(86 days)
CYMA Co2 laser systems when used in non fractional mode is intended use for Incision, Excision, Ablation, Vaporization and Coagulation of body soft tissues including intraoral tissues, in medical specialties including Dermatology and Plastic surgery, Otorhinolaryngology(ENT), Gynecology, Neurosurgery, Dental and Oral Surgery and Genitourinary Surgery . When used in Fractional mode intended use for Skin Resurfacing.
The CYMA Co2 laser System are emitting a invisible infrared laser with maximum power of 30 watt at 10.63 um and consist of .Infrared light laser oscillation in tubes ; Power supplies, with non contacted mode hand pieces, LCD touch screen display, on this panel also has key switch, emergency red button and the operation led are inserted and consists of main function, Optic main Bench assemble, Fiber optic Hand pieces, Co2 laser Scanner laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, Cooling system, LCD control Panel, Foot Pedal Switch Microcontroller manages the voltage and the Co2 laser Source. This converted light energy creates the Co2 infrared laser and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed multi spot Hand Piece. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
The provided document is a 510(k) summary for the CYMA Co2 laser, which is a medical device for surgical procedures. It details the device's classification, intended use, and comparison to a predicate device. However, it explicitly states under "6. Performance test" that “Clinical data is not presented in this submission.”
Therefore, based solely on the provided document, the following information related to acceptance criteria and performance studies for an AI/device (as implied by your request template) cannot be extracted:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria for clinical outcomes are provided, as no clinical data was submitted.
- Sample sized used for the test set and the data provenance: No test set data or provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
- Adjudication method for the test set: Not applicable as no test set data is presented.
- 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: This is not an AI-assisted device, and no such study is described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical ground truth data is presented.
- The sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable as no training set for an algorithm is mentioned.
What the document does state regarding "Performance test" is limited to:
The device's performance is demonstrated through adherence to the following mandatory and voluntary standards:
- IEC60601-1 part 1: General requirement for basic safety and essential performance.
- IEC60601-1-2: 2007 E M C test
- IEC60601-2-22 Part 2, Particular requirements for safety of diagnostic and Therapeutic laser
- IEC60825-1: 2nd ED, Equipment classification and requirement.
The document concludes that the proposed device shows "no significant different compare to the predicate device" in terms of safety and effectiveness, based on "every Safety test report." This suggests that the device meets safety and performance standards equivalent to similar legally marketed devices, primarily through engineering and bench testing, rather than human-centric clinical performance studies.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2015
WhiteCap Technologies LLC % Mr. Young Chi President Bio-Med USA Incorporated 27 New England Drive Ramsey, New Jersey 07446
Re: K150027
Trade/Device Name: CYMA Co2 laser 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, ONG Dated: January 8, 2015 Received: January 13, 2015
Dear Mr. Chi:
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
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Page 2 - Mr. Young Chi
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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for use statement
K150027 510 (K) number : Device name : CYMA co2 laser Indication for use : CYMA Co2 laser systems when used in non fractional mode is intended use for Incision, Excision, Ablation, Vaporization and Coagulation of body soft tissues including intraoral tissues, in medical specialties including Dermatology and Plastic surgery, Otorhinolaryngology(ENT), Gynecology, Neurosurgery, Dental and Oral Surgery and Genitourinary Surgery . When used in Fractional mode intended use for Skin Resurfacing. Prescription use or/and Over the Counter use XX (Part 21 CFR 801 Sub part D ) (Part 21CFR 801 Sub part C)
Please do not write below line-continued an another pages if needed Concurrence of CDRH, office of Device Evaluation ( ODE )
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510 (K) Summary
As required by CFR 807.92(c)
1. Sponsor
Prepared Jan 5, 2015
WhiteCap Technologies, LLC. 450 W 910S Suite 300. Heber City. UT84032 t: 1 435 503 6308 f: 435 654 0731
2. Submitter and Contact person
Bio-Med USA Inc. Young Chi, President. 27 New England Drive, Ramsey, NJ 07446. U.S.A. t: 1-973 278 5222 f: 1 201 934 6030 e mail: biomedusa@msn.com
3. Name of Device
| Trade name | CYMA |
|---|---|
| Classification name | Powered, Laser surgical instrument |
| Common name | Co2 laser |
| Regulation | 878.4810 Class II |
| Classification Panel | General and Plastic Surgery. |
| Product Code | GEX |
| Subsequent Product Code | ONG |
4. Legally marketed Predicate Device
| K123573 | YOULASER Co2 | Co2 laser | Quanta System SPA |
|---|---|---|---|
| --------- | -------------- | ----------- | ------------------- |
Proposed device are applying same Characteristics such as Design, Construction, Energy, Repetition rate, Cooling Systems, Intended use, Technical specification as predicate device, accordingly there has no new issues raised for safety and effectiveness.
5. Device Description
The CYMA Co2 laser System are emitting a invisible infrared laser with maximum power of 30 watt at 10.63 um and consist of .Infrared light laser oscillation in tubes ; Power supplies, with non contacted mode hand pieces, LCD touch screen display, on this panel also has key switch, emergency red button and the operation led are inserted and consists of main function,
Optic main Bench assemble, Fiber optic Hand pieces, Co2 laser Scanner laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, Cooling system, LCD control Panel, Foot Pedal Switch Microcontroller manages the voltage and the Co2 laser Source.
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This converted light energy creates the Co2 infrared laser and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed multi spot Hand Piece.
The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
6. Performance test
Clinical data is not presented in this submission, but manufactured in accordance with both mandatory and voluntary below standard
IEC60601-1 part 1 : General requirement for basic safety and essential performance. IEC60601-1-2: 2007 E M C test IEC60601-2-22 Part 2, Particular requirements for safety of diagnostic and Therapeutic laser IEC60825-1 :2nd ED, Equipment classification and requirement.
Proposed device, demonstrates no significant different compare to the predicate device
7. Intended use
CYMA Co2 laser systems when used in non fractional mode is intended use for Incision, Excision, Ablation, Vaporization and Coagulation of body soft tissues including intraoral tissues, in medical specialties including Dermatology and Plastic surgery, Otorhinolaryngology(ENT), Gynecology, Neurosurgery, Dental and Oral Surgery and Genitourinary Surgery .
When used in Fractional mode intended use for Skin Resurfacing.
8. Biocompatibility, Sterilization
This device are non-contacted mode, and do not need sterilization.
9.Conclusion.
CYMA Co2 laser system, in this submission, is substantially equivalent to several already cleared predicate device in respect to the Intended use, Main function, Technology, Principal operation and performance. And every Safety test report show it as safe and effective as predicate device and it does not raise any additional issues for safety and effectiveness.
§ 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.