(191 days)
The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures. It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open, general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. 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 Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
The Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is a sterile, single patient use device. The functionality is the same as the predicate devices.
The provided document, K101520, is a 510(k) summary for the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer. It claims substantial equivalence to a predicate device based on performance testing and functional similarities. However, the document does not contain the specific details required to fully address your request in terms of acceptance criteria, study design, and ground truth establishment, as the performance data section is very brief.
Here's an analysis based on the information available in the document and the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) | Notes on Sufficiency |
|---|---|---|---|
| Overall Functionality | Function as intended | "Bench and animal testing was performed to ensure the devices function as intended and meet design specifications." | Lacks specific metrics or thresholds. "Function as intended" is a general statement. |
| Design Specifications | Meet design specifications | "Bench and animal testing was performed to ensure the devices function as intended and meet design specifications." | Lacks specific design specs and how performance met them. |
| Equivalence to Predicate | Substantially equivalent to predicate device | "Based on performance testing and functional similarities to the predicate devices, the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer devices are substantially equivalent to the predicate devices." | This is a conclusion, not specific performance data against equivalence criteria. |
Missing Information:
The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum seal burst pressure, maximum thermal spread, specific transection time, etc.). It only provides a general statement that "Bench and animal testing was performed to ensure the devices function as intended and meet design specifications." Without these specific criteria, it's impossible to create a comprehensive table of acceptance criteria and reported performance with detailed metrics.
2. Sample Size for the Test Set and Data Provenance
Missing Information: The document does not specify the sample size used for either bench or animal testing. It also does not mention the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Missing Information: The document does not describe the establishment of a "ground truth" using experts. Performance testing for medical devices, especially electrosurgical ones, typically involves objective measurements (e.g., burst pressure, thermal spread, histological analysis) rather than expert consensus on subjective findings.
4. Adjudication Method for the Test Set
Missing Information: Since the document does not describe expert involvement for ground truth, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable: The device is an electrosurgical tissue sealer, not an imaging or diagnostic device that would typically involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant or mentioned in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable: The device is a physical electrosurgical instrument, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
Based on the nature of the device (electrosurgical tissue sealer) and the mention of "bench and animal testing," the ground truth for performance would likely be established through:
- Objective physical measurements: Such as burst pressure of sealed vessels, impedance measurements, thermal spread measurements.
- Histological analysis: Examination of tissue samples after sealing to assess cellular damage and seal integrity.
- Physiological outcomes in animal models: Such as hemostasis, healing, absence of complications.
Missing Information: The document does not explicitly detail the specific type of ground truth used for each aspect of testing or how it was established.
8. Sample Size for the Training Set
Not Applicable: This device is a traditional electrosurgical instrument, not a machine learning or AI-driven system that would typically require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of Conclusions from the Document:
- Study Performed: Bench and animal testing.
- Purpose of Study: To ensure the devices function as intended and meet design specifications.
- Conclusion of Study: Based on this testing, and functional similarities to predicate devices (SurgRx EnSeal Tissue Sealers, K072177), the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer devices are considered substantially equivalent to the predicate devices.
- Modifications: Differences include an improved ergonomic handle, larger shaft, jaw diameter, and jaw length/shape compared to the predicate device.
Overall, the provided 510(k) summary is very high-level regarding performance data. It states that testing was done to ensure functionality and design specifications were met, and that this supports substantial equivalence. However, it lacks detailed quantitative acceptance criteria and specific results that would typically be found in a more comprehensive study report.
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K101520
page ① of 2
510(k) SUMMARY
Ethicon Endo-Surgery, Inc Company DEC 1 0 2010 4545 Creek Road Cincinnati, OH 45242 Contact Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Phone: (513) 337-3566 FAX: (513) 337-2468 Email: rwood3@its.jnj.com
Date Prepared May 28, 2010
Device Name
- Trade Name: Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer .
- Common or Usual Name: Electrosurgical open instruments and accessories .
- Classification name: Electrosurgical Cutting and Coagulation Device and Accessories . (per 21 CFR section 878.4400) and Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120).
Predicate Devices
SurgRx EnSeal Tissue Sealers, K072177
Device Description
The Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is a sterile, single patient use device. The functionality is the same as the predicate devices.
Intended Use
The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures.
It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open, general, gynecological procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. 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.
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K101520
page ② of 2
The EnSeal Tissue Sealing Device has 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 Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is the same as the predicate devices in that they are electrosurgical bipolar vessel sealing instruments used to cut and seal vessels, cut, grasp and dissect tissues during surgery, and utilize the same technology. Differences with the device in this submission are improved ergonomic handle, larger shaft, jaw diameter, and jaw length/shape.
Performance Data
Bench and animal testing was performed to ensure the devices function as intended and meet design specifications.
Conclusions
Based on performance testing and functional similarities to the predicate devices, the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer devices are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, Inc. % Ms. Ruth Ann Wood 4545 Creek Road ML#132 Cincinnati, Ohio 45242
DEC 1 0 2010
Re: K101520
Trade/Device Name: Ethicon Endo-Surgery EnSeal® LCJ Tissue Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: December 2, 2010 Received: December 3, 2010
Dear Ms. Wood:
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, Or to 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 (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.
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Page 2 - Ms. Ruth Ann Wood
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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DEC 1 0 2010
510(k) number (if known):_K | 0 |5 2 o
Device Name: Ethicon Endo-Surgery EnSeal® LCJ Tissue Sealer
The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures.
It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open, general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. 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 Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
Prescription Use X (Per 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODE) Concurrence of CDRH.
Division Sign-Off
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101520
Page 66 of 87
§ 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.