STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE

K061835 · Stryker Instruments · GEI · Sep 8, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061835
• Device Name: STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE
• Applicant: Stryker Instruments
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator.

Device Story

Electrosurgical accessory; transfers power from electrosurgical generator to bipolar forceps. Reusable version supplied non-sterile (requires steam sterilization); disposable version supplied sterile (single-patient use). Used in clinical settings by healthcare providers. Connects to standard bipolar forceps and generator interfaces. Facilitates electrosurgical cutting and coagulation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrosurgical cable assembly; designed for standard bipolar forceps and generator connectors. Reusable variant requires steam sterilization; disposable variant provided sterile. No specific materials or software algorithms described.

Indications for Use

Indicated for transferring electrosurgical power to bipolar forceps from an electrosurgical generator. No specific patient population or contraindications described.

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

• Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable (K042608)
• Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable (K023996)

Submission Summary (Full Text)

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SEP - 8 2006

Page 1 of 2 stryker®

4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com

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Instruments

| K061835 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | |
| Device Sponsor: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
| Registration No.: | 1811755 |
| Trade Name: | Stryker Silverglide Bipolar Forceps Reusable Cable<br>Stryker Silverglide Bipolar Forceps Disposable Cable |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Name: | Bipolar Forceps Cable |
| Equivalent to: | K042608 Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable<br>K023996 Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable |
| Device Description: | The Stryker Silverglide Bipolar Forceps Reusable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Reusable Cable is supplied non-sterile. It must be steam sterilized before use.<br><br>The Stryker Silverglide Bipolar Forceps Disposable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Disposable Cables is supplied sterile, and is a single-patient use device. |
| Indications for Use: | The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. |
| Contraindications: | None |

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| Substantial Equivalence | 061835 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (SE) Rational: | The Stryker Silverglide Bipolar Forceps Reusable Cable and the Stryker<br>Silverglide Bipolar Forceps Disposable Cable have the same intended use<br>as the Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable<br>and the Modern Medical Equipment Mfg. Ltd. Disposable Bipolar<br>Forceps Cable. This device and the predicate device have the same<br>technological characteristics, the same operating principles and have similar<br>performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker Silverglide<br>Bipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar Forceps<br>Disposable Cable are substantially equivalent to legally marketed devices. |
| Submitted by: | Jean Sheppard |
| | Regulatory Analyst |
| | Signature |
| Date submitted: | |

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SEP - 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Instruments % Ms. Jean W. Sheppard Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K061835

Trade/Device Name: Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Biopolar forceps Disposable Cable Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 28, 2006 Received: June 29, 2006

Dear Ms. Sheppard:

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, Insting 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

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Page 2 - Ms. Jean W. Sheppard

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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely your

f-R Ralle

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 Statement

510(K) Number (if known): __ KO 6 1 8 35 Stryker Silverglide Bipolar Forceps Reusable Cable and Device Name: Stryker Silverglide Bipolar Forceps Disposable Cable Indications for Use: The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ or (per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ct. 22

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number: `k061835