(18 days)
No
The summary describes a bipolar electrosurgical instrument and generator, focusing on its intended use for cutting and sealing vessels and dissecting tissue. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are described as preclinical laboratory and bench tests, not studies involving AI/ML model training or validation.
No.
The device's intended use is to cut and seal vessels, grasp and dissect tissue during surgical procedures, which are interventional actions, not therapeutic ones.
No
The EnSeal™ PTC is described as a bipolar electrosurgical instrument used for cutting and sealing vessels, cutting, grasping, and dissecting tissue during surgery. Its intended use is for surgical procedures, not for diagnostic purposes.
No
The device description explicitly states it is a "bipolar electrosurgical instrument" and mentions its use with an "electrosurgical generator," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the EnSeal™ PTC is a surgical instrument used during surgery to cut and seal vessels, cut, grasp, and dissect tissue. It operates directly on the patient's body during a procedure.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to perform physical actions on tissue and vessels within the body.
Therefore, the EnSeal™ PTC falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EnSeal™ PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open or laparoscopic, general and gynerologic 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 resetting, 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.
Product codes
GEI, HGI
Device Description
EnSeal™ PTC with ERBE VIO 300 D. The functionality of the device is the same as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use X (Per 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KO71728 510(k) SUMMARY
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
Page 1 of ①
2. Device Name
Trade name: EnSeal™ PTC with ERBE VIO 300 D
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 # K031133, and the ERBE VIO ESU, Model VIO 300 D, # K060484 and EnSeal PTC # K061526.
4. Device Description
EnSeal™ PTC with ERBE VIO 300 D. The functionality of the device is the same as the predicate device.
5. Intended Use
The EnSeal™ PTC with ERBE VIO 300 D is 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 EnSeal™ PTC 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™ PTC with ERBE VIO 300 D is the same as the predicate device 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 with ERBE VIO 300 D is equivalent to the predicate device based on results of design validation. We believe that the EnSeal™ PTC with ERBE VIO 300 D is safe and effective and substantially equivalent to the predicate device.
1
Public Health Service
JUL 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SurgRx, Inc. % Ms. Linda S.M. Oleson Director, Clinical & Regulatory Affairs 101 Saginaw Drive Redwood City, California 94063
Re: K071728
Trade/Device Name: EnSeal™ PTC with ERBE VIO 300D Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: June 22, 2007 Received: June 25, 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
2
Page 2 - Ms. Linda S.M. 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,
Sincerely yours,
for
Mark N. Melkerson
Director
Director
Center for Devices and Radiological Health
Division of General, Restorative and Neurological Devices Office of Device Evaluation
.
Enclosure
3
Indications for Use Statement
Applicant: SurgRx, Inc.
KO71728 510(k) number (if known):
Device Name: EnSeal ™ PTC with ERBE VIO 300 D
Indications for Use:
The EnSeal™ PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open or laparoscopic, general and gynerologic 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 resetting, 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)