(17 days)
Not Found
No
The summary describes a standard electrosurgical system for cutting and sealing tissue and vessels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description explicitly states the functionality and components are the same as the predicate device, which is also a traditional electrosurgical system.
No
The device is described as an electrosurgical instrument used for cutting, sealing, grasping, and dissecting tissue during surgery, not for treating a disease or medical condition.
No
The device description and intended use state that it is for cutting, sealing, grasping, and dissecting tissue during surgery. There is no mention of it being used to diagnose conditions or disease.
No
The device description explicitly states it includes "bipolar electrosurgical instruments and an accessory adapter," which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used during 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 devices used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes based on sample analysis.
The device is a surgical tool used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with SurgRx electrosurgical generators. 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, colorectal, oncological procedures, Nissen fundoplication, hysterectomies, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection can be performed, on any size of tissue that 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 (comma separated list FDA assigned to the subject device)
GEI and HGI
Device Description
EnSeal™ Vessel Sealing and Hemostasis System. The functionality and components of the System are 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
Operating room / Surgical setting
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)
This modification does not affect performance of the System. Additional performance testing not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the text "APR - 1 2005". The text appears to be a date, with "APR" representing the month of April, "1" representing the first day of the month, and "2005" representing the year. The text is written in a simple, sans-serif font.
Image /page/0/Picture/1 description: The image shows the word "SURG" in white letters against a black oval background. The letters are bold and sans-serif. The oval is oriented horizontally. The image is simple and graphic.
K050671
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: 3/14/05
2. Device Name
Trade name: 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 # K031133
4. Device Description
EnSeal™ Vessel Sealing and Hemostasis System. The functionality and components of the System are 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
This modification does not affect performance of the System. Additional performance testing not required.
8. Conclusions
The EnSeal System is equivalent to the predicate devices based on results of design validation. We believe that the EnSeal Laparoscopic devices are safe and effective and substantially equivalent to the predicate devices.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2005
Ms. Linda Oleson Director of Clinical and Regulatory Affairs, Consultant SurgRx, Inc. 380 Portage Avenue Palo Alto, California 94306
Re: K050671
K030071
Trade/Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI and HGI Dated: March 14, 2005 Received: March 15, 2005
Dear Ms. Oleson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to commerce prior to May 26, 1776, the enastinen with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the ties labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA). it If your device is classimod (600 as 10, of the major regulations affecting your device can inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood accments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Ficase be advised that 1 1971 is notalies over device complies with other requirements of the Act that 157A has made a determination administered by other Federal agencies. You must or any receral statutes and reginations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cr K F art 807), labornig (21 OFA Part 820), and if applicable the electronic forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
2
Page 2 - Ms. Linda Oleson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'ls ough finding of substantial equivalence of your device to a legally premative noticated. The Presults 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 If you desire spocific adviser 3 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 other general mionnation 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/industry/support/index.html.
Sincerely yours,
R. O'Hara kr.
Miriam C. Provost, h.D. Acting 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.
KOSOB71 510(k) number (if known):_
Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System
Indications for Use:
The SurgRx EnSeal system includes bipolar electrosurgical instruments and an r the Ourgh & Enoud of cloud of electrosurgical generators. It is intended for use accessory adapter for use with startal a onecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general and gynecological surgical mulcations for use tholude open and reconstructive, bowel resections, procedures (including urologic, «rolegal, «role procedures, Nissen fundoplication, nysterectorines, onororectomies, etc.), or any procedure where vessel ligation (cutting and admesions, odprorecomise, otel), or any of any arrant of the devices can be used on seamly), ilssuc grasping and alsociation in the same as will fit in the jaws of the instruments.
The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be iffective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
Prescription Use (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:)
050671
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