The Kepler MedTec Disposable Bipolar Cables are intended to connect an electrosurgical device to an electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.

Device Description

The Kepler MedTec Disposable Bipolar Cable includes available in multiple colors. The Kepler MedTec Disposable Bipolar Cable is provided sterile.

Bipolar forceps (handpiece) are connected to a generator through a bipolar cable. The bipolar cable is flexible and delivers the electrical power from the generator to the binolar forcep. There is a male and female end termination on the cable. The male end termination (2-pin banana connector) is connected to the generator; the female end termination (2-pin plug type connector) to the bipolar forceps.

The Kepler MedTec Disposable Bipolar Cable is compatible with:

Bipolar Forceps using standard US connection with 5.8 mm spaced pins .
. VallyLab, Conmed, Medtronic and Bovie generators

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Kepler MedTec Disposable Bipolar Cable. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials for efficacy.

Here's a breakdown of the acceptance criteria and the "study" (which in this case is primarily a comparison) that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate)	Reported Device Performance (Kepler MedTec Disposable Bipolar Cable)
Intended Use/Indications for Use: Connecting an electrosurgical device to an electrosurgical generator; indicated for use with bipolar forceps during general surgical procedures.	Intended Use/Indications for Use: "Are intended to connect an electrosurgical device to an electrosurgical generator. Indicated for use with bipolar forceps during general surgical procedures." (Matches predicate)
Patient Usage: Single use disposable, provided sterile.	Patient Usage: "Single use disposable provided sterile." (Matches predicate)
Cable Length: Not explicitly an "acceptance criterion" but a feature for comparison.	Cable Length: 3660 mm (Equivalent to predicate's 366 cm).
Electrical Safety/EMC Compliance: IEC 60601-2-2 compliant.	Electrical Safety/EMC Compliance: "IEC 60601-2-2 compliant." Also explicitly stated: "Compliant with IEC 60601-2-2 (2006): Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment." (Matches predicate)
Sterilization Compliance:	"For EtO sterilization, compliant with ANSI/AAMI ISO 10993-7; ISO 11135-1; ISO 11137-1; ISO 11138-1"
Biocompatibility:	"Biocompatible"
Compatibility:	Compatible with "Bipolar Forceps using standard US connection with 5.8 mm spaced pins" and "VallyLab, Conmed, Medtronic and Bovie generators." (Implied acceptance criteria to function with common equipment)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of clinical testing. This submission did not involve a "test set" in the sense of patient data or clinical samples.
Data Provenance: Not applicable. The "study" for this 510(k) is a comparison of technical specifications and intended use against a legally marketed predicate device, not a clinical data collection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. Ground truth from experts is typically for diagnostic devices or those requiring expert interpretation of results, which is not the case for a disposable bipolar cable.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating the diagnostic or therapeutic effectiveness of a device compared to a standard of care, often with human readers interpreting results. This is beyond the scope of demonstrating substantial equivalence for a disposable cable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a passive accessory and does not involve algorithms or human-in-the-loop performance evaluation beyond its basic function of conducting electrical current safely.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the specifications and performance of the legally marketed predicate device (DeRoyal Industries, Inc. - Disposable Bipolar Electrosurgical Cable, K970993). The manufacturer established that the new device's features, intended use, and technical compliance meet or exceed those of the predicate. This is a regulatory "ground truth" rather than a clinical ground truth.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the machine learning or clinical study sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set. The "ground truth" for showing substantial equivalence was established by comparing the Kepler MedTec Disposable Bipolar Cable's specifications and performance to the pre-existing FDA-cleared predicate device (DeRoyal Disposable Bipolar cables). The applicant asserts that the devices share the same intended use, target population, clinical setting, and technology, and that any differences do not raise new issues of safety or effectiveness.

Summary

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K110462
Pg 1 of 2

Traditional 510(k) Summary

SEP 2 6 2011 .

Kepler MedTec A) SUBMITTED BY : 223 Avenue D Willston, VT 05495 Registration # 3008160705

CONTACT: Sharyn Orton, PhD MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 401-330-8264 508-231-8861 Fax

B) DEVICE NAME: Disposable Bipolar Cable

COMMON NAME: Disposable Bipolar Cable

DEVICE CLASS: 21 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories, Class II

PRODUCT CODE: GEI

C) PREDICATES:

. K970993 DeRoyal Industries, Inc. - Disposable Bipolar Electrosurgical Cable

D) DEVICE DESCRIPTION:

The Kepler MedTec Disposable Bipolar Cable includes available in multiple colors. The Kepler MedTec Disposable Bipolar Cable is provided sterile.

The Kepler MedTec Disposable Bipolar Cable is compatible with:

Bipolar Forceps using standard US connection with 5.8 mm spaced pins .
. VallyLab, Conmed, Medtronic and Bovie generators

E) INTENDED USE: The Kepler MedTec Disposable Bipolar Cable is intended to connect an electrosurgical device to an electrosurgical generator. It is indicated for use with bipolar forceps during general surgical procedures.

Kepler MedTec Traditional 510(k) Disposable Bipolar Cable September 2011 MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721

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K110462

pg 2 of 2

F) SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION

Device Features	Kepler MedTecDisposable Bipolar Cables	DeRoyalDisposable Bipolar cables
	TBD	K970993
Intended Use/Indicationfor Use	Are intended to connect an -electrosurgical device to anelectrosurgical generator.Indicated for use with bipolarforceps during general surgicalprocedures.	Indicated for use duringelectrosurgical procedures toprovide transmission ofelectrical power from aelectrosurgical generator to abipolar instrument
Patient Usage	Single use disposable providedsterile	Single use disposable providedsterile
Cable length	3660 mm	366 cm
Electrical safety/EMC	IEC 60601-2-2 compliant	IEC 60601-2-2 compliant

The Kepler MedTec Disposable Bipolar Cable has the same intended use, target population, clinical setting, and technology as the predicate device. Kepler MedTec believes that the differences between Kepler MedTec Disposable Bipolar Cable and the predicate (i.e. cable color, materials, any slight differences in dimensions; reusability) does not raise new issues of safety or effectiveness.

G) CONCLUSION

The Kepler MedTec Disposable Bipolar Cable has the same intended use, target population, clinical setting, and technology as the predicate devices. Kepler MedTec believes the Kepler MedTec Disposable Bipolar Cable is therefore substantially equivalent to the predicate devices based on intended usage, technology comparison and system performance.

H) TESTING

No clinical testing was submitted with this application.

I) OTHER

The Kepler MedTec Disposable Cable is:

� Compliant with IEC 60601-2-2 (2006): Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
For EtO sterilization, compliant with ANSVAAMI 10993-7; ISO 11135-1; ISO 11137-1; . ISO 11138-1
. Biocompatible

Kepler MedTec Traditional 510(k) Disposable Bipolar Cable September 2011 MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Kepler MedTec % MEDIcept. Inc. Sharyn Orton, Ph.D. 200 Homer Avenue Ashland, Massachusetts 01721

SEP 26 2011

· Re: K110462

Frade/Device Name: Kepler MedTec Disposable Bipolar Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 06, 2011 Received: September 08, 2011

Dear Dr. Orton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Sharyn Orton, Ph.D.

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 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.

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/CDRH/CDRHOffices/ucm11.5809.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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eric M. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K110462

Indications for Use Form

510(k) Number (if known):

Device Name: Disposable Bipolar Cable

..............................................................................................................................................................................

Indications for Use: The Kepler MedTec Disposable Bipolar Cables are intended to connect an electrosurgical device to an electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.

Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use 21CFR 801.109

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

..............................................................................................................................................................................

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110462

Kepler MedTec

Traditional 510(k) Disposable Bipolar Cable February 10, 2011 MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721

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.