(223 days)
Not Found
No
The document describes a laser system with manual controls (foot switch, touch-screen display) for adjusting output and mode. There is no mention of AI, ML, or any automated decision-making or analysis based on data input.
Yes
The device is intended for various surgical procedures, including incision, excision, vaporization, and coagulation of soft tissue, and specifically for the treatment of superficial vein reflux, which are all therapeutic interventions.
No.
The device is described as a medical laser intended for surgical procedures like incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue. Its function is to deliver laser light for therapeutic intervention, not to diagnose a condition.
No
The device description clearly states it is a "compact medical laser system" with a "flexible optical fiber" and a "foot switch" for activation, indicating it is a hardware device that delivers laser light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser system used for direct interaction with soft tissue during surgical procedures. This involves incision, excision, vaporization, ablation, hemostasis, or coagulation of tissue.
- Device Description: The device description details a laser system with a light delivery fiber, foot switch, and touch-screen controls for adjusting laser output. This is consistent with a surgical laser, not a device used for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is to directly interact with tissue during surgery.
N/A
Intended Use / Indications for Use
The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 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 (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, 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 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.
Product codes
GEX
Device Description
BWF-5 Medical Laser Series are compact medical laser systems. The laser light delivery system consists of a flexible optical fiber. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
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
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)
K053540, K082263, K083613, K060304, K972575, K062363, K060033, K071295, K070388
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.
0
MAY 1 2 2010
1693087
斗
510(k) SUMMARY
The Summary of Safety and Effectiveness on the LiteCure, LLC BWF-5 Medical Laser Series reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
| Applicant | LiteCure, LLC
250 Corporate Blvd., Suite B
Newark, Delaware 19702
Tel: 302-709-0408 |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | April 02, 2010 |
| Correspondent | Liang Lu, Regulatory Affairs Manager |
| Device Name | BWF-5 Medical Laser Series |
| Classification | Laser surgical instrument for use in general and plastic surgery and in
dermatology, 21 CFR 878.4810 |
| Predicate Device | K053540 INTERmedic Arfran, S.A., INTERmedic Diode Laser
Family 810 nm and 980 nm and the delivery accessories that are used
with them to deliver, ultrasound and RF Surgical 15TM, 30TM, 50TM,
100TM, 120TM and SR 15 OFTTM, MULTIDIODE PL3DTM,
ContrAgeTM, RF ContrAgeTM,MULTIDIODE VARIUSTM, VR1000TM,
MULTIDIODE ODONTTM; K082263 Biolitec, Inc., Ceralas E 980nm Diode Laser (Models
E15/980, E30/980); K083613 QUANTA SYSTEM POLYSURGE DIODE LASER
FAMILY; K060304 BioTex, Inc., PhoTex 15 Diode Laser Series: 810, 940, 980,
market clearance date March 21, 2006; and K972575 Laserscope, 800 Series Surgical Laser System Orion
Surgical Laser System Angled Delivery Devices (ADD Family
Product Line), market clearance date July 17, 1998. K062363 B&W Tek, Inc., BWF-5 Medical Laser Series. K060033 Sciton, Inc., Profile Multi-Platform System. K071295 Biolitec, Inc., 100W CERALAS D 980NM DIODE LASER K070388 Sciton, Inc., Profile Multi-Platform System |
| Intended Use | The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 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 (otolaryngology), dental procedures, arthroscopy,
gastroenterology, general surgery, dermatology, plastic surgery, podiatry,
urology, gynecology, neurosurgery (peripheral nervous system),
pulmonary surgery and thoracic surgery. The device is specifically
indicated for use as follows: |
| Intended Use
(continued) | 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 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of
reflux of great saphenous veins associated with varicose veins and
varicosities. |
| Description | BWF-5 Medical Laser Series are compact medical laser systems. The laser
light delivery system consists of a flexible optical fiber. Activation occurs
when the operator enables the laser and presses the foot switch. Release
the foot switch to deactivate the laser. Depending on laser system
configuration, the foot switch can function as on/off switch. A touch-
screen display panel allows the operator to adjust or set laser output level.
The laser can operate in continuous wave mode or controlled pulse mode. |
| Technological
Characteristics
and Substantial
Equivalence | The BWF-5 Medical Laser Series is as safe and effective as the predicate
devices. The BWF-5 Medical Laser Series has the same intended uses and
similar indications, technological characteristics (such as wavelength, laser
safety class, etc), and principles of operation as its predicate device. The
minor technological differences between the BWF-5 Medical Laser Series
and its predicate devices raise no new issues of safety or effectiveness.
Thus, the BWF-5 Medical Laser Series is substantially equivalent to its
predicate devices. |
| Compliance | 21 C.F.R. § 1040.10 & 1040.11 Performance Standards for Light Emitting Products;
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety,
1988; Amendment 1, 1991-11, Amendment 2, 1995 (2nd Edition);
IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety
- Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition
2:2001 with Amendment 1:2004);
IEC 60601-2-22 1995, 2nd Edition, "Medical electrical equipment - Part 2: Particular
requirements for the safety of diagnostic and therapeutic laser equipment"
IEC 60825-1 Ed. 2.0 (2007), Safety of laser products - Part 1: Equipment classification,
and requirements. |
1
510(k) SUMMARY continued
The Summary of Safety and Effectiveness on the LiteCure, LLC BWF-5 Medical Laser Series reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
:
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LiteCure, LLC % Intertek Testing Services Mr. Jay Y. Kogoma 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
MAY 1 2 2010
Re: K093087
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: May 05, 2010 Received: May 07, 2010
Dear Mr. Kogoma:
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
3
Page 2 - Mr. Jay Y. Kogoma
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 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/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely vours.
Sincerely yours,
Mark A. Milliken
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
510(k) Number (if known):
Device Name
Indications For Use:
The BWF-5 Medical Laser Series (810nm, 930nm, 1080mm 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 (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, 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 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.
Over-The-Counter Use Prescription Use AND/OR X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Oyler for mxm
(Digital Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093087