The TissueLink Bipolar Floating Ball device is a sterile, single use bipolar electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of mention to be asou in colligation for hemostatio sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, general and operaire surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance:

Crucial Note: The provided 510(k) summary (K020574) for the TissueLink Bipolar Floating Ball device does not contain the information requested in points 1-9 regarding performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. The document is primarily a notification of intent to market, a summary of safety and effectiveness, and an FDA letter confirming substantial equivalence to a predicate device.

It explicitly states: "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..." This indicates that substantial equivalence was established, likely based on design, materials, and intended use comparison to the predicate, rather than new, extensive clinical performance studies with acceptance criteria as one might expect for a novel or high-risk device.

Therefore, many of the requested details cannot be extracted from this document. However, I can explain why they are not present based on the nature of a 510(k) submission focusing on substantial equivalence.

Detailed Response based on provided document:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Reported Device Performance
Not specified Not specified

Explanation: The 510(k) summary does not list specific acceptance criteria or report detailed device performance data from a dedicated study. For devices seeking substantial equivalence, performance is typically inferred through comparison to the predicate device's known performance characteristics (e.g., power output, temperature profiling, safety features) rather than novel clinical endpoints with predefined acceptance thresholds.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document does not describe a "test set" in the context of a performance study.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable.
- Qualifications: Not applicable.
Explanation: Since no specific performance test set or ground truth establishment is described, neither the number nor the qualifications of experts are mentioned.
Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
Explanation: No test set or ground truth adjudication process is outlined in the submission.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done? No.
- Effect Size of Human Readers Improvement: Not applicable.
Explanation: This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key aspect. The TissueLink Bipolar Floating Ball device is an electrosurgical tool, and an MRMC study for improved human reader performance with AI assistance would not be relevant in this context.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done? No.
Explanation: This device is a surgical instrument operated by a human, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable.
Type of Ground Truth Used:
- Type of Ground Truth: Not applicable.
Explanation: The document does not describe a performance study requiring a "ground truth" to evaluate the device's output or diagnostic accuracy. Instead, substantial equivalence to the predicate is the primary basis for clearance.
Sample Size for the Training Set:
- Sample Size: Not applicable.
Explanation: As there's no mention of a machine learning component or an AI algorithm, a "training set" in this context is irrelevant.
How the Ground Truth for the Training Set Was Established:
- How Established: Not applicable.
Explanation: Similar to point 8, the concept of a training set ground truth does not apply to this type of medical device submission.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Summary of what the document DOES demonstrate:

The provided 510(k) summary (K020574) focuses on demonstrating substantial equivalence to a predicate device (TissueLink Monopolar Floating Ball). This means the manufacturer presented evidence that the new Bipolar Floating Ball device is as safe and effective as the previously cleared predicate device, based on similarities in:

Intended Use: "hemostatic sealing and coagulation of soft tissue at the operative site."
Operating Principles: Bipolar electrosurgery.
Materials and Design: (Though not detailed in this summary, these would be compared in the full submission).
Performance Characteristics: (Again, usually compared against the predicate's known performance limits rather than generating new clinical data with acceptance criteria for a 510(k) unless there are significant technological differences).

The FDA's letter confirms they found the device "substantially equivalent" for the stated indications for use. This regulatory pathway typically relies on comparison to existing devices rather than extensive novel clinical trials with predefined acceptance criteria for performance, especially for devices considered Class II where general controls and special controls are deemed sufficient.

Summary

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510(k) Premarket Submission – TissueLink Medical, Inc. – Bipolar Floating Ball device

K020574

MAY 2 0 2002

510(k) Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Application Information:

Date Prepared:	February 19, 2002
Submitter:	TissueLink Medical Inc.
Address:	One Washington Center Suite 400Dover, NH 03820
Contacts:	Vicki S. AnastasiDirectory Regulatory Affairs
Telephone Number:	(508) 922-1622
FAX Number:	(508) 497-9925
	Roberta L. Thompson
	Vice President, Clinical, Regulatory and Quality
Telephone Number:	(603) 742-1515 ext. 106
Fax Number:	(603) 742-1488
Device Information:
Trade Name:	TissueLink Bipolar Floating Ball device
Common Name:	Electrosurgery Cauterizing Pen
Classification Name:	Electrosurgical cutting and coagulation device and accessories, 21CFR878.4400

Predicate Devices:

Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball device is made to:

TissueLink Monopolar Floating Ball

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, formed by three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2002

Ms. Vicki S. Anastasi Director, Regulatory Affairs TissueLink Medical, Inc. One Washington Center, Suite 400 Dover, NH 03820

Re: K020574

Trade/Device Name: TissueLink Bipolar Floating Ball Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: II Product Code: GEI Dated: February 19, 2002 Received: February 21, 2002

Dear Ms. Anastasi:

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 -. Ms. Vicki S. Anastasi

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Submission – TissueLink Medical, Inc. – Bipolar Floating Ball device

Indications for use Statement

Page -

510(k) Number (if known):

020

Device Name:

TissueLink Bipolar Floating Ball device

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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Over-The-Counter Use
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(Per 21 CFR 801.109)
Optional Format 1-

	Miriam C. Provost
	(Division Sign-Off)
	Division of General, Restorative and Neurological Devices
510(k) Number	K020574

TissueLink Medical, Inc.

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.