(29 days)
The MedicalCV, Inc. Atrilaze™ Surgical Ablation System is Indicated for delivery of 810nm 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 Altrilaze Malleable S-2 Disposable Probe is used with the Atrilaze™ Surgical Ablation System which consists of a generator designed for the delivery of 8 l 0nm 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, ablation, coagulation and vaporization of tissue as required by the clinician
The provided text does not describe an AI/ML powered device and therefore lacks the detailed information required to fulfill the request. The document describes a traditional medical device, the Atrilaze™ Malleable S-2 Disposable Probe, which is a surgical laser instrument.
Based on the provided text, here's what can be extracted about the device's performance and testing, but it will not fully address the detailed requirements for AI/ML acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Non-toxic, non-hemolytic, non-pyrogenic. Material change (stainless steel to nitinol) had no impact on previously gathered test results (K040744). |
| Manufacturing Specifications | Compliance to manufacturing specifications for Power Output, Tip Pull-Off, Pressure, and Flow. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: The document does not specify country of origin or whether the tests were retrospective or prospective. It only mentions that biocompatibility testing was conducted under Good Laboratory Practices per 21 CFR Part 58.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to a traditional device performance study as described here. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is a traditional device performance study, not one requiring expert adjudication of results.
5. 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:
- Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML device. The "device" itself is a probe that delivers laser light, and its performance is measured against physical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this device's testing would be based on engineering specifications and established laboratory testing protocols for biocompatibility and physical performance (Power Output, Tip Pull-Off, Pressure, Flow). It's not a diagnostic device where pathology or expert consensus would establish ground truth for a condition.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device. There is no "training set" or corresponding ground truth to establish.
In summary, the provided document details the regulatory submission for a physical surgical laser probe, not an AI/ML-powered device. Therefore, most of the requested information pertinent to AI/ML device validation is not present.
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OCT 1 1 2005
Section II
KOS249S
Summary of Safety and Effectiveness (as required by 21 CFR 807.92)
Atrilaze™ Malleable S-2 Disposable Probe
| 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: | August 23, 2005 | Classification Name: Laser Instrument,Surgical Powered | |||
| Common Name: | Surgical Laser Instrument | Proprietary | Atrilaze™ MalleableS-2 Disposable Probe |
Description of Device: The Altrilaze Malleable S-2 Disposable Probe is used with the Atrilaze™ Surgical Ablation System which consists of a generator designed for the delivery of 8 l 0nm 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, ablation, coagulation and vaporization of tissue as required by the clinician
Statement of Intended Use: The stated intended use of the Atrilaze Malleable S-2 Disposable Probe is the same as the MedicalCV Atrilaze™ Surgical Ablation System. It is indicated for the delivery of 810nm laser light to soft tissue to include cardiac tissue, during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissuc.
- Warning: The Atrilaze 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, mav occur as a complication of laser use, Burns can occur if the laser energy is not correctly applied. These complications may be scrious.
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Summary of S&E Page 2 of 2
The Atrilaze Malleable S-2 Disposable Probe is the same as that Technological Comparison: of the existing Non-Malleable Disposible Probe that was granted market clearance under K040744. The 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 Malleable S-2 Disposable Probe was compared to the following predicate device(s):
- MedicalCV, Inc. Non-Malleable Disposable Probe (K040744) .
- CardioFocus, Inc. Malleable Surgical Lightstic 180 (K013901) .
Results of biocompatibility testing support statement that the material change Testing: from stainless steel to nitinol had no impact on previously gathered test results (K040744). The probe is 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 Mallcable S-2 Disposable Probe included compliance to manufacturing specifications for Power Output, Tip Pull-Off. Pressure and Flow for the fiber optic light delivery device. Testing demonstrated that the Altrilaze Malleable S-2 Disposable Probe is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services. The seal features an abstract image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
FEB 2 1 2008
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 55077-4424
Re: K052495 Trade/Device Name: Atrilaze™ Malleable Ablation Probe 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: OLC, GEX Dated: September 9, 2005 Received: September 12, 2005
Dear Mr. Steger:
This letter corrects our substantially equivalent letter of October 11, 2005.
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,
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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Page 1 of 1
Indications for Use Statement
KOS 2495 510(K) Number:
Atrilaze™ Malleable Ablation Probe Device Name:
Indications for Use: The MedicalCV, Inc. Atrilaze™ Surgical Ablation System is Indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during murcated for deirery of Oromin labor agently of excision, 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. and perforation, rupture of tearing of thouse, may be and 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
(Division Division of General, Restorat and Neurological De
510(k) I
§ 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.