(90 days)
No
The device description focuses on the physical properties and function of laser fibers for endovascular coagulation, with no mention of AI or ML. The performance studies compare the device to predicate devices based on animal studies and clinical technique, not on algorithmic performance.
Yes
The device is intended for "endovascular coagulation of the greater saphenous vein... in patients with superficial vein reflux," which is a treatment for a medical condition.
No
The device is a fiber delivery system for laser energy, intended for endovascular coagulation (treatment) of veins, not for diagnostic purposes.
No
The device description clearly outlines physical components (fibers, connectors) and their interaction with laser systems, indicating it is a hardware device, not software-only.
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 the greater saphenous vein of the thigh in patients with superficial vein reflux." This describes a therapeutic procedure performed within the patient's body.
- Device Description: The device is a fiber optic cable designed to deliver laser energy for tissue coagulation. This is a physical intervention, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Product codes
GEX
Device Description
SLT Venous FDS products include the Venous Diffusing Fiber, the Venous Conical Fiber, and the Venous Flat Fiber.
SLT Venous Diffuser Fibers are flexible fibers with an active diffusing portion that diffuses the laser energy in a uniform pattern about its active diffusing length, resulting in a cylindrical or elongated spheroidal zone of coagulation.
SLT Venous Conical Fibers splay the laser energy radially at their distally conical portion, providing a much smaller and more focused coagulation zone than the Venous Diffuser Fiber.
SLT Venous Flat Fibers direct the laser energy forward from their distally flat end, providing the highest energy density of the three SLT Venous Fibers.
SLT Venous Fibers are available with SLT proprietary connectors (to fit SLT Contact Laser™ Systems) and SMA-905 connectors (to fit lasers with standard SMA-905 launch interfaces).
SLT Venous Diffuser Fibers are compatible for use only with lasers having wavelengths between 980nm and 1064nm.
SLT Venous Conical and Flat Fibers are compatible for use with lasers having wavelengths between 810nm and 1064nm.
SLT Venous Fibers are flexible and therefore, when used for endovascular applications, a catheter, cannula, or similar device should be used to insert the fiber into the vein.
SLT Venous Fiber products are sold sterile, and are intended for single use only.
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
Animal studies have demonstrated the substantially equivalent safe and effective performance of the SLT Venous Conical and Flat Fiber Delivery Systems with the legally marketed fiber delivery system in the Diomed 810 Surgical Lasers and EVLT™ Procedure Kit (K012398) to the legally marketed Ceralas D10-60 810nm Diode Laser System and ELVS Procedure Kit (K020835), and to the legally marketed Ceralas D Diode 980nm Laser System (K013691).
Animal studies have demonstrated the substantially equivalent safe and effective performance of the SLT Venous Flat Fiber Delivery System with the legally marketed VNUS® Closure™ System (K003092, K982816, K974521).
The intended use, method of tissue interaction (thermal), clinical technique and animal study results of the SLT Venous Flat Fiber Delivery System is the same or very similar to those of the legally marketed legally marketed Ceralas D Diode 980nm Laser System (K013691).
The materials used in the SLT Venous Fiber Delivery Systems are biocompatible.
Toxological testing and evaluation per both USP Class VI and ISO 10993-1, including hemocompatibility testing per ISO 10993-4, were successfully performed.
Key Metrics
Not Found
Predicate Device(s)
Diomed 810nm Surgical Lasers and EVLT Procedure Kit (K012398), VNUS® Closure™ System (K003092), VNUS® Closure™ System (K982816), VNUS® Closure™ System (K974521), Ceralas D10-60 810nm Diode Laser System and ELVS Procedure Kit (K020835), Ceralas D Diode 980nm Laser System (K013691)
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
Image /page/0/Picture/0 description: The image contains a logo for Surgical Laser Technologies. The logo has the letters SLT in bold black font on the left side of the image. To the right of the letters are the words Surgical, Laser, and Technologies stacked on top of each other in a smaller font.
147 Keystone Drive Montgomeryville, Pennsylvania 18936-9638
Tel: (215) 619-3600 (800) 366-4758 Fax: (215) 619-3209
AND AND ALL BA
JAN 2 7 2003
510(k) SUMMARY SLT Venous Fiber Delivery Systems
This 510(k) summary of safety and effectiveness information for the SLT Venous Fiber Delivery Systems is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Surgical Laser Technologies, Inc. Applicant:
Surgical Laser Technologies, Inc. Address: 147 Keystone Drive Montgomeryville, PA, 18936
Davis Woodward Contact Person: Vice President, CFO
(215) 619 3600 Telephone: (215) 619 3209 (fax)
Preparation Date: October 9, 2002
"SLT Venous Fiber Delivery Systems", comprised of the following models: Proprietary Device Name:
| Model Name | Model Number |
|---|---|
| Venous Flat Fiber, SLT | 0041-6772 |
| Venous Flat Fiber, SMA-905 | 0041-6781 |
| Venous Conical Fiber, SLT | 0041-6752 |
| Venous Conical Fiber, SMA-905 | 0041-6761 |
| Venous Diffuser Fiber, SLT | 0041-6912 |
| Venous Diffuser Fiber, SMA-905 | 0041-6921 |
Surgical Laser Fiber Delivery System Common Name:
Laser surgical instrument for use in general and plastic surgery and in Classification dermatology (see 21 CFR 878.4810). Name:
Product Code: GEX
79, General and Plastic Surgery Panel:
1
| Legally Marketed
Predicate Devices: | Diomed 810nm Surgical Lasers and EVLT Procedure Kit (K012398)
VNUS® Closure™ System (K003092)
VNUS® Closure™ System (K982816)
VNUS® Closure™™ System (K974521)
Ceralas D10-60 810nm Diode Laser System and ELVS Procedure Kit
(K020835)
Ceralas D Diode 980nm Laser System (K013691) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of the
Device: | SLT Venous FDS products include the Venous Diffusing Fiber, the Venous
Conical Fiber, and the Venous Flat Fiber.
SLT Venous Diffuser Fibers are flexible fibers with an active diffusing
portion that diffuses the laser energy in a uniform pattern about its active
diffusing length, resulting in a cylindrical or elongated spheroidal zone of
coagulation.
SLT Venous Conical Fibers splay the laser energy radially at their distally
conical portion, providing a much smaller and more focused coagulation
zone than the Venous Diffuser Fiber.
SLT Venous Flat Fibers direct the laser energy forward from their distally
flat end, providing the highest energy density of the three SLT Venous
Fibers.
SLT Venous Fibers are available with SLT proprietary connectors (to fit
SLT Contact Laser™ Systems) and SMA-905 connectors (to fit lasers with
standard SMA-905 launch interfaces).
SLT Venous Diffuser Fibers are compatible for use only with lasers having
wavelengths between 980nm and 1064nm.
SLT Venous Conical and Flat Fibers are compatible for use with lasers
having wavelengths between 810nm and 1064nm.
SLT Venous Fibers are flexible and therefore, when used for endovascular
applications, a catheter, cannula, or similar device should be used to insert
the fiber into the vein.
SLT Venous Fiber products are sold sterile, and are intended for single use
only. |
| Indications for Use: | The SLT Venous Fiber is intended for use in endovascular coagulation of
the greater saphenous vein of the thigh in patients with superficial vein
reflux. |
| Substantial
Equivalence: | The intended use, method of tissue interaction, specifications, clinical
technique and animal study results of the SLT Venous Conical and Flat
Fiber Delivery Systems are the same or very similar to those of the legally
marketed fiber delivery system in the Diomed 810 Surgical Lasers and
EVLT™ Procedure Kit (K012398), to the legally marketed Ceralas D10-60
810nm Diode Laser System and ELVS Procedure Kit (K020835), and to the
legally marketed Ceralas D Diode 980nm Laser System (K013691). |
| | The intended use, method of tissue interaction (thermal), clinical technique
and animal study results of the SLT Venous Diffuser Fiber Delivery System
is the same or very similar to those of the legally marketed VNUS®
Closure™ System (K003092, K982816, K974521). |
| | The intended use, method of tissue interaction (thermal), clinical technique
and animal study results of the SLT Venous Flat Fiber Delivery System is
the same or very similar to those of the legally marketed Ceralas D Diode
980nm Laser System (K013691). |
| Safety and
Effectiveness: | Animal studies have demonstrated the substantially equivalent safe and
effective performance of the SLT Venous Conical and Flat Fiber Delivery
Systems with the legally marketed fiber delivery system in the Diomed 810
Surgical Lasers and EVLT™ Procedure Kit (K012398) to the legally
marketed Ceralas D10-60 810nm Diode Laser System and ELVS Procedure
Kit (K020835), and to the legally marketed Ceralas D Diode 980nm Laser
System (K013691). |
| | Animal studies have demonstrated the substantially equivalent safe and
effective performance of the SLT Venous Flat Fiber Delivery System with
the legally marketed VNUS® Closure™ System (K003092, K982816,
K974521). |
| | The intended use, method of tissue interaction (thermal), clinical technique
and animal study results of the SLT Venous Flat Fiber Delivery System is
the same or very similar to those of the legally marketed legally marketed
Ceralas D Diode 980nm Laser System (K013691). |
| | The materials used in the SLT Venous Fiber Delivery Systems are
biocompatible. |
| | Toxological testing and evaluation per both USP Class VI and ISO 10993-1,
including hemocompatibility testing per ISO 10993-4, were successfully
performed. |
| Conclusion: | Based on the foregoing, Surgical Laser Technologies, Inc., believes that the
SLT Venous Fiber Delivery Systems are substantially equivalent to and as
safe and effective as the legally marketed fiber delivery system in the
Diomed 810 Surgical Lasers and EVLT™ Procedure Kit (K012398), the
legally marketed VNUS® Closure™ System (K003092, K982816,
K974521), the legally marketed Ceralas D10-60 810nm Diode Laser System
and ELVS Procedure Kit (K020835), and the Ceralas D Diode 980nm Laser
System (K013691). |
.
.
.
2
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2003
Surgical Laser Technologies, Inc. Davis Woodward Vice President, CFO 147 Keystone Drive Montgomervville, Pennsylvania 18936
Re: K023624
Trade/Device Name: SLT Venous Fiber Delivery Systems Regulation Number: 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 25, 2002 Received: October 29, 2002
Dear Mr. Woodward:
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
4
Page 2 - Mr. Davis Woodward
(21 CFR Part 807); labeling (21 CFR Part 801); 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. 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. 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
for 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
5
5. STATEMENT OF INDICATIONS FOR USE
| Applicant: | Surgical Laser Technologies, Inc.
147 Keystone Drive
Montgomeryville, PA, 18936
Establishment registration number: 2523356 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K023624 |
| Device Name: | SLT Venous Fiber Delivery Systems |
| Indications for Use: | The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenou 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 CFR 801.109) √
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
saphenous
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
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