(232 days)
Not Found
No
The document describes a laser surgery fiber and its intended use, device description, and performance. There is no mention of AI or ML technology in any section.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "surgical procedures" including "incision, vaporization, ablation, hemostasis or coagulation of soft tissue" and "lithotripsy," which are all therapeutic interventions.
No
The OBERON laser surgery fiber is described as being used for delivery of laser light in surgical procedures for incision, vaporization, ablation, hemostasis, or coagulation of soft tissue, and lithotripsy. These are all therapeutic or interventional applications, not diagnostic ones.
No
The device description clearly states it is a "laser surgery fiber" and describes physical components like the fiber core, cladding, protective sheath, and distal tip configurations. This indicates a hardware device, not software only.
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 laser surgery fiber for delivering laser light to soft tissue during surgical procedures. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description focuses on the physical components of the fiber and its material, consistent with a surgical tool.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The summary of performance studies mentions the device's operation and comparison to predicate devices, but not any diagnostic performance metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver energy for surgical intervention, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The OBERON, laser surgery fiber, Side Fire laser surgery fibers 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 OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a 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- 2100mm) OBERON laser surgery fiber 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 (532mm - 2100mm) with peak and continuous power from 1-100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and 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
GEX
Device Description
The OBERON's laser surgery fiber 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 also used with hand pieces. OBERON's laser surgery fiber 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, 400, 550, 600microns) are offered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 OBERON's laser surgery fiber is well established and documented so no performance testing is included. The OBERON's laser surgery 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)
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.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be flowing or merging together.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2014
OBERON GmbH Fiber Technologies % Dr. Armin Kaus MED-Fibers Incorporated 7404 West Detroit Street, Suite 140 Chandler, Arizona 85226
Re: K140470
Trade Name: OBERON Laser Surgery Fiber 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 12, 2014 Received: September 17, 2014
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
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours, Binita S. Ashar -S 2014.10.15 15:29:03 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K140470
Device Name OBERON Laser Surgery Fiber
Indications for Use (Describe)
The OBERON, laser surgery fiber, Side Fire laser surgery fibers 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 OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a 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- 2100mm) OBERON laser surgery fiber 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 (532mm - 2100mm) with peak and continuous power from 1-100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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.
OBERON 's Laser Surgery Fiber
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
OBERON GmbH Fiber Technologies Freiheitstrasse 120 15745 Wildau GERMANY Phone: +49 3375 21500-0 Fax: +49 3375 21500-10
Official Correspondent:
Dr. Armin Kaus, Ph.D. 7404 W. Detroit Street, STE 140 Chandler, AZ 85226
Date Prepared: October 7, 2014
Name of Device and Name of Sponsor
OBERON Laser Surgery Fiber
OBERON GmbH Fiber Technologies Freiheitsstrasse 120 15745 Wildau, GERMANY
Common or Usual Name
Nd:YAG-, Ho:YAG-, KTP- and Diode Laser -- Laser Fiber Delivery Systems
Classification Name
Surgical Laser Accessory Regulation: 21 CFR §878.4810 Classification: II Product Code: GEX
4
Predicate Devices
1 - Per 21 CFR 807.92 item (6) Summary with comparison values
| | OBERON GmbH
The fiber optic laser delivery
devices are intended for
delivery of laser light to soft
tissue in the contact and
noncontact mode during
surgical procedures including
via endoscopes and
cystoscopes. The laser fiber
is intended for use with any
cleared surgical laser with an
SMA 905 and
compatible connectors. | MED-Fibers, Inc.
K124003
The surgical fiber optic
Laser delivery devices
are intended for delivery
of laser light to soft tissue
in the contact and non con-
tact mode during surgical
procedures. The delivery device
is intended for use with any
surgical lasers with cleared
laser with a compatible SMA
905 and compatible connectors. | Fiberoptic Fab
K120810
The fiber optic laser delivery
system is intended for delivery
of laser light to soft tissue in
the contact and non
contact mode during surgical
procedures. The fiber optic
delivery System is intended
for use with any cleared
surgical laser with an SMA
905. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | | | |
| Delivery Systems | | | |
| Fiber | Flexible Fiber | Flexible Fiber | Flexible Fiber |
| Material | Quartz Glass | Quartz Glass | Quartz Glass |
| Core Diameter
Proximal end | 200 - 600 micron
SMA 905 and other
compatible connectors | 200 - 1000 micron
SMA 905 and other
compatible connectors | 200 - 1000 micron
SMA 905, SMA
906 and other compatible
connectors |
| Distal end | flat, shaped, ball,
round, side fire, radial | flat, side fire and different
shapes | flat, shaped, side fire |
| Sterile (Yes/No) | Yes | Yes | Yes |
| Max Recommended Power | Core Size: 200, 272 μ $20 W$
365 μ $40 W$
500 μ $100 W$
400, 600 μ HPCS $30 W$
600 µIRHCN $100 W$
800 and 1000μ N/A | up to $45 W$
up to $60 W$
up to $100 W$
up to $40 W$
up to $100 W$
up to $200W$ | up to $45 W$
up to $113 W$
N/A
N/A
up to $100 W$
up to $200 W$ |
| Indication for use | The laser delivery devices
are intended for use in
laser based surgical
application to deliver
the laser light to soft
tissue during surgical
applications. The delivery
device is cleared for
surgical lasers with
compatible SMA 905
connectors. It is indicated
for use in general surgery
applications for incision,
excision, vaporization,
ablation and or coagulation.
It is indicated for use in
soft tissue procedures with
cleared surgical laser systems
with different wavelength.
It is also indicated for use
with cleared compatible
laser systems in lithotripsy
for the desired application. | The surgical fiber optic laser
delivery devices, Endo-ENT
fibers, side fire Fibers and Endo
probes in the contact and non-
contact mode during surgical
procedures including via
endoscopes and cysto-scopes. The
surgical laser
fiber is intended for use with any
cleared surgical laser with an
SMA 905 and compatible
connectors. The surgical fibers
are indicated for use in general
surgery applications for incision,
excision, vaporization, ablation,
hemostasis, or coagulation. It is
also indicated for use In open or
closed endo- scopic applications
where incision, excision, tissue
dissection, excision of ex-
ternal tumors and lesions
complete or partial resection of
intern. organs, It is also intended
as an aid for otology procedures.
In addition all surgical devices
are intended for use in lithotripsy
applications with cleared laser
Systems. | The fiber optic laser delivery
system is 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 or
lesions, complete or partial
resection of internal organs,
tumors or lesions, tissue vapo-
rization, hemostasis and or
coagulation may be indicated.
It is also indicated for use in
lithotripsy with a compatible
laser cleared for the desired
application. Its intended to use
for different cleared lasers with
peak and continuous
power from 1W - 200W. |
5
Intended Use / Indications of Use
The OBERON's, laser surgery fiber, is 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 OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 or compatible connectors.
The OBERON, laser surgery fibers, Side Fire Laser surgery fibers and Dental 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 OBERON laser surgery fibers are intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers laser are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, 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) QBERON laser surgery fiber 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 - 100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gastroenterology, gynecology,
6
vascular surgery, neurosurgery, plastic surgery, ENT and 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
OBERON's laser surgery fiber 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 also used with hand pieces.
OBERON's laser surgery fiber 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, 400, 550, 600microns) are offered.
Performance Data
The performance of the OBERON's laser surgery fiber is well established and documented so no performance testing is included. The OBERON's laser surgery fiber delivery system operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices.
Substantial Equivalence
The OBERON's laser surgery fibers are as safe and effective for the indications for use as the Laser Peripherals, Leoni, Lumenis, MED-Fibers, Cynosure, Fiberoptic Fabrications and CermaOptec fiber optic laser delivery systems previously cleared thus the OBERON's laser surgery fibers are substantially equivalent.
| Signed: | |
|---|---|
| Dr. Armin Kaus, Ph.D. | |
| Official Correspondent |