(192 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, electrical safety, biocompatibility, and basic functionality (cutting and coagulation) of a standard bipolar forceps. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is described as allowing 'control of bleeding of small vessels by bipolar coagulation', which is a therapeutic action (coagulation to stop bleeding).
No
The device description and intended use clearly state that the Bipolar Forceps are used for tissue grasping, control of bleeding, and coagulation, which are therapeutic and surgical functions, not diagnostic.
No
The device description clearly describes a physical, hand-held medical device (Bipolar Forceps) with specific dimensions, materials, and intended use involving physical interaction with tissue and electrical energy. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Tissue grasping and control of bleeding of small vessels by bipolar coagulation." This describes a surgical procedure performed on a patient's body, not a test performed on a sample taken from a patient's body.
- Device Description: The description details a surgical instrument used for grasping tissue and applying electrical energy for coagulation. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample analysis, or diagnostic results.
IVDs are used to examine specimens (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
Tissue grasping and control of bleeding of small vessels by bipolar coagulation.
Product codes
GEI
Device Description
The Bipolar Forceps device is a single use hand held insulated medical device approximately 295mm in overall length featuring a 190mm distance from the user's grasp to the tip. The bayonet offset is 1.5cm. The tips are Titanium Nitride coated and have polished contact surfaces 1.5mm wide by 1cm long. The device is offered in straight and 20 degree angled tips. The Bipolar Forceps are sold as a single use sterile packaged device used in general surgical procedures.
The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.
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
Used only by personnel with training in electrosurgical 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)
Biocompatibility testing for the intended application of the Bipolar Forceps was performed as suggested by the International Standards Organization (ISO) 10993 Guidelines, FDA General Program Memorandum No. G95-1 and the Office of Device Evaluation (ODE) Bluebook Memorandum G95-1 "Use of ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
The device was also subjected to performance testing after sterilization using animal tissue of various diameters to simulate vessels at different power settings. The device properly cut and coagulated the tissue.
The subject device was subjected to testing including:
- Electrical safety .
- Biocompatibility .
- Packaging validation .
- Shipping & transportation .
- . Aging Shelf Life
- . Hi-Pot
The testing found no issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K131058
510(k) Summary for Boston Endo Surgical Technologies (division of Lacey Manufacturing) Bipolar Forceps
SUBMITTER/510(K) HOLDER 1.
Boston Endo Surgical Technologies (division of Lacey Manufacturing) 1146 Barnum Avenue Bridgeport, CT 06610
Contact Name: James Rogers. Email: JRogers@peplacey.com Telephone: (203) 336-7453
Date Revised: July 1, 2013
Prepared By: JA
2. DEVICE NAME
| Proprietary Name: | Bipolar Forceps |
|---|---|
| Common/Usual Name: | Bipolar Forceps |
| Classification: | Class 2, 21 CFR 878.4400 |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessories |
| Product Code: | GEI |
3. PREDICATE DEVICES
K032327 Modern Medical Bipolar Forceps .
DEVICE DESCRIPTION 4.
The Bipolar Forceps device is a single use hand held insulated medical device approximately 295mm in overall length featuring a 190mm distance from the user's grasp to the tip. The bayonet offset is 1.5cm. The tips are Titanium Nitride coated and have polished contact surfaces 1.5mm wide by 1cm long. The device is offered in straight and 20 degree angled tips. The Bipolar Forceps are sold as a single use sterile packaged device used in general surgical procedures.
The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm
1
pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.
INTENDED USE 5.
Tissue grasping and control of bleeding of small vessels by bipolar coagulation.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Bipolar Forceps substantially equivalent to the Modern Medical Bipolar Forceps cleared under 510(k) K032327. The only difference between the devices is that the subject device is provided sterile and is for one time use, whereas the predicate device is reusable. The materials and design are identical.
7. PERFORMANCE TESTING
Biocompatibility testing for the intended application of the Bipolar Forceps was performed as suggested by the International Standards Organization (ISO) 10993 Guidelines, FDA General Program Memorandum No. G95-1 and the Office of Device Evaluation (ODE) Bluebook Memorandum G95-1 "Use of ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
| Test | Conclusion |
|---|---|
| Cytotoxicity | Non-cytotoxic |
| Irritation | Non-irritating |
| Sensitization | Non-sensitizing |
The device was also subjected to performance testing after sterilization using animal tissue of various diameters to simulate vessels at different power settings. The device properly cut and coagulated the tissue.
8. SAFETY AND EFFICACY
The subject device was subjected to testing including:
- Electrical safety .
- Biocompatibility .
- Packaging validation .
- Shipping & transportation .
- . Aging Shelf Life
- . Hi-Pot
The testing found no issues of safety or effectiveness.
2
9. CONCLUSION
Boston Endo Surgical Technologies believes that based on the indications for use, technological characteristics, and comparison to predicate devices the Bipolar Forceps has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.
- .
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
October 25, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Endo Surgical Technologies, Incorporated Mr. James Rogers Regulatory Affairs, Manager 1146 Barnum Avenue Bridgeport, Connecticut 06610.
Re: K131058
Trade/Device Name: Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 14, 2013 Received: August 16, 2013
Dear Mr. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. James Rogers
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark Nijelkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K131058
Device Name: Bipolar Forceps
Indications for Use:
Tissue grasping and control of bleeding of small vessels by bipolar coagulation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
an small of the hostin or more and the man the money of the stars and the country of the collection of the collection of the
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
pitally signed by Long H. Chen -A Long H. Chen -A 005FDA, Bu=People, cn=Long H. Chana
0.9.2342.19200300.100.1.1=13300369056
Date: 2013.11.05 06:44.29 -05:00 I
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.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Division Sign-off) Division of Surgical Devices 510(k) Number: K131058
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