(11 days)
The EnSeal™ PTC TRIO of the EnSeal™ Vessel Sealing and Hemostasis system is a bioolar electrosurgical instrument for use with 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.
EnSeal™ Vessel Sealing and Hemostasis System. The functionality of the System is the same as the predicate device.
The provided 510(k) summary for the EnSeal™ PTC TRIO of the EnSeal™ Vessel Sealing & Hemostasis System does not contain sufficient information to fulfill all aspects of your request regarding acceptance criteria and a detailed study.
Here's what can be extracted based on the provided text, and where information is missing:
Missing Information:
The document primarily focuses on establishing substantial equivalence to a predicate device based on the functionality of the system and preclinical laboratory (bench) and performance tests. It does not detail specific acceptance criteria with numerical targets or comprehensive clinical study results. There is no mention of a test set, ground truth experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details. This is typical for a 510(k) submission that relies on substantial equivalence to a predicate device for safety and effectiveness, rather than a de novo or PMA submission requiring extensive clinical trial data detailing explicit performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Function as Intended | "devices function as intended" |
| Meet Design Specifications | "meet design specifications" |
| Safety and Effectiveness | "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." |
| Vessel Sealing Capacity | Intended for use on "vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments." (This is from the Indications for Use, not a performance criterion per se, but states the functional claim). |
| Tissue Dissection and Grasping | Intended for use to "cut and seal vessels, cut, grasp and dissect tissue during surgery." (This is from the Indications for Use, stating functional claim). |
| Equivalence to Predicate Device (K050671, K061526, K062949, K063097) | "The functionality of the System is the same as the predicate device." and "The EnSeal™ System is equivalent to the predicate device based on results of design validation." |
Detailed Study Information (Based on available text):
2. Sample size used for the test set and the data provenance:
- Not explicitly stated. The document refers to "Preclinical laboratory (bench) and performance tests" and "design validation" without providing details on specific sample sizes for these tests or the origin of any data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not mentioned. The submission describes device testing (likely in a lab/bench setting), not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
- Not applicable / Not mentioned. This type of adjudication is typically for clinical or diagnostic accuracy studies, which are not detailed here.
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:
- No. An MRMC study is not mentioned. This device is an electrosurgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an electrosurgical instrument for human use, not an algorithm.
7. The type of ground truth used:
- Not applicable / Not mentioned. For bench and performance tests of a surgical instrument, "ground truth" would likely relate to objective measurements of sealing strength, cut efficacy, temperature profiles, etc., against predefined engineering or performance specifications. The document states "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."
8. The sample size for the training set:
- Not applicable / Not mentioned. This is not a machine learning or AI device that would typically involve a "training set."
9. How the ground truth for the training set was established:
- Not applicable / Not mentioned. See point 8.
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K070165
510(k) SUMMARY
Page ① of ①
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
JAN 2 9 2007
2. Device Name
Trade name: EnSeal™ PTC TRIO of the 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 #: K050671, K061526, K062949, K063097.
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 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.
Page ①
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SurgRx, Inc. % Ms. Linda S. M. Oleson Director of Clinical & Regulatory Affairs 101 Saginaw Drive Redmond City, California 94063
JAN 2 9 2007
Re: K070165
Trade/Device Name: EnSeal™ PTC TRIO of the SurgRx™ EnSeal™ Vessel Sealing & Hemostatis System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HGI Dated: January 16, 2007 Received: January 18, 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 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
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): K070165
Device Name: EnSeal™ PTC TRIO of the SurgRx™ EnSeal™ Vessel Sealing & Hemostasis System
Indications for Use:
The EnSeal™ PTC TRIO of the EnSeal™ Vessel Sealing and Hemostasis system is a bioolar electrosurgical instrument for use with 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)
(Division Sign=Off) Division of General, Restorative, and Neurological Devices
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Devices
$\frac{M}{a}$ K070165
5100k) Number
§ 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.