(98 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrosurgical functionality and comparison to predicate devices without mentioning AI/ML.
Yes
A therapeutic device is one used for treatment or surgery, and this electrosurgical instrument is clearly intended for various surgical procedures to cut, seal, grasp, and dissect tissue.
No
Explanation: The device is described as an electrosurgical instrument for cutting, sealing, grasping, and dissecting tissue during surgery. Its intended use is for surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is an "electrosurgical instrument" and mentions "vessel ligation (cutting and sealing), tissue grasping and dissection," which are physical actions performed by hardware. The summary also refers to "bench and performance tests" which are typical for hardware devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used during surgical procedures to cut, seal, grasp, and dissect tissue and vessels. This is a direct intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- No Specimen Examination: The description of the EnSeal PowerTip does not involve the examination of any specimens outside of the body. It is used directly on the patient's tissues and vessels during surgery.
Therefore, the EnSeal PowerTip falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
Device Description
EnSeal PowerTip with EnSeal Universal. The functionality of the devices are the same as the predicate devices.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031133, K043008, K050671, K061526, K062949, K063097, K070165, K070896, K072177, K072493
Reference Device(s)
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
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.
2
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
3
Indications for Use Statement
Applicant: SurgRx, Inc.
510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EnSeal PowerTip with EnSeal Universal
Indications for Use:
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.
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
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