(19 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 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 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.
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.
The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.
The information provided is extremely limited regarding the acceptance criteria and study details. This 510(k) summary (K062949) for the SurgRx EnSeal Vessel Sealing & Hemostasis System states its substantial equivalence to a predicate device (K061526) based on design validation and preclinical laboratory (bench) and performance tests. However, it does not include any specific acceptance criteria or detailed study results.
Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer many of your specific questions as the information is simply not present in the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or reported device performance are detailed in the provided documents. The submission only states: "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided.
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)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. Furthermore, this device is an electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm; it is a physical electrosurgical instrument. The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The submission mentions "Preclinical laboratory (bench) and performance tests." For an electrosurgical instrument, ground truth would typically be established through direct measurement of physical parameters (e.g., seal strength, burst pressure, thermal spread, cutting efficacy, tissue impedance) against engineering specifications and comparison to predicate devices, often using ex vivo or in vivo animal models. However, the specific type of ground truth and the metrics used are not detailed in this summary.
8. The sample size for the training set
This information is not provided. As this is an electrosurgical instrument, the concept of a "training set" in the context of machine learning is not directly applicable. If it refers to data used for initial design and optimization, those details are not given.
9. How the ground truth for the training set was established
This information is not provided, and the concept of a "training set" for ground truth establishment, typically associated with AI/ML, isn't directly relevant to this type of device.
Summary of what we can glean from the provided text:
- Device Type: Electrosurgical Vessel Sealing & Hemostasis System.
- Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K061526).
- Evaluation Method: Preclinical laboratory (bench) and performance tests.
- Conclusion: The device is considered safe, effective, and substantially equivalent to the predicate based on "design validation."
- Key Detail Gap: The submission lacks specifics on acceptance criteria, test methodologies, sample sizes, and detailed performance data, which are typically found in the full 510(k) submission, but not in this summary.
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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: 9/27/2006
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 # 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 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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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: K062949
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: September 28, 2006 Received: September 29, 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 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 -- 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 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,
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): _
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 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 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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devic
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510(K) Number | 1062949
§ 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.