(266 days)
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for :
· Benign vascular lesions and vascular dependent lesions removal
The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.
The provided text describes a medical device, a Laser Treatment System, and its substantial equivalence to a predicate device for FDA clearance. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria from a clinical performance perspective.
The document focuses on:
- Regulatory Clearance (K211722): This is an FDA 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device, not necessarily clinical efficacy.
- Device Description and Intended Use: The device is a "Laser Treatment System" for "Benign vascular lesions and vascular dependent lesions removal."
- Comparison to Predicate Device (K172193): The comparison table highlights technological characteristics like product code, regulation number, indications for use, laser classification, wavelength, frequency, pulse duration, and compliance with various safety and biocompatibility standards.
- Performance Data (Non-Clinical):
- Biocompatibility Testing: Evaluated according to ISO 10993-1, covering Cytotoxicity, Irritation, and Sensitization. All acceptance criteria for these biocompatibility tests were met.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested to comply with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.
Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and the study proving it, as this information is not present in the provided text.
If this were a clinical study, the requested information would typically look something like this (hypothetical example, as the data is missing):
Hypothetical Acceptance Criteria and Performance (Based on common laser efficacy studies, NOT from the provided text)
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Hypothetical) |
|---|---|---|
| Clinical Clearance | ≥ 75% average lesion clearance after X treatments | 82% average lesion clearance |
| Adverse Event Rate | < 5% incidence of persistent erythema or scarring | 3% incidence of transient erythema |
| User Satisfaction | ≥ 80% satisfaction score (Likert scale) | 88% satisfaction score |
| Pain Scale Reduction | ≥ 50% reduction in VAS pain score after treatment | 65% reduction in VAS pain score |
2. Sample Size and Data Provenance
- Test Set Sample Size: (Information not available in text. If applicable, would be a number of patients or lesions.)
- Data Provenance: (Information not available in text. If applicable, would specify country/region and if it was prospective/retrospective.)
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: (Information not available in text.)
- Qualifications of Experts: (Information not available in text. If applicable, would specify specialties like "Dermatologists with 5+ years of experience in laser treatments".)
4. Adjudication Method
- Adjudication Method: (Information not available in text. In clinical studies, this could be "independent review by 2 dermatologists, with a third adjudicator in case of disagreement (2+1)".)
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No, the provided document does not mention an MRMC comparative effectiveness study for human readers with or without AI assistance. The device is a laser system, not an AI diagnostic tool that assists human readers.
6. Standalone Performance
- Standalone Performance: Not applicable for a laser treatment system in the context of "algorithm only without human-in-the-loop performance." The device is a physical therapeutic tool operated by a clinician.
7. Type of Ground Truth Used
- Type of Ground Truth: (Information not available in text. For laser efficacy, this would typically involve clinical assessments (e.g., photographs, visual grading scales, objective measurements like chromameter readings for redness/pigmentation), patient-reported outcomes, and possibly histological examination in some cases.)
8. Sample Size for Training Set
- Training Set Sample Size: Not applicable. The provided document concerns a physical device, not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
- Ground Truth for Training Set: Not applicable, as it's not an AI algorithm requiring a training set.
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February 25, 2022
Canadian Pioneer Medical Technology Corporation Rashid Reza Mir Sayah Unit 2 -210 Drumlin Circle, Concord Vaughan, Ontario L4K 3E3 Canada
Re: K211722
Trade/Device Name: Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis 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: January 17, 2022 Received: January 19, 2022
Dear Rashid Reza Mir:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 mediation-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.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211722
Device Name
Laser Treatment System Models: Nyx Plus, Grace Plus, Ares, Nemesis
Indications for Use (Describe)
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for :
· Benign vascular lesions and vascular dependent lesions removal
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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510(k) summary
I Submitter
Canadian Pioneer Medical Technology Corporation 210 Drumlin Circle #2 , Vaughan, Ontario, L4K 3E3, Canada
Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: 4377727788 Email: Canadianpioneer@yahoo.com Date of preparation: May 29, 2021
II Subject Device
Trade Name of Device: Laser Treatment System, Model: Nyx Plus , Grace Plus, Ares .Nemesis Common name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery
III Predicate Device
Trade Name of Device: Modified Alma Lasers Soprano XLTM Family of Multi-Application and Multi-Technology Platforms [SopranoXL. SopranoXLi, Soprano ICE and Soprano ICE Platinum] with Trio Diode Laser Module Common name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery 510(k) number: K172193
IV Device description
The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A
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microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.
V Intended use of device and Indications for Use
Intended Use
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for : · Benign vascular lesions and vascular dependent lesions removal
VI Comparison of technological characteristics with the predicate devices
The indication of the proposed device is covered by the predicated devices. The laser treatment system includes four models of machines and the simultaneous triple wavelength applicator for all four models.
| Devicefeature | Laser Treatment System(subject device) | Modified Alma LasersSoprano XL. Family ofMulti-Application &Multi-TechnologyPlatforms (K172193) |
|---|---|---|
| Productcode | GEX | GEX |
| Regulationnumber | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indicationsfor use | The indication of use of 3wavelength 755,808,1064handpiece (trio istreatment of Benignvascular lesions andvascular dependentlesions removal | The indication of use of triois treatment of Benignvascular lesions andvascular dependent lesionsremoval |
| Laserclassification | Class IV | Class IV |
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| Wavelength | The Simultaneoustriple-wavelength laserdevice (trio)755-808-1064 nm | Trio 755-808-1064 nm |
|---|---|---|
| Frequency | 1-10Hz | 0.5 |
| PulseDuration | 5-300 (to 400 optional) | 3.3-200ms |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 |
| ElectricalSafety | Comply with IEC60601-1,IEC60601-2-22 | Comply with IEC60601-1,IEC60601-2-22 |
| EMC | Comply withIEC60601-1-2, | Comply with IEC60601-1-2, |
| Laser safety | Comply with IEC60825-1,IEC60601-2-22 | Comply with IEC60825-1,IEC60601-2-22 |
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Laser Treatment System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface –intact skin" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Laser Treatment System. The system has been tested to comply with the following standards:
- IEC 60601-1:2012 Medical Electrical Equipment Part 1: General Requirements For -Basic Safety And Essential Performance;
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- IC 60601-2-22: 2007 (Third Edition) + A1:2012 for use inconjunction with IEC 60601-1: -2005 (Third Edition) + A1:2012
- -IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
VIII Conclusion
The Laser Treatment System is substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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.