(22 days)
Not Found
No
The summary describes a laser system and associated accessories for endovascular procedures, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is intended for endovascular coagulation of blood vessels, specifically the greater saphenous vein, to treat superficial vein reflux, which is a therapeutic intervention.
No
The device is described as being used for endovascular coagulation, which is a therapeutic procedure, not a diagnostic one. No diagnostic function is mentioned in the "Intended Use/Indications for Use" or "Device Description" sections.
No
The device description explicitly lists multiple hardware components, including needles, introducer sheaths, guidewires, and surgical accessories, in addition to the laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for endovascular coagulation of blood vessels," specifically the "greater saphenous vein in the thigh." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The components listed (needles, introducer sheaths, guidewires, etc.) are all instruments used for accessing and treating blood vessels within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, this device is a therapeutic medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux.
Product codes
GEX
Device Description
The Ceralas D 980 nm Laser with Endo Laser Vein System Kit consists of the cleared Ceralas D 980 and the ELVeS. Twelve versions of the ELVeS kit contain various combinations of the following components: (1) 19 gauge needle; (2) 21 gauge needle; (3) 5 French (F) introducer sheath; (4) 5 F introducer sheath/dilator; (5) a 0.035" J-tip guidewire; (6) a 0.018" J-tip guidewire; (7) surgical drape; (8) surgical tape; and (9) a surgical pen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater saphenous vein in 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
The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.
Key Metrics
Not Found
Predicate Device(s)
Ceralas D Diode Laser System (980 nm and 810 nm)
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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Ko24088 1/2
JAN 02 2003
510(k) Summary Ceralas Diode 980 nm Laser System with Endo Laser Vein System Kit
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: December 11, 2002
Name of Device and Name/Address of Sponsor
Ceralas D Diode Laser System with Endo Laser Vein System Kit biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser and accessories
Predicate Devices
Ceralas D Diode Laser System (980 nm and 810 nm)
Intended Use/Indication for Use
The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux.
Technological Characteristics
The Ceralas D 980 nm Laser with Endo Laser Vein System Kit consists of the cleared Ceralas D 980 and the ELVeS. Twelve versions of the ELVeS kit contain various combinations of the following components: (1) 19 gauge needle; (2) 21 gauge needle; (3) 5 French (F) introducer sheath; (4) 5 F introducer sheath/dilator; (5) a 0.035" J-tip guidewire; (6) a 0.018" J-tip guidewire; (7) surgical drape; (8) surgical tape; and (9) a surgical pen.
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K024088 2/2
Performance Data
The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.
Substantial Equivalence
The Ceralas D 980 nm Laser System with ELVeS has the same intended use and indications for use as the cleared Ceralas D 980 nm Laser System and Ceralas D 810 nm Diode Laser System and the same technological characteristics as the cleared Ceralas D 810 and the cleared Ceralas D 980. The technological differences between the Ceralas D 980 with ELVeS kit and the cleared Ceralas D 980 is the addition of the ELVeS kit, which is cleared for use with the Ceralas D 810 for the same indication. Thus, the ELVeS kit is not a new technological characteristic for diode lasers for endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux. Thus, the Ceralas D 980 with ELVeS is substantially equivalent to its predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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0 Corporate Boulevard Rockville MD 20850
Biolitec. Inc. c/o Hogan & Hartson, L.L.P. Jonathan S. Kahan 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K024088
Trade/Device Name: Ceralas Diode 980 nm Laser System with Endo Laser Vein System Kit Regulation Number: 878.4810 Regulation Name: Surgical laser and accessories Regulatory Class: Class II Product Code: GEX Dated: December 11, 2002 Received: December 11, 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
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Page 2 – Mr. Jonathan S. Kahan
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 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
Indications for Use Statement
K024088 510(k) Number (if known):
Device Name: Ceralas D 980 nm Diode Laser System with Endo Laser Vein System Kit
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)
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
(k) Number K024088