The EnSeal PowerTip is an electrosurgical instrument for use with the EnSeal Universal electrosurgical generator. It is intended for use during open or faparoscopic, 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), 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 cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies.

The EnSeal PowerTip has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

Device Description

EnSeal PowerTip with EnSeal Universal. The functionality of the devices are the same as the predicate devices.

AI/ML Overview

The provided text indicates that the K081129 submission for the "EnSeal PowerTip with EnSeal Universal" is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.

Therefore, the documentation does not contain the specific information requested in your prompt regarding acceptance criteria, a dedicated study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's what can be inferred from the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The submission is a 510(k) for substantial equivalence. It does not present new acceptance criteria or clinical performance data in this format.

2. Sample size used for the test set and the data provenance:

Not Applicable. No explicit "test set" in the context of a de novo clinical study is described. The device's safety and effectiveness are established by demonstrating functional similarities and preclinical testing in comparison to predicate devices.
The provenance is "Preclinical laboratory (bench) and performance tests," suggesting in-house testing rather than human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the sense of expert consensus on clinical outcomes, is not established or reported for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No adjudication method is mentioned as there is no described test set requiring one.

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 is an electrosurgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is an electrosurgical instrument, not an algorithm, so this concept does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable (in the clinical sense). For a 510(k) based on substantial equivalence, the "ground truth" essentially revolves around the performance characteristics of the predicate devices and whether the new device functions similarly and meets its design specifications during preclinical (bench) testing. The text 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. This is an electrosurgical instrument, not a learning algorithm or AI.

9. How the ground truth for the training set was established:

Not Applicable. This is an electrosurgical instrument, not a learning algorithm or AI.

Summary based on the provided text:

The submission K081129 is a 510(k) for an electrosurgical instrument. Its approval is based on demonstrating substantial equivalence to existing predicate devices (e.g., K031133, K063195, K031079, K051644). The "study" proving the device met criteria was primarily preclinical laboratory (bench) and performance tests aimed at ensuring the device functions as intended and meets design specifications, consistent with the performance of its predicates. There are no detailed clinical study results, acceptance criteria tables, sample sizes for test sets, expert ground truth establishment, or AI-related metrics (like MRMC or standalone performance) reported in this summary.

Summary

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K081129

510(k) SUMMARY

1. Submitter Name and Address

JUL 2 8 2008

SurgRx, Inc. 101 Saginaw Drive Redwood City, CA 94063 Contact: Linda Oleson Phone: (650) 482-2400 ext 107 Date: 6/13/08

2. Device Name

Trade name: EnSeal PowerTip with EnSeal Universal

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 Devices

EnSeal Vessel Sealing and Hemostasis System: K031133, K043008, K050671, K061526, K062949, K063097, K070165, K070896, K072177, K072493, LigaSure Advance: K063195, Gyrus Bipolar Needle Electrode: K031079, ValleyLab ForceTriad: K051644.

4. Device Description

EnSeal PowerTip with EnSeal Universal. The functionality of the devices are the same as the predicate devices.

5. Intended Use

The EnSeal PowerTip with EnSeal Universal generator is intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cuf, grasp and dissect tissue and/or seal vessels during surgery. The cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies. The SurgRx EnSeal PowerTip with EnSeal Universal 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 PowerTip with EnSeal Universal generator is the same as the predicate devices in that they are electrosurgical instruments with monopolar and bipolar capabilities.

7. Performance Data

Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications.

8. Conclusions

Based on performance testing and functional similarities to the predicate devices, we believe the EnSeal PowerTip with EnSeal Universal generator 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 Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SurgRX, Inc. % Ms. Linda Oleson Director of Clinical & Regulatory Affairs Consultant 101 Sawinaw Drive Redwood City, California 94063

JUL 2 8 2008

Re: K081129

Trade/Device Name: EnSeal PowerTip with EnSeal Universal Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 13, 2008 Received: June 17, 2008

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 Mav 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 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 W. Milliman

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: EnSeal PowerTip with EnSeal Universal

Indications for Use:

The cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies.

The EnSeal PowerTip 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)

FOR M. MELKERSON

Olvision Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number K081129

Section 4 - 2

Regulation Number and Section

§ 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.