The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device consists of an Insulated Handle and a Shaft and Electrode Tip. The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current. The activation of RF current is accomplished by a single push button on the top of the handle. The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length 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 electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip. These devices use technology substantially equivalent to the TissueLink Solid Cylinder Monopolar Device (K014260). Both consist of an electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy. Resection Devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

AI/ML Overview

The provided text describes a 510(k) summary for the Saline Enhanced Electrosurgical Resection (SEER) Device, now called "Resection Device." However, it does not include a detailed study or specific acceptance criteria with reported device performance metrics in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.

Based on the provided information, here's what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary states that "There are no significant differences in technology, performance, or intended use between the Resection Device and the given predicate device," and that the device "conforms to the requirements of safety standard IEC 60601-2-2." This implies that the device meets some performance standards, but the specific acceptance criteria and detailed reported performance metrics are not explicitly listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The 510(k) summary does not describe any specific test set or clinical study conducted with human or animal subjects that would require sample sizes or data provenance details. The demonstration of safety and effectiveness appears to be primarily based on substantial equivalence to the predicate device and conformance to an international safety standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Since no specific test set or clinical study for performance evaluation is described, there's no mention of experts or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. 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

This information is not provided. The device is an electrosurgical tool, not an AI or imaging diagnostic device, so an MRMC study with human readers is not relevant to its intended use.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The "Resection Device" is a physical electrosurgical tool, not an algorithm, so the concept of standalone algorithmic performance doesn't apply. It's intended for human-in-the-loop use by a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided.

8. The sample size for the training set

This information is not provided.

9. How the ground truth for the training set was established

This information is not provided.

Summary of what is available regarding acceptance and performance:

The document emphasizes substantial equivalence to the TissueLink Solid Cylinder Monopolar Device (K014260) as the primary method of demonstrating safety and effectiveness.

Acceptance Criteria (Implied):
- Substantial equivalence to the predicate device (TissueLink Solid Cylinder Monopolar Device K014260) in technology, performance, and intended use.
- Conformity to safety standard IEC 60601-2-2.
- Sterility (sterilized using ethylene oxide gas).
- Single-use only.
Reported Device Performance (Implied):
- Functions for cutting and coagulating soft tissue using radiofrequency (RF) current and sterile saline, similar to the predicate.
- Meets dielectric withstand requirements for accessories.
- No significant differences in technology, performance, or intended use compared to the predicate.
- Meets the requirements of safety standard IEC 60601-2-2.

In essence, the "study" that proves the device meets acceptance criteria, as presented in this 510(k) summary, is the assertion of substantial equivalence to a legally marketed predicate device, along with adherence to a recognized international safety standard. No specific clinical performance study or testing data with sample sizes, expert evaluations, or ground truth establishment is detailed in this regulatory submission summary.

Summary

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Page 1 of 3

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

082 5568

GENERAL INFORMATION:

NOV 1 7 2008

510k Owner's Name Address

Bovie Medical 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs Telephone #: (727) 384-2323 FAX Number: (727) 347-9144

Date Prepared:

Contact Person

September 2, 2008

DEVICE DESCRIPTION:

Trade Name:

Common Name:

Classification Name:

Saline Enhanced Electrosurgical Resection (SEER) Device

Resection (Cutting and Coagulation) Device

Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878.4400; Class II; Product Code: GEI)

Predicate Device:

TissueLink Solid Cylinder Monopolar Device (K-01260)

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Page 2 of 3

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

DEVICE DESCRIPTION:

Predicate Devices:

TissueLink: Solid Cylinder Monopolar Device

K014260

INTENDED USE:

DEVICE COMPONENTS AND OPERATION:

1. Insulated Handle:
  The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current for the device.

The activation of RF current is accomplished by a single push button on the top of the handle.

The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length 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 of the Insulated Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

1. Shaft and Electrode Tip:
  The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip.

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KO82568

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

Page 3 of 3

These devices use technology substantially equivalent to the TissueLink Solid Cylinder Monopolar Device (K014260). Both consist of an electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.

Resection Devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

The Resection Device conforms to the requirements of safety standard IEC 60601-2-2.

There are no significant differences in technology, performance, or intended use between the Resection Device and the given predicate device. There are no new questions raised regarding safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2008

Bovic Medical % Mr. Richard Kozloff VP, Quality Assurance/Regulatory Affairs 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Re: K082568

Trade/Device Name: Resection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 6, 2008 Received: November 7, 2008

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. Iisting of devices, good manufacturing practice, 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 may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. Richard Kozloff

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prosmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse vents (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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

Enclosure

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Indications for Use

510(k) Number (if known): K082568

Device Name: Resection Device

Indications for Use:

Prescription Use V (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 (ODE)

Neil ReOphm formxm

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number K082568

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.