TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110

K042608 · Tecno Instruments (Pvt.) , Ltd. · GEI · Oct 18, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042608
• Device Name: TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110
• Applicant: Tecno Instruments (Pvt.) , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An electrosurgical cable is a device intended to connect Electrosurgical Generator with electrosurgical cutting & coagulation devices.

Device Story

Reusable bipolar cables; connect electrosurgical generators to bipolar forceps; facilitate electrical energy transfer for cutting and coagulation. Silicone construction; flexible; autoclavable; 3-meter length; single, two, or three-core configurations. Male/female end terminations; male connects to generator, female to forceps. Used in clinical settings by healthcare professionals. Provides physical link for electrosurgical procedures; enables energy delivery to surgical site; supports surgical cutting and coagulation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing in accordance with ANSI/AAMI HF18-2001 and IEC 60601-2-2 (3rd ed) for high-frequency surgical instruments.

Technological Characteristics

Silicone material; flexible; autoclavable. 3-meter length; single, two, or three-core configurations. Male/female end terminations. Complies with ANSI/AAMI HF18-2001 and IEC 60601-2-2 standards. Passive electrical conductor.

Indications for Use

Indicated for connecting electrosurgical generators to electrosurgical cutting and coagulation devices. No specific patient population, age, or gender restrictions provided.

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

• Quantum Instruments Corp. all models

Submission Summary (Full Text)

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: KO42608

#### Submitter's Identification: 1.

Tecno Instruments (Pvt) Ltd. 316-C Small Industrial Estate Sialkot-51340 (PAKISTAN) Tel: [phone] / 552681

Date Summary Prepared: October 11, 2004

#### Name of the Device: 2.

Tecno Reusable Bipolar Cables, Model (190-100 and 190-110)

#### 3. Common or Usual Name:

Electrosurgical Bipolar Cable

#### 4. Predicate Device Information:

Quantum Instruments Corp. all models

#### క. Device Description:

All bipolar forceps are connected to ES Generator through ES Cables. There is a male and female end termination on these cables, usually male end termination is connected with the ES Generator, while female end termination is connected with the bipolar forceps. The cable is made of Silicone material which is flexible as well as autoclavable. The silicone cable can be further classified as single-core, two-core and three-core cable depending on the intended use. The usual length of an electrosurgical cable is 3 meters.

#### 6. Intended Use:

An electrosurgical cable is a device intended to connect Electrosurgical Generator with electrosurgical cutting & coagulation devices.

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#### Comparison to Predicate Devices: 7.

The Tecno ES Cables are substantially equivalent the Quantum Instruments Corp. ES Cables, as well as other legally-marketed electrosurgical cables. It has same standard fitting on the ES generator side and same fitting on the instrument side.

The Tecno ES Cables is similar to the Quantum predicates in its intended use, safety and efficacy, design specification, power source and performance criteria. The Tecno device may differ from the predicates in color and size. However, these differences raise no issues of safety or effectiveness.

### Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence are as follows:

Testing was conducted in accordance with ANSI/AAMI HF18-2001 and IEC 60601-2-2 (3 ed), Medical Electrical Equipment - Part 2-2: Particular requirements of high frequency surgical instruments on Bipolar Cables. Test results concluded that cable meets the requirement of safety and effectiveness

#### Discussion of Clinical Tests Performed: 9.

Not Applicable

#### 10. Conclusions:

Testing performed on Techno instrument Bipolar cables indicated it is safe and effective and performs as well as the predicate device when used in accordance with the instruction for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2004

Tecno Instruments (PVT) Ltd. C/o Mohan Ratanchandani MDI Consultants, Inc. 55 Northern Boulevard Suite 200 Great Neck, New York 11021

Re: K042608

K042006
Trade/Device Name: Tecno Reusable Bipolar Cables, Model (190-100 and190-110) Regulation Number: 21 CFR 878.4400 Regulation Name: 21 OF R 9701 cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23, 2004 Received: September 24, 2004

Dear Mr. Ratanchandani:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 re(x) pe device is substantially equivalent (for the indications felerenced above une nave determines and marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device American be and continerec prior to May 20, 1978, are econdance with the provisions of the Federal Food, Drug. devices mat nave been receised in quire approval of a premarket approval application (PMA). and Costience Act (Act) that to not require subject to the general controls provisions of the Act. The I bu may, merclore, market the act include requirements for annual registration, listing of gencial controls provisions of vactice, 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 II your device is classified (500 above) als. Existing major regulations affecting your device can may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods or cents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dr o ibsualles sour device complies with other requirements of the Act that I DA has made a acternmentations administered by other Federal agencies. You must or any I cacial statutes and registments, including, but not limited to: registration and listing (21 Comply with an the Fee 870 cart 801); good manufacturing practice requirements as set CI IT rat 6077, laoomig (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mohan Ratanchandani

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter natification. The FDA finding of substantial equivalence of your device to a legally premated 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Exhibit B

Page 1 _ of _ 1 _

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Tecno Reusable Bipolar Cables, Device Name Model (190-100 and 190-110)

Indications For Use: Tecno Reusable Bipolar cables model (190-100 and indloutions intended to connect Electrosurgical Generator with electrosurgical cutting & coagulation devices.

Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use YES (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFT 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)