(131 days)
Not Found
No
The summary describes a laser system and associated components for endovascular coagulation, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is intended for endovascular coagulation of blood vessels, specifically the greater saphenous vein, which is a medical treatment for a disease condition (superficial vein reflux).
No
The device is intended for endovascular coagulation, which is a treatment, not a diagnostic purpose. Its indications involve treating superficial vein reflux, not diagnosing it.
No
The device description explicitly lists physical components (radial fiber, access needle, introducer sheath/dilator, guidewire) and the intended use is a physical procedure (endovascular coagulation), indicating it is a hardware-based medical device.
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. This is a therapeutic procedure performed within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The components listed (radial fiber, access needle, introducer sheath/dilator, guidewire) are all tools used for accessing and treating blood vessels directly within the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to treat a condition directly within the body.
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.
For endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The ELVeS kit with Radial Fibers contain the following components: (1) radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ceralas D Diode Laser System (1470nm, 980 nm and 810 nm) with ELVeS Kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary Endo Laser Vein System Kit with Radial Fiber
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
OCT 2 7 2010
Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611
Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: June 7, 2010
Name of Device and Name/Address of Sponsor
Endo Laser Vein System Kit (ELVeS®) with Radial Fiber Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser accessories
Predicate Devices
Ceralas D Diode Laser System (1470nm, 980 nm and 810 nm) with ELVeS Kit
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 ELVeS kit with Radial Fibers contain the following components: (1) radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire.
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.
1
Substantial Equivalence
The ELVes with Radial Fiber uses previously cleared radial fiber technology (K924258) and has the same intended use and indications for use as the cleared Ceralas D 1470, 980 and 810nm ELVeS kits. 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 ELVeS is substantially equivalent to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle or bird with outstretched wings, rendered in black lines. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is also in black and is arranged to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biolitec, Inc. % Genmarhay BDA Mr. Harry Hayes 1349 Main Road Granville, Massachusetts 01034
OCT 2 7 2010
Re: K101712
Trade/Device Name: Endo Laser Vein System Kit with Radial Fiber Regulation Number: 21 CFR 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: October 12, 2010 Received: October 13, 2010
Dear Mr. Hayes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Mr. Harry Hayes
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
OCT 2 7 2010
Device Name: Endo Laser Vein System Kit with Radial Fiber
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 _ V (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Neil K. Arlen for nxn
Division of Oil, Gas
(Division S. Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101712