(22 days)
Not Found
No
The device description and performance summary indicate a passive fiber optic delivery system with no mention of computational processing, image analysis, or adaptive behavior typically associated with AI/ML.
Yes
The device is described as a "surgical fiber optic laser delivery device" intended for various surgical procedures, including incision, excision, vaporization, and coagulation of tissue, as well as photocoagulation and lithotripsy, all of which are therapeutic interventions.
No
The device is a surgical fiber optic laser delivery device intended for various surgical procedures such as incision, excision, vaporization, and coagulation of soft tissue, not for diagnosis.
No
The device is a physical fiber optic laser delivery system, not software. The description details hardware components like fiber core, cladding, protective sheath, and connectors.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical fiber optic laser delivery device used for delivering laser light to soft tissue during surgical procedures. This involves direct interaction with the patient's body for therapeutic purposes (incision, excision, vaporization, etc.).
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Lack of Specimen Analysis: The description of the MED-Fibers device does not mention any analysis of biological specimens. Its function is to deliver energy (laser light) to tissue in situ.
Therefore, the MED-Fibers surgical fiber optic laser delivery device falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 or SMA 905 compatible connectors. In addition cleared lasers with SMA 906 connectors.
The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various vascular tumors. MED-Fibers surgical fiber optic delivery device is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
MED-Fibers surgical laser delivery system fibers contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be used with hand pieces. MED-Fibers surgical laser delivery system fibers has no differences in technology and as such does not raise any new questions on safety or efficacy. Various core diameter sizes (200, 272, 365, 550, 600, 800 and 1000 microns) are offered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, osseous tissue, intraocular, greater saphenous vein
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)
The performance of the MED-Fibers surgical laser fiber delivery systems is well established and documented so no performance testing is included. The MED-Fibers surgical laser fiber delivery system operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices.
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.
K972272, K011207, K050738, K011703, K050108, K934008, K943445, K943444, K943526, K943527, K941909, K110080, K113858, K113792, K120926, K120810, K121127
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510 (k) SUMMARY
This 510(k) summary of safety and effectiveness is submitted in accordance with all of the requirements
and follows Office of Device Evaluation guidance concerning the organization of a 510 (k) summary.
MED-Fibers Fiber Optic Laser Delivery System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
MED-Fibers, Inc. 2675 E. Bartlett Place Chandler, AZ 85249 Phone: (480) 516 8454 (480) 621 6040 Fax:
Dr. Armin Kaus, Ph.D. Contact Person:
December 14, 2012 Date Prepared:
Name of Device and Name of Sponsor
MED-Fibers Surgical Laser Fibers
MED-Fibers, Inc. 2675 E. Bartlett Place Chandler, AZ 85249
Common or Usual Name
Nd:YAG-, Ho:YAG-, KTP- and Diode Laser -- Fiber Optic Laser Delivery Systems
Classification Name
Surgical Laser Accessory Regulation: 21 CFR §878.4810 Classification: II Product Code: GEX
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124203 Page ② of ③
Predicate Devices
| Laser Peripherals Bare Fibers | (K972272) |
|---|---|
| Laser Peripherals Reusable Bare Fibers | (K011207) |
| FiberTech (LEONI) Bare Fibers (single and reusable) | (K050738) |
| Lumenis SlimLineEZ Fiber Delivery Device | (K011703) |
| InnovaQuartz (AMS) Sure Flex Laser Fiber | (K050108) |
| CeramOptec MegaBeam Fiber Laser Delivery Systems | |
| K943444, K943526, K943527, K941909 | (K934008, K943445) |
| BioLitec Radial Emitting shaped Fiber Optic delivery System | (K110080) |
| BioLitec MegaBeam Endo-ENT-Probe | (K113858) |
| BioLitec MegaBeam Endocular- and Aspirating Endo Probe | (K113792) |
| BARD Medical Holmium Laser Fibers | (K120926) |
| Fiberoptic Fabrications Laser Delivery System | (K120810) |
| Cynosure SideLaze800 Side Fire Firing Laser delivery device | (K121127) |
Intended Use / Indications of Use
The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 or SMA 905 compatible connectors. In addition cleared lasers with SMA 906 connectors.
The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors
13
2
s Page 3 of 3
and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various vascular tumors. MED-Fibers surgical fiber optic delivery device is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Technical Characteristics
MED-Fibers surgical laser delivery system fibers contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be used with hand pieces. MED-Fibers surgical laser delivery system fibers has no differences in technology and as such does not raise any new questions on safety or efficacy. Various core diameter sizes (200, 272, 365, 550, 600, 800 and 1000 microns) are offered.
Performance Data
The performance of the MED-Fibers surgical laser fiber delivery systems is well established and documented so no performance testing is included. The MED-Fibers surgical laser fiber delivery system operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices.
122
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved shapes that resemble ribbons or banners. The overall design is simple and recognizable, representing the department's role in health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Med-Fibers, Incorporated % Armin Kaus, Ph.D. President/Chief Executive Officer 2675 East Bartlett Place Chandler, Arizona 85249
January 17, 2013
Re: K124003 Trade/Device Name: MED-Fibers Surgical Laser Fibers 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: December 20, 2012 Received: December 26, 2012
Dear Dr. Kaus:
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 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
4
Page 2 -- Armin Kaus, Ph.D.
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K2400}
Indication of Use Statement
5IO(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K
Device Name: MED-Fibers Surgical Laser Fibers
The MED-Fibers, surgical fiber optic laser delively device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 connector. In addition cleared lasers with SMA 906 comlectors. The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm-2100nm)
MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue (Diode Laser 532nm- 2100nm). MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating/irrigating as an adjunct to vitrectomy surgery. (Diode Laser 532nm-2100nm), Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various (Diode Laser 532nm-2100mm) MED-Fibers surgical fiber optic delivery device is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, 1.44YAG and Diode Lasers (532nm-2100m) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, demlatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21. C.F.R. 807 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 2013.01.16 15:45:09-05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number