(16 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, 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.
The RF-60 generator/controller which is used in conjunction with the EnSeal System. The functionality and remaining components of the System are the same.
The provided 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System (K043008) does not include detailed acceptance criteria or a specific study designed to prove the device meets such criteria.
Instead, the submission relies on the concept of substantial equivalence to a predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K031133). The performance data section broadly states:
"Preclinical laboratory (bench & live animal studies) and performance tests were executed to ensure the devices function as intended and meet design specifications."
This phrasing indicates that internal testing was conducted, but it doesn't provide the level of detail requested in the prompt regarding specific acceptance criteria and the study design to evaluate them.
Therefore, I cannot provide the requested information in the table or answer most of the follow-up questions because the necessary details are not present in the provided document.
However, I can extract what is explicitly stated:
Information Not Available in the Provided Document:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence rather than explicit performance benchmarks for this specific device.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not explicitly stated for bench or animal studies beyond "function as intended and meet design specifications."
- The sample size for the training set: Not applicable/not provided. This is a medical device, not a machine learning model with a training set.
- How the ground truth for the training set was established: Not applicable/not provided.
Information that can be inferred or is broadly stated:
- Study Type: Preclinical laboratory (bench & live animal studies) and performance tests. These are internal validation studies, not typically large-scale clinical trials with human subjects for product clearance in this context.
- Purpose of Studies: "to ensure the devices function as intended and meet design specifications." This broadly implies that the "acceptance criteria" were the device's design specifications for functionality and safety.
- Conclusion: "The EnSeal System is equivalent to the predicate devices based on results of design validation." and "We believe that the RF-60 generator/controller used in conjunction with the EnSeal devices is safe and effective and substantially equivalent to the predicate devices."
In summary, the 510(k) submission describes a reliance on the existing predicate device's safety and effectiveness, supported by internal "preclinical laboratory (bench & live animal studies) and performance tests" to demonstrate that the functionality and design specifications of the new component (RF-60 generator/controller) are met and maintain substantial equivalence. Specific, quantifiable acceptance criteria and detailed study designs for those criteria are not part of this public summary.
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NOV 17 2004
510(k) SUMMARY
1. Submitter Name and Address
K04 300
SurgRx, Inc. 380 Portage Avenue Palo Alto, CA 94306 Contact: Linda Oleson Phone: (650) 739-0920 xt 107 Date: 10/28/04
2. Device Name
Trade name: EnSeal Vessel Sealing & Hemostasis System (with RF-60 generator/controller)
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
The RF-60 generator/controller which is used in conjunction with the EnSeal System. The functionality and remaining components of the System are the same.
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 & live animal studies) 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 devices based on results of design validation. We believe that the RF-60 generator/controller used in conjunction with the EnSeal devices is safe and effective and substantially equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes on its wing, symbolizing service, knowledge, and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2004
Ms. Linda Oleson Director of Clinical and Regulatory Affairs SurgRx, Inc. 380 Portage Avenue Palo Alto, California 94306
Re: K043008
Ko43000
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, HGI Dated: October 29, 2004 Received: November 1, 2004
Dear Ms. Oleson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be devermined 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 commerce pror to rita) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmeter For (100) in the device, subject to the general controls provisions of the Act. The r ou may, aroney in one of the Act include requirements for annual registration, listing of general bonation profictive, 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 such additional controls. Existing major regulations affecting your device can may or sueyeer to back as a suese as 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.
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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 with and w yourse of substantial equivalence of your device to a legally promative noticated.com - 11:22 Links.
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 If you desire specific acreeliance at (240) 276-0115. Also, please note the regulation entitled, Connect the Ories of Course 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 micronational 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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.
1043008 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 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 faparoscopic 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_ (Per 21 CFR 801.109) ાર
Over-The-Counter Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE --- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
al. Restorative,
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B-1
510(k) Number K043008
§ 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.