(58 days)
No
The description focuses on the electrosurgical and mechanical functions of the device (sealing, cutting, grasping, dissection) and its compatibility with a specific generator. There is no mention of AI or ML capabilities.
Yes
The device is used to seal and cut vessels and tissue during surgery, which directly addresses a medical condition or aims to improve physiological function.
No
Explanation: The device is described as a surgical instrument for cutting, sealing, grasping, and dissecting tissue during surgery. Its intended use is therapeutic, not diagnostic.
No
The device description clearly outlines a physical surgical instrument with a grip housing, shaft, jaws, knife, and power cord. It is a hardware device that utilizes electrical energy for sealing and cutting tissue.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ENSEAL X1 Curved Jaw and ENSEAL X1 Straight Jaw Tissue Sealers are surgical instruments used during surgery to seal and cut tissue and vessels. They directly interact with the patient's body during a procedure.
- Intended Use: The intended use clearly states "for use during open or laparoscopic surgery" and describes procedures like "bowel resections, gynecology, gastric, urologic and thoracic surgical procedures." This is a description of surgical intervention, not laboratory testing of specimens.
- Device Description: The description details the mechanical and electrical components used for grasping, sealing, and cutting tissue in vivo.
The device is a surgical instrument used for therapeutic and procedural purposes, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The ENSEAL X1 Curved Jaw and ENSEAL X1 Straight Jaw Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are indicated for use during open or laparoscopic surgery.
Indications for use include open and laparoscopic general surgical procedures (including bowel resections, gynecology, gastric, urologic and thoracic surgical procedures) where vessel ligation (sealing and cutting), division of lymphatics, tissue grasping and dissection is performed. The devices can be used on vessels and vascular bundles up to and including 7 mm in diameter.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HGI
Device Description
The ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers are sterile, single-patient-use surgical instruments used to coagulate and transect vessels up to and including 7 mm in diameter, tissue, and/or vascular bundles. These devices are 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 Curved and Straight Jaw Tissue Sealers have separate seal and cut capabilities. The lower jaw of the ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers 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™ X 1 Curved and Straight Jaw Tissue Sealer instruments are designed for use exclusively with the Ethicon Generator G11(GEN11). software version 2016-1 or later, or other compatible Ethicon generators. Refer to the Ethicon Generator's Manual for more information.
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 Performance data was not included as part of this premarket notification. There is no change in the technological characteristics between the subject device ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers and cleared predicates; Curved Jaw Tissue Sealer (K201066) and Straight Jaw Tissue Sealer (K201696).
An acute animal study was conducted that evaluated the performance of ENSEAL X1 Curved and Straight Jaw Tissue Sealers in gastric procedures.
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
April 13, 2023
Ethicon Endo-Surgery, LLC Ekta Patel Senior Regulatory Affairs Program Lead 475 Calle C Guaynabo, PR 00969
Re: K230387
Trade/Device Name: ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 13, 2023 Received: February 14, 2023
Dear Ekta Patel:
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/cdrh/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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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.
Mark
Trumbore -S
Digitally signed by Mark
Trumbore -S
Date: 2023.04.13
13:04:03 -04'00'
Mark Trumbore, 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
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Indications for Use
Submission Number (if known)
Device Name
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)
Indications for Use (Describe)
The ENSEAL X1 Curved Jaw and ENSEAL X1 Straight Jaw Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are indicated for use during open or laparoscopic surgery.
Indications for use include open and laparoscopic general surgical procedures (including bowel resections, gynecology, gastric, urologic and thoracic surgical procedures) where vessel ligation (sealing and cutting), division of lymphatics, tissue grasping and dissection is performed. The devices can be used on vessels and vascular bundles up to and including 7 mm in diameter.
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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510(k) Summary
I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
| Contact: | Ekta Patel
Senior Regulatory Affairs Program Lead
Ethicon Endo-Surgery, Inc. |
|----------|------------------------------------------------------------------------------------|
| Phone: | 513-337-1124 |
| Email: | epatelho@its.jnj.com |
Date Prepared: February 13, 2023
II. SUBJECT DEVICES
Trade Name:
- ENSEAL™ X1 Curved Jaw Tissue Sealers .
- ENSEAL™ X1 Straight Jaw Tissue Sealers .
| Common or Usual Name: | Electrosurgical, Cutting & Coagulation Instrument |
|---|---|
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Gynecologic Electrocautery and Accessories | |
| Classification Number: | 21 CFR 878.4400, 21 CFR 884.4120 |
| Regulatory Class: | II |
| Product Code: | GEI, HGI |
PREDICATE DEVICES III.
| Predicate
Device 510(k)
| Number | Predicate Device Name | Predicate Device Product Codes |
|---|---|---|
| K201066 | ENSEAL TM X1 Curved Jaw Tissue Sealers | NSLX125C, |
| NSLX137C, | ||
| NSLX145C | ||
| K201696 | ENSEAL TM X1 Straight Jaw Tissue Sealers | NSLX125S, |
| NSLX137S |
These predicates have not been subjected to a recall related to these design modifications.
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There is no change in the technological characteristics between the Subject devices (ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers) and the Predicate devices (Curved Jaw Tissue Sealers-K201066 and Straight Jaw Tissue Sealers-K201696) which were cleared separately on 01/22/2021 and 12/21/2020.
| Product Code | Device Full Name | 510(k) Number |
|---|---|---|
| GEN11 | Generator G11 | K160554 |
| FSW11 | Generator G11 Footswitch | K101990 |
IV. DEVICE DESCRIPTION
The ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers are intended to cut and seal vessels, and to cut, grasp, and dissect tissue during surgery.
The ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers are sterile, single-patient-use surgical instruments used to coagulate and transect vessels up to and including 7 mm in diameter, tissue, and/or vascular bundles. These devices are 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 Curved and Straight JawTissue Sealers have separate seal and cut capabilities. The lower jaw of the ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers 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™ X 1 Curved and Straight Jaw Tissue Sealer instruments are designed for use exclusively with the Ethicon Generator G11(GEN11). software version 2016-1 or later, or other compatible Ethicon generators. Refer to the Ethicon Generator's Manual for more information.
INDICATIONS FOR USE V.
The ENSEAL™ X1 Curved Jaw and ENSEAL™ X1 Straight Jaw Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are indicated for use during open or laparoscopic surgery.
Indications for use include open and laparoscopic general surgical procedures (including bowel resections, gynecology, gastric, urologic and thoracic surgical procedures) where vessel ligation (sealing and cutting), division of lymphatics, tissue grasping and dissection is performed. The devices can be used on vessels and vascular bundles up to and including 7 mm in diameter.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Technological Characteristics
The ENSEAL™ X 1 Curved and Straight Jaw Tissue Sealers (Subject devices) have the same technological characteristics (i.e., design, material, principle of operations, energy sources etc.) as the predicate devices; ENSEAL® X1 Curved Jaw Tissue Sealers (K201066) and ENSEAL® X1 Straight Jaw Tissue Sealers (K201696). Both the subject and predicate devices are intended to cut and seal vessels, and to cut, grasp, and dissect tissue during surgery. Similarities and differences with the subject devices compared to the predicate devices cleared under K201066 and K201696 are listed below.
The subject and predicate sealers have the following identical technological characteristics:
- Intended use
- Contraindications
- Materials
- Operational principles
- Sterilization Method
- Packaging
- Shelf-Life
The following differences exist between the subject and predicate sealers:
- Indication for Use
VII. PERFORMANCE DATA:
Bench Performance data was not included as part of this premarket notification. There is no change in the technological characteristics between the subject device ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers and cleared predicates; Curved Jaw Tissue Sealer (K201066) and Straight Jaw Tissue Sealer (K201696).
Animal Testing
An acute animal study was conducted that evaluated the performance of ENSEAL X1 Curved and Straight Jaw Tissue Sealers in gastric procedures.
VIII. CONCLUSION
The testing criteria demonstrates that the subject devices; ENSEAL X1 Curved and Straight Jaw Tissue Sealers perform substantially equivalent to the predicate devices and does not raise new questions of safety and effectiveness.