(90 days)
Not Found
Not Found
No
The description focuses on standard electrosurgical technology with temperature control and safety features, without mentioning any AI/ML components or capabilities.
Yes.
Explanation: The device is intended for medical procedures (coagulate soft tissues and blood, produce hemostasis) and is used by a physician during surgery. This aligns with the definition of a therapeutic device as it treats or manages a medical condition.
No
The device description states its intended use is for coagulation and hemostasis during surgical procedures, which are therapeutic functions, not diagnostic. It applies radiofrequency energy to tissue for treatment rather than for obtaining information about a patient's condition.
No
The device description explicitly states it is comprised of an Electrosurgical Unit (ESU), Electrosurgical Probe, and accessories, which are hardware components.
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 "coagulate soft tissues" and "coagulate blood and soft tissues to produce hemostasis" during open, general surgical procedures. This involves direct interaction with tissue within the body, not the examination of samples taken from the body.
- Device Description: The description details an electrosurgical unit and probe that apply radiofrequency energy to tissue. This is a therapeutic or surgical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly modify tissue through coagulation.
N/A
Intended Use / Indications for Use
The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Boston Scientific Tissue Coagulation System is comprised of an Electrosurgical Unit (ESU), Electrosurgical Probe, and accessories for the application of radiofrequency energy to tissue. The ESU supplies up to 150 watts of radiofrequency energy in unipolar mode to the electrodes of the Electrosurgical Probe under temperature control while continuously monitoring and displaying actual power delivered, actual electrode temperature, and time of power duration. User controls are provided for setting desired temperature, maximum power output, and duration of power delivery. ESU safety features include overvoltage, overcurrent, and overpower shutdowns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; open, general surgical procedures
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)
Not Found
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.
Vallev Lab Force 40, VNUS Medical Closure™ System, Somnus Medical Model 615, Oratec ORA-50™, Arthrocare Electrosurgery System, Wappler Electrosurgical Unit, Ximed Medical Electrode Probe. and Circon Surgical Instruments
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
3 1998 SEP
981,981/
510(k) SUMMARY (as required by 21 CFR 807.87(h)) E.
May 23, 1998 Date Prepared:
Boston Scientific Corporation Sponsor: 2710 Orchard Parkway San Jose CA 95134 (408) 895-3500 Telephone: Contact: Steve.Jwanouskos Senior Director, Regulatory Affairs Title: and Quality Compliance
| Trade Name: | Boston Scientific Tissue Coagulation System |
|---|---|
| Common Name: | Electrosurgical System |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II-21 CFR 878.4400 |
| Predicate Devices: | Vallev Lab Force 40, VNUS Medical Closure™ System, Somnus |
| Medical Model 615, Oratec ORA-50™, Arthrocare Electrosurgery | |
| System, Wappler Electrosurgical Unit, Ximed Medical Electrode | |
| Probe. and Circon Surgical Instruments |
The Boston Scientific Tissue Coagulation System is comprised of an Device Description: Electrosurgical Unit (ESU), Electrosurgical Probe, and accessories for the application of radiofrequency energy to tissue. The ESU supplies up to 150 watts of radiofrequency energy in unipolar mode to the electrodes of the Electrosurgical Probe under temperature control while continuously monitoring and displaying actual power delivered, actual electrode temperature, and time of power duration. User controls are provided for setting desired temperature, maximum power output, and duration of power delivery. ESU safety features include overvoltage, overcurrent, and overpower shutdowns.
Intended Use: The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 1998
Mr. Steve Jwanouskos Senior Director, Regulatory Affairs and Quality Compliance Boston Scientific Corporation 2710 Orchard Parkway San Jose, California 95134
Re: K981981
Trade Name: Boston Scientific Tissue Coagulation System Regulatory Class: II Product Code: GEI Dated: June 3, 1998 Received: June 5, 1998
Dear Mr. Jwanouskos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 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). 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, listing 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 (Premarket Approval), 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 895. A substantially equivalent determination-assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Steve Jwanouskos
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten. Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
D. INDICATIONS FOR USE STATEMENT
1981981 510(k) Number (if known):___
Boston Scientific Tissue Coagulation System Device Name:
Indication For Use:
The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
piolleto
of General Restorative De De C 981981 J Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)