The VascuClear Precision Bipolar is a sterile, bipolar electrosurgical instrument with features to dissect, coagulate, and transect (cut) tissue with an integral knife blade. The device is compatible with a 5mm trocar and utilizes bipolar energy from standard bipolar generators. The instrument consists of three main parts as follows: 1. A handle with two sliding buttons. One button opens and closes the jaw of the device for grasping and clamping. The other button moves the integral knife blade back and forth. A standard pigtail cord is attached to the handle. 2. A shaft that connects the handle to the working end. The shaft is approximately 0.2 inches (5mm) in diameter and 16.5 inches (42cm) long from the handle to the tip of the instrument. 3. The working end of the instrument that consists of jaws, electrode surfaces and an integral knife with a dissecting tip.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the VascuClear Precision Bipolar. This submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the non-clinical performance and the basis for the substantial equivalence claim.

Acceptance Criteria and Device Performance

A formal table of acceptance criteria and reported device performance in the context of an AI/software study is not provided, as this document is for a physical electrosurgical instrument seeking 510(k) clearance based on substantial equivalence.

The document states that the acceptance criteria for the non-clinical testing were to confirm that:

"the modifications function as intended"
"did not adversely affect the operation of the instrument"
"Electrical safety and biocompatibility testing were also performed to confirm the safety and effectiveness of the VascuClear Precision Bipolar."

The reported device performance indicates that the tests performed met these criteria, leading to the conclusion that the modified device's technological characteristics and principles of operation are the same as the predicate device.

Study Information (Non-Clinical Testing)

The document refers to "NON-CLINICAL PERFORMANCE DATA" for the VascuClear Precision Bipolar.

Sample size used for the test set and the data provenance: Not applicable. This refers to non-clinical testing (e.g., bench testing for function, electrical safety, biocompatibility), not a test set of data. The provenance of the data would be internal laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be adherence to engineering specifications and safety standards, not expert interpretation of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to non-clinical testing, not a clinical data review process.
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: Not applicable. This is a physical medical device, not an AI/software product, and therefore no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an AI/software product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical performance data, the ground truth would be established by engineering specifications, international safety standards (e.g., for electrical safety), and biocompatibility standards.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of the document's relevance to your request:

The provided text from a 510(k) summary focuses on demonstrating "substantial equivalence" of a modified electrosurgical instrument to a predicate device. The performance data mentioned relates to non-clinical testing (functional, electrical safety, biocompatibility) to ensure the modifications did not negatively impact the device's operation. It does not contain information about clinical trials, AI/ML performance, or data sets and ground truth as typically described for software-based medical devices.

Summary

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NOV - 1 2010

K102983

Page 1 of 2

510(k) Summary

SUBMITTER:

Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004

CONTACT PERSON:

Scott Light Regulatory Affairs Manager Phone: (303) 467-6313 (303) 467-6502 Fax:

DATE PREPARED: September 30, 2010

DEVICE TRADE NAME: VascuClear Precision Bipolar

COMMON/USUAL NAME: Electrosurgical Instruments

CLASSIFICATION NAME: Electrosurgical, cutting & coagulation & accessories

CLASSIFICATION: Class II (Product Code GEI)

PREDICATE DEVICE: ClearGlide Precision Bipolar (K003587)

DEVICE DESCRIPTION:

The instrument consists of three main parts as follows:

1. A handle with two sliding buttons. One button opens and closes the jaw of the device for grasping and clamping. The other button moves the integral knife blade back and forth. A standard pigtail cord is attached to the handle.
1. A shaft that connects the handle to the working end. The shaft is approximately 0.2 inches (5mm) in diameter and 16.5 inches (42cm) long from the handle to the tip of the instrument.
The working end of the instrument that consists of jaws, electrode surfaces and an integral knife 3. with a dissecting tip.

INDICATIONS FOR USE:

The VascuClear Precision Bipolar is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of vessels.

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2983

Page 2 of ②

TECHOLOGICAL CHARACTERISTICS:

The technological characteristics and principles of operation of the modified device are the same as the predicate device. Both instruments consist of the same main components; a handle with two slide buttons, a two pin electrical connector, a stainless steel shaft, jaws with bipolar electrodes and an integral knife blade. Both instruments have mechanical jaws to grasp tissue and vessels. The "Clamp" button is used to open and close the jaws. The shape and material of the upper jaw was changed to improve its strength. The color of the upper jaw was changed from clear to blue to improve its visibility during use. Both instruments have a sharp edged knife to dissect tissue and transect vessels. The "Cut" button is used to move the knife blade back and forth. Coagulation occurs between electrode surfaces located within the jaws on both instruments. Coagulation energy is controlled externally for both instruments. Springs were added to the buttons to improve the ergonomics of the instrument for ease of use.

NON-CLINICAL PERFORMANCE DATA:

Testing was performed to confirm that the modifications function as intended and did not adversely affect the operation of the instrument. Electrical safety and biocompatibility testing were also performed to confirm the safety and effectiveness of the VascuClear Precision Bipolar.

CONCLUSIONS:

The VascuClear Precision Bipolar has the same intended use, principles of operation and technological characteristics as the predicate device. The VascuClear is substantially equivalent to the ClearGlide Precision Bipolar,

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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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

Sorin Group USA, Inc. % Mr. Scott Light Regulatory Affairs Manager 14401 West 65th Way Arvada, Colorado 80004

NOV - 1 2010

Re: K102983

Trade/Device Name: VascuClear Precision Bipolar Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 29, 2010 Received: October.07., 2010

Dear Mr. Light:

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 - Mr. Scott Light

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/ucm115809.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/ReportaProblem/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,

FOR

Mark N. Malkerson

DEP DIR

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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Indications For Use

NOV - 1 2010 K102983 510(k) Number (If known):

Device Name: VascuClear Precision Bipolar

Indications For Use:

The VascuClear Precision Bipolar is intended for endoscopic and open tissue dissection, bipolar coagulation, and transection of vessels.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K102983

. .

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.