BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Devices are sterile, single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Description

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are sterile. single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

DEVICE COMPONENTS AND OPERATION:

1. Insulated Handle:
  The Insulated Handle encases the shaft and tip and one of the controlling mechanisms for the flow of saline. The activation of RF current is accomplished by footswitch.

There are two flow control mechanisms so the flow of saline (one directly on the handle and a roller clamp just proximal to the handle). Saline flow can be regulated by the user within the sterile field. The saline delivery tubing is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag.

The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug.

The insulation on the Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

1. Shaft and Electrode Tip:
  The electrode tip delivers RF energy for coagulation and delivers saline which is gravity-fed from an intravenous bag to the tip. There are three handle shape configurations: straight shaft, angled shaft, and laparoscopic shaft. Each is constructed of the same materials.

These devices use technology substantially equivalent to the Aquamantys SS4.0 Bipolar Sealer (K-063639) and the Aquamantys 6.0 Bipolar Sealer (K-052859). Both consist of an electrode tip that is used to coagulate tissue through the utilization of high frequency radiofrequency energy and saline.

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

These devices conform to the requirements of safety standard IEC 60601-2-2. There are no significant differences in technology, performance, or intended use between BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices and predicate devices. There are no new questions raised regarding safety or effectiveness.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device, structured according to your request.

Please note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence. It focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with clinical performance metrics as one might find for a novel device or a clinical trial. Therefore, some of the requested information (especially regarding clinical performance, expert involvement for ground truth, and human-in-the-loop studies) is not present in this type of regulatory submission and cannot be extracted.

Acceptance Criteria and Device Performance Study for BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for clinical performance. The "acceptance criteria" here are implicitly related to meeting the fundamental safety and effectiveness requirements by being similar to already approved devices. The "study" refers to the comparison made against the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit from Document)	Reported Device Performance (as demonstrated by equivalence)
Intended Use	Deliver RF energy and saline for coagulation of soft tissue and bone.	Identical to predicate devices (Aquamantys 2.3 and 6.0 Bipolar Sealer and SS4.0 Bipolar Sealer).
Technology	Utilize bipolar electrosurgery with saline enhancement.	"Uses technology substantially equivalent to" predicate devices.
Material/Construction	(Not explicitly stated as criteria, but implied through substantial equivalence)	"Each is constructed of the same materials" (referring to handle configurations, though not explicitly compared to predicate materials). All components designed for safe operation.
Sterilization	Must be sterile.	"Provided sterile, sterilized using ethylene oxide gas."
Single Use	Must be for single use only.	"For single use only."
Safety Standards	Conform to relevant safety standards.	"These devices conform to the requirements of safety standard IEC 60601-2-2."
Performance	Coagulation of soft tissue and bone (implicitly similar performance as predicates).	"There are no significant differences in technology, performance, or intended use between BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices and predicate devices."
Safety/Effectiveness	No new questions raised regarding safety or effectiveness.	"There are no new questions raised regarding safety or effectiveness."

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

This document does not describe a clinical "test set" with a specific sample size in the way one would for a clinical trial assessing performance. The evaluation is based on a comparison to predicate devices, focusing on technological equivalency, intended use, and safety standards. Therefore, there is no discrete sample size used for a test set or information on data provenance (e.g., country of origin, retrospective/prospective) in the context of clinical performance data in this 510(k) summary. The "test" is largely a comparison of specifications and design to the predicates, combined with compliance to safety standards.

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

This information is not provided as the submission is a 510(k) for substantial equivalence and does not detail a study where expert-established ground truth for a test set would be required for performance evaluation in the clinical sense.

4. Adjudication Method for the Test Set

This information is not provided as there is no described clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable/not provided. The device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human cognitive performance or AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided. The device is a surgical instrument and does not involve standalone algorithm performance in the context of AI or diagnostic imaging.

7. The Type of Ground Truth Used

The 'ground truth' in this 510(k) context is implicitly the established safety and effectiveness of the predicate devices (TissueLink: Aquamantys 2.3 Bipolar Sealer and 6.0 Bipolar Sealer, and Aquamantys SS4.0 Bipolar Sealer). The submission aims to demonstrate that the new device operates similarly and meets the same safety profiles as these already approved devices. Therefore, the "type of ground truth" is regulatory approval and established performance of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. As explained, the device is an electrosurgical tool, not an AI or machine learning model that would require a "training set."

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

This information is not applicable/not provided for the reasons stated in point 8.

Summary

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510(k) SUMMARY (per CFR21 807.92(c))

GENERAL INFORMATION:

MAR 1 8 2010

510k Owner's Name	Bovie Medical
Address	5115 Ulmerton Road
	Clearwater, Florida 33760-4004
Contact Person	Richard A. Kozloff
	Vice-President; Quality Assurance/Regulatory Affairs
	Telephone #: (727) 384-2323
	FAX Number: (727) 347-9144
Date Prepared:	March 9, 2010

DEVICE DESCRIPTION:

Trade Name:	BOSS Bipolar Operative Saline-Enhanced Sintered SteelCoagulation Device
Common Name:	Resection (Cutting and Coagulation) Device
Classification Name:	Electrosurgical Cutting and Coagulation Devices andAccessories (21CFR 878.4400; Class II;Product Code: GEI)

DEVICE DESCRIPTION:

Predicate Devices:

TissueLink: Aquamantys 2.3 Bipolar Sealer

K-052859

TissueLink: Aquamantys 6.0 Bipolar Sealer K-052859

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510(k) SUMMARY (per CFR21 807.92(c))

INTENDED USE:

DEVICE COMPONENTS AND OPERATION:

1. Insulated Handle:
  The Insulated Handle encases the shaft and tip and one of the controlling mechanisms for the flow of saline. The activation of RF current is accomplished by footswitch.

The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug.

The insulation on the Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

1. Shaft and Electrode Tip:
  The electrode tip delivers RF energy for coagulation and delivers saline which is gravity-fed from an intravenous bag to the tip. There are three handle shape configurations: straight shaft, angled shaft, and laparoscopic shaft. Each is constructed of the same materials.

5-3

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510(k) SUMMARY (per CFR21 807.92(c))

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

MAR 1 8 2010

Bovie Medical % Mr. Richard A. Kozloff Vice - President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004

Re: K092149

Trade Name: BOSS Bipolar Operative Saline-Enhanced Sintered Steel) Coagulation Device

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 9, 2010 Received: March 10, 2010

Dear Mr. Kozloff:

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 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

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Page 2 - Mr. Richard A. Kozloff

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/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,

Mark N. Melkerson

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

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Indications for Use

510(k) Number (if known):

Device Name: BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device

Indications for Use:

Prescription Use イ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

FOR M. MELKERSON

Sien Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092149

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.