(64 days)
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Nd:YAG handpiece is indicated for:
- At the 1064nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
- At the 532nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial telangiectasias, as, angiomas, and leg veins, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er:YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy is a wavelength of 2940nm. This handpiece can be removed and replaced with a q-switch Nd:YAG handpeice emitting wavelengths of 1064nm and 532nm laser energy can be added. The user activates the laser emission by means of a footswitch.
The provided text does not describe any acceptance criteria or a study that proves the device meets those criteria.
Instead, the document is a 510(k) Summary for a medical device (Triplex Er:YAG / Nd:YAG Laser System) seeking FDA clearance. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving efficacy against predetermined performance acceptance criteria through clinical studies.
The document explicitly states:
- "Results of Clinical Study: None" under the "Performance Data" section.
- The conclusion is that the device is "comparable to the predicate device in terms of indications for use, technical specifications, operating performance features, general design."
Therefore, I cannot fill in the table or answer the specific questions about acceptance criteria and studies because the provided document indicates that no such study was performed or required for this type of FDA clearance. The clearance was based on technological characteristics and substantial equivalence, not performance against acceptance criteria derived from a clinical trial.
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Attachment 5 510(K) Summary Triplex Er:YAG / Nd:YAG Laser System
APR 2 7 2011
This 510(K) Summary of safety and effectiveness for the Triplex Er:YAG / Nd:YAG Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Sandstone Medical Technologies, LLC |
|---|---|
| Address: | 105 Citation CourtBirmingham, AL 35209 |
| Contact Person: | Mark Rohrer |
| Telephone:Email: | 205-290-8251 - phonessmed@bellsouth.net |
| Preparation Date: | February 15, 2011 |
| Device Trade Name: | Triplex Er:YAG / Nd:YAG Laser System |
| Common Name: | ER:YAG Laser and Nd:YAG Laser |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 |
| Marketed PredicateLegallyDevice: | MLT Erbium:YAG Laser System (K)032599Ultralight II Nd:YAG Laser System (K)082407 |
| Description of the TriplexEr:YAG / Nd:YAG Laser System: | The Apex system and controls are contained in a singleconsole. Electrical power is supplied to the console by thefacility's power source. There are 2 handpieces with thesystem. One is an Er:YAG laser which contains the lasercavity in the head of the handpiece. The second is anIntense Pulsed Light. These handpieces can be removedby the user and interchanged. The Er:YAG Laser energy isa wavelength of 2940nm. |
| This handpiece can be removed and replaced with a q-switch Nd:YAG handpeice emitting wavelengths of 1064nmand 532nm laser energy can be added. | |
| The user activates the laser emission by means of afootswitch. | |
| Intended use of the TriplexEr:YAG / Nd:YAG LaserSystem: | The Er:YAG handpiece is designed specifically forsuperficial skin ablation resulting in skin dermabrasion, andthe treatment of wrinkles. In addition this system is intendedfor coagulation, vaporization, ablation, or cutting of softtissue (skin) in dermatology, plastic surgery (includingaesthetic surgery). |
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The Nd:YAG handpiece is indicated for:
- At the 1064nm wavelength dark ink tattoo removal, . removal of pigmented lesions and the removal or lightening of hair.
- At the 532nm wavelength removal of red ink . tattoos, treatment of vascular lesions including facial telangiectasias, as, angiomas, and leg veins, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
None Performance Data:
Results of Clinical Study: None
Summary of Technological Characteristics:
| Sandstone MedicalTechnologies LLC TriplexEr:YAG / Nd:YAG System | Sandstone MedicalTechnologies LLC Nd:YAG(Predicate Device) | |
|---|---|---|
| Energy | Up to 1000mJ | Up to 1000mJ |
| Maximum Fluence | 12J/cm2 | 12J/cm2 |
| Wavelength | 1064nm and 532nm | 1064nm and 532nm |
| Spot Size | up to 5mm | up to 5mm |
| Pulse Width | 10ns | 10ns |
| Repetition Rate | 1-5Hz | 1-5Hz |
| Aiming Beam | HeNe | HeNe |
| Sandstone MedicalTechnologies LLC TriplexEr:YAG / Nd:YAG LaserSystem | Sandstone MedicalTechnologies LLC Er:YAGLaser (Predicate) | |
|---|---|---|
| Wavelength | 2940nm | 2940nm |
| Max Power | 2.4 W | 2.4 W |
| Max Fluence | 8 J/cm2 | 8 J/cm2 |
| Pulse Width | 300 hs | 300 hs |
| Repetition Rate | Up to 10 pulse per second | Up to 10 pulse per second |
| Spot Size | 1.5mm, 3mm, 6mm, 9mm | 1.5mm, 3mm, 6mm, 9mm |
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| Conclusion: | The Triplex Er:YAG / Nd:YAG Laser System iscomparable to the predicate device in terms ofindications for use, technical specifications, operatingperformance features, general design. |
|---|---|
| ------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
:
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 7 2011
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Birmingham, Alabama 35209
Re: K110502
Trade/Device Name: Triplex Er:YAG / Nd:YAG Laser System 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: February 14, 2011 Received: February 22, 201-1
Dear Mr. Rohrer:
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
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Page 2 - Mr. Mark Rohrer
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 (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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Aty B. R. h
her
Mark N. Melkersor Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Triplex Er:YAG / Nd:YAG Laser System Device Name:
The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Nd:YAG handpiece is indicated for:
- At the 1064nm wavelength dark ink tattoo removal, removal of pigmented o lesions and the removal or lightening of hair.
- At the 532nm wavelength removal of red ink tattoos, treatment of vascular . lesions including facial-and-leg-veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
Prescription Use __ XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Nilk R Ogden for mkm
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative 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.