(17 days)
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 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, urologic procedures, Nissen fundoplication, hysterectomies, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection in the same instrument can be used on tissue of any amount 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.
EnSeal™ Vessel Sealing and Hemostasis System. The functionality and components of the System are the same as the Predicate Device.
The provided text is a 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System. It states that the device is a modification of a previously cleared device (K031133) and does not require additional performance testing because the modification does not affect the system's performance. Therefore, typical acceptance criteria and a study demonstrating performance against those criteria, as one might find for a novel device, are not detailed in this document.
However, based on the information provided, we can deduce some aspects and limitations regarding "acceptance criteria" and "study."
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The submission states: "This modification does not affect performance of the System. Additional performance testing not required." This implies that the device is expected to meet the same performance criteria as its predicate device (K031133), but those specific criteria are not listed here.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. As "additional performance testing not required," there would likely not have been a new test set for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study was not performed or mentioned in this document. The submission focuses on substantial equivalence based on the predicate device's performance, not comparative effectiveness with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable as the device is an electrosurgical system, not an AI algorithm.
7. Type of Ground Truth Used
Not explicitly stated for this submission. For the original predicate device, performance would typically be evaluated against established biological, surgical, or engineering outcomes relevant to vessel sealing and hemostasis (e.g., burst pressure, thermal spread, tissue effect).
8. Sample Size for the Training Set
Not applicable as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary derived from the document:
The core "acceptance criterion" for this specific 510(k) submission (K050671) is substantial equivalence to the predicate device (K031133). The "study" that proves the device meets this "acceptance criterion" is the design validation that demonstrated the modification did not alter the existing system's performance.
From the text:
- Acceptance Criterion: Substantial equivalence to the predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K031133), based on the functionality and components remaining the same. The implicit performance criteria are those established for the original predicate device.
- Study Proving Acceptance: "Results of design validation." The document explicitly states: "This modification does not affect performance of the System. Additional performance testing not required." This implies that the design validation assessed that the changes did not negatively impact the previously established performance of the predicate device.
The document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive new performance studies if the changes are minor or do not impact core functionality.
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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.
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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
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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
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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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§ 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.