The CONMED ALTRUS® Thermal Tissue Fusion System is indicated for open and laparoscopic techniques in general surgical and gynecological procedures for ligating (sealing) and dividing (cutting) of tissue when hemostasis is desired.

Device Description

The CONMED Altrus Thermal Tissue Fusion system consists of the following:

CONMED Altrus Thermal Tissue Fusion Energy Source .
CONMED Altrus Thermal Tissue Fusion Handpiece. .
The CONMED Altrus Thermal Tissue Fusion system employs focused thermal energy and pressure to simultaneously seal and/or seal and divide tissue. By applying direct heat instead of electrical, radio frequency or ultrasonic energy, the ConMed Altrus products can reduce the potential of unintended thermal injury.
The energy source uses an LCD display, a power supply, amplifiers and associated electronic components coupled with several microprocessors and associated software to provide the energy to the accompanying handpiece. The energy source works in harmony with the handpiece in a closed loop communication process. This process allows for the handpiece to provide information to the energy source regarding the tissue and adjust the predetermined electrical parameters in response to the effect on the tissue. As energy is delivered to the heaters in the distal portion of the handpiece, these heaters increase in temperature, by means of simple resistive heating. This thermal effect coupled with mechanical pressure on the vessel provides the means for the fusion of the tissue between the jaws to form the ligation (seal) The cutting effect is accomplished in a similar manner, with a different set of parameters controlled by the software.
The CONMED Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.
Energy is delivered to the heaters by a cable which provides power to the handpiece as well as allows for communication to and from the handpiece.

AI/ML Overview

The CONMED Altrus Thermal Tissue Fusion System is a medical device that uses focused thermal energy and pressure to seal and/or divide tissue, aiming to reduce the potential for unintended thermal injury compared to traditional electrosurgical methods.

Here's an analysis of the provided information regarding its acceptance criteria and the study that proves it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) premarket notification summary, does not explicitly list quantitative acceptance criteria in a table format. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence implies that the new device is as safe and effective as a legally marketed device.

Therefore, the "acceptance criteria" here are implicitly linked to the performance characteristics of the predicate devices. The document states:

Implicit Acceptance Criterion (based on Predicate)	Reported Device Performance (CONMED Altrus)
Function as intended (tissue sealing/division)	"Preclinical laboratory and performance testing were performed to ensure the devices functioned as intended..."
Meet design specifications	"...and met design specifications."
Substantially equivalent or better than predicate devices in function, construction, intended use, and indications for use	"Sufficient data was obtained to demonstrate the CONMED Altrus Thermal Tissue Fusion System was substantially equivalent to or better than the predicate devices." "The data provide demonstrates the CONMED Altrus Thermal Tissue Fusion system is substantially equivalent to the identified predicate devices in function, construction, intended use, and indications for use."
Compliance with applicable ISO 60601 Standards	"The CONMED Altrus Thermal Tissue Fusion System complies with all the applicable ISO 60601 Standards..."
Biocompatibility of patient/clinician contacting surfaces	"...as well as being wholly composed of biocompatible materials for all patient or clinician contacting surfaces."

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

The summary states that "Preclinical laboratory and performance testing were performed." However, it does not provide specific details about the sample sizes used for these tests, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This level of detail is typically found in the full testing reports that accompany a 510(k) submission, but is not included in this summary.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any testing. Given that the testing mentioned is "preclinical laboratory and performance testing," it is likely that engineering and clinical experts were involved in designing and evaluating the tests, but this is not explicitly stated.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Since the testing mentioned is "preclinical laboratory and performance testing" rather than human clinical trials involving subjective interpretation, a formal adjudication process (like 2+1 or 3+1 for image reviews) would not typically be applicable or described in this type of submission summary.

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

No MRMC comparative effectiveness study was done or is mentioned. The CONMED Altrus system is a surgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of improving human reader performance with AI assistance is not relevant to this device.

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

The CONMED Altrus Thermal Tissue Fusion System is a physical medical device (energy source and handpiece) used directly by a surgeon. It is not an algorithm that operates standalone. Therefore, a standalone algorithm-only performance test is not applicable and was not performed. The performance is inherently "human-in-the-loop" as a surgeon manipulates the device.

7. The Type of Ground Truth Used

Based on the description of "preclinical laboratory and performance testing," the ground truth would likely be established through:

Direct observation and measurement of physical outcomes: e.g., tensile strength of sealed vessels, burst pressure, time to seal, charring, tissue division efficacy, and temperature profiles.
Engineering specifications and standards: Confirming the device operates within defined parameters (e.g., power output, temperature control, mechanical force).
Comparative results against predicate devices: Demonstrating similar or superior performance to existing, legally marketed devices.

Pathology or outcomes data are not explicitly mentioned in this summary but could be part of comprehensive preclinical testing to assess tissue effects.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since the CONMED Altrus Thermal Tissue Fusion System is a hardware device with associated software controlling its operation, but not an AI/ML device in the modern sense, the term "training set" for algorithm development is not applicable or mentioned in this summary. The software parameters are likely determined through engineering design, testing, and optimization rather than an iterative machine learning training process.

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

As "training set" for an AI/ML algorithm is not applicable, the question of how its ground truth was established is also not relevant to this device. The "ground truth" for the device's design and operating parameters would be established through engineering principles, benchtop testing, and preclinical studies to ensure safety and effectiveness.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Conmed Electrosurgery. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "ELECTROSURGERY" in a smaller font. Above the logo is the number "K101534".

Page 1 of 2

NOV 2 4 2010

Summary of Safety and Effectiveness

Submitted by:	CONMED Electrosurgery Division14603 East Fremont AvenueCentennial, CO 80112 USATelephone: 303-269-8224Facsimile: 866-205-9495
Contact Person:	Shawn Riedel
Date Prepared:	March 29, 2010
Proprietary Name:	CONMED Altrus® Thermal Tissue Fusion System
Classification Name:	Electrosurgical Cutting and Coagulation Device and accessories21 CFR 878.440079 GEI
Predicate Device:	This product is similar in design, composition, and function to the:Valleylab LigaSure Vessel Sealing System (K981916) cleared August28, 1998, as well as theUltraCision Harmonic Scalpel System (K002906) cleared December15, 2000

Device Description:

The CONMED Altrus Thermal Tissue Fusion system consists of the following:

CONMED Altrus Thermal Tissue Fusion Energy Source .
CONMED Altrus Thermal Tissue Fusion Handpiece. .

The CONMED Altrus Thermal Tissue Fusion system employs focused thermal energy and pressure to simultaneously seal and/or seal and divide tissue. By applying direct heat instead of electrical, radio frequency or ultrasonic energy, the ConMed Altrus products can reduce the potential of unintended thermal injury.

The energy source uses an LCD display, a power supply, amplifiers and associated electronic components coupled with several microprocessors and associated software to provide the energy to the accompanying handpiece. The energy source works in harmony with the handpiece in a closed loop communication process. This process allows for the handpiece to provide information to the energy source regarding the tissue and adjust the predetermined electrical parameters in response to the effect on the tissue. As energy is delivered to the heaters in the distal portion of the handpiece, these heaters increase in temperature, by means of simple resistive heating. This thermal effect coupled with mechanical pressure on the vessel provides the means for the fusion of the tissue between the jaws to form the ligation (seal) The cutting effect is accomplished in a similar manner, with a different set of parameters controlled by the software.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a sequence of characters and numbers: "K101 534.". The characters and numbers are written in a simple, handwritten style. The sequence starts with the letter 'K', followed by the numbers '101', then a space, and then the numbers '534', ending with a period.

Page 2

ସ୍ନ ସ

The CONMED Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.

Energy is delivered to the heaters by a cable which provides power to the handpiece as well as allows for communication to and from the handpiece.

Indications For Use:

Technological Characteristics:

The technological characteristics of the system are similar to the predicate devices. The clinical applications for the sealing and/or separation of tissue are the same. The CONMED Altrus Thermal Tissue Fusion System is different from the predicates in that it utilizes thermal energy versus Radiofrequency energy (Ligasure) or Ultrasonic energy (UltraCision). Additionally the CONMED Altrus Thermal Tissue Fusion System utilizes thermal energy for cutting versus a mechanical blade found in the predicate (Ligasure).

Both predicate devices are used in general surgical procedures where ligation of vessels is performed.

The CONMED Altrus Thermal Tissue Fusion System complies with all the applicable ISO 60601 Standards as well as being wholly composed of biocompatible materials for all patient or clinician contacting surfaces.

Performance testing:

Preclinical laboratory and performance testing were performed to ensure the devices functioned as intended and met design specifications. Sufficient data was obtained to demonstrate the CONMED Altrus Thermal Tissue Fusion System was substantially equivalent to or better than the predicate devices.

Summary: The data provide demonstrates the CONMED Altrus Thermal Tissue Fusion system is substantially equivalent to the identified predicate devices in function, construction, intended use, and indications for use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, abstract design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

ConMed Corporation % Intertek Testing Services NA, Inc. Ms. Paula Wilkerson, RAC 2307 East Aurora road, Unit B7 Twinsburg, Ohio 44087

NUV 2 4 2010

Re: K101534

Trade/Device Name: CONMED® ALTRUS Thermal Tissue Fusion System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 11, 2010 Received: November 12, 2010

Dear Ms. Wilkerson:

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

{3}------------------------------------------------

Page 2 - Ms. Paula Wilkerson, RAC

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of niedical 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/A.boutFDA/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark A. Milkeren

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K101534

י "" 4 NOV 2

Device Name: CONMED ALTRUS® Thermal Tissue Fusion System

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Wilkerson

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

510(k) Number K101534

Page __ of __

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.