Designed to grasp, manipulate and coagulate selected tissue for single use in general surgical procedures. These forceps can be sold with or without irrigation and are provided sterile. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator and irrigation module. Stingray Ultralite Disposable Irrigation Forceps can 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 Ultralite Disposable Irrigation 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 disposable bipolar forceps design for single use in general surgical procedures. They are connected through a suitable birolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate, or irrigate selected tissues. The semi rigid irrigation tube is designed to carry nonpyrogenic fluid through the instrument and outputted to the tip end. 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 alloy tip. The devices are provided sterile ethylene oxide (ETO) and in sterile packs.

AI/ML Overview

The provided text describes a 510(k) summary for the "Stingray Ultralite Disposable Irrigation Bipolar Forceps." This submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI/medical imaging device. Therefore, many of the requested elements are not applicable to this type of medical device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety	"The new device is manufactured by the same company in the same way as the new device, it is as safe and effective as the predicate device." "Stingray Ultralite Disposable Irrigation Forceps were designed and manufactured to the same specifications as Stingray Electrosurgical Forceps K083162, which have been subject to bench and standards testing indicating the device is safe and effective."
Effectiveness	"The new device is manufactured by the same company in the same way as the new device, it is as safe and effective as the predicate device." "Stingray Ultralite Disposable Irrigation Forceps were designed and manufactured to the same specifications as Stingray Electrosurgical Forceps K083162, which have been subject to bench and standards testing indicating the device is safe and effective."
Adherence to Standards	Designed to meet or exceed ANSI/AAMI HF18-2001 and IEC 60601-2-2:2006 voluntary standards.
Substantial Equivalence	"few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not applicable as the submission relies on documentation of a previously cleared predicate device and adherence to established standards, not a specific "test set" of data for performance evaluation in the way an AI/imaging device would. The "study" referenced for the predicate device appears to be bench and standards testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. The device is a surgical instrument, and its safety and effectiveness are established through engineering design, material selection, manufacturing processes, and compliance with recognized industry standards, not through expert-labeled ground truth like in an AI/imaging study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. The evaluation method described is a comparison to a predicate device and adherence to industry standards, not a review of a data set that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. This submission concerns a physical surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this type of device is inherent in its design, manufacturing, and compliance with recognized safety and performance standards for electrosurgical instruments. The safety and effectiveness of the predicate device (K083162) would have been established through bench testing and adherence to relevant industry standards (ANSI/AAMI HF18-2001, IEC 60601-2-2:2006).

8. The sample size for the training set:

This information is not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable. This is not an AI/machine learning device.

Summary

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K102752 Exhibit 5: 510(K) Summary

510(K) Summary Prepared August 15, 2010

STINGRAY SURGICAL PROUCTS INC 801 APPLE TREE LANE BOCA RATON, FL 33486 TEL: 561-210-7582 FAX: 561-210-5608 Contact Brian McBrinn, Regulatory Affairs

1. Identification of the Device: Proprietary-Trade Name: Stingray Ultralite Disposable Irrigation Bipolar Forceps Classification Name: Electrosurgical cutting and coagulation device and accessories Product Codes Product Code GEI Common/Usual Name: Bipolar Forceps Single Use
1. Equivalent legally marketed devices: Stingray Ultralite Disposable Irrigation Forceps are substantially equivalent to Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps K080187 and Stingray Electrosurgical Forceps K083162 based on the device similarity to predicated device.
1. Indications for Use (intended use) Designed to grasp, manipulate and coagulate selected tissue for single use in general surgical procedures. These forceps can be sold with or without irrigation amd are provided sterile. Thev are connected through a suitable bioolar cable with the bipolar output of an electrosurgical generator and irrigation module. Stingray Ultralite Disposable Irrigation Forceps can 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 Ultralite Disposable Irrigation 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 disposable bipolar forceps design for single use in general surgical procedures. They are connected through a suitable birolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate, or irrigate selected tissues. The semi rigid irrigation tube is designed to carry nonpyrogenic fluid through the instrument and outputted to the tip end. 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 alloy tip. The devices are provided sterile ethylene oxide (ETO) and in sterile packs.
1. Safety and Effectiveness, comparison to predicate device, Stingray Ultralite Disposable Irrigation Forceps were designed and manufactured to the same specifications as Stingray

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1. Safety and Effectiveness, comparison to predicate device, Stingray Ultralite Disposable Irrigation Forceps were designed and manufactured to the same specifications as Stingray Electrosurgical Forceps K083162, which have been subject to bench and standards testing indicating the device is safe and effective. They have been designed to meet or exceed ANSI/AAMI HF18-2001 and IEC 60601-2-2:2006 voluntary standards. Since the new device is manufactured by the same company in the same way as the new device, it is as safe and effective as the predicate device.

6. Substantial Equivalence Chart

Charateristic	Description ofStingray UltraliteIrrigatingForceps	Olsen Medical SingleUse Bayonet BipolarIrrigating ForcepsK080187	Stingray ElectrosurgicalForceps K083162
Intendended Use	Bipolarelectrosurgicalprocedures	Same	Same
Configuration	Coated handle,bipolar connector,stainlessSteel, Irrigation	Same	Same
Generator	Bipolarelectrosurgical	Same	Same
Connector	2 pin bipolar,insulated	Same	Same
Materials	Nylon coated,stainless steel,plastic connector	Same	Same
Non Stick Tip	Silver Alloy	N/A	Same
Irrigation	Class VI PVC lumen	Same	Same
Sterilization	ETO	Same	Same
Safety	60601-2-2: Medicalelectrical equipment- Part2-2: Particularrequirements for thesafety ofhigh frequencysurgical equipment	Same	Same
Standards	ANSI/AAMI HF18-2001:ElectrosurgicalDevices	Same	Same

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1. Conclusion: After analyzing bench and standards testing data of Stingray Electrosurgical Forceps K083162, and the comparison of Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps K080187, it is the conclusion of Stingray Surgical Inc. that the Stingray Ultralite Disposable Irrigating Bipolar 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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has its head turned to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Stingray Surgical Products Incorporated % Mr. Brian McBrinn Regulatory Affairs 801 Apple Tree Lane Boca Raton, Florida 33486

NOV - 9 2011

Re: K102752

Trade/Device Name: Stingray Ultralite Disposable Irrigating Biopolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 2, 2011 Received: November 4, 2011

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, 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 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

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Page 2 - Mr. Brian McBrinn

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

yours,

Melkerson

Mark N. Mell Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K102752

Device Name: _Stingray Ultralite Disposable Irrigating Bipolar Forceps

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division Sign of Surgical, Orthopedic, Divisionative Devices

510(k) Number K102752

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.