The ATRILAZE™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.

The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.

Device Description

The ATRILAZE™ Surgical Ablation System consists of a Laser Energy Generator, system cart, fluid delivery pump, fluid delivery tubing set and a fixed or flexible surgical ablation wand of various lengths. The wand is an intraoperative, sterile, single-use device designed to apply laser energy to cardiac tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the wand tip. The fluid delivery tubing may be provided together with the wand or as an accessory device. The fluid delivery pump and laser energy generator are sold separately. The wand includes a ridged metallic shaft or a flexible shaft of various lengths, and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.

AI/ML Overview

The provided text describes a 510(k) submission for the ATRILAZE™ Surgical Ablation System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or the device's ability to "meet acceptance criteria" in terms of clinical outcomes with specific numerical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/ML devices.

Therefore, the requested information elements related to clinical performance metrics, sample sizes for test and training sets, ground truth establishment by experts, and MRMC studies are not applicable to this type of device and submission. The "acceptance criteria" here refer to demonstrating that the new device performs similarly and safely to the predicate device under specified laboratory conditions.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an ablation system, the "acceptance criteria" are implied to be that the device adheres to its specifications and produces similar lesion characteristics to the predicate device.

Acceptance Criterion (Implied)	Reported Device Performance
Adherence to specifications (functional and safety)	"Testing demonstrated that adherence to specifications was demonstrated." This indicates that the device met its design and functional requirements.
Lesion characteristics (substantially equivalent to predicate)	"the lesions obtained using the ATRILAZE™ wand with 1083nm laser light are substantially equivalent to those obtained with the currently cleared ATRILAZE™ Surgical Ablation System wavelengths." This is the key equivalence finding for the new 1083nm wavelength.
Sterility and fluid path integrity	Both the new device and the predicate are "provided sterile with a sterile fluid path for saline delivery at the laser tip." (This is a design feature, not a performance metric from the "Testing" section, but implies an underlying acceptance criterion).
Compatibility with existing laser energy generator and connectors	Both devices "utilize the same laser energy generator and are connected via an SMA 905 connector." (Implies compatibility was accepted).

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

Sample Size for Test Set: Not specified. The document only states "Testing demonstrated that adherence to specifications was demonstrated." and that "lesions obtained using the ATRILAZE™ wand... are substantially equivalent." This implies a series of laboratory or bench tests were conducted, likely including tests on tissue phantoms or ex vivo tissue, but the specific number of tests or samples is not detailed.
Data Provenance: Not specified. Given the nature of the device, it's highly probable that the testing was conducted in a laboratory or bench setting rather than using patient data from a specific country, and would be considered prospective for the specific tests performed.

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

Number of Experts: Not applicable. For a device like a surgical ablation system, "ground truth" typically refers to physical measurements of ablation lesions (e.g., depth, width, morphology) rather than an expert's interpretation of images or clinical findings.
Qualifications of Experts: Not applicable. The "ground truth" in this context would be derived from direct physical measurements and potentially histopathological analysis, which would be performed by qualified laboratory personnel or pathologists, but "experts" in the sense of clinical decision-makers are not involved in establishing this type of ground truth for substantial equivalence.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving disagreements among multiple human readers for diagnostic tasks. This device demonstrates physical performance and substantial equivalence to a predicate, not diagnostic accuracy.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a surgical tool.
Effect Size of Human Readers with vs. without AI: Not applicable, as no MRMC study was conducted and the device is not an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable. This device is a surgical tool, not an algorithm. Its performance is always predicated on human operation. The "testing" mentioned would be analogous to a standalone performance test for a mechanical or electrical device, verifying its functional specifications.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for evaluating the "lesions obtained" would likely be based on physical measurements (e.g., macroscopic and/or microscopic assessment of lesion depth, width, volume) in tissue samples, potentially supported by histopathology to confirm cellular changes. For "adherence to specifications," the ground truth would be the specified engineering tolerances and performance parameters of the device itself.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML device that requires a "training set."

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.

Summary

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

Summary of Safety and Effectiveness (as required by 21 CFR 807.92)

AUG - 8 2008

ATRILAZE™ Surgical Ablation System [(K08XXXX)]

K081457

Submitter:	MedicalCV, Inc.9725 South Robert TrailInver Grove Heights, MN 55077USA
Contact:	Kirk S, HonourRegulatory, Clinical & Quality ManagementPhone: 651-452-3000Fax: 651-452-4948
Date of Summary:	[DATE]
Product Code:	GEX, OCL
Classification Name:	Laser Instrument, Surgical Powered
Common Name:	Surgical Laser Instrument
Proprietary Name	ATRILAZET™ Surgical Ablation System

Description of Device:

Statement of Intended Use:

Confidential MedicalCVTM, Inc. Revision: 21-May-2008

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

The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.

Warning:

The ATRILAZE™ Surgical Ablation System is not indicated for the treatment of cardiac arrhythmias.

The risk of actual damage to adjacent organs from the instrument exists and perforation, rupture or tearing of tissue, may occur as a complication of laser use. Burns can occur if the laser energy is not correctly applied. These complications may be serious.

Technological Comparison:

The ATRILAZE™ Surgical Ablation System was compared to the current ATRILAZE™ Surgical Ablation System (K060680).

Both the currently available device and the ATRILAZE™ wand as reviewed in this 510(k) are provided sterile with a sterile fluid path for saline delivery at the laser tip. Both fiber optic delivery systems utilize the same laser energy generator and are connected via an SMA 905 connector to deliver laser energy to the target tissue.

For purposes of this submission, the ATRILAZE™ Surgical Ablation System was compared to the following predicate devices: ATRILAZE™ Surgical Ablation System (K060680).

Testing:

Testing demonstrated that adherence to specifications was demonstrated and the lesions obtained using the ATRILAZE™ wand with 1083nm laser light are substantially equivalent to those obtained with the currently cleared ATRILAZE™ Surgical Ablation System wavelengths.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MedicalCV, Inc. % Mr. Kirk S. Honour Regulatory, Clinical & Quality Management 9725 South Robert Trail Inver Grove Heights, Minnesota 55077-4424

AUG - 8 2008

Re: K081457

Trade/Device Name: ATRILAZETM Surgical Ablation System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insgrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 21, 2008 Received: May 28, 2008

Dear Mr. Honour:

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.

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

Page 2 - Mr. Kirk S. Honour

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 Protmarket, 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 yours.

Mark N Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(K) Number: K081457

ATRILAZE™ Surgical Ablation System Device Name:

Indications for Use:

The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.

Warning:

The ATRILAZE™ Surgical Ablation System is not indicated for the treatment of cardiac arrhythmias.

Prescription Use X (Per 21 CFR 801.109)

Over--the-Counter Use

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

Division

Division Jign-Ui Division of General, Restorative, and Neurological Devices

510(k) Number /ic(r)457

Confidential MedicalCVTM, Inc. Revision: 21-May-2008

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.