The Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (Catalog No. 20-0XXX) is a single use product sold sterile and is intended for use in electrosurgery for coagulation and irrigation of tissue. This device is intended for use with the OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set or similar design of Bipolar Cord and Irrigation Tubing.

Device Description

OLSEN MEDICAL Single Use Bayonet Bipolar Irrigating Forceps is packaged sterile with a nonpyrogenic fluid pathway. It consists of an inlet pathway running into a transparent rigid PVC tube attached to the right hand prong of the bayonet forceps. This gives the surgeon a visual of the fluid pathway which facilitates the local fluid irrigation through the forceps. The device is for Single Use Only and is designed for use with bipolar electrosurgical units.

AI/ML Overview

The provided text describes a 510(k) summary for the Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps. This is a medical device submission, and the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving experts, algorithms, or ground truth as would be done for an AI/ML device.

Therefore, many of the requested points are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document

states the device "meet[s] or exceed[s] the minimum qualification criteria for the predicate device."
"conforms to applicable ASTM and ISO Standards."
"Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."

However, specific numerical acceptance criteria (e.g., "coagulation time < X seconds") and corresponding reported performance values for those criteria are not provided in this summary. The assessment of performance is based on demonstrating substantial equivalence to predicate devices, which implies the predicate devices already met established performance standards.

2. Sample size used for the test set and the data provenance:

Not applicable. This submission focuses on demonstrating substantial equivalence through comparison of design, materials, and intended use, along with conformity to industry standards. It does not describe a "test set" for performance evaluation in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of "ground truth" or "experts" in the context of establishing performance for this device as it's not an AI/ML diagnostic or predictive tool.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication process is described in this submission.

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:

Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

Not applicable. There is no "ground truth" discussed in the context of this device being a medical instrument for surgery. Performance is evaluated against engineering and safety standards, and equivalence to existing devices.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

Not applicable. As above, there is no AI/ML component or training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The "study" to prove the device meets criteria (or rather, is safe and effective) is a substantial equivalence assessment against two predicate devices:

Q2 Medical's Bayonet Forceps Bipolar Irrigating (K002752)
Dermacare's Disposable Bipolar Cord and Bipolar Forceps (K884656)

The document states:

"The new device is technologically the same as the predicate device."
"Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device."
"The device conforms to applicable ASTM and ISO Standards."
"Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."
A "Device Comparison Table" and "Device Comparison Photographs" were provided to the FDA to "supports our claim of substantial equivalence," highlighting the similarities and differences in intended use, materials, design, and functionality.

The FDA's letter of clearance (K080187) confirms that based on this information, the device was found to be "substantially equivalent" to the legally marketed predicate devices, thereby allowing it to proceed to market. This type of submission relies on the established safety and efficacy of the predicate devices.

Summary

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K80187

510 (k) Summary Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps

Company Name and Address:

Olsen Medical 3001 West Kentucky Street Louisville, KY 40211 Phone (502) 772-4280 Fax (502) 772-4282

Contact Information:

John Waters Director of Quality & Regulatory Affairs Olsen Medical 3001 West Kentucky Street Louisville, KY Telephone (502)772-4280 Facsimile (502)772-4282 Email johnw@olsenmedical.com

Device Classification:

Electrosurgical Cutting and Coaqulation Device & Accessories are Class II devices per 21 CFR 878.4400

Statement of Substantial Equivalence:

Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps are substantially equivalent to Q2 Medical's Bayonet Forceps Bipolar Irrigating (K002752) and Dermacare's Disposable Bipolar Cord and Bipolar Forceps (K884656) based on the device's similarity to the predicated device in intended use, materials, design, and functionality. Both of these predicate devices were owned, manufactured and marketed by Olsen Medical.

Indications for Use:

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EXECUTIVE SUMMARY

Description

Indications for Use

The Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (Catalog No. 20-0XXX) is a single use product sold sterile and is intended for use in electrosurgery for coagulation and irrigation of tissue. This device is intended for use with the Olsen Medical Integrated Irrigation Tubing and Bipolar Cord Set or similar design of Bipolar Cord and Irrigation Tubing.

Please read the instruction manuals supplied with the irrigation module and the bipolar coagulator or electrosurgical systems before using this product.

Summary of Performance Testing

The new device is technologically the same as the predicate device. Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device. The device conforms to applicable ASTM and ISO Standards. Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition.

Device Comparison Table

The attached table shows the differences and similarities between the Olsen Medical Integrated Irrigation Tubing and Bipolar Cord Set and the predicate device. This table supports our claim of substantial equivalence.

Device Comparison Photographs

The attached photographs of the predicate and the new device support our claim of substantial equivalence.

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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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Olsen Medical % Mr. John P. Walters Director of Quality & Regulatory Affairs 3001 West Kentucky Street Louisville, Kentucky 40211

Re: K080187

Trade/Device Name: Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 21, 2008 Received: April 25, 2008

Dear Mr. Walters:

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.

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. John P. Walters

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 Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (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 vours.

Mark M. Mullens

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):

Device Name: Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps

Indications For Use:

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Nilke Soln for axm

Division of General, Restorative, and Neurological Devices

510(k) Number K080187

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.