The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It is intended for use during open or laparoscopic, general and general and general to cut and seal vesses, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including unologic, 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 SurgHx 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.

Device Description

The EnSeal Laparoscopic devices are tubular instruments with grasping jaws at the distal end, which are actuated by a handle at the proximal end of the device. The distal end contains bipolar electrodes for sealing vessels, and a mechanical cutting blade for transecting vessels. The EnSeal Open devices are reusable forceps-type devices with one snap-in single use, disposable bipolar electrode, and one permanent, reusable electrode in the jaws of the device. Connectors attached to an electrical cable connect the device to the ECA (EnSeal Controller Adapter) accessory which connects the device to a standard O.R. electrosurgical generator.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": null,
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Preclinical laboratory (bench studies) were executed, but specific sample sizes are not provided. The data provenance is described as 'preclinical laboratory (bench studies)', which typically implies prospective testing conducted in a controlled environment.",
  "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)": "The human factors evaluation involved 'physicians' who provided input in pre-clinical and bench testing. The specific number and qualifications of these physicians are not detailed.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study primarily involved preclinical laboratory (bench studies) and user feedback, not a standard adjudication process for a diagnostic or AI device.",
  "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 document describes a medical device for surgical procedures (vessel sealing and hemostasis system), not an AI-based diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This device is a surgical instrument that requires a human operator, not an autonomous algorithm.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the preclinical laboratory (bench studies), the 'ground truth' would be the objective performance metrics established by the design specifications, such as sealing strength, transection effectiveness, and tissue dissection capabilities. These are typically measured directly in a lab setting.",
  "8. The sample size for the training set": "Not applicable. This is not an AI/ML device that requires a training set in the typical sense.",
  "9. How the ground truth for the training set was established": "Not applicable. This is not an AI/ML device."
}

Summary

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lot 2

510(k) SUMMARY

1. Submitter Name and Address

SurgRx, Inc. 380 Portage Avenue Palo Alto, CA 94306 Contact: Linda Oleson Phone: (650) 739-0920 xt 107 Date: 6/10/03

2. Device Name

Trade name: EnSeal Vessel Sealing & Hemostasis System

Common name: Electrosurgical open and laparoscopic instruments and accessories

Classification name: Electrosurgical Cutting and Coaqulation Device and Accessories (per 21 CFR section 878.4400) and Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120).

3. Predicate Device

ValleyLab LigaSure Vessel Sealing System (K981916).

4. Device Description

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 devices are similar to the predicate devices in that they are all bipolar instruments used to cut and seal vessels, grasp and dissect tissue, utilizing RF powered distal ends. They vary in technological characteristics by jaw design.

7. Performance Data

Preclinical laboratory (bench studies) and performance tests were executed to ensure the devices functioned as intended and met design specifications.

8. Conclusions

The EnSeal devices outperformed the predicate devices in comparative preclinical testing. Based on performance and functional similarities to the predicate devices, we believe the EnSeal devices are safe and effective and substantially equivalent to the predicate devices.

380 PORTAGE AVE • PALO ALTO • CALIFORNIA • 94306 PHONE: (650) 739-0920 • FAX: (650) 739-0929 E-10

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K031133 2 of 2

· Pacemakers and implanted cardioverter/defibrillators can be adversely affected by RF signals. Consult the pacemaker/cardioverter/defibrillator manufacturer for further information when use of electrosurgical equipment is planned in patients with these devices. If the patient has an internal cardiac defibrillator (ICD), contact the ICD manufacturer instructions before performing electrosurgery. This treatment may cause multiple activations of an ICD.
· SurgRx recommends against the use of laparoscopic surgery on pregnant patients.
· SurgRx recommends against the use of electrosurgery for circumcisions.

. . .

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.

3. Engineering Specifications

See Attachment 4 for engineering drawings/physical descriptions of the devices and complete materials lists.

a) Components

Open Instruments
Reusable Handle :	Surgical stainless steel
Jaws (disposable andreusable portions):	Surgical stainless steel, carbon filled polyethylene,polyetherimide (Ultem), silicone, silicone coating.
Laparoscopic Instruments
Handle:	Acrylonitrile-butadiene-styrene Terpolymer (ABS)
Jaws:	Surgical stainless steel, carbon filled polyethylene,silicone coating.
I-Beam:	Surgical stainless steel

c) Human Factors

Shaft:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Instruments are designed similar to currently marketed devices. The device has been evaluated from the user perspective in pre-clinical and bench testing by physicians, and taken into consideration as design input. Devices should be easily adaptable to users.

polyolefin shrink tubing - black.

Surgical stainless steel, heat shrink insulation of

d) Packaging

All SurgRx EnSeal products packaging shall conform to the International Safe Transit Association (Project 1A and Project 2A) requirements for packaged products weighing less than 100 pounds. Customer over shippers shall meet the following ASTM 4169-99 standards for: Impact Test Criteria, Static Compression Test Criteria, Vibration Test Criteria.

Laparoscopic devices will be packaged on a chip board tray in a Tyvek pouch for radiation sterilization, and placed in a chip board box. Six unit boxes will be packaged in a corrugated over shipper.

The non-sterile Open device handles will be packaged in a bubble-wrap pocket and placed in a corrugated cardboard box for shipping.

Disposable electrodes will be packaged in a Tyvek pouch for radiation sterilization and 12 unit pouches will be placed in a chipboard box.

The ECA box will be placed in an anti-static bag, surrounded by protective foam cushioning and placed in a corrugated box. ECA Accessories (batteries in a ziplock bag, footswitch in a ziplock bag, Reusable Extension Cable in a ziplock bag) will be placed in a packaging insert corrugated box and placed in the same box as the ECA (see Attachment 4 for exploded view).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized depiction of an eagle or other bird, with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2003 JUL

Surgrx, Inc. c/o Mr. Morten Simon Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K031133

Trade/Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System Regulation Number: 21 CFR 884.4120, 21 CFR 878.4400 Regulation Name: Gynecologic electrocautery and accessories Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: June 17, 2003 Received: June 19, 2003

Dear Mr. Christensen:

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 (OS) 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 - Mr. Morten Simon Christensen

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Applicant: SurgAx, Inc.

Kostla 3 510(k) number (if known):_

Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System

Indications for Use:

Indications for use include open and laparoscopic general and gynecological surgical procedures (including unlogic, thoracic, plastic and reconstructive, bowel resections, hysterectornies, cholecystectornies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cuting 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 SurgHx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterlization procedures. Do not use this system for these procedures.

(Please DO NOT WRITE BELOW THIS LINE - Continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_

(Optional Format 1-2-96)
Page 1 of 1

for Mark N. Millen
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K031133
D-8
06/27/2003 09:56AM

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.