(66 days)
Not Found
Not Found
No
The provided text describes a medical laser device and its intended uses for various surgical procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description or intended use.
Yes
The device is described as being used for "treatment of reflux of great saphenous veins associated with varicose veins and varicosities," and "treatment of incompetence and reflux of superficial veins in the lower extremity," which are therapeutic applications. Additionally, its general indications include "incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue," which are surgical procedures performed to treat conditions.
No
The document describes the device's intended use for surgical procedures involving incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, primarily for therapeutic purposes, not for diagnosing conditions.
No
The device is described as a "Medical Laser Series" with specific wavelengths (810nm, 930nm, 1080nm, 1320nm), indicating it is a hardware device that emits laser light for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the BWF-5 Medical Laser Series is for the direct treatment of soft tissue and veins within the body during surgical procedures. It delivers laser light to perform actions like incision, excision, vaporization, and coagulation.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens taken from the patient. Its function is to interact directly with the patient's tissues.
Therefore, the BWF-5 Medical Laser Series falls under the category of a surgical laser device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BWF-5 Medical Laser Series (810nm, 930nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolary). And and procedures, arthroscopy, gastroenterology, general surgery, dermatology, glastic, sugery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows:
LASER 980nm: Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
LASER 1320mm: Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.
LASER 810nm: Indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in ear, nose and throat, oral, thigh (Greater Saphenous Vein), lower extremity (superficial veins)
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): 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.
Not Found
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird-like figure, with three stylized lines forming its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 3, 2012
Litecure, LLC % Liang Lu Quality and Regulatory Manager 250 Corporate Boulevard, Suite B Newark, New Jersey 19702
Re: K123031
Trade/Device Name: BWF-5 Medical Laser Series 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: September 15, 2012 Received: September 28, 2012
Dear Liang Lu:
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 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
1
Page 2 - Liang Lu
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,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K / 23 03 |
Device Name: BWF-5 Medical Laser Series
Indications for Use:
The BWF-5 Medical Laser Series (810nm, 930nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolary). And and procedures, arthroscopy, gastroenterology, general surgery, dermatology, glastic, sugery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows:
LASER 980nm:
Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
LASER 1320mm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.
LASER 810nm:
Indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden
2012.11.29 09:02:15 -05'00'
(Division Sign-Off) Division of Surgical Device: 510(k) Number .