(178 days)
Not Found
No
The description focuses on the mechanical and electrical functions of bipolar forceps for tissue manipulation and coagulation, with no mention of AI or ML capabilities.
Yes
The device is designed to coagulate tissue using electrosurgical energy during surgical procedures, which is a therapeutic function.
No
Explanation: The device is designed to grasp, manipulate, and coagulate tissue using electrosurgical energy during general surgical procedures, which is a therapeutic function, not a diagnostic one. There is no mention of it being used to identify or analyze a medical condition.
No
The device description explicitly states it is constructed of physical materials (stainless steel, nylon coating, non-stick tip) and is a physical instrument (forceps) used in surgical procedures, indicating it is a hardware device.
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 directly on a patient's tissue in vivo.
- Device Description: The description reinforces this by detailing its use in surgical procedures, grasping and manipulating tissue, and using electrosurgical energy for coagulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health.
IVD devices are specifically designed for testing samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely focused on surgical intervention on living tissue.
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 electrosurgical 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)
Not Found
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
The device trade name and common/classifications name are:
Device Trade Name
Stingray Electrosurgical Forceps
Common Name
Bipolar Forceps
Classification Name
Electrosurgical cutting and coagulation device and accessories
Address, Registration #, and Contact Information
Device Name
The address and registration number of the manufacturer site for the electrosurgical forceps is:
Manufacturer
Stingray Surgical Products LLC 156 NW 16 Street Boca Raton, FL 33432
FDA Registration #: 3006059917
Contact Information
Name: Brian McBrinn Position: Quality Manager Phone: (561) 210-7582 Fax: (561) 210-5608 brian@stingraysurgical.com
| Device Class and Classification | Stingray Electrosurgical Forceps have been classified as: |
|---|---|
| --------------------------------- | ----------------------------------------------------------- |
| Classification: Class IIClassification Panel: General and Plastic Surgical DevicesProduct Code: GEIC.F.R Section: 878.4400 | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
No performance standards have been established under Section 513/514 of the Food, Drug and Cosmetic Act for electrosurgical forceps.
1
| Predicate
Device
Information | The predicate device is the Stingray Electrosurgical Forceps [K083162,
concurrence date 01/12/2009].
Useful Life: The lifetime of the device has been best estimated based on the average age of devices returned for repair. When a device requires repair, it has exceeded its useful lifetime. Therefore the lifetime of the devices produced by Stingray Surgical Products LLC has been determined to be two (2) years. The performance characteristics of the device have been validated through twenty (20) sterilization cycles. Additional limit testing was conducted by subjecting the device to forty (40) sterilization cycles with no degradation observed. It is estimated that twenty sterilization cycles exceeds the estimated amount of cycles for a single device in use for two years. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling and
Intended Use | Draft “Instructions for Use” can be found in Attachment B.
No changes have been made to the device labeling and no modifications to the device labeling are included in this submission. Therefore no labeling has been provided within this submission.
Substantial changes to the Instructions for Use are proposed within this submission including a change of steam sterilization method and an update to the cleaning/reprocessing instructions. Additional instructions are proposed for cautions, precautions, use, handling, storage, warranty, and repair.
The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
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 electrosurgical 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.
This is the same intended use as previously cleared for the Stingray Electrosurgical Forceps, K083162.
The statement of Indications for Use can be found in section 6. |
| Device
Description and
Comparison | 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.
Comparison: The Change Summary can be found in section 10 which provides the comparison to the predicate device |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 10, 2013
Stingray Surgical Products LLC % Mr. Brian McBrinn Quality Manager 156 NW 16th Street Boca Raton, Florida 33432
Re: K123478
Trade/Device Name: Stingray Electrosurgical Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 09, 2013 Received: April 16, 2013
Dear Mr. McBrinn:
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. Iisting 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
3
Page 2 - Mr. Brian McBrinn
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 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.
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/ReportalProblem/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/Resourcesfor You/Industrv/default.htm.
Sincerely yours, FOR
Peter Dig Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123478
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 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 electrosurgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal stenlization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
(Division Sign-Off)
For
Division of Surgical Devices
510(k) Number K123478