(90 days)
Ceralas D10-60 810nm Diode Laser, Diomed 810nm Surgical Laser
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or descriptions of training/test sets, which are typical indicators of AI/ML technology in medical devices. The focus is on the endovascular coagulation of a vein using a laser, and the predicate devices are also laser systems.
Yes
The intended use describes "endovascular coagulation," which is a therapeutic procedure to treat superficial vein reflux.
No.
The intended use is for endovascular coagulation, which is a treatment, not a diagnosis.
No
The summary describes a device used for endovascular coagulation, which is a physical procedure requiring hardware (likely a laser or similar energy source) to perform the coagulation. The predicate devices listed are also surgical lasers, further indicating a hardware component. The lack of information about software in the summary also supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux." This describes a therapeutic procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description (or lack thereof): While the device description is not found, the intended use clearly points to a device used within the body for treatment, not for analyzing samples.
- Anatomical Site: The anatomical site is the "greater saphenous vein of the thigh," which is a part of the patient's circulatory system, not a specimen being analyzed.
Therefore, the device described is a therapeutic device used for a medical procedure, not an IVD.
N/A
Intended Use / Indications for Use
In addition to the already cleared indications for use: For use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Product codes
GEX
Device Description
The Ceralas D10-60 Diode Laser and the predicate devices operate with a power range of 1-60W in the CW or pulsed mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater saphenous vein of the thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ceralas D10-60 810nm Diode Laser, Diomed 810nm Surgical Laser
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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020835 1/2
JUN 1 2 2002
510(k) Summary Ceralas Diode Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611
Contact Person: Carol J. Morello, V.M.D. Date prepared: March 7, 2002
Name of Device and Name/Address of Sponsor
Ceralas Diode Laser System (Model D10-60) Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Classification Name
Surgical laser
Predicate Device
Diomed 810nm Surgical Laser Biolitec Ceralas D10-60 810nm Diode Laser
Intended Use / Indications For Use
In addition to the already cleared indications for use: For use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
1
020835 2/2
Technological Characteristics
The Ceralas D10-60 Diode Laser and the predicate devices operate with a power range of 1-60W in the CW or pulsed mode.
Substantial Equivalence
The new Ceralas D10-60 has the exact same intended use as the cleared Ceralas D10-60 and the Diomed Laser and the same indications as the combination of Ceralas D10-60 and Diomed Laser. The new Ceralas D10-60 also have the same technological characteristics as the cleared Ceralas D10-60 and very similar technological characteristics as the Diomed Laser. The minor technological differences between the new Ceralas D10-60 and the Diomed Laser raise no new questions of safety or effectiveness. Thus, the new Ceralas D10-60 is substantially equivalent.
2
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines above them that could represent hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2002
Biolitec. Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson 555 Thirteenth Street, N. W. Washington, D.C. 20004-1109
Re: K020835
Trade Name: Ceralas D10-60 810 Diode Laser System and ELVS Procedure Kit Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: February 27, 2002 Received: March 14, 2002
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
3
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" (21CFR 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 yours,
Stupt Plurde
Celia 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
4
- cc:
- HFZ-404 510(k) Staff .
- HFZ-410 DGRND
. D.O
5
. 510(k) Number (if known):_K O 20 8 3)
Device Name: Ceralas D 10-60 810 nm Diode Laser System
Indications for Use:
In addition to the Ceralas D 10-60 810 nm Diode Laser System's previously-cleared indications, this device is indicated for 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)
Hypt Plurds
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020835
Prescription Use \ (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)