The EnSeal™ PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open and laparoscopic, general and gynerologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resetting, 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 SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
EnSeal™ PTC with ERBE VIO 300 D. The functionality of the device is the same as the predicate device.
The provided text is a 510(k) summary for the EnSeal™ PTC with ERBE VIO 300 D, an electrosurgical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study with specific acceptance criteria as one might see for novel AI/software devices. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, as typically outlined for AI/ML device studies, is not present in this type of submission.
Here's an analysis based on the provided text, highlighting what is and is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| This information is not explicitly stated in the 510(k) summary. The submission asserts substantial equivalence based on the device's functionality being "the same as the predicate device" and successful "Preclinical laboratory (bench) and performance tests." | The device "function[s] as intended and meet[s] design specifications." The device is "safe and effective and substantially equivalent to the predicate device." |
Explanation: In a 510(k) for an electrosurgical device like this, acceptance criteria would typically revolve around electrical safety, mechanical integrity, and functional performance (e.g., sealing strength, cut time, minimal thermal spread) compared to the predicate. However, these specific criteria and quantitative results are not detailed in this summary. The summary simply states that the tests "ensure the devices function as intended and meet design specifications."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document only mentions "Preclinical laboratory (bench) and performance tests."
- Data Provenance: Not specified. The tests were "preclinical laboratory (bench)" tests, suggesting an in-house or contracted lab environment, but geographical origin is not mentioned. They would be considered prospective for the specific tests conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not specified. This type of device performance testing does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging AI algorithm would. Device performance is measured by objective metrics (e.g., burst pressure, temperature).
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus ground truth in studies involving human interpretation (e.g., reviewing medical images). This is a physical device, and its performance is measured mechanically and electrically, not through human consensus on a diagnosis.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: The device itself is "standalone" in its electrosurgical function, but the context of "standalone performance" typically refers to an algorithm's performance without human intervention. This device performs its function directly. Therefore, this question is not fully applicable in the context of an AI/ML algorithm. The "Preclinical laboratory (bench) and performance tests" assess the device's inherent function, which could be considered its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For electrosurgical devices, "ground truth" is established through engineering and scientific principles. Examples might include:
- Physical measurements: Tensile strength of sealed vessels, burst pressure, impedance, power output.
- Histopathology: To assess thermal damage zones in sealed tissue (though not mentioned in the summary).
- Objective functional assessments: Such as sealing time, cutting efficacy, and lack of electrical leakage.
The summary does not detail the specific ground truth metrics but states tests were performed to ensure it "function[s] as intended and meet[s] design specifications."
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. As there is no training set for an AI/ML model, this question does not apply.
Study Description:
The study proving the device meets its "acceptance criteria" (which are generally implied to be equivalent performance to the predicate) is described as "Preclinical laboratory (bench) and performance tests." The conclusion drawn from these tests is that the device "function[s] as intended and meet[s] design specifications" and is "safe and effective and substantially equivalent to the predicate device." The study's focus was on demonstrating substantial equivalence to the previously cleared devices (EnSeal™ Vessel Sealing and Hemostasis System # K031133, and the ERBE VIO ESU, Model VIO 300 D, # K060484 and EnSeal PTC # K061526). This type of submission relies on comparative analysis of technological characteristics and performance data, rather than establishing de novo safety and effectiveness through a comprehensive multi-site clinical trial with specific performance endpoints often seen for novel therapeutic or diagnostic devices.
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KO71728 510(k) SUMMARY
1. Submitter Name and Address
SurgRx, Inc. 101 Saginaw Drive Redwood City, CA 94063 Contact: Linda Oleson Phone: (650) 482-2400 ext 107 Date: 1/16/07
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2. Device Name
Trade name: EnSeal™ PTC with ERBE VIO 300 D
Common name: Electrosurgical open and laparoscopic 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).
3. Predicate Device
EnSeal™ Vessel Sealing and Hemostasis System # K031133, and the ERBE VIO ESU, Model VIO 300 D, # K060484 and EnSeal PTC # K061526.
4. Device Description
EnSeal™ PTC with ERBE VIO 300 D. The functionality of the device is the same as the predicate device.
5. Intended Use
The EnSeal™ PTC with ERBE VIO 300 D is intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue and/or seal vessels during surgery. The EnSeal™ PTC has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
6. Technological Characteristics
The EnSeal™ PTC with ERBE VIO 300 D is the same as the predicate device utilizing RF powered bipolar distal ends.
7. Performance Data
Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications.
8. Conclusions
The EnSeal™ PTC with ERBE VIO 300 D is equivalent to the predicate device based on results of design validation. We believe that the EnSeal™ PTC with ERBE VIO 300 D is safe and effective and substantially equivalent to the predicate device.
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Public Health Service
JUL 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SurgRx, Inc. % Ms. Linda S.M. Oleson Director, Clinical & Regulatory Affairs 101 Saginaw Drive Redwood City, California 94063
Re: K071728
Trade/Device Name: EnSeal™ PTC with ERBE VIO 300D Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: June 22, 2007 Received: June 25, 2007
Dear Ms. Oleson:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Linda S.M. Oleson
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html (
Sincerely yours,
Sincerely yours,
for
Mark N. Melkerson
Director
Director
Center for Devices and Radiological Health
Division of General, Restorative and Neurological Devices Office of Device Evaluation
.
Enclosure
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Indications for Use Statement
Applicant: SurgRx, Inc.
KO71728 510(k) number (if known):
Device Name: EnSeal ™ PTC with ERBE VIO 300 D
Indications for Use:
The EnSeal™ PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open or laparoscopic, general and gynerologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resetting, 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 SurgRx EnSeal Vessel Sealing & Hemostasis System 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)
§ 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.