(279 days)
Ceralas D Diode Laser System, VNUS Closure System, DioMed, Inc.'s 810 nm Surgical Laser and EVLT Procedure Kit Laser
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No
The summary describes a diode laser system for endovascular coagulation and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "endovascular coagulation of blood vessels" and "superficial vein reflux," which are therapeutic applications aimed at treating medical conditions.
No
The device is described as a laser system for endovascular coagulation of blood vessels, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states "Ceralas D 980 nm Diode Laser System (Model D50)", indicating a hardware system (laser) is the primary component, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endovascular coagulation of blood vessels," specifically the "greater saphenous vein of the thigh." This is a therapeutic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
- Device Description: The description is of a laser system used for a surgical procedure.
- Lack of IVD-related information: The document does not mention any aspects related to laboratory testing, specimen analysis, or diagnostic information derived from samples.
Therefore, the Ceralas D 980 nm Diode Laser System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ceralas D 980 nm Diode Lasers are intended for endovascular coagulation of blood vessels. The Ceralas D 980 nm Diode Lasers are indicated for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 60601-1; IEC 601-2-22; and EN 60825-1.
In addition, biolitec performed a single arm, open study at a single site with two clinical investigators to determine the ability of the Ceralas D Laser System to treat superficial vein reflux of the greater saphenous vein. Ninety-six percent of the patients enrolled in the study achieved complete closure of the vein. All adverse events were of limited duration and resolved completely.
Key Metrics
Ninety-six percent of the patients enrolled in the study achieved complete closure of the vein.
Predicate Device(s)
Ceralas D Diode Laser System, VNUS Medical Technologies' VNUS Closure System, DioMed, Inc.'s 810 nm Surgical Laser and EVLT Procedure Kit Laser
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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AUG 1 3 2002
510(k) Summary Ceralas Diode Laser System (K013691)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611
Contact Person: Carol J. Morello, V.M.D. Date prepared: May 29, 2001
Name of Device and Name/Address of Sponsor
Ceralas D 980 nm Diode Laser System (Model D50) biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser
Predicate Devices
Ceralas D Diode Laser System VNUS Medical Technologies' VNUS Closure System DioMed, Inc.'s 810 nm Surgical Laser and EVLT Procedure Kit Laser
Intended Use/Indication for Use
The Ceralas D 980 nm Diode Lasers are intended for endovascular coagulation of blood vessels. The Ceralas D 980 nm Diode Lasers are indicated for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Performance Data
The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 60601-1; IEC 601-2-22; and EN 60825-1.
In addition, biolitec performed a single arm, open study at a single site with two clinical investigators to determine the ability of the Ceralas D Laser System to treat
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013691 2/2
superficial vein reflux of the greater saphenous vein. Ninety-six percent of the patients enrolled in the study achieved complete closure of the vein. All adverse events were of limited duration and resolved completely.
Substantial Equivalence
The Varicose Vein Ceralas D has the same intended use and indications for use as VNUS Medical Technologies' VNUS Closure System and Diomed, Inc.'s 810 nm Surgical Laser and EVLT Procedure Kit laser. In addition, the superficial vein reflux Ceralas D is the exact same device as the cleared Ceralas D. Furthermore, clinical data demonstrate that the superficial vein reflux Ceralas D is substantially equivalent for endovascular coagulation of blood vessels in patients with superficial vein reflux.
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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 lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2002
Biolitec. Inc. c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-5910
Re: K013691
Trade/Device Name: Ceralas D 980nm Diode Laser Systems Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: May 29, 2002 Received: May 29, 2002
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 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.
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Page 2 – Mr. Jonathan Kahan
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vour
Sincerely yours,
Stypt Rhodes
ia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 1
Indications for Use Statement
510(k) Number (if known): K013691
Device Name: Ceralas D Diode Laser System
In addition to the already cleared indications:
The Ceralas D 980 nm Diode Lasers are indicated for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)
Stup Edwards
(Divisio Division of General Bertorative and Neurological Devices
510(k) Number_K DI3691