(16 days)
Not Found
No
The summary describes a standard electrosurgical system for cutting and sealing tissue and vessels, with no mention of AI or ML capabilities.
No
The device is used for cutting, sealing, grasping, and dissecting tissue during surgery, primarily for vessel litigation and hemostasis, which are surgical tools rather than therapeutic interventions aimed at treating a disease or condition.
No
The text describes the device's function as cutting and sealing vessels, and grasping and dissecting tissue during surgery. It does not mention any function for diagnosing conditions.
No
The device description explicitly mentions a "RF-60 generator/controller" and "electrosurgical instruments," which are hardware components. The intended use also describes physical actions like cutting, sealing, grasping, and dissecting tissue, which are performed by hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during surgical procedures to cut and seal vessels, cut, grasp, and dissect tissue. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description mentions a generator/controller and instruments used in surgery. This aligns with surgical equipment, not diagnostic tests performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on surgical manipulation of tissue and vessels within the body.
N/A
Intended Use / 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 gynecological 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HGI
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.
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
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 & live animal studies) 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): 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 word "SURGRX" in white letters on a black oval background. The letters are bold and sans-serif. The letters appear to be slightly distressed, with some small areas of the letters missing. The oval is oriented horizontally.
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.
1
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.
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 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
3
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,
Page 1 of 1
B-1
510(k) Number K043008