(22 days)
The EnSeal™ PTC Tissue Sealing Device of the EnSeal™ Vessel Sealing and Hemostasis system is a bipolar 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™ PTC Tissue Sealing Device. The functionality of the device 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 text describes a 510(k) premarket notification for the EnSeal™ PTC Tissue Sealing Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical study data with acceptance criteria and detailed performance metrics as would be found in a PMA.
Therefore, the input does not contain the kind of detailed information about acceptance criteria and a study proving those criteria that your request anticipates for a medical device with an AI component or complex performance claims requiring extensive clinical validation. The document states "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." and "The EnSeal™ PTC Tissue Sealing Device is equivalent to the predicate device based on results of design validation." This suggests that the studies performed were primarily bench testing and design validation to show the new device operates similarly to the predicate, not a clinical trial with specific performance targets against a ground truth.
Given the available information, I cannot complete most of the requested fields. Here's what I can extract and what is missing:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of a table with specific thresholds (e.g., sensitivity > X%, specificity > Y%). It broadly states that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." This implies that the acceptance criteria were likely related to engineering specifications and functional equivalence to the predicate device, but these are not enumerated. The reported performance is a general statement of "design validation" demonstrating equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. Likely related to meeting design specifications and functional equivalence to predicate device. | "designs function as intended and meet design specifications." |
| "equivalent to the predicate device based on results of design validation." |
2. Sample size used for the test set and the data provenance
The document mentions "Preclinical laboratory (bench) and performance tests" but does not specify the sample size for these tests. There's no mention of a "test set" in the context of patient data, data provenance (country of origin), or whether the data was retrospective or prospective, as this device uses bench testing for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The clearance is based on bench testing and design validation against engineering specifications and predicate device performance, not clinical interpretation against a ground truth established by experts.
4. Adjudication method for the test set
Not applicable. There's no mention of a "test set" requiring adjudication in the context of this 510(k) submission.
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
Not applicable. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it's a physical surgical tool.
7. The type of ground truth used
The "ground truth" for this submission would be defined by engineering standards, functional specifications, and the performance characteristics of the predicate device, demonstrated through bench testing. It does not involve expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth to establish for it in this context.
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510(k) SUMMAR
APR 2 4 2007
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
2. Device Name
Trade name: EnSeal™ PTC Tissue Sealing Device
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™ PTC Tissue Sealing Device of the EnSeal™ Vessel Sealing and Hemostasis System # K061526, K063097.
4. Device Description
EnSeal™ PTC Tissue Sealing Device. The functionality of the device is the same as the predicate device.
5. Intended Use
The SurgRx EnSeal™ PTC Tissue Sealing 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™ PTC Tissue Sealing Device 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 seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SurgRx, Inc. % Ms. Linda Oleson Director, Clinical & Regulator Affairs Consultant 101 Saginaw Drive Redwood City, California 94063
APR 2 4 2007
Re: K070896
Trade/Device Name: EnSeal™ PTC Tissue Sealing Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: March 30, 2007 Received: April 2, 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 Amendents, or to devices that have been reclassified in accordance with the provisions of the Federall Food, Dr w 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 1171, The general controls provisions of the Act include requirements for annual registration, insting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, nound 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, IDA mad 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 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,
for
Mark N. Mallekase
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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K 070896
Indications for Use Statement
Applicant: SurgRx, Inc.
510(k) number (if known):
Device Name: EnSeal™ PTC Tissue Sealing Device
Indications for Use:
The EnSeal™ PTC Tissue Sealing Device of the EnSeal™ Vessel Sealing and Hemostasis system is a bipolar 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 (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)
Concurred
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(Lasion Sign-Off) Division of General, Restorativ
Number 168781
Page 1 of 1
§ 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.