Tecno Reusable Bipolar cables model (190-100 and 190-110) are intended to connect Electrosurgical Generator with electrosurgical cutting & coagulation devices.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tecno Reusable Bipolar Cables:

The provided document is a 510(k) summary for a medical device called "Tecno Reusable Bipolar Cables." This type of document is for regulatory submission to the FDA (Food and Drug Administration) and typically focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting extensive performance data against explicit acceptance criteria in the way a clinical study for a novel device would.

Based on the provided text, the device itself is a cable that connects an electrosurgical generator to electrosurgical cutting & coagulation devices. As such, the "performance" is primarily about its electrical and mechanical integrity, safety, and compatibility.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Electrical Safety	Compliance with relevant electrical safety standards for high-frequency surgical instruments (e.g., insulation integrity, leakage currents).	"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." This indicates the cables met the safety requirements specified in these established standards.
Functional Equivalence	Ability to successfully connect to standard ES Generators and bipolar forceps, facilitating electrosurgical cutting and coagulation.	"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." This implies functional equivalence, meaning it performs its intended connecting role.
Biocompatibility/Material Safety	Materials used are safe for human contact and can withstand sterilization (autoclaving).	"The cable is made of Silicone material which is flexible as well as autoclavable." While not explicitly stated as an "acceptance criterion," the material choice and autoclavable property are inherently tied to safety and reusability.
Durability/Reusability	Ability to withstand repeated use and sterilization cycles.	"Tecno Reusable Bipolar Cables." While no specific number of cycles or test results are provided, the "reusable" designation implies it meets some internal or industry standard for durability after sterilization, which would have been validated during the testing to the mentioned standards.
Overall Safety & Effectiveness	Does not raise new questions of safety or effectiveness compared to predicate devices.	"Test results concluded that cable meets the requirement of safety and effectiveness." "The Tecno device may differ from the predicates in color and size. However, these differences raise no issues of safety or effectiveness." This is a regulatory conclusion based on all testing.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of cables or components tested. The testing refers to "cable" in the singular ("cable meets the requirement") but this likely represents testing a representative sample or lot of the models (190-100 and 190-110).
- Data Provenance: Not explicitly stated, but typical for 510(k) submissions, these would be prospective engineering and bench tests conducted by the manufacturer or an accredited testing lab during the device development and validation phase. The country of origin for the manufacturing is Pakistan (Tecno Instruments (Pvt) Ltd. is located in Sialkot, Pakistan). However, the testing location is not specified, but it would have been conducted to international standards (ANSI/AAMI HF18-2001 and IEC 60601-2-2).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is an electrosurgical cable, and its performance (electrical safety, mechanical integrity) is evaluated against engineering standards and specifications, not against human expert interpretation or ground truth in the medical sense (like diagnosing a disease from an image). The "ground truth" here is the adherence to the technical requirements of the referenced standards.
Adjudication method for the test set:
- Not Applicable. This is not a study involving human adjudication of medical findings. The "adjudication" is met by verifying that test results demonstrably fall within the parameters set by the ANSI/AAMI and IEC standards.
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:
- No. An MRMC study is relevant for diagnostic or AI-assisted interpretation devices. This device is an electrosurgical cable; therefore, this type of study is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The testing performed (bench testing to ANSI/AAMI HF18-2001 and IEC 60601-2-2) assesses the device's inherent performance and safety characteristics in isolation, independent of human interaction during use. This is a "standalone" evaluation of the cable's physical and electrical properties. There is no algorithm involved.
The type of ground truth used:
- Engineering and Safety Standards: The "ground truth" is defined by the requirements and test methods outlined in the specific consensus standards, namely ANSI/AAMI HF18-2001 and IEC 60601-2-2 (3rd ed.). These standards specify acceptable limits for electrical characteristics, mechanical strength, material properties, and safety features for electrosurgical accessories.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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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: +92 432 552723 / 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:

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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)

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)

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.