(223 days)
No
The document describes a laser system and handpiece for surgical procedures, focusing on mechanical and optical components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for medical procedures such as incision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic actions to treat or modify tissues.
No
This device is indicated for surgical procedures involving incision, ablation, vaporization, and coagulation of tissues, not for diagnosis.
No
The device description explicitly details physical hardware components including a laser system, fibers, and a stainless steel handpiece. The performance studies also focus on the validation of the physical handpiece.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used to perform surgical procedures (incision, ablation, vaporization, coagulation) on body soft tissues. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a laser system and handpiece used to deliver laser energy for tissue manipulation and treatment. This aligns with a surgical tool, not a device used to examine specimens from the body to provide diagnostic information.
- No mention of in vitro testing: The text does not mention any analysis of samples (blood, tissue, etc.) outside of the body.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly interact with and modify tissue during surgery.
N/A
Intended Use / Indications for Use
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical special laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.
Product codes
GEX
Device Description
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece are used together to perform the intended use above. The FELS 25A Laser and BeamPath Fibers remain unchanged. Additionally, the BeamPath fibers that deliver the laser energy, are cleared for laparoscopic use. The BeamPath Fiber Optic Handpiece (K081939) has been modified to the FlexGuide™ Ultra handpiece, which includes a sterilization tray and are sold as non-sterile reusable devices. The FlexGuide Ultra is a flexible handpiece that consists of three main sections: the proximal rear sealing cap, handpiece body/cannula and distal tip. The material of the FlexGuide Ultra handpiece is stainless steel. The OmniGuide BeamPath fiber (K070157, K093451) is inserted through the flexible handpiece proximal rear sealing cap and is fixated so that it is visualized through two site holes at the handpiece distal tip. The OmniGuide FELS 25A Laser System (K093251) still generates the CO2 laser energy, which is transmitted through the fiber. During the procedure the surgeon grasps and holds the distal tip of the FlexGuide Ultra with a grasper. The FlexGuide Ultra distal tip may be used in either non-contact mode or contact mode. The surgeon may also use the distal tip to enable tissue manipulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues including intra-oral tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Performance testing has validated the FlexGuide Ultra handpiece. Engineering analysis and bench testing concluded that the FlexGuide Ultra can be grasped, manipulated and confirmed the modified handpiece does not affect its purpose and performance when compared to the OmniGuide predicate handpiece. Additionally, the review of the technical characteristics, indications for use, risk analysis, verification and validation information provided in this 510(k) Premarket Notification demonstrates the OmniGuide FlexGuide Ultra handpiece, when used in conjunction with OmniGuide BeamPath fibers, are as safe and effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081939, K093251, K070157, K093451
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
September 25, 2014
OmniGuide Incorporated Ms. Nicole Rasmussen Senior Regulatory Specialist One Kendall Square, Suite B1301 Cambridge, Massachusetts 02139
Re: K140378
Trade Name: OmniGuide Laser System with FlexGuide™ Ultra 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: August 29, 2014 Received: September 2, 2014
Dear Mr. Rasmussen:
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
1
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,
David Krause -S
for
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) K140378
Device Name OmniGuide Laser System with FlexGuide™ Ultra
Indications for Use (Describe)
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical special laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the OmniGuide Surgical logo. The logo consists of the words "OmniGuide" in black text, with the word "SURGICAL" in smaller blue text underneath. To the left of the text is a blue circular graphic. There are two light blue and gray curved lines in the background.
510(k) Summary
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. Submitter's Information
| Name: | OmniGuide, Inc. |
|---|---|
| Address: | OmniGuide, Inc. |
| One Kendall Square | |
| Suite B1301 | |
| Cambridge, MA 02139 | |
| Phone: (617) 551-8426 | |
| Fax: (617) 551-8445 | |
| Contact: | Nicole Boeyink |
Contact: Nicole Rasmussen Sr. Regulatory Affairs Specialist
Date Prepared: September 24, 2014
2. Device Information
| Trade/Proprietary Name: OmniGuide Laser System with FlexGuide™ Ultra | |
|---|---|
| Common/Usual Name: | Fiber Optic Handpiece |
| CO2 Laser Powered Surgical Instrument | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery |
| and in dermatology (21 CFR § 878.4810) | |
| Product Code: | GEX |
3. Predicate Devices
Handpiece: See Tables 1 & 2
OmniGuide, Inc. OmniGuide BeamPath Fiber Optic Handpiece System & Sterilization Tray K081939
4
Image /page/4/Picture/0 description: The image shows the logo for OmniGuide Surgical. The logo consists of two concentric blue circles on the left, with the text "OmniGuide" in black to the right of the circles. Below "OmniGuide" is the word "SURGICAL" in blue, written in a smaller font. There is a registered trademark symbol to the right of the word "Guide".
Laser: No Changes
OmniGuide, Inc. OmniGuide BeamPath FELS 25A CO2 Laser System K093251
Fibers: No Changes, see Table 1.
OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGuide Fiber K070157
OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGuide Fiber w/Low Loss Tip K093451
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Image /page/5/Picture/0 description: The image features the logo for OmniGuide Surgical. The logo consists of a stylized "O" formed by two concentric blue circles, with the text "OmniGuide" in black to the right of the circle. Below "OmniGuide" is the word "SURGICAL" in smaller, uppercase letters. The background includes two curved, gradient bands in shades of blue and gray, adding a modern and clean aesthetic to the overall design.
Intended Use 4.
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical specialties: general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.
Device Description న.
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece are used together to perform the intended use above. The FELS 25A Laser and BeamPath Fibers remain unchanged. Additionally, the BeamPath fibers that deliver the laser energy, are cleared for laparoscopic use. The BeamPath Fiber Optic Handpiece (K081939) has been modified to the FlexGuide™ Ultra handpiece, which includes a sterilization tray and are sold as non-sterile reusable devices. The FlexGuide Ultra is a flexible handpiece that consists of three main sections: the proximal rear sealing cap, handpiece body/cannula and distal tip. The material of the FlexGuide Ultra handpiece is stainless steel. The OmniGuide BeamPath fiber (K070157, K093451) is inserted through the flexible handpiece proximal rear sealing cap and is fixated so that it is visualized through two site holes at the handpiece distal tip. The OmniGuide FELS 25A Laser System (K093251) still generates the CO2 laser energy, which is transmitted through the fiber. During the procedure the surgeon grasps and holds the distal tip of the FlexGuide Ultra with a grasper. The FlexGuide Ultra distal tip may be used in either non-contact mode or contact mode. The surgeon may also use the distal tip to enable tissue manipulation.
Performance Testing 6.
Performance testing has validated the FlexGuide Ultra handpiece. Engineering analysis and bench testing concluded that the FlexGuide Ultra can be grasped, manipulated and confirmed the modified handpiece does not affect its purpose and performance when compared to the OmniGuide predicate handpiece. Additionally, the review of the technical characteristics, indications for use, risk analysis,
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Image /page/6/Picture/0 description: The image features the logo for OmniGuide Surgical. The logo consists of a circular design with the word "OmniGuide" in bold, black letters, with the word "SURGICAL" in smaller, blue letters underneath. The logo is positioned on the left side of the image, with two curved, light blue and gray lines extending horizontally to the right.
verification and validation information provided in this 510(k) Premarket Notification demonstrates the OmniGuide FlexGuide Ultra handpiece, when used in conjunction with OmniGuide BeamPath fibers, are as safe and effective as its predicate device.
7. Substantial Equivalence
The FlexGuide Ultra Handpiece is substantially equivalent to its predicate device when used according to its intended use. This statement is based on the information provided in this 510(k) Premarket Notification which demonstrates the FlexGuide Ultra handpiece shares the similar intended uses, operating principles, similar technical characteristics and incorporates the same basic handpiece design when compared to the original cleared handpiece. The handpiece also shares a similar intended use as the predicate fibers, which are used in conjunction with the FlexGuide Ultra to transmit CO2 laser energy to the treatment site.
| | OmniGuide Laser
System with
FlexGuide™ Ultra
(K140378 pending) | OmniGuide
BeamPath Fiber
Optic Handpiece
System
(K081939) | OmniGuide Beam
Path CO 2 Mark III
WaveGuide Fiber
(K070157) | OmniGuide
BeamPath CO2
Mark III
WaveGuide Fiber
w/Low Loss Tip
(K093451) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The OmniGuide
Laser System with
FlexGuide™ Ultra,
which includes the
FELS 25A Laser,
BeamPath Fibers
and the FlexGuide™
Ultra handpiece, is
indicated for use to
enable the surgeon
to perform incision,
excision, ablation,
vaporization and
coagulation of body
soft tissues
including intra-oral
tissues. This system
is intended for use
with a grasper in the
following medical
specialties: general
laparoscopic | The OmniGuide
BeamPath® Fiber
Optic Handpiece
System and
Sterilization Tray is
indicated for use in
conjunction with
OmniGuide's
waveguide fibers to
enable the surgeon to
perform incision,
excision, ablation,
vaporization and
coagulation of body
soft tissues including
intra-oral tissues. It is
indicated in the
medical specialties of
general and plastic
surgery,
oral/maxillofacial
surgery, dentistry, | The OmniGuide
Mark Ill WaveGuide
Fiber is indicated for
the incision, excision,
ablation, vaporization
and coagulation of
body soft tissues
including intra-oral
tissues. It
is indicated in the
medical specialties of
general and plastic
surgery,
oral/maxillofacial
surgery, dentistry,
dermatology,
gynecology,
otorhinolaryngology,
gastroenterology,
neurosurgery,
urology, and
pulmonology. and | The OmniGuide
Beam Path CO 2
Mark II WaveGuide
Fiber with Low
Profile/Low Loss
Tip is indicated for
the incision, excision,
ablation, vaporization
and coagulation of
body
soft tissues including
intra-oral tissues. It is
indidated in the
medical specialties of
general
and plastic surgery,
oral/maxillofacial
surgery, dentistry,
dermatology,
gynecology,
otorhinolaryngology,
gastroenterology. |
| Table 1. Predicate Device Indications for Use Comparison | |||
|---|---|---|---|
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Image /page/7/Picture/0 description: The image shows the logo for OmniGuide Surgical. The logo consists of three concentric blue circles on the left side of the image. To the right of the circles is the word "OmniGuide" in black font, with the word "SURGICAL" in blue font underneath. There is a registered trademark symbol to the right of the word "OmniGuide".
| surgical procedures,
gynecologic
laparoscopic
surgical procedures,
urologic surgical
procedures,
otorhinolaryngology
surgical procedures. | dermatology,
gynecology,
otorhinolaryngology,
gastroenterology,
neurosurgery,
urology, and
pulmonology. | can be used in open
surgical procedures
as well as endoscopic
minimally invasive
procedures in
conjunction with
rigid or flexible
endoscopes, such as
in laryngoscopy,
gastroscopy,
colonoscopy,
laparoscopy,
thoracoscopy,
hysteroscopy and
bronchoscopy.
The indications for
use for which the
delivery system is
used for are
dependent upon the
cleared indications
for use of the laser
system and those
laser system
accessories to which
it is attached. | neurosurgery,
urology, and
pulmonology, and
can be used in open
surgical procedures
as well as endoscopic
minimally invasive
procedures
in conjunction with
rigid or flexible
endoscopes, such as
in laryngoscopy,
gastroscopy,
colonoscopy,
laparoscopy,
thoracoscopy,
hysteroscopy and
bronchoscopy.
The indications for
use for which the
delivery system is
used for are
dependent upon the
cleared indications
for use of the laser
system and those
laser system
accessories to which
it is attached. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Table 2. Predicate Handpiece Specification Comparison
| | OmniGuide Laser System with
FlexGuide™ Ultra
(K140378 pending) | OmniGuide BeamPath Fiber Optic
Handpiece System
(K081939) |
|--------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------|
| Handpiece
Lumen
Material | 304 Stainless Steel | 304 Stainless Steel Hypodermic Tubing |
| Lumen
Length | 50cm | Up to 60cm |
| Handpiece
Design | Distal tip, handpiece body/cannula, rear
sealing cap | Distal tip, handpiece body/cannula, rear
sealing cap |
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Image /page/8/Picture/0 description: The image shows the logo for OmniGuide Surgical. The logo consists of a blue circle with the words "OmniGuide" in black letters inside the circle. Below the circle, the word "SURGICAL" is written in blue letters. The logo is simple and modern, and it is likely used to represent a company that specializes in surgical products or services.
| Distal Tip | Used in either non-contact mode or contact
mode, and may be used to enable tissue
manipulation. | Used in either non-contact mode or contact
mode, and may be used to enable tissue
manipulation. |
|------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Mechanism of
Action | Handpiece is used to guide and protect
BeamPath® fibers | Handpiece is used to guide and protect
BeamPath® fibers |
| Operating
Principle | To enable precision control and to stabilize
surgeon hand motion | To enable precision control and to stabilize
surgeon hand motion |
8. Conclusions
OmniGuide conducted device performance non-clinical verification and validation testing. Results from the testing shows similar performance profiles when comparing the modified flexible handpiece to the original handpiece design. As confirmed in this 510(k) submission, testing was performed to confirm the modifications to the flexible handpiece when compared to its predicate device did not raise any new concerns of safety or effectiveness, alter the fundamental scientific technology of the device, nor affect its mode of use. OmniGuide believes the modified handpiece is substantially equivalent to its predicate handpiece based on similar specifications, performance data, intended use, and the handpiece mechanism of action. Thus, the FlexGuide Ultra handpiece is as safe, as effective and performs similar to the predicate handpiece.