ENSEAL PTC TRIO

K070165 · Surgrx, Inc. · GEI · Jan 29, 2007 · General, Plastic Surgery

Device Facts

Record IDK070165
Device NameENSEAL PTC TRIO
ApplicantSurgrx, Inc.
Product CodeGEI · General, Plastic Surgery
Decision DateJan 29, 2007
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 878.4400
Device ClassClass 2
AttributesTherapeutic

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.

Device Story

EnSeal™ PTC TRIO is a bipolar electrosurgical instrument used with a radiofrequency (RF) generator; designed for open and laparoscopic general and gynecologic surgery. Device functions by delivering RF energy to distal jaws to grasp, dissect, cut, and seal tissue and vessels up to 7 mm. Operated by surgeons in clinical settings. Output is mechanical tissue manipulation and thermal coagulation/sealing. Benefits include effective vessel ligation and tissue management during various surgical procedures. System functionality is identical to predicate devices.

Clinical Evidence

Bench testing only. Preclinical laboratory and performance tests were conducted to ensure the device functions as intended and meets design specifications.

Technological Characteristics

Bipolar electrosurgical instrument; RF-powered distal ends; designed for open and laparoscopic use; compatible with RF generators.

Indications for Use

Indicated for 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 requiring vessel ligation, tissue grasping, and dissection. Suitable for vessels up to 7 mm and tissue bundles fitting within instrument jaws. Contraindicated for tubal sterilization or coagulation.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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 Page 1 of 1 Devices \$\frac{M}{a}\$ K070165 5100k) Number
Innolitics
510(k) Summary
Decision Summary
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