(14 days)
The Styla MicroLaser™/StylaOrtho™ is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The Styla MicroLaser™/StylaOrtho™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharingeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
The Styla MicroLaser™/StylaOrtho™ are the first soft-tissue laser developed as a handheld unit. It is wireless, lightweight, easy to set up, simple to use, requires less power, and cost efficient.
With the Styla MicroLaser™/StylaOrtho™ Zap Lasers introduces a miniature X-Y adjusting module for coupling a diode laser with a disposable fiber. Fiber accuracy is better than 5 um and the alignment is extremely stable. A module with a specific lens was developed by Zap Lasers in order to achieve such precision and alignment. Such a design greatly simplifies the fiber management and setup of operatory time as the fiber is attached into the tip allowing this item to be disposable and simple to be used. No fiber scoring is needed as the disposable tip is provided already scored to decrease setup tip and user's error.
The Laser and Control Box comprise the following major modules:
The laser diode assembly contains one single emitter laser diode of 2.0 watt output power (Class IV laser) lasing at 808 nm. The diode laser is directly coupled to a lens and aligned to the fiber optic inside the removable tips, using (patent pending) a 2 axis laser alignment system. It also contains a 5 m W power, 650 nm laser diode coupled to the same fiber optic. The laser's visible light is designed to aid the user to aim the tip of the delivery fiber onto the tissue.
The Styla Microlaser™/StylaOrtho™ is designed to dissipate heat during normal operation and may feel warm to the touch after prolonged use. The laser module is mounted towards the tip of the unit, which acts as a heat sink during normal operation. The temperature is monitored by a sensor that prevents overheating.
Laser power controller provides electric power to the diodes in continuous wave and pulsed mode. It supplies about 2 VDC and current up to 4A to the diodes. The controller contains a high efficiency DC to DC converter that converts the battery voltage to the precise voltage needed for laser operation. This ensures that the majority of the energy is used for light and not converted into heat.
The delivery tips with fiber built in consist of 400 micron core multi-mode optical fiber, and a precise alignment mechanism. The fiber is factory installed into the tip and requires no installation by the end user.
The foot-switch is a standard (UL-approved) commercial foot-switch that provides hands-free ON/OFF capabilities. This switch controls initiation/termination of laser power from the distal end of the delivery fiber wirelessly.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Styla MicroLaser™/StylaOrtho™ device:
This 510(k) summary is for a Class II surgical laser device, and the primary method for demonstrating safety and effectiveness is through establishing substantial equivalence to existing predicate devices, rather than conducting new, de novo clinical trials with specific acceptance criteria and performance metrics in the way one might expect for a novel AI/software device.
Therefore, many of the requested categories (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of submission. The 'study' in this context refers to the comparison against predicate devices and adherence to regulatory standards.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use & Indications | Must be substantially equivalent to predicate devices. | Styla MicroLaser™/StylaOrtho™ has intended use and indications for use previously cleared by FDA for predicate devices. |
| Technical Characteristics | Must be similar to those of cleared predicate devices. | Technical characteristics are similar to those of the cleared Odyssey Navigator and EZLase. |
| Laser Output Values | Must be within previously cleared values of predicate dental laser systems. | Laser output values are well within previously cleared values of the predicate dental laser system. |
| Safety and Effectiveness | Must demonstrate proven safety and effectiveness for claimed indications, similar to predicate devices. | Predicate devices and other cleared laser systems with similar power outputs have proven safety and effectiveness in the treatment of the claimed indications. |
| Performance Standards | Compliance with specific FDA (21 CFR 1010 & 1020, Laser Notice 50) and international standards (IEC60601-1, IEC60601-2-22, IEC60825-1). | The device complies with 21 CFR 1010 & 1020, with permissible deviations relative to Laser Notice 50. It also complies with IEC60601-1:1995+A1+A2, IEC60601-2-22:1995, and IEC60825-1:1993+A1+A2. |
| Manufacturing & Quality | Compliance with general controls and voluntary standards (SOPs, vendor/process cert, QSR, ISO materials, eGMP, ISO 9000 series). | Zap Lasers, LLC intends to comply fully with general controls. Various voluntary performance standards are utilized. |
| Heat Dissipation | Designed to dissipate heat during normal operation and prevent overheating. | The device is designed to dissipate heat and has a sensor to prevent overheating. |
| Fiber Accuracy/Alignment | Precision in fiber coupling and alignment. | Fiber accuracy is better than 5 µm and alignment is extremely stable. (A module with a specific lens was developed to achieve this precision and alignment). |
| Sterilization & Packaging | Appropriate sterilization, packaging, and storage procedures. | Device is supplied non-sterile; disposable tips are non-sterile and to be discarded. Packaging is typical medical grade. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This submission relies on substantial equivalence to predicate devices, not a test set of data from human or phantom subjects.
- Data Provenance: Not applicable in the context of a "test set." The "data" primarily comes from the regulatory clearance of predicate devices and adherence to manufacturing/performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.
4. Adjudication Method for the Test Set:
- Not applicable. There was no test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for demonstrating substantial equivalence for a Class II surgical laser device where technical performance and equivalence to predicates are the key elements.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a physical medical device (a surgical laser), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Not applicable in the typical sense of a clinical trial. The "ground truth" for this submission is implicitly derived from the established safety and effectiveness of the predicate devices as previously cleared by the FDA, and the device's adherence to relevant performance and safety standards. The assessment is about whether the new device performs effectively and safely like already-approved devices, not about its ability to diagnose or measure against a gold standard in a new context.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is not an AI/ML device, so there is no training set or ground truth established in that context.
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Appendix D PREMARKET NOTIFICATION [510(k)] Summary
510(K) Summary of Safety and Effectiveness Premarket Notification 510(k)
Zap Lasers, LLC 2621-B Pleasant Hill Road Pleasant Hill, Ca. 94523
MAY 1-4-2008
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1. Device Name:
Trade Name: Styla MicroLaser™/StylaOrthoTM Common Name(s): Surgical Laser System Classification Name(s): Laser, Surgical
2. Establishment Name & Registration Number: Name: Zap Lasers, LLC Number: applied/pending
3. Classification(s):
$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 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. Class II.
Device Class: Class II for all requested indications Classification Panel: General and Plastic Surgery & Others Product Code(s): GEX
4. Section 514 Compliance
Zap Lasers, LLC intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, and 520 of the Food, Drug, and Cosmetic Act.
5. Performance Standards
United States Food and Drug Administration mandated performance standards for this device exist and are provided under Sections 21 CFR 1010 & 1020, with permissible deviations relative to Laser Notice 50, dated July 26, 2001. The device also complies with IEC60601-1:1995+A1+A2, IEC60601-2-22:1995, and IEC60825-1:1993+A1+A2. In addition, various voluntary performance standards are utilized. Voluntary standards utilized include Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and eGMP & ISO 9000 series quality regulations.
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6. Special Controls:
All Class II devices are subject to Special Controls.
. . Labeling:
The laser system discussed in this premarket notification will be manufactured by Zap Lasers, LLC and labeled as such. Zap Lasers, LLC will market the system exclusively to healthcare facilities, physicians and dentists. In addition to the usual package and identification labeling, the following additional Warnings, Cautions & Precautions statements are displayed as appropriate on or within the device packaging. They are repeated here for ease of use.
Warning: Federal (United States) Law restricts this device to sale by or on the order of a physician or dentist only.
9. Predicate Device (legally marketed comparison device)
Zap Lasers, Inc. believes that the following surgical laser systems are substantially equivalent to the Styla MicroLase™/OrthoLase™- surgical diode system.
10. Summary of Equivalence:
There are no unique applications, material or specifications presented herein. Evidence of equivalence has been demonstrated through:
- . The Styla MicroLase™/StylaOrtho™ intended use and indications for use were previously cleared by FDA for the predicate devices.
- The technical characteristics of the Styla MicroLase™/StylaOrtho™ are similar to those of the . cleared Odyssey Navigator and the EZLase.
- Laser output values of the Styla MicroLase™/StylaOrthot™ are well within previously cleared . values of the predicate dental laser system as described.
- The predicate devices and other previously cleared laser systems with similar power outputs have � a proven safety and effectiveness in the treatment of the claimed indications.
- Safety and performance testing. .
Therefore, the Styla MicroLase™/StylaOrtho™ is substantially equivalent to its predicate devices cited above and raises no new safety and/or effectiveness issues.
11. Device Description:
The progress achieved in recent years in fiber optics and diode lasers technology has made it possible to have commercial devices with multi-watt output power in near-infrared spectrum from about 0.5-mm diameter single-core fiber.
This laser technology is now being used in many areas of medicine and dentistry, particularly oral surgery, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery. The intended uses of these laser devices include hemostasis, incision, excision,
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ablation, vaporization, and coagulation of tissue. In dentistry, usage of laser devices ranges from cosmetic surgery to treating periodontal disease.
As the dental laser industry grows, there is an increased demand for portable soft tissue lasers. In today's market, customers want a more portable laser solution to avoid office clutter and to reduce setup time. It has also become apparent that a relatively low-power laser (2.0 maximum watts and 808 mm) covers the vast majority of laser surgical requirements. The Styla MicroLaser™/ StylaOrtho™ are the first soft-tissue laser developed as a handheld unit. It is wireless, lightweight, easy to set up, simple to use, requires less power, and cost efficient.
With the Styla MicroLaser™/StylaOrtho™ Zap Lasers introduces a miniature X-Y adjusting module for coupling a diode laser with a disposable fiber. Fiber accuracy is better than 5 um and the alignment is extremely stable. A module with a specific lens was developed by Zap Lasers in order to achieve such precision and alignment. Such a design greatly simplifies the fiber management and setup of operatory time as the fiber is attached into the tip allowing this item to be disposable and simple to be used. No fiber scoring is needed as the disposable tip is provided already scored to decrease setup tip and user's error.
Laser and Control Box:
The Laser and Control Box comprise the following major modules:
The laser diode assembly contains one single emitter laser diode of 2.0 watt output power (Class IV laser) lasing at 808 nm. The diode laser is directly coupled to a lens and aligned to the fiber optic inside the removable tips, using (patent pending) a 2 axis laser alignment system. It also contains a 5 m W power, 650 nm laser diode coupled to the same fiber optic. The laser's visible light is designed to aid the user to aim the tip of the delivery fiber onto the tissue.
The Styla Microlaser™/StylaOrtho™ is designed to dissipate heat during normal operation and may feel warm to the touch after prolonged use. The laser module is mounted towards the tip of the unit, which acts as a heat sink during normal operation. The temperature is monitored by a sensor that prevents overheating.
Laser power controller provides electric power to the diodes in continuous wave and pulsed mode. It supplies about 2 VDC and current up to 4A to the diodes. The controller contains a high efficiency DC to DC converter that converts the battery voltage to the precise voltage needed for laser operation. This ensures that the majority of the energy is used for light and not converted into heat.
The delivery tips with fiber built in consist of 400 micron core multi-mode optical fiber, and a precise alignment mechanism. The fiber is factory installed into the tip and requires no installation by the end user.
The foot-switch is a standard (UL-approved) commercial foot-switch that provides hands-free ON/OFF capabilities. This switch controls initiation/termination of laser power from the distal end of the delivery fiber wirelessly.
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12. Applicant Name & Address: Zap Lasers, LLC 2621 Pleasant Hill Road Pleasant Hill, CA 94523
13. Company Contact:
Jay Goble, DDS Zap Lasers, LLC 2621 Pleasant Hill Road Pleasant Hill, CA 94523 Phone: 888-876-4546 Fax: 925-930-6776
14. Submission Correspondent
Jay Goble, DDS Zap Lasers, LLC 2621 Pleasant Hill Road Pleasant Hill, CA 94523
15. Manufacturing Facility:
The devices are physically manufactured at ZAP Laser, LLC premises in Pleasant Hill, CA. The devices are manufactured by ZAP Lasers, LLC for distribution in the U.S.A.
16. Sterilization, Packaging & Storage Information:
The diode laser device is not supplied sterile. The disposable plastic hand piece tips are supplied nonsterile by the manufacturer and are to be discarded in an infectious waste container (SHARPS) after each use. There is no re-sterilization procedure indicated.
Packaging materials are typical medical grade tubes, plastic trays, peel-type pouches of the generic mylar/non-woven sandwich variety etc. All packages should be intact upon receipt. Packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination.
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Image /page/4/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Zap Lasers, LLC % Underwriters Laboratories Inc. Mr. Morten Christensen 455 East Trimble Road San Jose, California 95131
Re: K081214 Trade/Device Name: Styla MicroLaser™/StylaOrtho™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insgrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 20, 2008 Received: March 24, 2008
Dear Mr. Christensen:
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
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Page 2 - Mr. Morten Christensen
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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Tab 2 Indications for Use Statement
evice Name: Styla MicroLaser™/StylaOrtho™
KO
Indication for Use:
The Styla MicroLaser™/StylaOrtho™ is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The Styla MicroLaser™/StylaOrtho™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharingeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Neil R. Oplen Gorman
Concurrence of CDRH, Office of In Vitro Diag Distigly B
Division of General, Restorativ and Neurological Devices
510(k) Number
§ 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.