K Number
K140459
Device Name
ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM
Manufacturer
Date Cleared
2014-07-11

(137 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
More Information

No
The description mentions "microprocessors and associated software" and a "closed loop communication process" that adjusts parameters based on tissue information. It also mentions a "modification to the algorithm". While this indicates sophisticated control logic, there is no mention of AI, ML, or related concepts like training data, models, or neural networks. The system appears to use predetermined parameters and feedback loops rather than learning or adaptive algorithms.

Yes
The device is used for ligating (sealing) and dividing (cutting) blood vessels and tissue bundles during surgical and gynecological procedures to achieve hemostasis, which is a therapeutic effect aimed at stopping bleeding and facilitating healing.

No

The device is used to ligate (seal) and divide (cut) blood vessels and tissue, which are therapeutic actions, not diagnostic.

No

The device description explicitly states it consists of both an energy source and a handpiece, which are physical hardware components used to deliver thermal energy and pressure for tissue fusion and cutting. While it mentions software within the energy source, the device is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "ligate (seal) and divide (cut) blood vessels and tissue bundles" during surgical procedures. This is a direct therapeutic or surgical intervention on the patient's body.
  • Mechanism of Action: The device uses thermal energy and pressure to physically seal and cut tissue. This is a mechanical and thermal process applied directly to the tissue.
  • Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.

The Altrus Thermal Tissue Fusion System is a surgical device used for tissue manipulation and hemostasis during procedures, not for diagnostic testing.

N/A

Intended Use / Indications for Use

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.

Product codes

GEI

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

open and laparoscopic techniques in general surgical and gynecological procedures

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

Altrus® Thermal Tissue Fusion System ConMed Corporation K101534, Ultracision Harmonic Scalpel System Ethicon Endo-Surgery, Inc. K002906, Ligasure Vessel Sealing System Valleylab, Inc. K981916

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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):

1

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 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 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

2

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

F. Intended Use

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.

G. Indications for Use

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.

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

4

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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