STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS

K102752 · Stingray Surgical Products, Inc. · GEI · Nov 9, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102752
• Device Name: STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
• Applicant: Stingray Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

Disposable bipolar forceps for general surgery; used to grasp, manipulate, and coagulate tissue. Device connects to external electrosurgical generator and irrigation module via bipolar cable. Surgeon activates coagulation via footswitch; electrosurgical energy delivered to tissue through forceps tips. Irrigation tube delivers nonpyrogenic fluid to tip. Used in clinical surgical settings. Benefits include precise tissue coagulation and irrigation capability in a single-use, sterile format.

Clinical Evidence

Bench testing only. Device performance validated against ANSI/AAMI HF18-2001 and IEC 60601-2-2:2006 standards. No clinical data provided.

Technological Characteristics

Materials: stainless steel, nylon coating, silver alloy non-stick tip, Class VI PVC irrigation lumen. Energy: bipolar electrosurgical current. Connectivity: 2-pin bipolar connector. Sterilization: Ethylene Oxide (ETO). Standards: ANSI/AAMI HF18-2001, IEC 60601-2-2:2006.

Indications for Use

Indicated for grasping, manipulating, and coagulating tissue during general surgical procedures. Contraindicated for tubal sterilization or tubal coagulation for sterilization procedures.

Regulatory Classification

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.

Predicate Devices

• Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (K080187)
• Stingray Electrosurgical Forceps (K083162)

Submission Summary (Full Text)

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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: [phone] FAX: [phone] 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
- 2. 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.
- 3. 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.
- 4. 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.
- 5. 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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- 5. 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 of<br>Stingray Ultralite<br>Irrigating<br>Forceps | Olsen Medical Single<br>Use Bayonet Bipolar<br>Irrigating Forceps<br>K080187 | Stingray Electrosurgical<br>Forceps K083162 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------|
| Intendended Use | Bipolar<br>electrosurgical<br>procedures | Same | Same |
| Configuration | Coated handle,<br>bipolar connector,<br>stainless<br>Steel, Irrigation | Same | Same |
| Generator | Bipolar<br>electrosurgical | Same | Same |
| Connector | 2 pin bipolar,<br>insulated | Same | Same |
| Materials | Nylon coated,<br>stainless steel,<br>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: Medical<br>electrical equipment<br>- Part<br>2-2: Particular<br>requirements for the<br>safety of<br>high frequency<br>surgical equipment | Same | Same |
| Standards | ANSI/AAMI HF18-<br>2001:<br>Electrosurgical<br>Devices | Same | Same |

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- 7. 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 [phone] or [phone] 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

Indications for Use

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

Device Name: _Stingray Ultralite Disposable Irrigating Bipolar Forceps

Indications for 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 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.

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