(120 days)
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.
The provided 510(k) summary for the Biolitec Inc.'s 15W Ceralas Diode 1470nm Laser System (Model D1470) does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format of a diagnostic test.
Instead, this submission is centered on demonstrating substantial equivalence to existing predicate devices.
However, I can extract the relevant information regarding performance claims and the basis for market clearance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness comparable to predicate devices for intended use. | The Ceralas D1470 is "as safe and effective" as the predicate devices (CoolTouch CTEV Nd:YAG, CoolTouch CT3S Nd:YAG, Sciton Profile Multi-Platform System). |
| Technological Characteristics substantially similar to predicate devices. | The Ceralas D1470 has "substantially similar technological characteristics" to the predicate devices. |
| Intended Use/Indications for Use aligned with predicate devices. | The Ceralas D1470 has the "same intended uses and similar indications" as its predicate devices. Specifically, it's indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. |
| No new issues of safety or effectiveness raised by minor technological differences. | "The minor technological differences between the Ceralas D1470 and its predicate device raises no new issues of safety or effectiveness." |
| Demonstrated performance equivalent to predicate devices. | "Performance testing of the Ceralas D1470 demonstrates no significant difference as compared to the cleared CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a specific clinical trial or test set with a defined sample size for performance evaluation in the context of diagnostic accuracy. The "performance testing" mentioned is likely related to engineering and bench testing to demonstrate the laser's physical characteristics (e.g., power output, wavelength stability) and safety, rather than a clinical outcome study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The submission is not about a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of a test set requiring adjudication in the context of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a laser system, not a diagnostic imaging or AI-assisted diagnostic device where MRMC studies are typically performed.
6. Standalone Performance
The device is a standalone laser system. Its "performance" is inherent in its operation (e.g., light delivery, power). The document states "Performance testing... demonstrates no significant difference" compared to predicate devices, implying fundamental functional equivalency.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI is not relevant here. The "truth" established for this device's acceptance is its ability to perform its intended function (delivering laser light for soft tissue procedures and treatment of varicose veins) safely and effectively, which is assessed through comparison to established predicate devices and technical specifications.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of the Study/Evidence:
The "study" presented here is a demonstration of substantial equivalence rather than an independent clinical trial to establish new safety and efficacy endpoints. The manufacturer's approach is to assert that the Biolitec 15W Ceralas D 1470nm Diode Laser is as safe and effective as three identified predicate devices (CoolTouch CTEV Nd:YAG, CoolTouch CT3S Nd:YAG, and Sciton Profile Multi-Platform System) because:
- It has the same intended uses and similar indications (treatment of reflux of saphenous veins associated with varicose veins and varicosities).
- It has substantially similar technological characteristics.
- Performance testing (likely bench and engineering tests, not clinical patient studies) showed no significant difference compared to the predicate devices.
- Any minor technological differences raise no new concerns regarding safety or effectiveness.
Therefore, the acceptance criteria are implicitly met by demonstrating that the new device does not introduce new safety or efficacy concerns compared to legally marketed devices already established as safe and effective for the indicated uses.
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510(k) SUMMARY
Biolitec Inc.'s 15W Ceralas Diode 1470nm Laser System (Model D1470)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson 555 13th Street NW Washington DC 20004
Phone: (202) 637-5794 Facsimile: (202) 637-5910
Contact Person: Jonathan S. Kahan
Date Prepared: December 5, 2007
Name of Device and Name/Address of Sponsor
15W Ceralas D 1470nm Diode Laser (Model D1470)
Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Common or Usual Name
Diode Laser
Classification Name
Laser, Surgical Diode Laser System
Predicate Devices
CoolTouch Model CT3S Nd:YAG laser (K040921) CoolTouch CTEV and CT3S 1320 Nd:YAG laser (K051434) CoolTouch CTEV Nd:YAG Iaser (K061618) CoolTouch LC160 CTEV Nd:YAG laser (K062210) Sciton, Inc., Profile Multi-Platform System (K060033)
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073063
Intended Use / Indications for Use
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Technological Characteristics
The Ceralas D1470 has substantially similar technological characteristics as compared to the CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.
Performance Data
Performance testing of the Ceralas D1470 demonstrates no significant difference as compared to the cleared CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System.
Substantial Equivalence
The Ceralas D1470 is as safe and effective as the CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System. The Ceralas D1470 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas D1470 and its predicate device raises no new issues of safety or effectiveness. Thus, the Ceralas D1470 is substantially equivalent.
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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 features a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
FEB 27 Your
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolitec, Inc. % Hogan & Hartson, L.L.P. Mr. Jonathan S. Kahan Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K073063
Trade/Device Name: 15W Ceralas D 1470nm Diode Laser (Model D1470) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 5, 2007 Received: December 5, 2007
Dear Mr. Kahan:
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
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Page 2 - Mr. Jonathan S. Kahan
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 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 Postmarket 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 vours.
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
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Indications for Use Statement
510(k) Number (if known): K073063
Device Name: 15W Ceralas D 1470nm Diode Laser (Model D1470)
Indications for Use:
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Prescription Use __ X__ (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C,F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___________________________________________________________________________________________________________________________________________________________________
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073063
§ 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.