(27 days)
The Medical CV Atrilaze™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm 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 Surgical Ablation System consists of a generator designed for the delivery of 810nm or 1064nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal end. The system may be used in conjunction with surgical treatment for hemostasis, incision, coagulation and vaporization of tissue as required by the clinician.
Here's a breakdown of the acceptance criteria and study information for the Atrilaze™ Surgical Ablation System, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Power Output (Manufacturing Specs) | Not explicitly stated as a numerical acceptance criterion, but "compliance to manufacturing specifications for Power Output" was a performance test. The results generally indicate compliance as substantial equivalence to the predicate device was found. |
| Lesion Characteristics (Visual) | Not explicitly stated as a numerical acceptance criterion, but visual evaluation of lesions obtained using the 1064nm wavelength on cardiac tissue was performed. |
| Lesion Characteristics (Histology) | Not explicitly stated as a numerical acceptance criterion, but histology evaluation of lesions obtained using the 1064nm wavelength on cardiac tissue was performed. |
| Substantial Equivalence | Testing demonstrated that lesions obtained using the Nd:YAG laser at 1064nm wavelength are substantially equivalent to those obtained with the currently cleared laser at 810nm wavelength (the predicate device K040744 & K052495). This is the overarching acceptance criterion for the modification to the device (new wavelength). |
| Biocompatibility | For the fiber optic delivery systems (probes), the acceptance criteria (and results from prior submissions K040744 & K052495) were that the materials are non-toxic, non-hemolytic, and non-pyrogenic. Since there was no change to the probe design, packaging, or sterilization, additional testing was not required for the current submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "visual and histology evaluation of the lesions obtained using 1064nm wavelength on cardiac tissue" but does not specify the number of lesions or tissue samples.
- Data Provenance: Not explicitly stated, but given the nature of the device (surgical ablation system) and the testing (cardiac tissue), it is highly likely to be pre-clinical/laboratory testing on ex vivo or in vivo animal models, rather than human data. The document does not specify country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated, though it can be inferred that the visual and histology evaluations would be performed by qualified professionals such as pathologists or biomedical researchers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. Given the context of visual and histology evaluation, single or multiple expert assessments would be expected, but no specific adjudication process (e.g., 2+1, 3+1) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed. The study focused on technical performance and substantial equivalence of the device's output (lesion characteristics) when using a new wavelength, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical surgical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study would not be relevant.
7. Type of Ground Truth Used
- Direct Measurement/Observation and Expert Evaluation:
- Histology: Provides microscopic examination of tissue, considered a high-fidelity ground truth for tissue effects.
- Visual Evaluation: Direct observation of the lesions.
- Power Output Compliance: Measured against manufacturing specifications.
8. Sample Size for the Training Set
- Not applicable. This device is a physical surgical laser system and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
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APR 1 1 2006
Page I of 2
Section II
Summary of Safety and Effectiveness (as required by 21 CFR 807.92)
Atrilaze™ Surgical 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: | March 14, 2006 | Classification Name: | Laser Instrument,Surgical Powered |
| Common Name: | Surgical Laser Instrument | Proprietary | AtrilazeTM SurgicalAblation System |
The Altrilaze Surgical Ablation System consists of a generator Description of Device: designed for the delivery of 810nm or 1064nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal end. The system may be used in conjunction with surgical treatment for hemostasis, incision, coagulation and vaporization of tissue as required by the clinician.
The MedicalCV Atrilaze Surgical Ablation System is indicated Statement of Intended Use: for the delivery of 810mm or 1064nm 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 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 faser energy is not correctly applied. These complications may be serious.
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Technological Comparison: The current Atrilaze Surgical Ablation System (K040744 & K052495) consists of a standalone surgical laser emitting 810mm light and a disposable fiber optic delivery system (probe). The fiber optic delivery system is coupled to the laser via an SMA 905 connector to deliver laser radiation to the targeted tissue. The proposed modification to the currently marketed Atrilaze™ Surgical Ablation System is to provide the end-user with an alternate laser generator (wavelength) for ablating soft tissue by providing the end user the option of using either a gallium aluminum arsenide (GaAlAs) semiconductor diode laser at a wavelength of 810nm or a Neodymium-yttrium-aluminum-garnet (Nd:YAG) laser at a wavelength of 1064nm. There is no change to the currently available fiber optic delivery systems (probes). which are coupled to either laser via an SMA 905 connector to deliver laser radiation to the target tissue. For purposes of this submission, the Nd: YAG laser (1064nm) used in conjunction with the Atrilaze Surgical Ablation System was compared to the following predicate device:
Medical CV Atrilaze™ Surgical Ablation System (K040744 & K052495) .
The results of biocompatibility testing conducted on the disposable fiber optic Testing: delivery systems (probes) contained in the original submissions (K040744 & K052495) support that the materials used in the manufacture of the disposable probe are non-toxic, non-hemolytic, and non-pyrogenic. All biocompatibility testing was conducted under Good Laboratory Practices per 21 CFR Part 58. Since there has been no change to the design, packaging and/or sterilization process for the disposable probe additional biocompatibility or sterilization testing was determined not to be required.
Performance testing for the Atrilaze Surgical Ablation System utilizing the Nd: Y AG 1064nm laser included compliance to manufacturing specifications for Power Output, with visual and histology evaluation of the lesions obtained using 1064nm wavelength on cardiac tissue. Testing demonstrated that lesions obtained using the Nd: Y AG laser at 1064nm wavelength are substantially equivalent to those obtained with the currently cleared laser at 810nm wavelength.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
FEB 2 1 2008
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MedicalCV, Inc. c/o Mr. Denny Steger VP. Regulatory Affairs/Ouality Assurance 9725 South Robert Trail Inver Grove Heights, MN 55077
Re: K060680 Trade/Device Name: Atrilaze™ Surgical 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: March 14, 2006 Received: March 15, 2006
Dear Mr. Steger:
This letter corrects our substantially equivalent letter of April 11, 2006.
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.
elzmell
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(K) Number:
Device Name: Atrilaze™ Surgical Ablation System
Indications for Use: The Medical CV Atrilaze™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm 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™ Surgical Ablation System is not indicated for the treatment Warning: 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.
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 | K060680 |
§ 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.