(252 days)
The MedicalCV, Inc. Atrilaze™ Soft Tissue Ablation System is indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, dissection, vaporization, ablation, or coagulation of soft tissue.
The Altrilaze Soft Tissue Ablation System consists of a generator designed for the delivery of 810nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal rond. The system may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coaeglytion and vaporization of tissue as required by the clinician.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: | Non-toxic, non-hemolytic, non-pyrogenic |
| Materials used in the disposable probe must be biocompatible. | |
| Manufacturing Specifications Compliance: | Compliance to manufacturing specifications for: |
| - Power Output | - Power Output |
| - Tip Pull-Off | - Tip Pull-Off |
| - Pressure (for fiber optic delivery device) | - Pressure |
| - Flow (for fiber optic delivery device) | - Flow |
| Visual Evaluation of Lesions on Cardiac Tissue: | Lesions obtained using the Atrilaze System on cardiac tissue were visually evaluated. |
| Substantial Equivalence: | Demonstrated substantial equivalence to predicate devices (Biolitec/Ceramoptec Ceralas D10-25 and CardioFocus Diode Laser System) for the incision, dissection, vaporization, ablation or coagulation of soft tissue. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of an algorithm or diagnostic device. This document describes a traditional medical device (a surgical laser system), and the testing performed is related to its physical and functional characteristics, not an AI or diagnostic algorithm applied to data.
Data Provenance: Not applicable in the context of an AI/diagnostic device. The testing involved biocompatibility testing and performance testing of the physical laser system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a surgical laser system, not an AI or diagnostic algorithm that relies on expert interpretation of "ground truth" for a test set. The visual evaluation of lesions on cardiac tissue would likely involve medical professionals (e.g., surgeons, pathologists), but the number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not applicable as the device is a surgical laser system, not an AI or diagnostic algorithm that requires adjudication of expert opinions for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret cases, and is not applicable to a surgical laser device described here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study as would be understood for an algorithm was not done. The device is a surgical laser system, and its performance is inherently tied to its use by a clinician.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the verifiable outcomes of the testing performed on the physical device. This includes:
- Laboratory-established standards for biocompatibility: Demonstrating non-toxicity, non-hemolysis, and non-pyrogenicity.
- Manufacturing specifications: Compliance with objective measurements of power output, tip pull-off strength, pressure, and flow.
- Visual evaluation of tissue effects: Observation of lesions on cardiac tissue, likely compared against expected outcomes for surgical lasers.
- Predicate device performance: The ability to perform equivalently to established predicate devices for soft tissue incision, dissection, vaporization, ablation, and coagulation.
8. The Sample Size for the Training Set
This information is not applicable. The device is a surgical laser system, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of medical device.
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Section II
12040144
NOV 3 0 2004
Summary of Safety and Effectiveness (as required by 21 CFR 807.92)
Atrilaze™ Soft Tissue Ablation System
| Submitter: | MedicalCV, Inc.9725 South Robert TrailInver Grove Heights, MN 55077USA | Contact: | Denny StegerV.P. RA/QAPhone: 651 452 3000Fax: 651 452 4948 |
|---|---|---|---|
| Date of Summary: | November 18, 2004 | Classification Name: | Laser Instrument,Surgical Powered |
| Common Name: | Surgical Laser Instrument | Proprietary | Atrilaze™ Soft TissueAblation System |
Description of Device: The Altrilaze Soft Tissue Ablation System consists of a generator designed for the delivery of 810nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal rond. The system may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coaeglytion and vaporization of tissue as required by the clinician.
The MedicalCV Atrilaze Soft Tissue Ablation System is Statement of Intended Use: indicated for the delivery of 810nm laser light to soft tissue to include cardian tissue, driving surgical procedures. Indications include the incision, excision, dissection, vaportization, ablation or coagulation of soft tissue.
The Atrilaze Ablation System is not indicated for the treatment of cardiac Warning: 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.
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Technological Comparison: The Atrilaze Soft Tissue Ablation System is a self contained compact surgical laser that utilizes gallium aluminum arsenide (GaAAs) semiconductor diodes to generate near-infrared laser radiation. A fiber optic delivery system (probe) is coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissue(s). For purposes of this submission, the Atrilaze Soft Tissue Ablation System was compared to the following predicate device(s):
- Biolitec/Ceramoptec Ceralas D10-25 Fiber-coupled Diode Laser System (K001975) .
- CardioFocus Diode Laser System (K013201) .
The results of biocompatibility testing support that the materials used in the Testing: manufacture of the Altrilaze Soft Tissue Ablation disposable probe are non-toxic, non-hemolytic, and non-pyrogenic. All biocompatibility testing was conducted under Good Laboratory Practices per 21 CFR Part 58. Performance testing for the Atrilaze Soft Tissue Aboation System y rluded compliance to manufacturing specifications for Power Output, Tip Pull-Off, Pressure and Flow for the fiber optic delivery device, also visual evaluation of the lesions obtained using the Altrilaze Soft Tissue Ablation System on cardiac tissue was performed. Testing demonstrated that the Altrilaze Soft Tissue Ablation System is substantially equivalent to the predicated and ablation of soft tissue.
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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 with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MedicalCV, Inc c/o Mr. Denny Steger
Vice President Regulatory Affairs/Quality Assurance 9725 South Robert Trail Inver Grove Heights, MN 55077
Re: K040744 Trade/Device Name: Atrilaze™ Soft Tissue Ablation System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: August 31, 2004 Received: September 1, 2004
FEB 2 1 2008
Dear Mr. Steger:
This letter corrects our substantially equivalent letter of November 30, 2004.
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 (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 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.
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Page 2 - Mr. Denny Steger
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.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html
Sincerely yours,
el.qmee
Bram D. Zuekerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use Statement
K040744 510(K) Number:
Atrilaze™ Ablation System Device Name:
Indications for Use: The MedicalCV, Inc. Atrilaze™ Soft Tissue Ablation System is indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, dissection, vaporization, ablation, or coagulation of soft tissue.
The Atrilaze™ Ablation System is not indicated for the treatment of Warning: 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.
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Please do not write below this line - Continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative.
and Neurological Devices
510(k) Number K040744
§ 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.