(8 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 unlake polluding and reconstructive, bowel resections, hysterectomies, cholecysted, theracter, plactions and resolunts, bowel resedunts. edbacialysis contrasses in the secures, 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 medical device in question is the SurgRx EnSeal Vessel Sealing & Hemostasis System.
1. Acceptance Criteria and Reported Device Performance:
The document mentions that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." However, no specific quantitative acceptance criteria or their corresponding performance results are provided in the extracted text. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against pre-defined thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "Preclinical laboratory (bench) and performance tests."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not specify the number of experts used and their qualifications for establishing ground truth for any test set.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to a predicate device.
6. Standalone (Algorithm Only) Performance:
This device is an electrosurgical instrument system, not an AI-powered algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable.
7. Type of Ground Truth Used:
The document implies that the ground truth for "design validation" was based on the "function as intended" and "meet design specifications." This suggests a bench test and performance test-driven ground truth, likely based on engineering specifications and direct observation of the device's physical performance (e.g., ability to seal vessels of a certain size, cutting capabilities). It is not pathology, outcomes data, or expert consensus in a diagnostic sense.
8. Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a training set. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established:
This device is not an AI/ML algorithm that requires a training set. Therefore, this question is not applicable.
Summary of the Study:
The study performed was a design validation using "Preclinical laboratory (bench) and performance tests." The primary objective was to demonstrate substantial equivalence to a predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K061526). The document concludes that "The EnSeal System is equivalent to the predicate device based on results of design validation." It is implied that the device met its design specifications and performed as intended in these preclinical tests, thus satisfying the requirement for substantial equivalence. No detailed analytical study with quantitative acceptance criteria, specific test data, or statistical analysis against the predicate device is provided in the summary.
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OCT 1 8 2006
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1. Submitter Name and Address
SurgRx, Inc. 101 Saginaw Drive Redwood City, CA 94063 Contact: Linda Oleson Phone: (650) 482-2400 ext 107 Date: 10/6/06
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 Gynery and Generalian Books and Rocessories (per 21 CFR 884.4120).
3. Predicate Device
EnSeal™ Vessel Sealing and Hemostasis System # K061526
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 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.
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 device based on results of design validation. We believe that the EnSeal devices are safe and effective and substantially equivalent to the predicate device.
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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 features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2006
SurgRx, Inc. % Ms. Linda S.M. Oleson Director of Clinical & Regulatory Affairs 101 Saginaw Drive Redwood City, California 94063
Re: K063097
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: October 6, 2006 Received: October 10, 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, 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 CFPA 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 - Ms. 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 logally 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.
P.R. M.N. Muller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Applicant: SurgRx, Inc.
510(k) number (if known): K063097
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 unlake polluding and reconstructive, bowel resections, hysterectomies, cholecysted, theracter, plactions and resolunts, bowel resedunts.
edbacialysis contrasses in the secures, 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)
and Neurologic
510(k) Number _K063045
§ 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.