(28 days)
No
The document describes a surgical laser fiber and its performance characteristics, with no mention of AI or ML.
Yes.
The device is a surgical laser fiber used for ablation, coagulation, incision, excision, or vaporizing in soft/hard-tissue applications, all of which are therapeutic interventions.
No
The device description indicates that the OmniGuide PRIMA Surgical Laser fibers are "intended for use in laser surgical procedures including, but not limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing." These are all surgical functions, not diagnostic ones. The testing described also focuses on performance characteristics related to energy delivery and mechanical stability of the fibers, not diagnostic capabilities.
No
The device description explicitly states it is a "fiber optic delivery system" and mentions physical components like "SMA-905, SMA-906 with RFID and Manufacturer's specific RFID connectors and the Fiber Optic." The performance studies also detail bench testing on the physical fiber and its mechanical properties. This indicates a hardware component is central to the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text clearly states the device is indicated for use in "all surgical specialties" for procedures like "ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application." This describes a device used during surgical procedures on the patient's body, not for testing samples outside the body.
- Device Description: The description reinforces this by mentioning "laser surgical procedures including, but not limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application." It describes a "surgical laser fiber optic delivery system."
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used to deliver laser energy directly to tissue during surgery.
N/A
Intended Use / Indications for Use
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500mm - 2200mm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are intended for use with any cleared surgical laser with an SMA 905 connector, or manufacturer specific connectors and adapters.
Product codes
GEX
Device Description
Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but not limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this 510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specific RFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)].
The Family of OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including open, laparoscopic or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 14 of this 510(k) Premarket Notification.
The history of laser fibers originated with the development of lasers used in the medical community. They have been prevalent in surgical applications for the past 63 years. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate areas in the body.
The technology of inputting light energy into a fiber optic cable in order to provide a workable tool for physicians has been relatively unchanged since the inception of medical lasers.
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)
Bench testing (see Section 21) on the subject device has shown the device to perform as intended with the same technological principle, fit, form, function, method of operating, including but not limited to the listed date below. The subject device is substantially equivalent to the predicate device and reference devices in the following attributes: Indications for Use, Intended Use, Sterilization Technique, Performance Characteristics, Energy used and delivered, Design, Materials, Packaging, Shelf-Life, Safety, Manufacturing, Clinical setting, Mechanism Action, Anatomical Site, Biocompatibility.
The performance test reports focus on the key features of the fiber. These included the following testing (depending on need):
- Power & Energy input versus output
- Homogeneity of output light (spot check, beam profile)
- High-power testing
- Bend radius testing
- Pull testing
- Feature specific testing was conducted to demonstrate equivalence to the predicate device and reference devices: safety, performance, integrity, stability, transport, label integrity, packaging of sterilized fibers. Reference section 21 for the following tests: Performance test of Prima 150 laser fiber on RevoLix HTL; Performance test of Prima 1000 laser fiber on RevoLix HTL; Performance test of PrimaSidefire laser fiber on RevoLix HTL; Test of mechanical stability of Prima 150 micron laser fiber, Test of mechanical stability of Prima 1000 micron laser fiber, and Test of mechanical stability of Prima 550 micron laser fiber.
Additional Feature testing conducted in the predicate Device LISA Laser Surgical Fiber K220189.
Much of the testing performed was based on a specific feature approach. Those features indicated in K220189 performance testing were 1) Scatter Free Fiber, 2) Expanded transmission of laser wavelength/energy, and 3) distal tip configuration, 4 Nav Tip tested for ability to traverse deflected endoscope. These test reports show the features identified are proven to be safe and effective. Other reports are similar in that they indicate passed testing of specific features or overall products.
Conclusion: A direct comparison of key characteristics demonstrates that Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers are substantially equivalent/same as the predicate device in terms of materials of construction, energy use and delivery, chemical/electrical/mechanical/thermal safety, manufacturing, intended uses, surgical use of the devices, technological considerations, packaging, safety and performance characteristics [807.92(a)(4)]. Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers family of laser fibers as safe, as effective and perform as well as the predicate devices. The small difference to the predicate device does not raise different questions of safety and efficacy, rather guarantees trained clinicians the use of validated FDA cleared laser fibers.
Performance testing was conducted in order to demonstrate the specifications and performance of OmniGuide Prima Surgical Laser Fibers and to verify that no different questions of safety and effectiveness have been raised due to the small modification's introduction. Test and assessment results indicated that the subject OmniGuide Prima Surgical Laser Fibers perform in accordance with its requirements and specifications, in similarity to its predicate family and do not raise new safety or efficacy risks/questions.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2023
Omni-Guide Holdings, Inc. Carlos Acosta Global Director Regulatory Affairs & Ouality Assurance 43 Manning Road Billerica, Massachusetts 01821
Re: K230819
Trade/Device Name: OmniGuide RFID 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: March 17, 2023 Received: March 24, 2023
Dear Carlos Acosta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black and appears to be centered. The background is a light blue color, with a faint watermark-like design.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230819
Device Name OmniGuide PRIMA Surgical Laser fibers
Indications for Use (Describe)
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500mm - 2200mm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are intended for use with any cleared surgical laser with an SMA 905 connector, or manufacturer specific connectors and adapters.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical an OmniGuide Company", and the third logo is for "LISA Laser Products an OmniGuide Company". All three logos have a similar design, with the company name in gray text surrounded by a blue circle.
008_510(k)_Summary
| Classification Name | Common Name | Trade Name/Proprietary Name |
|---|---|---|
| Part 878 General and Plastic Surgery | ||
| 21 CFR §874.4680 | Laser Instrument, Surgical | OmniGuide Prima Surgical Laser Fibers |
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of Omni Guide knowledge.
Omni-Guide Holdings, Inc. is submitting this 510(k) of equivalent OmniGuide Prima Surgical Laser Fibers equivalent to our predicate devices, LISA Laser Surgical Fibers and cleared under Omni-Guide Holdings, Inc. own 510(k) K220189. LightGuide Optics International Ltd., is our Contract Manufacturer (CMO), a CMO of equivalent fibers (reference FDA Establishment Registration & Device Listing ID# 3012669557: - Powered Laser Surgical Instrument - Slimline Endo Fibers; Slimline Endo SIS Fibers; Slimline EZ SIS Fiber; Slimline Fibers; Slimline GI SIS Fiber; Slimline SIS Fibers). The manufacturing process of OmniGuide Prima Surgical Laser Fibers and sterilization are the same process to current FDA fibers manufactured by LGO, as well as the predicate device LISA Laser Surgical Fibers.
OmniGuide Prima Family of Surgical Laser Fibers and the Primary Predicate Device, share the same intended use, indication for use, human factors, design, performance, materials, manufacturing, mechanical safety, biocompatibility, sterilization. There minor difference in the technological characteristics do not raise any questions of safety or performance data demonstrates the OmniGuide are as safe and effective as the listed predicate. OmniGuide Prima Surgical Laser Fibers are substantially equivalent to its predicate device.
| Submitter: | Omni-Guide Holdings, Inc.
43 Manning Drive
Billerica, MA 01821 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Carlos O. Acosta
Phone: 617-551-4400 Ext. 563
Fax: 888-490-6020 |
| Date of
Preparation: | February 22, 2023 |
| Type of 510(k)
Submission: | Special |
| Device
Identification: | Device Name and Classification 807.92(a)(2):
Trade Name: OmniGuide Prima Surgical Laser Fibers
Classification Name: Laser surgical instrument for use in general and plastic surgery and in
dermatology |
| Regulatory
Class: | II |
| Product Code: | GEX |
| Panel
Classification | General and Plastic Surgery (21 CFR §878.4810) |
| Predicate
Device: | Primary Predicate Device:
OmniGuide LISA Laser Family of Surgical Laser Fibers
Delivery Device 510(k) = K220189 |
4
Image /page/4/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical an OmniGuide Company", and the third logo is for "LISA Laser Products an OmniGuide Company". All three logos have a similar design, with the company name in gray text and a blue circle around the name.
| Device
Description: | Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality
surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but not
limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application
for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this
510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specific
RFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)]. | | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------|
| Intended
Use:
Indications
For Use: | Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which
compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical
laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters | | | |
| Substantial | | Comparison Table: Subject vs. Primary Predicate Devices | | |
| Equivalence
Comparison
Table | Characteristic | Subject Device
OmniGuide Prima Surgical Laser Fibers | Primary Predicate, OmniGuide LISA
Laser Surgical Fibers, K220189 | Equivalence |
| | 510(k) Number | Pending | K220189 | N/A |
| | Product Code | GEX | GEX | Same/
Equivalent |
| | Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| | Regulation Name | Laser surgical instrument for use in general
and plastic surgery and in dermatology | Laser surgical instrument for use in general
and plastic surgery and in dermatology | Same/equivalent |
| | Components | Connector configurations offered suitable to
multiple laser platforms | Connector configurations offered suitable to
multiple laser platforms | Same/Equivalent |
| | Technological
characteristics | High OH or Low OH silica material w/low
attenuation of light wavelengths between
532nm - 2100nm | High OH or Low OH silica material w/low
attenuation of light wavelengths between
532nm - 2100nm | Same/Equivalent |
| | Silica/Silica
fibers/hard clad
fibers | Fiber having a Numerical
Aperture (NA) between 0.22 - 0.48 | Fiber having a Numerical
Aperture (NA) between 0.22 - 0.48 | Same/Equivalent |
| | Fiber distal tip | Multiple configurations of distal tips
offered to provide the most suitable
performance for the application | Multiple configurations of distal tips
offered to provide the most suitable
performance for the application | Same/Equivalent |
| | Used with
attachments | Core diameters are offered in a range of
sizes suitable to user needs | Core diameters are offered in a range of
sizes suitable to user needs | Same/Equivalent |
| Intended Use | | | Same/Equivalent | |
| Indication for Use | Omni-Guide Holdings, Inc. single-use
OmniGuide PRIMA Surgical Laser fibers are
indicated for use in all surgical specialties in
which compatible laser systems with
operational wavelengths between 500nm -
2200nm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use
OmniGuide PRIMA Surgical Laser fibers
devices are intended for use with any
cleared surgical laser with an SMA 905
connector, SMA 906 connector, or
manufacturer specific connectors and
adapters. | OmniGuide LISA Laser Surgical Fibers are
intended for use with any cleared surgical
laser with an SMA 905 connector, SMA
906 connectors, or manufacturer specific
connectors and adaptors
OmniGuide LISA Laser Surgical Fibers are
indicated for use in all surgical specialties
in which compatible laser systems with
operational wavelengths between 500nm -
2200nm have received regulatory
clearance. | Same/Equivalent | |
| Connectors | SMA 905 connector, SMA 906 connector,
or manufacturer specific connectors and
adaptors | SMA 905 connector, SMA 906 connector,
or manufacturer specific connectors and
adaptors | Same/Equivalent | |
| Fiber
Construction | Core - Fused Silica
Clad - Fused Silica or Fluoropolymer Hard
Cladding
Buffer - Fluoropolymer
Hard Cladding or Silicone Acrylate Jacket -
Nylon, Polyimide, or Teflon | Core - Fused Silica
Clad - Fused Silica or Fluoropolymer Hard
Cladding
Buffer - Fluoropolymer
Hard Cladding or Silicone Acrylate Jacket -
Nylon, Polyimide, or Teflon | Same/Equivalent | |
| Fiber Numerical
Aperture | Fiber having a numerical Aperture (NA)
between 0.22-048 | Fiber having a Numerical Aperture (NA)
between0.22-048 | Same/Equivalent | |
| Peak and
Continuous
Wave lengths | 500nm-2200nm | 500nm-2200nm | Same/Equivalent | |
| Power Ranges | 1-300 Watts | 1-300 Watts | Same/Equivalent | |
| Diameter | Core diameters are offered in a range of
sizes suitable to user needs | Core diameters are offered in a range of
sizes suitable to user needs | Same/Equivalent | |
| Fiber Distal Tip | Multiple configurations of distal tips offered
to provide the most suitable performance for
the application | Multiple configurations of distal tips
offered to provide the most suitable
performance for the application | Same/Equivalent | |
| Compatibility
with surgical laser
systems | Fibers are compatible with any cleared laser
system with an appropriate connection
system | Fibers are compatible with any cleared laser
system with an appropriate connection
system | Same/Equivalent | |
| Sterilization | EtO | EtO | Same/Equivalent | |
Omni-Guide Holdings, Inc.
43 Manning Road
Billerica, MA 01821 web omni-guide.com
office 617.551.4400
fax 888.490.6020
Confidential
Page 2 of 7
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Image /page/5/Picture/0 description: The image shows three logos. The first logo is for OmniGuide Surgical, with the word "OmniGuide" in a sans-serif font above the word "Surgical". The second logo is for Domain Surgical, with the word "Domain" in a sans-serif font above the word "Surgical". The third logo is for LISAL Pro, with the word "LISAL" in a sans-serif font above the word "Pro". All three logos have a blue circle around the words.
6
Image /page/6/Picture/0 description: The image shows three logos. The first logo is for OmniGuide Surgical, the second logo is for Domain Surgical, and the third logo is for LISA Laser Products. All three logos have a blue circle around the name of the company.
Omni-Guide Holdings, Inc.
43 Manning Road
Billerica, MA 01821 web omni-guide.com
office 617.551.4400
fax 888.490.6020
Confidential
Page 4 of 7
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Image /page/7/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical An OmniGuide Company", and the third logo is for "LISALaser Products An OmniGuide Company". All three logos have a similar design, with the company name inside of a double-lined circle.
| Non-Clinical
Performance
Data: | Bench testing (see Section 21) on the subject device has shown the device to perform as intended
with the same technological principle, fit, form, function, method of operating, including but not
limited to the listed date below. The subject device is substantially equivalent to the predicate
device and reference devices in the following attributes: | | | | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------|--|
| | ➤ Indications for Use
➤ Intended Use
➤ Sterilization Technique
➤ Performance Characteristics
➤ Energy used and delivered | | ➤ Design
➤ Materials
➤ Packaging
➤ Shelf-Life
➤ Safety | | ➤ Manufacturing
➤ Clinical setting
➤ Mechanism Action
➤ Anatomical Site
➤ Biocompatibility | |
| Performance
Testing
Summary | The performance test reports focus on the key features of the fiber. These included the following
testing (depending on need):
- Power & Energy input versus output
- Homogeneity of output light (spot check, beam profile)
- High-power testing
- Bend radius testing
- Pull testing
- Feature specific testing was conducted to demonstrate equivalence to the predicate device and
reference devices: safety, performance, integrity, stability, transport, label integrity, packaging of
sterilized fibers. Reference section 21 for the following tests: Performance test of Prima 150 laser
fiber on RevoLix HTL; Performance test of Prima 1000 laser fiber on RevoLix HTL; Performance
test of PrimaSidefire laser fiber on RevoLix HTL; Test of mechanical stability of Prima 150 micron
laser fiber, Test of mechanical stability of Prima 1000 micron laser fiber, and Test of mechanical
stability of Prima 550 micron laser fiber,
Additional Feature testing conducted in the predicate Device LISA Laser Surgical Fiber K220189.
Much of the testing performed was based on a specific feature approach. Those features indicated in
K220189 performance testing were 1) Scatter Free Fiber, 2) Expanded transmission of laser
wavelength/energy, and 3) distal tip configuration, 4 Nav Tip tested for ability to traverse deflected
endoscope. These test reports show the features identified are proven to be safe and effective. Other
reports are similar in that they indicate passed testing of specific features or overall products | | | | | |
| Animal Testing | This product category does not require animal testing. | | | | | |
| Clinical
Performance
Data: | This product category does not require clinical testing. | | | | | |
| Compliance to
Standards | Document
Number | Title | | | | |
| | ISO 11135-1 | Sterilization of Health Care Products - Ethylene Oxide - Requirements for
the development, validation and routine control of a sterilization process for
medical devices | | | | |
| | ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements
for materials, sterile barrier systems and packaging systems | | | | |
| | ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and testing | | | | |
| | ISO 10993-5 | Biological Evaluation of Medical Devices - Part 5: Tests for in vitro
cytotoxicity | | | | |
| | ISO 10993-7 | Biological Evaluation of Medical Devices - Part 7: Tests for Ethylene
Oxide Sterilization Residuals | | | | |
| | ISO 10993-10 | Biological Evaluation of Medical Devices – Part 5: Tests for Irritation and
Skin Sensitization | | | | |
| | ISO 10993-11 | Biological Evaluation of Medical Devices - Part 5: Tests for Systemic | | | | |
Page 5 of 7
8
Image /page/8/Picture/0 description: The image shows three logos for different surgical companies. The first logo is for OmniGuide Surgical, the second logo is for Domain Surgical, and the third logo is for LISA Laser Products. All three logos have a similar design, with a blue circle around the company name. The text below the company name indicates that LISA Laser Products and Domain Surgical are OmniGuide companies.
| ISO 14971 | Medical devices -- Application of Risk Management to Medical Devices |
|---|---|
| ASTM D4169 | Standard Practice for Performance Testing of Shipping Containers and Systems |
| ASTM F88-09 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| ASTM F2096-11 | Standard Test Method for Detecting Gross Leaks in Packaging by Internal |
| Pressurization (Bubble Test) | |
| ASTM F1980-07 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for |
| Medical Devices | |
| ISO 14644-1 | Cleanrooms and associated controlled environments - Part 1: Classification |
| of air cleanliness by particle concentration | |
| AAMI TR12 | Designing, Testing, and Labeling Reusable Medical Devices for |
| Reprocessing in Health Care Facilities | |
| ISO 17664 | Sterilization of medical devices-Information to be provided by the |
| manufacturer for the processing of sterilizable medical devices | |
| ISTA Project 2A | Series, Partial-Simulation Performance Test |
| ASTM F56-13 | Standard Practice for Assessment of Hemolytic Properties of Materials, |
| 2013 | |
| ASTM F619-14 | Standard Practice for Extraction of Medical Plastics |
| Device | |
| Description | The Family of OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices |
| indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The | |
| Fibers are intended for use in laser surgical procedures including open, laparoscopic or endoscopic | |
| ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for | |
| which compatible lasers are applicable. Product description, length, laser wavelength compatibility | |
| can be found in Section 14 of this 510(k) Premarket Notification. | |
| The history of laser fibers originated with the development of lasers used in the medical community. | |
| They have been prevalent in surgical applications for the past 63 years. The fibers allow energy to be | |
| delivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energy | |
| through the glass provides users the ability to direct the energy to the appropriate areas in the body. | |
| The technology of inputting light energy into a fiber optic cable in order to provide a workable tool | |
| for physicians has been relatively unchanged since the inception of medical lasers. |
All Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers are marketed to physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber secured in a coil circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. Often sold in quantities of 1-5 for single use, they are packaged in a shelf box and distributed in a separate shipper. The reusable fibers are marketed in single unit shelf boxes.
The construction of the fibers is dependent of the application to which it's marketed. There are two main methods of attaching the connector - crimp and adhesive. The crimp offers a reliable connection that will not be affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not an issue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best serve the environment where they are utilized.
| Conclusion: | A direct comparison of key characteristics demonstrates that Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers are substantially equivalent/same as the predicate device in terms of materials of construction, energy use and delivery, chemical/electrical/mechanical/thermal safety, manufacturing, intended uses, surgical use of the devices, technological considerations, packaging, safety and performance characteristics [807.92(a)(4)]. Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers family of laser fibers as safe, as effective and perform as well as the predicate devices. The small difference to the predicate device does not raise different questions of safety and efficacy, rather guarantees trained clinicians the use of validated FDA cleared laser fibers. |
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Image /page/9/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical", and the third logo is for "LISA Laser Products". All three logos have a similar design, with the company name in gray text and a blue circle around the name. The logos appear to be for medical or surgical companies.
Performance testing was conducted in order to demonstrate the specifications and performance of OmniGuide Prima Surgical Laser Fibers and to verify that no different questions of safety and effectiveness have been raised due to the small modification's introduction. Test and assessment results indicated that the subject OmniGuide Prima Surgical Laser Fibers perform in accordance with its requirements and specifications, in similarity to its predicate family and do not raise new safety or efficacy risks/questions.