(104 days)
Not Found
No
The document describes a fiber optic laser delivery system and does not mention any AI or ML components or functionalities.
Yes.
The device is a fiber optic laser delivery system intended for use in surgical procedures for incision, excision, vaporization, ablation, hemostasis, coagulation of soft tissue, and lithotripsy, which are all therapeutic interventions.
No
The device is described as a "fiber optic laser delivery system intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures," for actions such as "incision, excision, vaporization, ablation, hemostasis or coagulation." These are therapeutic or surgical functions, not diagnostic ones.
No
The device description explicitly states it is a "fiber optic laser delivery system" composed of "quartz fiber core with a coaxially mounted protective sheath" and can be used with "handpieces," indicating it is a physical hardware device.
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 "fiber optic laser delivery system" 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 optic system, not on any reagents, calibrators, or other elements typically associated with in vitro diagnostic tests.
- Lack of Diagnostic Language: The text does not mention analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Surgical Applications: The listed indications for use are all surgical procedures (incision, excision, vaporization, ablation, hemostasis, coagulation, lithotripsy).
In vitro diagnostics are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to deliver energy for surgical intervention, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical 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. It 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 (635-1900nm) with peak and continuous power from 1-200W. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The fiber optic laser delivery system contains the same components and design as the already cleared CeramOptec MegaBeam optical fibers and the Biolitec radial emitting shaped fiber optic delivery system. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath. The fibers distal tip can be several configurations and the fiber can be used with handpieces. This is industry standard for delivery systems thus no questions of safety or efficacy are raised.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, ear, nose and throat and oral surgery (otolaryngology), gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications
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 fiber optic laser delivery systems is well established and documented so no performance testing is included. The fiber optic delivery systems 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.
K934008, K943445, K943444, K943526, K943527, K941909, K110080
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
120810
JUN 2 8 2012
510(k) SUMMARY
Fiberoptic Fabrications Inc.'s Fiberoptic Laser Delivery System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Fiberoptic Fabrications, Inc. 495 Main Street Wilbraham, MA 01095 (413) 374-4303 Phone: Facsimile: (413) 599-1640
Carol J.Morello,VMD Contact Person:
Date Prepared: June 5, 2012
Name of Device and Name/Address of Sponsor
Fiberoptic Fabrications Fiber optic Laser Delivery System
Fiberoptic Fabrications, Inc. 495 Main Street Wilbraham, MA 01095
Common or Usual Name
Fiber optic laser delivery system
Classification Name
Surgical laser accessory
Predicate Devices
CeramOptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (K110080).
1
Kizogies pg. 2 of
Intended Use / Indications for Use
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, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical 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. It 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 (635-1900nm) with peak and continuous power from 1-200W. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.
Technical Characteristics
The fiber optic laser delivery system contains the same components and design as the already cleared CeramOptec MegaBeam optical fibers and the Biolitec radial emitting shaped fiber optic delivery system. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath. The fibers distal tip can be several configurations and the fiber can be used with handpieces. This is industry standard for delivery systems thus no questions of safety or efficacy are raised.
Performance Data
The performance of the fiber optic laser delivery systems is well established and documented so no performance testing is included. The fiber optic delivery systems operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices.
Substantial Equivalence
The Fiberoptic Fabrications fiber optic laser delivery systems are as safe and effective for the indications for use as the CeramOptec fiber optic laser delivery systems and the Biolitec radial emitting shaped fiber optic delivery system previously cleared thus the Fiberoptic Fabrications fiber optic laser delivery systems are substantially equivalent.
2
THAHD THEVILLANUQH ANTALI SITAO ARATH
THAHD EDWALAVUQA TATATATAAUS
| Intended Use | Fiberoptic Fabrications | Fiberoptic Fabrications | CeramOptec MegaBeam fiber optic laser delivery systems K934008,K943445,K943444,K94 3526,K943527.K941909 | Biolitec radial emitting shaped fiber optic delivery K110080 | ||
|---|---|---|---|---|---|---|
| Intended Use: 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, | ||||||
| including via endoscopes. The | ||||||
| fiber optic laser delivery | ||||||
| system is intended for use | ||||||
| with any cleared surgical | ||||||
| laser with an SMA 905 or | ||||||
| SMA 905 compatible | ||||||
| connector | CeramOptec MegaBeam fiber | |||||
| optic laser delivery systems | ||||||
| K934008,K943445,K943444,K94 | ||||||
| 3526,K943527.K941909 | ||||||
| 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, including via | ||||||
| endoscopes. The fiber optic | ||||||
| laser delivery system is | ||||||
| intended for use with any | ||||||
| surgical laser with an SMA | ||||||
| 905 compatible connector. | Biolitec radial emitting shaped | |||||
| fiber optic delivery | ||||||
| K110080 | ||||||
| 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, including via | ||||||
| endoscopes. The fiber optic | ||||||
| laser delivery system is | ||||||
| intended for use with any | ||||||
| surgical laser with an SMA | ||||||
| 905 compatible connector. | Indications for Use | |||||
| It is indicated for use in general surgical 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. It 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 (635- 1900nm) with peak and continuous power from 1- 200W. | It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, endovenous occlusion of the greater saphenous vein, laser assisted lipolysis, and benign prostatic hyperplasia with a compatible laser cleared for use in the desired applications. 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. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application | It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, endovenous occlusion of the greater saphenous vein, laser assisted lipolysis, and benign prostatic hyperplasia with a compatible laser cleared for use in the desired applications. 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. |
K120819 Par
3 of S
3
.
:
Kizozic
4 વદ્યદ ద్రా
4
| | Fiberoptic Fabrications | CeramOptec MegaBeam fiber
optic laser delivery systems
K934008,K943445,K943444,K94
3526,K943527.K941909 | Biolitec radial emitting shaped
fiber optic delivery
K110080 |
|----------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Delivery Systems | | | |
| Fiber
Material | Flexible fiber
Quartz glass | Flexible fiber
Quartz glass | Flexible fiber
Quartz glass |
| Core diameter | 200-1000um | 200 - 1000um | 600 |
| Proximal end | SMA 905 connector or SMA 905
compatible connector | SMA 905 connector
HGM connector or other | SMA 905 connector
HGM or other |
| Sterile | Sterile | Sterile | Sterile |
| Distal End | Shaped fibers, side fibers, hand
pieces. Shaped fibers
include:flat, orb, cone, chisel, or
radial. | Shaped fibers, side fibers, hand
pieces. Shaped fibers
include:flat, orb, cone, or chisel | Side fibers |
| Max | Core size: 230um
365um
400um
600um
800um
1000um | 45W
113W
135W
200W
200W
200W | Up to 25W
N/A
N/A
200W
200W
200W |
| Recommended
Power | | Up to 25W
N/A
N/A
200W
200W
200W | |
ર જુદ રિ
.
. . . .
izeole
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 8 2012
Fiberoptic Fabrications, Incorporated % Ms. Carol J. Morello, VMD 495 Main Street Wilbraham, Massachusetts 01095
Re: K120810
Trade/Device Name: Fiber optic laser delivery system 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 28, 2012 Received: June 05, 2012
Dear Ms. Morello:
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
6
Page 2 - Ms. Carol J. Morello
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 (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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours
for Dabo
Nor. Car. 1.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): K120810
Device Name: Fiber optic laser delivery system
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, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical 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. It 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 (635-1900nm) with recommended peak and continuous power from 1-200W based upon fiber diameter. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.
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)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Surgical, Orthopedic,
and Restorative Devices
| Page | 1 of 1 |
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| 510(k) Number | K120810 |
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