(118 days)
Not Found
No
The device description focuses on a heat detection mechanism and simple electronic logic (disengaging a foot switch, audible alarm, light) to respond to overheating. There is no mention of learning, adaptation, complex pattern recognition, or any terms associated with AI/ML.
No.
The device is an accessory to a medical laser, designed to deliver laser radiation to a surgical site and ensure safety by detecting overheating and shutting down the laser. It does not directly provide therapy.
No
The device is an accessory (fiber optic waveguide with a safety feature) for medical lasers, designed to deliver laser radiation. It does not diagnose medical conditions.
No
The device description explicitly states that the product includes an "electronic device" (the LASERGUARD™ accessory) which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "accessory to a medical laser" for delivering laser radiation to a surgical site. This is a therapeutic or surgical application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties of the fiber optic cable and the function of the LaserGuard™ accessory in detecting overheating and shutting down the laser. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not contain any of the typical indicators of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection of specific analytes or biomarkers
- Providing diagnostic information about a patient's condition
- Use in a laboratory setting for diagnostic testing
The device's function is to safely deliver laser energy for medical procedures, which falls under the category of a medical device used for treatment or surgery, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Optical Integrity General Shaped Fibers with LaserGuard™ are intended to be used as an accessory to a medical laser. For specific applications, refer to the Instructions for Use documentation supplied with the laser system being used with the LaserGuard™ system.
Product codes
GEX
Device Description
The product submitted herein is, in fact, the predicate device fitted with a LaserGuard™ device as an accessory. The basic device is a wave guide for laser light sources and will transmit light between 532 and 2100 nanometer wavelengths. The cladding of the fibers is either doped silica or a polymer. The outer buffer material is either Nylon or Tefzel. The LASERGUARD™ accessory included with the submitted product is an electronic device that will detect heat generated as a result of the fiber overheating anywhere along the light path and will disengage the foot switch of the laser thereby putting the laser in standby mode. The LASERGUARD™ will also indicate by an audible alarm and a light that the fiber has overheated. Both the predicate device and the submitted products are capable of delivering laser radiation from a laser instrument to the surgical site with minimal loss. Both deliver wavelengths from 532 to 2100 nanometers as, for example, is generated by Ho:YAG or Nd:YAG lasers. The laser energy is emitted through a flat, orbed or conical tip located at the distal end of the fiber. Both the predicate and submitted products are offered in a range of core sizes from 145 to 940 micrometer silica cores and are from 2.5 to 5.0 meters in length. The products are supplied in sterile and non-sterile as well as single-use and re-usable versions.
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
Bench testing demonstrated that Optical Integrity's General Shaped Fiber with LASERGUARD™ performed the same as the predicate device, Optical Integrity's General Shaped Fiber (without the LASERGUARD™ accessory). I.E. there was no difference in the energy delivered by the undamaged fiber with or without the LASERGUARD™ accessory in place. Additionally, the test results establish that the LASERGUARD™ will shut down the laser, as intended, when a fiber break occurs and indicate such by an audible alarm and an indicator light. (Test report is in Section 18, Bench Tests)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing demonstrated that Optical Integrity's General Shaped Fiber with LASERGUARD™ performed the same as the predicate device, Optical Integrity's General Shaped Fiber (without the LASERGUARD™ accessory). I.E. there was no difference in the energy delivered by the undamaged fiber with or without the LASERGUARD™ accessory in place. Additionally, the test results establish that the LASERGUARD™ will shut down the laser, as intended, when a fiber break occurs and indicate such by an audible alarm and an indicator light. (Test report is in Section 18, Bench Tests)
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/0 description: The image shows a handwritten alphanumeric string. The string starts with the letter 'K', followed by the numbers '100194'. The numbers are written in a cursive style, and the overall image has a slightly rough, handwritten appearance.
MAY 2 0 2010
510(k) Summary Prepared on 20 July 2009
| Submitted By: Optical Integrity, Inc.,
Location: 7500 McElvey Road, Panama City Beach, Florida, Zip 32408.
| Contact: Ron Bowman at (850) 233-5312 ext. 209 | |
|---|---|
| Trade Name: | |
| Common Name: | |
| Classification name: | Optical Integrity General Shaped Fiber with LaserGuard(tm) |
| surgical laser fiber | |
| Laser surgical instrument for use in general and plastic surgery and in | |
| dermatology | |
| Product Code: | |
| CFR reference: | GEX |
| 21 CFR 878.4810 | |
| Predicate device: | Optical Integrity, Inc. General Shaped Fiber, 510(k) number K022338 |
| and Dornier Midelas laser EPS mode. | |
| Product Description: | |
| Technological | |
| Characteristics: | The product submitted herein is, in fact, the predicate device fitted with |
| a LaserGuard™ device as an accessory. The basic device is a wave | |
| guide for laser light sources and will transmit light between 532 and | |
| 2100 nanometer wavelengths. The cladding of the fibers is either doped | |
| silica or a polymer. The outer buffer material is either Nylon or Tefzel. | |
| The LASERGUARD™ accessory included with the submitted product is an | |
| electronic device that will detect heat generated as a result of the fiber | |
| overheating anywhere along the light path and will disengage the foot | |
| switch of the laser thereby putting the laser in standby mode. The | |
| LASERGUARD™ will also indicate by an audible alarm and a light that the | |
| fiber has overheated. | |
| Both the predicate device and the submitted products are capable of | |
| delivering laser radiation from a laser instrument to the surgical site with | |
| minimal loss. Both deliver wavelengths from 532 to 2100 nanometers | |
| as, for example, is generated by Ho:YAG or Nd:YAG lasers. The laser | |
| energy is emitted through a flat, orbed or conical tip located at the distal | |
| end of the fiber. Both the predicate and submitted products are offered | |
| in a range of core sizes from 145 to 940 micrometer silica cores and are | |
| from 2.5 to 5.0 meters in length. The products are supplied in sterile | |
| and non-sterile as well as single-use and re-usable versions. | |
| Indications for Use: | |
| for both the | |
| submitted product | |
| and the predicate | |
| device. | The Optical Integrity General Shaped Fibers with LaserGuard™ are intended to |
| be used as an accessory to a medical laser. For specific applications, refer to | |
| the Instructions for Use documentation supplied with the laser system being | |
| used with the LaserGuard™ system. | |
| Comparison of | |
| submitted product to | |
| predicate device, | |
| technological | |
| characteristics: | The submitted product, Optical Integrity General Shaped Fiber with |
| LASERGUARD™, is the predicate device fitted with an accessory capable | |
| of detecting when the fiber material experiences a rapid rise in | |
| temperature. This rapid rise in temperature occurs, for example, when | |
| the fiber breaks as a result of a small bend radius. With the predicate | |
| device, an operator must detect such a break by observing the changes | |
| in energy delivery at the fiber tip and then respond to them by releasing | |
| the foot or hand held switch in order to stop damage to the endoscope | |
| or hand piece. With the LASERGUARD™ detector, the laser is | |
| automatically put in standby, thereby limiting damage to endoscopes or | |
| other fiber containing devices. | |
| Additionally, if the fiber is used as a bare fiber for tissue ablation and the | |
| tip of the fiber becomes contaminated and as a result the fiber heats up, | |
| then the LASERGUARD™ will likewise, put the laser in standby and alert | |
| the operator that a thermal runaway event has occurred. The surgeon | |
| can then determine what course of action to take. That way, the | |
| submitted device can assist the surgeon in delivering the appropriate | |
| energy to ablate the desired tissue while minimizing collateral damage. | |
| Summary of | |
| Performance Data | Bench testing demonstrated that Optical Integrity's General Shaped |
| Fiber with LASERGUARD™ performed the same as the predicate device, | |
| Optical Integrity's General Shaped Fiber (without the LASERGUARD™ | |
| accessory). I.E. there was no difference in the energy delivered by the | |
| undamaged fiber with or without the LASERGUARD™ accessory in place. | |
| Additionally, the test results establish that the LASERGUARD™ will shut | |
| down the laser, as intended, when a fiber break occurs and indicate | |
| such by an audible alarm and an indicator light. (Test report is in | |
| Section 18, Bench Tests) |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 0 2010
Optical Integrity, Inc. % Mr. Ronald E. Bowman 7500 McElvey Road Panama City Beach, Florida 32408
Re: K100194
Trade/Device Name: Optical Integrity General ShapedFiber with LaserGuard™ 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 17, 2010 Received: May 18, 2010
Dear Mr. Bowman: .
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
3
Page 2 - Mr. Ronald E. Bowman
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/ReportalProblem/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
Sincerely yours,
for
Mark N. Melkerson
Mark N. Mel Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(K) Number: K100194
Device Name: Optical Integrity General Shaped Fiber with LaserGuard™
Indications for Use:
The Optical Integrity General Shaped Fibers with LaserGuard™ are intended to be used as an accessory to a medical laser. For specific applications, refer to the Instructions for Use documentation supplied with the laser system being used with the LaserGuard™ system.
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
_or Over-the-Counter Use _
Neil K. Oden for mxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100194
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