The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect.

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 modified Altrus Thermal Tissue Fusion System consists of the following devices:

Altrus Thermal Tissue Fusion Energy Source
Altrus Thermal Tissue Fusion Handpiece

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

The energy source uses as 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 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 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 modified ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a 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. The handpieces are available in 5mm and 10mm sizes with three shaft lengths for use in laparoscopic and open general surgical and gynecological procedures. Energy is delivered to the heaters by a cable which provides power to the handpiece as well as allows for communication between the handpiece and the energy source.

The purpose of this submission is to clear the following modifications to the device: (1) change in potting compound from Hysol to EPO-TEK 930-4: (2) change in dimensions and the addition of holes to the spacer component of the handpiece; (3) increase of the maximum number of activations to 450; (4) change in power supply and hardware components of the energy source; (5) modification to the algorithm, seal time and temperature to improve seal performance; (6) slight material changes to accommodate new suppliers; and (7) various changes to improve device manufacturability or cosmetic appearance

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ConMed Altrus® Thermal Tissue Fusion System:

Due to the nature of the provided document (a 510(k) summary for a medical device), the information is presented in a regulatory context, focusing on demonstrating substantial equivalence to predicate devices rather than detailing a specific clinical study with detailed acceptance criteria and performance metrics in the way a diagnostic AI device might.

Therefore, for several of your requested points, the information is either not present in this type of document or is framed differently than for an AI diagnostic study. I will answer based only on the text provided.

Acceptance Criteria and Device Performance

Acceptance Criterion (Implied)	Reported Device Performance
Compliance with design specifications	Device complies with design specifications.
Compliance with applicable standards (AAMI/ANSI ES60601-1:2005, ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, ISO 10993-7:2008)	Design verification testing demonstrates compliance with these standards.
Biocompatibility of patient-contacting materials (ISO 10993-1:2009)	Material analysis demonstrates compliance with ISO 10993-1:2009.
Substantial equivalence to predicate devices in performance	Performance testing demonstrates the device performance is substantially equivalent to the predicate devices.
Maintenance of safety and efficacy with modifications	Differences between predicate and modified design do not raise new risks of safety or efficacy.

Note on Acceptance Criteria: The document primarily uses the concept of "substantial equivalence" as the overarching acceptance criterion, meaning the modified device performs similarly to or better than previously cleared predicate devices without introducing new questions of safety or effectiveness. Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI diagnostic studies are not applicable here as it's a surgical instrument.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "non-clinical bench and simulated use testing" and "performance testing" but does not give specific sample sizes for these tests (e.g., number of tissue samples, number of seals performed).
- Data Provenance: Not specified. Given it's "non-clinical bench and simulated use testing," it implies laboratory or simulated environments, rather than human clinical data from a specific country. This is retrospective in the sense that it's testing a completed device design, but it's not "retrospective data" in the sense of analyzing past patient records.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a surgical device demonstrating performance related to tissue fusion and division, ground truth would likely be established through objective physical measurements (e.g., burst pressure, tensile strength of seals, histological analysis of tissue, visual inspection for effective cutting/sealing), rather than expert clinical consensus on images or diagnostic interpretations. The document does not mention human experts establishing ground truth for performance tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. As noted above, the "ground truth" for this type of device performance testing would typically be objective physical measurements, not human adjudication of diagnostic interpretations.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI diagnostic algorithms where human readers interpret medical images. The Altrus system is a surgical instrument.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone testing was done. The "non-clinical bench and simulated use testing" and "performance testing" referenced in section H assess the device's inherent performance characteristics (e.g., seal strength, cutting ability, thermal management) independently of a specific human operator's skill or interpretation. The device's "algorithm, seal time and temperature" were modified and presumably tested for their direct impact on seal performance. However, there's always a human using the surgical device, so it's not "algorithm-only" in the diagnostic sense, but the engineering performance tests are standalone.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the "type of ground truth." However, based on the nature of the device (thermal tissue fusion system), ground truth would likely be established through:
  - Physical measurements: e.g., burst pressure testing of sealed vessels, tensile strength of fused tissue, measurement of thermal spread, assessment of cutting completeness.
  - Histological analysis: Microscopic examination of treated tissue to confirm cell fusion and integrity.
  - Compliance with engineering specifications: Verification that the device operates within defined parameters (e.g., temperature, power output).
The sample size for the training set:
- Not applicable/Not specified. This is not an AI diagnostic algorithm that requires a "training set" of data in the machine learning sense. The device's "algorithm" controls its operational parameters (seal time, temperature) and would have been developed through engineering design, prototyping, and iterative testing, not by training on a large dataset.
How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons stated above. The device's internal parameters (like seal time and temperature for its algorithm) would have been established through engineering principles, material science, and empirical testing to achieve the desired tissue effect.

Summary

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510(k) Summary of Safety and Effectiveness

JUL 1 1 2014

, ----

ConMed Altrus® Thermal Tissue Fusion System

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number

A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502

Establishment Registration: 1320894

B. Company Contact

Lisa Anderson Manager, Regulatory Affairs T: (315) 624-3371 F: (315) 624-3225

C. Device Name

Altrus® Proprietary Name: Thermal Tissue Fusion System Common Name: Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Regulation Number: 878.4400 Product Code: GEI (79) Regulatory Class: = Panel: General and Plastic Surgery

D. Predicate Device

Device Name: Company Name: 510(k):

Altrus® Thermal Tissue Fusion System ConMed Corporation K101534

Device Name: Company Name: 510(k):

Ultracision Harmonic Scalpel System Ethicon Endo-Surgery, Inc. K002906

Device Name: Ligasure Vessel Sealing System Company Name: Valleylab, Inc. K981916

E. Device Description

510(k):

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The modified Altrus Thermal Tissue Fusion System consists of the following devices:

Altrus Thermal Tissue Fusion Energy Source
1108 1 1 1111

Image /page/1/Picture/3 description: The image shows a medical device with a screen. The device is gray and blue, and the screen displays a red line. There are some symbols on the bottom of the device. The device appears to be used for medical procedures.

Altrus Thermal Tissue Fusion Handpiece
Image /page/1/Picture/5 description: The image shows a medical device, possibly a surgical instrument. It has a handle with the word "ALTRUS" printed on it. The device features a long, thin probe extending from the front, suggesting it's designed for precise procedures.

The modified ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a parallel jaw closure mechanism with one flat iaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. The handpieces are available in 5mm and 10mm sizes with three shaft lengths for use in laparoscopic and open general surgical and gynecological procedures. Energy is delivered to the heaters by a cable which provides

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power to the handpiece as well as allows for communication between the handpiece and the energy source.

F. Intended Use

G. Indications for Use

H. Non-clinical Performance Testing / Substantial Equivalence

Non-clinical bench and simulated use testing demonstrated the modified Altrus Thermal Tissue Fusion System is substantially equivalent to the identified predicate devices with regard to intended use, materials, technology, and performance. Design verification testing demonstrates the devices comply with design specifications and the applicable sections of AAMI/ANSI ES60601-1:2005, ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, and ISO 10993-7:2008. Material analysis demonstrates the patient contacting materials of the modified Altrus handpiece comply with the requirements of ISO 10993-1:2009. Performance testing demonstrates the device performance is substantially equivalent to the predicate devices.

I. Conclusions

The differences between the predicate and the modified design do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the modified ConMed Altrus® Thermal Tissue Fusion System is safe and effective for its intended use and is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged around the caduceus in a circular fashion.

Public Health Service

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

July 11, 2014

ConMed Corporation Ms. Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica, New York 13502

Re: K140459

Trade/Device Name: Altrus Thermal Tissue Fusion System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 10, 2014 Received: June 11, 2014

Dear Ms. Anderson:

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 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

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Page 2 - Ms. Lisa Anderson

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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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 yours,

David Krause -S

for

Binita S. Ashar. M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140459

Device Name Altrus Thermal Tissue Fusion System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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.