(24 days)
Quantum Instruments Corp. all models
Not Found
No
The device description and performance studies focus on the physical properties and electrical safety of a cable, with no mention of AI/ML algorithms or data processing.
No.
This device is an electrosurgical cable designed to connect an electrosurgical generator to cutting and coagulation devices; it does not directly provide therapy but is an accessory to a therapeutic system.
No.
The device is a cable intended to connect an electrosurgical generator with cutting and coagulation devices. Its function is to transmit energy for surgical procedures, not to diagnose a condition.
No
The device description clearly indicates the device is a physical cable made of silicone material, intended to connect hardware components (electrosurgical generator and forceps). It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect an Electrosurgical Generator with electrosurgical cutting & coagulation devices. This describes a surgical accessory used during a medical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a cable made of silicone for connecting electrosurgical equipment. This aligns with surgical accessories, not IVD devices which typically involve reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on in vitro testing.
Therefore, the Tecno Reusable Bipolar cables are surgical accessories, not IVD devices.
N/A
Intended Use / Indications for Use
An electrosurgical cable is a device intended to connect Electrosurgical Generator with electrosurgical cutting & coagulation devices.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Quantum Instruments Corp. all models
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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.
1
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.
2
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.
3
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
4
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)