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.

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Stingray Electrosurgical Forceps, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a predicate device comparison rather than explicit acceptance criteria with specific numerical thresholds for performance. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is therefore reported as being "SAME" or equivalent to the predicate device's characteristics.

Characteristic	Acceptance Criteria (Implicit - Equivalence to Predicate)	Reported Device Performance (Stingray Electrosurgical Forceps)
Intended Use	Bipolar electrosurgical procedures (same as predicate)	SAME
Configuration	Coated handle, bipolar connector, stainless steel, and non-stick plated tip (same as predicate)	SAME
Generator	Bipolar electrosurgical (same as predicate)	SAME
Connector	2 pin bipolar, insulated (same as predicate)	SAME
Materials	Nylon coated stainless steel (same as predicate)	SAME
Sterilization	Autoclave (same as predicate)	SAME
Safety	Meets 60601-2-2 (same as predicate)	SAME
Standards	Meets ANSI/AAMI HF18-2001 (same as predicate)	SAME

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document refers to "bench and standards testing data" (Section 5. Safety and Effectiveness, comparison to predicate device, and Section 7. Conclusion), but does not provide details on the number of samples or specific test configurations used.
Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the tests were retrospective or prospective. It only states that "bench and standards testing" was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is not an AI/ML or diagnostic device that requires expert ground truth establishment for a test set. The evaluation is based on engineering and safety standards and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is described as the evaluation is based on objective bench and standards testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a medical device (electrosurgical forceps), not an AI/ML diagnostic or image analysis tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through bench testing against established standards and comparisons to a predicate device.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for this device is compliance with established engineering standards (60601-2-2, ANSI/AAMI HF18-2001) and demonstrated equivalence in physical and functional characteristics to a legally marketed predicate device (ProMed Instruments GmbH DORO® Non-Stick Bipolar Forceps K070997). This falls under the category of bench testing and standards compliance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

Summary

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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

1. 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
1. Equivalent legally marketed devices: ProMed Instruments GmbH DORO® Non-Stick Bipolar Forceps K070997
1. 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.
1. 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.
1. 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.

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K08 3162

page (2) of (2)

Characteristic	ProMed Instruments GmbH DORO®Non-Stick Bipolar Forceps K070997	Stingray ElectrosurgicalForceps
Intended Use:	Bipolar electrosurgical procedures	SAME
Configuration	Coated handle, bipolar connector, stainlesssteel, 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 - Part2-2: Particular requirements for the safety ofhigh frequency surgical equipment	SAME
Standards	ANSI/AAMI HF18-2001: ElectrosurgicalDevices	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.

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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.

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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.