(77 days)
Not Found
No
The description focuses on the mechanical and electrical function of bipolar forceps for tissue manipulation and coagulation, with no mention of AI or ML technologies.
Yes
The device is designed to "grasp, manipulate and coagulate selected tissue," which are actions aimed at treating or modifying a biological condition (tissue coagulation).
No
The device is described as a surgical tool designed to grasp, manipulate, and coagulate tissue using electrosurgical energy for general surgical procedures. Its function is to perform a therapeutic action (coagulation), not to identify or assess a medical condition.
No
The device description clearly states it is a physical instrument (forceps) made of stainless steel, nylon coating, and a non-stick tip, designed to grasp and manipulate tissue. It is used in conjunction with an electrosurgical generator and footswitch, 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 "Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures." This describes a surgical instrument used on the patient's tissue, not a device used to test samples from the patient outside the body.
- Device Description: The description reinforces this by detailing its function in grasping, manipulating, and coagulating tissue using electrosurgical energy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on surgical intervention and tissue manipulation within the body.
N/A
Intended Use / Indications for Use
Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Product codes
GEI
Device Description
These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.
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
Not Found
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)
The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices.
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
510(k) Summary Prepared October 23, 2008 K083162
STINGRAY SURGICAL PRODUCTS INC 801 APPLE TREE LANE BOCA RATON, FL 33486 Tel 561-210-7582 Fax 561-210-5608 Contact: Mark McBrinn, President
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- Identification of the Device: Proprietary-Trade Name: Stingray Electrosurgical Forceps Classification Name: Electrosurgical cutting and coagulation device and accessories Product Codes Product Code GEI Common/Usual Name: Bipolar Forceps
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- Equivalent legally marketed devices: ProMed Instruments GmbH DORO® Non-Stick Bipolar Forceps K070997
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- Indications for Use (intended use) Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
-
- Description of the Device: These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices.
1
K08 3162
page (2) of (2)
| Characteristic | ProMed Instruments GmbH DORO®
Non-Stick Bipolar Forceps K070997 | Stingray Electrosurgical
Forceps |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Intended Use: | Bipolar electrosurgical procedures | SAME |
| Configuration | Coated handle, bipolar connector, stainless
steel, and non-stick plated tip | SAME |
| Generator | Bipolar electrosurgical | SAME |
| Connector | 2 pin bipolar, insulated | SAME |
| Materials | Nylon coated stainless steel | SAME |
| Sterilization | Autoclave | SAME |
| Safety | 60601-2-2: Medical electrical equipment - Part
2-2: Particular requirements for the safety of
high frequency surgical equipment | SAME |
| Standards | ANSI/AAMI HF18-2001: Electrosurgical
Devices | SAME |
6. Substantial Equivalence Chart
7. Conclusion
:
After analyzing bench and standards testing data, it is the conclusion of Stingray Surgical Inc. that the Stingray Electrosurgical Forceps are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stingray Surgical Products, Inc. % Kamm & Associates Mr. Daniel Kamm, P.E. P.O. Box 7007 Deerfield, Illinois 60015
JAN 12 2009
Re: K083162
Trade/Device Name: Stingray Electrosurgical Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 17, 2008 Received: December 23, 2008
Dear Mr. Kamm:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.
( :
3
Page 2 - Mr. Daniel Kamm, P.E.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark. N. Milham
Mark N. Melkerson . Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K08 3162
Device Name: Stingray Electrosurgical Forceps
Indications For Use:
Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Milfredph for men
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K083162
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