(13 days)
The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic 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 researcines, 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™ Vessel Sealing & Hemostasis System. The functionality of the System is the same as the Predicate Device. The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.
The provided 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System (K061526) states that preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications. The submission then concludes that the system is equivalent to its predicate device based on these design validation results.
However, the summary does not provide specific details about the acceptance criteria or the study that "proves the device meets the acceptance criteria" in the format of the requested table and detailed analysis. This type of information is typically considered proprietary and is not fully disclosed in a public 510(k) summary. The summary focuses on establishing substantial equivalence to a predicate device (K031133) rather than presenting a detailed performance study with explicit acceptance criteria and results.
Therefore, I cannot fully complete the requested table and analysis due to the limited information available in the provided document.
Here's what can be inferred and what is missing:
Inferred Information from the 510(k) Summary
The summary indicates that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." This implies that the device was evaluated for its ability to cut and seal vessels, grasp and dissect tissue effectively and safely, similar to its predicate device.
Missing Information - Cannot be Extracted from the Provided Document
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific parameters related to sealing strength, hemostasis, tissue dissection efficacy, thermal spread, etc., were not explicitly detailed in the provided document. | Specific performance values (e.g., vessel bursting pressure, tissue cutting speed, time to hemostasis, maximum thermal spread) were not explicitly detailed in the provided document. |
Reason for missing information: The 510(k) summary did not disclose the specific quantifiable acceptance criteria or the detailed results of the performance tests. It broadly states that tests were done to "meet design specifications."
2. Sample size used for the test set and the data provenance
Reason for missing information: The document does not specify the sample size (e.g., number of vessels, tissues, or animals tested) used in the preclinical laboratory and performance tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Reason for missing information: The document does not mention the involvement of experts for establishing ground truth, as this type of preclinical testing typically involves engineers and researchers evaluating physical performance rather than clinical expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Reason for missing information: This is not applicable to the preclinical bench and performance tests described. Adjudication methods are typically used in clinical studies involving human readers or evaluators.
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
Reason for missing information: This information is not relevant to the device described. The EnSeal system is an electrosurgical instrument, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Reason for missing information: This is not applicable. The EnSeal system is a medical device requiring direct human operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Reason for missing information: For preclinical bench testing of an electrosurgical device, the "ground truth" would typically be established by objective measurements against engineering specifications and validated experimental methods (e.g., bursting pressure measurements for seals, microscopic analysis of tissue effects, temperature readings). The document does not specify these methods.
8. The sample size for the training set
Reason for missing information: Not applicable to this type of device. "Training set" is a concept used in machine learning and AI development, not for the validation of an electrosurgical instrument in the manner described. The device's design is based on engineering principles and previous predicate device experience, not a "training set" in the AI sense.
9. How the ground truth for the training set was established
Reason for missing information: Not applicable for the same reason as point 8.
In summary, the provided 510(k) summary states that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications," leading to the conclusion of substantial equivalence. However, it explicitly lacks the granular detail regarding acceptance criteria, sample sizes, expert involvement, and specific performance results that would be needed to fulfill the request.
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JUN 15 2006
KOG1526 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: 6/1/2006
2. Device Name
Trade name: EnSeal Vessel Sealing & Hemostasis System
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
4. Device Description
EnSeal™ Vessel Sealing and Hemostasis System. The functionality of the System is the same as the Predicate Device.
5. Intended Use
The SurgRx EnSeal devices are 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 SurgRx EnSeal Vassel 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.
6. Technological Characteristics
The EnSeal electrosurgical instruments are the same as the predicate devices 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 System is equivalent to the predicate devices based on results of design validation. We believe that the EnSeal devices are safe and effective and substantially equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and three lines representing its legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 15 2006
SurgRx, Inc. % Linda S.M. Oleson Director, Clinical & Regulatory Affairs 101 Saginaw Drive Redwood City, California 94063
Re: K061526
Trade/Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: June 1, 2006 Received: June 2, 2006
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. Iisting 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 mav 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 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 – Linda S.M. Oleson
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 vours,
Helen Lemmercus
Mark N. Muller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
Applicant: SurgRx, Inc.
1061526 510(k) number (if known):
Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System
Indications for Use:
The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic 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 researcines, 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 (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulun Lemer
Division of Gen and Neurological De
Page 1 of 1
510(k) Number K061521
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§ 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.