(90 days)
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.
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.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for "SLT Venous Fiber Delivery Systems," which focuses on establishing substantial equivalence to previously marketed devices rather than detailing specific performance acceptance criteria and a study to meet them.
Here's what the document does provide:
- Device Description and Intended Use: The SLT Venous Fiber Delivery Systems are intended for endovascular coagulation of the greater saphenous vein in patients with superficial vein reflux.
- Predicate Devices: The document lists several predicate devices (e.g., Diomed 810nm Surgical Lasers and EVLT Procedure Kit, VNUS® Closure™ System, Ceralas D Diode Laser Systems) for comparison.
- Basis for Substantial Equivalence: The submission states that the intended use, method of tissue interaction, specifications, clinical technique, and animal study results are "the same or very similar" to the predicate devices.
- Safety and Effectiveness: Animal studies were performed to demonstrate "substantially equivalent safe and effective performance" to the predicate devices. Biocompatibility testing (USP Class VI and ISO 10993-1, including hemocompatibility per ISO 10993-4) was also successfully performed.
Missing Information:
The document does not include:
- A table of specific acceptance criteria (e.g., specific quantitative metrics for coagulation effectiveness, safety endpoints).
- Reported device performance against such criteria.
- Details on the sample size used for any test set in the animal studies.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used or their qualifications.
- Adjudication method.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with/without AI assistance.
- Results from standalone (algorithm only) performance studies.
- The specific type of ground truth used in the animal studies (beyond "animal studies").
- Sample size for any training set.
- How ground truth for a training set was established.
The document primarily focuses on asserting substantial equivalence based on general performance observations in animal studies and biocompatibility, rather than providing a detailed breakdown of acceptance criteria and a quantitative study proving adherence to them as would be expected for an AI/CADe device.
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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:
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| Legally MarketedPredicate 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 theDevice: | SLT Venous FDS products include the Venous Diffusing Fiber, the VenousConical Fiber, and the Venous Flat Fiber.SLT Venous Diffuser Fibers are flexible fibers with an active diffusingportion that diffuses the laser energy in a uniform pattern about its activediffusing length, resulting in a cylindrical or elongated spheroidal zone ofcoagulation.SLT Venous Conical Fibers splay the laser energy radially at their distallyconical portion, providing a much smaller and more focused coagulationzone than the Venous Diffuser Fiber.SLT Venous Flat Fibers direct the laser energy forward from their distallyflat end, providing the highest energy density of the three SLT VenousFibers.SLT Venous Fibers are available with SLT proprietary connectors (to fitSLT Contact Laser™ Systems) and SMA-905 connectors (to fit lasers withstandard SMA-905 launch interfaces).SLT Venous Diffuser Fibers are compatible for use only with lasers havingwavelengths between 980nm and 1064nm.SLT Venous Conical and Flat Fibers are compatible for use with lasershaving wavelengths between 810nm and 1064nm.SLT Venous Fibers are flexible and therefore, when used for endovascularapplications, a catheter, cannula, or similar device should be used to insertthe fiber into the vein.SLT Venous Fiber products are sold sterile, and are intended for single useonly. |
| Indications for Use: | The SLT Venous Fiber is intended for use in endovascular coagulation ofthe greater saphenous vein of the thigh in patients with superficial veinreflux. |
| SubstantialEquivalence: | The intended use, method of tissue interaction, specifications, clinicaltechnique and animal study results of the SLT Venous Conical and FlatFiber Delivery Systems are the same or very similar to those of the legallymarketed fiber delivery system in the Diomed 810 Surgical Lasers andEVLT™ Procedure Kit (K012398), to the legally marketed Ceralas D10-60810nm Diode Laser System and ELVS Procedure Kit (K020835), and to thelegally marketed Ceralas D Diode 980nm Laser System (K013691). |
| The intended use, method of tissue interaction (thermal), clinical techniqueand animal study results of the SLT Venous Diffuser Fiber Delivery Systemis 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 techniqueand animal study results of the SLT Venous Flat Fiber Delivery System isthe same or very similar to those of the legally marketed Ceralas D Diode980nm Laser System (K013691). | |
| Safety andEffectiveness: | Animal studies have demonstrated the substantially equivalent safe andeffective performance of the SLT Venous Conical and Flat Fiber DeliverySystems with the legally marketed fiber delivery system in the Diomed 810Surgical Lasers and EVLT™ Procedure Kit (K012398) to the legallymarketed Ceralas D10-60 810nm Diode Laser System and ELVS ProcedureKit (K020835), and to the legally marketed Ceralas D Diode 980nm LaserSystem (K013691). |
| Animal studies have demonstrated the substantially equivalent safe andeffective performance of the SLT Venous Flat Fiber Delivery System withthe legally marketed VNUS® Closure™ System (K003092, K982816,K974521). | |
| The intended use, method of tissue interaction (thermal), clinical techniqueand animal study results of the SLT Venous Flat Fiber Delivery System isthe same or very similar to those of the legally marketed legally marketedCeralas D Diode 980nm Laser System (K013691). | |
| The materials used in the SLT Venous Fiber Delivery Systems arebiocompatible. | |
| Toxological testing and evaluation per both USP Class VI and ISO 10993-1,including hemocompatibility testing per ISO 10993-4, were successfullyperformed. | |
| Conclusion: | Based on the foregoing, Surgical Laser Technologies, Inc., believes that theSLT Venous Fiber Delivery Systems are substantially equivalent to and assafe and effective as the legally marketed fiber delivery system in theDiomed 810 Surgical Lasers and EVLT™ Procedure Kit (K012398), thelegally marketed VNUS® Closure™ System (K003092, K982816,K974521), the legally marketed Ceralas D10-60 810nm Diode Laser Systemand ELVS Procedure Kit (K020835), and the Ceralas D Diode 980nm LaserSystem (K013691). |
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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
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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
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5. STATEMENT OF INDICATIONS FOR USE
| Applicant: | Surgical Laser Technologies, Inc.147 Keystone DriveMontgomeryville, PA, 18936Establishment 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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§ 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.