(229 days)
Dental, oral, and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue
Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Removal of inflamed edematous tissue.
The Odyssey Navigator Diode Laser is a portable device for delivering laser energy to surfaces within the oral cavity. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to the surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 650mm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option.
The working end of the delivery fiber is a disposable single-use tip which is attached to a metal autoclavable handpiece. This handpiece system is provided with the device. The fiber tip attachment assembly is delivered sterilized in individual mylar blister packages. Sterlization is accomplished by Irradiation.
The activation of the working beam diodes is completed by use of a foot-actuated switch.
The provided text is a 510(k) Summary for the Odyssey Navigator Diode Laser, seeking substantial equivalence to existing predicate devices. It describes the device's technical specifications, intended uses, and compliance with performance standards. However, it does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance data in the way requested by the prompt (i.e., sensitivity, specificity, accuracy, etc., from a clinical trial).
Instead, the document details the technical characteristics of the new device and compares them to legally marketed predicate devices to establish substantial equivalence. This is a common approach for 510(k) clearances for devices like this, where clinical performance is often inferred from the known performance of substantially equivalent predicate devices with similar technological characteristics and intended uses.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy). Instead, it relies on demonstrating that the new device's technical specifications (performance characteristics) are similar to those of legally marketed predicate devices.
| Characteristic | Acceptance Criteria (from Predicate Devices) | Reported Device Performance (Odyssey Navigator) |
|---|---|---|
| Wavelength | Around 810 nm (Odyssey 2.4G) or 980 nm (SiroLaser) | 810±20 nm |
| Power Output | 0.1 - 5.0 watts (Odyssey 2.4G) or 0.5 - 7.0 watts (SiroLaser) | 0.1 - 3.0 watts |
| Aiming Beam | 630-650 nm, 3mW (Odyssey 2.4G) or 630-680 nm (SiroLaser) | 630-650 nm, 2mW |
| Cooling System | Fan air cooled (both predicates) | Fan air cooled |
| Pulse Control | Digital emission control (both predicates) | Digital emission control |
| Laser Source | Solid-state diode (both predicates) | Solid-state diode |
| Power Req. | 100-240 VAC @ 50-60 Hz, 1.5A (Odyssey 2.4G) | 100-240 VAC @ 50-60 Hz, 0.5A (switchable) |
| Dimensions | 10" x 8" x 4" (Odyssey 2.4G) or 7.5" x 3.5" x 2-1/8" (SiroLaser) | 7" x 4" x 2-3/8" |
| Weight | 6.5 lbs (Odyssey 2.4G) or 1 lb, control unit only (SiroLaser) | 1 lb, control unit only |
| User Interface | LED Display, Membrane Touch Pad (Odyssey 2.4G) or LCD Touch Screen (SiroLaser) | LCD Touch Screen |
| Compliance | 21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, IEC 60825-1 (Implicit for predicates) | Complies with these standards and deviations |
| Intended Uses | Similar to predicates | Dental, oral, soft tissue surgery, periodontal procedures |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Information not provided. This document does not describe a clinical trial or performance study with a test set of data. The submission relies on technical characteristics for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Information not provided. No ground truth establishment is described as there is no performance study where expert assessment would be needed for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Information not provided. No adjudication method is necessary because no clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This document is for a laser device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device (diode laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Information not provided for a clinical performance study. The "ground truth" here is effectively the accepted performance and safety of the predicate devices.
8. The sample size for the training set
- Not applicable / Information not provided. This is not a machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Information not provided. As there is no training set, this information is not relevant.
Summary of the Study (as presented in the 510(k) Summary):
The "study" presented here is a technical and regulatory comparison rather than a clinical performance study. The manufacturer, Ivoclar Vivadent, Inc., performed a detailed comparison of their new device, the Odyssey Navigator Diode Laser, against two legally marketed predicate devices: the Odyssey 2.4G Diode Laser (also by Ivoclar Vivadent, Inc.) and the SiroLaser (by Sirona Dental Systems, Gmbh).
The purpose of this comparison was to demonstrate substantial equivalence to the predicate devices. This demonstration is achieved by showing that the Odyssey Navigator shares:
- Similar indications for use in the oral environment.
- Similar design features (wavelength, operating controls, laser delivery method).
- Similar methods of control systems, safety features, and performance monitoring.
- Similar performance specifications (power output, energy type).
- Compliance with recognized performance standards (21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, and IEC 60825-1).
The "study" concludes that "The Odyssey Navigator Diode Laser is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards."
In essence, the "proof" that the device meets acceptance criteria is its demonstration of substantial equivalence in technical and functional characteristics to devices already cleared for market, along with compliance to relevant safety standards for laser products.
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510(k) Summary of Safety and Effectiveness
lvoclar Vivadent, Inc. 175 Pineview Dr., Amherst, NY 14228 Tel: 716-691-0010 Fax: 716-691-2294
Donna Hartnett, Preparation Date: June 27, 2006
Device Name:
| Trade Name: | Odyssey Navigator Diode Laser |
|---|---|
| Common Name: | 810nm Diode Laser |
| Product Classification: | Laser, Dental, Soft Tissue |
MAR 2 1 2007### Legally Marketed Predicate Devices for Substantial Equivalence:
Odyssey 2.4G Diode Laser, Manufactured by Ivoclar Vivadent, Inc.
SiroLaser, Manufactured by Sirona Dental Systems, Gmbh
Rationale for Substantial Equivalence:
The aforementioned laser devices and their accompanying delivery systems share similar indications for use in the oral environment, similar design features including wavelength, operating controls, and laser delivery method. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output and energy type.
Description of Submitted Device:
The Odyssey Navigator Diode Laser is a portable device for delivering laser energy to surfaces within the oral cavity. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to the surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 650mm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option.
The working end of the delivery fiber is a disposable single-use tip which is attached to a metal autoclavable handpiece. This handpiece system is provided with the device. The fiber tip attachment assembly is delivered sterilized in individual mylar blister packages. Sterlization is accomplished by Irradiation.
The activation of the working beam diodes is completed by use of a foot-actuated switch.
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Intended Uses of the Odyssey Navigator Diode Laser: The device is intended to be used for a variety of surgical procedures on soft tissue within the oral cavity including:
Dental, oral, and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket Removal of inflamed edematous tissue.
Technological Characteristics and Substantial Equivalence:
The Odyssey 2.4G uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 650nm adjustable output aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emission. The maximum output of the unit 5 watts.
The SiroLaser utilizes solid-state diode lasers to generate laser energy in the 980nm range. The power range is from 0.5 - 7.0 watts and operates in continuous or pulse mode. The system utilizes an optical fiber to transmit laser energy from the control unit to the work site. The distal end of the fiber is contained with a metal handpiece and terminates in a disposable handpiece tip. The system features an LCD touchscreen to access the controls and features of the system.
Performance Standards:
The Odyssey Navigator Diode Laser complies with the performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50. dated July 26, 2001. The device also complies with IEC 60601-1:1998+A1+A2, IEC 60601-2-22:1995. and IEC 60825-1:1993+A1+A2.
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Clinical Performance Data
| Ivoclar Vivadent, Inc.Odyssey Navigator DiodeLaser | Ivoclar Vivadent, Inc.Odyssey 2.4G Diode Laser | Sirona Dental Systems, GmbhSiroLaser | |
|---|---|---|---|
| Wavelength | 810±20 nm | 810±20 nm | 980 nm |
| Power | 0.1 - 3.0 watts | 0.1 - 5.0 watts | 0.5 - 7.0 watts |
| Aiming Beam | 630-650 nm, 2mW | 630-650 nm, 3mW | 630-680 nm, powerunavailable |
| Cooling System | Fan air cooled | Fan air cooled | Fan air cooled |
| Pulse Control | Digital emission control | Digital emission control | Digital emission control |
| Laser Source | Solid-state diode | Solid-state diode | Solid-state diode |
| PowerRequirements | 100-240 VAC @ 50-60 Hz,0.5A (switchable) | 100-240 VAC @ 50-60 Hz,1.5A (switchable) | unknown |
| Dimensions | 7" x 4" x 2-3/8" | 10" x 8" x 4" | 7.5" x 3.5" x 2-1/8" |
| Weight | 1 lb, control unit only | 6.5 lbs | 1 lb, control unit only |
| User Interface | LCD Touch Screen | LED Display, MembraneTouch Pad | LCD Touch Screen |
| 510(k) Number | Pending this application | K050453 | K053161 |
Conclusion
The Odyssey Navigator Diode Laser is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.
.
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Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings. The image is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ivoclar Vivadent, Inc. % Ms. Donna Marie Hartnett Director QA/Regulatory Affairs 175 Pineview Drive Amherst, New York 14228
MAR 2 1 2007
Re: K062258
Trade/Device Name: Odyssey Navigator Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 5, 2007 Received: March 6, 2007
Dear Ms. Hartnett:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Donna Marie Hartnett
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K062258 |
|---|---|
| --------------------------- | --------- |
Device Name: Odyssey Navigator Laser
Indications For Use:
Dental, oral, and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue
Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Removal of inflamed edematous tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | ✓ |
|---|---|
| OR Over-The-Counter Use |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 12062258 |
|---|---|
| --------------- | ---------- |
§ 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.