEAL X1 Tissue
Sealers (Curved Jaw)
(Subject device) | ENSEAL G2 Tissue
Sealers
(Predicate device) | ENSEAL X1 Tissue Sealer
(Curved and straight Jaw)
(Reference device) |
|------------------------------------|--------------------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------|
| Sterility Method | Ethylene Oxide
Sterilization | Gamma Irradiation (Co60) | Ethylene Oxide
Sterilization |
| Sterility Assurance Level
(SAL) | 10-6 | Same | Same |
Device Comparison Table: Technology and Performance Specifications
5
| K201066 | Page 3 of 5 | ||
|---|---|---|---|
| Characteristic/ | |||
| Specification | ENSEAL X1 Tissue | ||
| Sealers (Curved Jaw) | |||
| (Subject device) | ENSEAL G2 Tissue | ||
| Sealers | |||
| (Predicate device) | ENSEAL X1 Tissue Sealer | ||
| (Curved and straight Jaw) | |||
| (Reference device) | |||
| Patient Use | Single Use | Same | Same |
| Radiofrequency (RF) | |||
| Max Power | 120 Watts | 45 Watts | 120 Watts |
| RF Max Voltage | 90 Vrms | 85 Vrms | 90 Vrms |
| RF Max Current | 3 Amps | 1.4 Amps | 3 Amps |
| RF Electrosurgical | |||
| Output | Bipolar, no neutral | ||
| electrode | Same | Same | |
| Shaft Diameter | 5.5 mm | Same | same |
| Jaw Types | Curved | Curved | Curved |
| Jaw Length | Curved: 24 mm | Curved: 19 mm | 24 mm |
| Jaw Width | Curved: 5 mm | Curved: 3 mm | 5 mm |
| Shaft Lengths | 25, 37 & 45 cm | 14, 25, 35 & 45 cm | 25, 37 & 45 cm |
| Jaw compression | |||
| mechanism | Compression is provided | ||
| by closing the handle | Compression is provided | ||
| as the I-BLADE is | |||
| advanced | Compression is provided by | ||
| closing the handle | |||
| Packaging | Rigid blister and Tyvek | Same | Same |
| Energy Activation | |||
| Method | Foot or Hand Switch | Same | Same |
| Vessel Seal Performance | 240 mmHg | ||
| Burst Pressure | Same | Same | |
| Maximum Indicated | |||
| Vessel Size | 7 mm | Same | Same |
| Handle Type | Ergonomic 'Squeeze' | ||
| Grip | Same | Same | |
| Handle Type / Latch | |||
| function | Latch at full closure | No latch at full closure | Latch at full closure |
Performance Data
Bench testing and laboratory evaluations in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the ENSEAL X1 Tissue Sealer performs as intended.
Biocompatibility testing
The biocompatibility of materials used in the ENSEAL X1 Tissue Sealers were 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.
6
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.
Sterilization/Shelf-Life
The ENSEAL X1 Tissue Sealers were validated to achieve a sterility assurance level of 10-6 using Ethylene Oxide per ISO 11135. The designated shelf-life for the ENSEAL X1 Tissue Sealer is 5-years.
Mechanical Testing
The following mechanical testing were carried out to verify that the ENSEAL X1 Tissue Sealers performed as expected:
- Axial Jaw Retention Strength
- Compression System Stress Test ●
- Hinge Pin Weld Strength ●
The results of the mechanical testing demonstrated the ability of the ENSEAL X1 Tissue Sealers to perform as expected and risks associated with mechanical failures is minimized.
Bench Testing
Sealed vessel burst pressure test was 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 left and right burst 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 versus the predicate device to investigate differences 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 four 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.
Chronic/ Survival Animal Testing
Testing was performed in a chronic survival study with the ENSEAL X1 Tissue Sealers vs. the predicate device to investigate differences in the tissue effects between 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 (±2) day survival testing was performed in ten animals for each device targeting arteries, veins and vessel pedicles less than or equal to 7mm in diameter. The results of the survival study
7
Page 5 of 5
demonstrated the ability of the ENSEAL X1 Tissue Sealers to perform as well as the historical performance of 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 pre-clinical animal testing performed demonstrate that the ENSEAL X1 Tissue Sealer is substantially equivalent to the identified predicate device for requested intended use.