(301 days)
No
The summary describes a medical device kit for endovascular coagulation using a laser fiber, focusing on the physical design of the fiber and clinical performance compared to predicate devices. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
Yes
The device is intended for "endovascular coagulation of blood vessels" to treat "superficial vein reflux" in the Greater Saphenous Vein, which directly addresses a medical condition.
No
The device is intended for endovascular coagulation, a treatment procedure, not for diagnosing conditions.
No
The device description explicitly lists physical components (fiber, needle, sheath/dilator, guidewire) and describes a physical procedure (endovascular coagulation), indicating it is a hardware-based medical device.
No, 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 of the thigh." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device components (fiber, needle, sheath, guidewire) are all designed for a surgical or interventional procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with specimens in this way.
The device is clearly intended for a therapeutic intervention within the body, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The device is intended for endovascular coagulation of blood vessels. Th indicated for the endovascular coagulation of the Greater Saphenous Vein of the thigh in patients with superficial vein reflux.
Product codes
GEX
Device Description
The ELVeS kit with 2 Ring Radial Fibers contain the following components: (1) 2 ring radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K101712 and K112299 except for the 2 ring radial tip design. The design provides 2 adjacent points of radial emission.
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
The clinical effectiveness is equivalent to its predicate devices, as evidence by several clinical evaluations.
In one study, the circumferential ablation of the vein with introduction of the 2 ring radial fiber provided a better outcome following EVLA: 1) reduction in recanalization rates 2) reduction in applied Watt/LEED. & 3) reduction in adverse events; including bruising, pain, induration & numbness. The study supported the conclusion concluded that EVLA with 2 ring radial fiber for GSV and SSV is an effective and safe procedure, giving the advantage of decreasing delivered energy during the procedure and also providing very good occlusion rates with lowered rates of side/adverse effects.
Another study demonstrated an effective method to treat large insufficient GSV (diameter above 8 mm) by using the 2 ring radial-fiber. The procedure needed less energy and resulted in an optimal homogenous radiation. The patient satisfaction rate was high and the clinical evaluators could demonstrate that modified CEAP severity was much better after 1&2 days. No significant difference was observed in the occlusion-rate between subgroups of >8mm dia. and 12 mm) greater saphenous veins (GSV) with the 2 ring radial fiber compared to radio frequency (RF) energy. VCSS scores were improved after the procedures and there was no statistically significant difference between groups. There was also no statistically significant difference in patient satisfaction between groups. Both treatment modalities were safe and effective in the treatment of very large diameter GSVs. The 2-ring radial fiber also resulted in almost no pain.
Sterilization cycle parameters and the validation reports showed an acceptable sterility was achieved with the device.
Key Metrics
Not Found
Predicate Device(s)
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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K130681 Page 1 of 2
JAN - 8 2014
K130681 - 510(k) Summ Endovascular Laser Venous System Kit with 2 Ring Radial En
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Biolitec SIA
Kaniera iela 10a, Riga, LV-1063 Latvia * (413) 525-0600 or 413-250-0779 Phone: Facsimile: * (413) 525-0611
Contact Person: *Harry Hayes, Ph.D. – Regulatory Consultant Date prepared: March 4, 2013
Name of Device and Name/Address of Sponsor
Endovascular Laser Venous System Kit (ELVeS®) with 2 Ring Radial K Biolitec SIA Kaniera iela 10a, Riga, LV-1063 Latvia
Classification Name Surgical laser accessories
Predicate Devices
ELVeS Kit with Radial Fiber
Intended Use/Indication for Use
The device is intended for endovascular coagulation of blood vessels. Th indicated for the endovascular coagulation of the Greater Saphenous Vein of the thigh in patients with superficial vein reflux.
Technological Characteristics
The ELVeS kit with 2 Ring Radial Fibers contain the following components: (1) 2 ring radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K101712 and K112299 except for the 2 ring radial tip design. The design provides 2 adjacent points of radial emission.
1
Performance Data
The device complies with the following voluntary consensus standards: 21 C.F.R. & 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1. and ANSI/AAMI/ISO 10993-7.
The clinical effectiveness is equivalent to its predicate devices, as evidence by several clinical evaluations.
In one study, the circumferential ablation of the vein with introduction of the 2 ring radial fiber provided a better outcome following EVLA: 1) reduction in recanalization rates 2) reduction in applied Watt/LEED. & 3) reduction in adverse events; including bruising, pain, induration & numbness. The study supported the conclusion concluded that EVLA with 2 ring radial fiber for GSV and SSV is an effective and safe procedure, giving the advantage of decreasing delivered energy during the procedure and also providing very good occlusion rates with lowered rates of side/adverse effects.
Another study demonstrated an effective method to treat large insufficient GSV (diameter above 8 mm) by using the 2 ring radial-fiber. The procedure needed less energy and resulted in an optimal homogenous radiation. The patient satisfaction rate was high and the clinical evaluators could demonstrate that modified CEAP severity was much better after 1&2 days. No significant difference was observed in the occlusion-rate between subgroups of >8mm dia. and 12 mm) greater saphenous veins (GSV) with the 2 ring radial fiber compared to radio frequency (RF) energy. VCSS scores were improved after the procedures and there was no statistically significant difference between groups. There was also no statistically significant difference in patient satisfaction between groups. Both treatment modalities were safe and effective in the treatment of very large diameter GSVs. The 2-ring radial fiber also resulted in almost no pain.
Sterilization cycle parameters and the validation reports showed an acceptable sterility was achieved with the device.
Substantial Equivalence
The ELVeS with 2 Ring Radial Fiber is substantially identical to that cleared under K101712 and K112299 and has the same intended use and indications for use as the cleared Evolve HPD 980-1470nm Multiwavelength and Ceralas 1470, 980 and 810nm ELVeS kits. Thus, the ELVeS with 2 Ring Radial Fiber is substantially equivalent to its predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biolitec SIA Dr. Harry Hayes Regulatory Consultant Kaniera iela 10a Riga, LV-1063 Latvia
January 8, 2014
Re: K130681
Trade/Device Name: Endo Laser Vein System Kit with 2 Ring 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: November 22, 2013 Received: December 11, 2013
Dear Dr. 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.
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
3
Page 2 - Dr. Harry Hayes
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 (OS) 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 CER Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua G. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K130681
Device Name: Endo Laser Vein System Kit with 2 Ring Radial Fiber
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 _ OR Over The Counter Use (Per 21 C.F.R. 801.109) (Optional Format 1-2-96)
Image /page/4/Picture/7 description: The image contains a combination of text and symbols. The text includes "Neil R" and "2014.01". There is also a symbol that appears to be a stylized logo or emblem, possibly related to an organization or company. The image also contains the characters "-05'00'".
(Division Sign-Off) for BSA
Division of Surgical Devices
510(k) Number _K130681