(228 days)
Not Found
No
The summary describes a laser system with standard controls and safety features, with no mention of AI/ML, image processing, or data-driven decision-making.
Yes
The device is described as treating benign vascular and benign pigmented lesions, indicating a therapeutic purpose to address and improve these conditions.
No
The device is intended for treatment (vaporization and photocoagulation) of lesions, not for diagnosis.
No
The device description clearly states it is a laser system, a Class IV solid state diode laser, and includes hardware components like a control panel, foot switch, transfer fiber, and handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of benign vascular and pigmented lesions through vaporization and photocoagulation using laser energy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a laser system that delivers energy to tissue. This is consistent with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies mentioned are related to safety and compliance with standards for medical devices, not performance metrics typically associated with IVDs (like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly interacts with and treats tissue, which is a therapeutic function.
N/A
Intended Use / Indications for Use
The QuadroStarPROYELLOW (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions. The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Product codes
GEX
Device Description
The QuadroStarPRO Laser system is a laser Class IV, solid state diode laser, which emits laser radiation with a wavelength of either 577 nm or 532 nm. It`s pulse duration can be varied from millisecond pulses up to continuous operation. The laser power up to 8 Watts is transmitted to the tissue through a transfer fiber and a handpiece, optionally a scanner can be operated. The laser system consists of: Laser system including control panel (user interface) Foot switch A transfer fiber with handpiece, optional different spacers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The QuadroStarPRO laser system is tested according to following standards: ISO 14971:2009 DIN EN 60601-1:2006 DIN EN 60601-1-2:2007 DIN EN 60601-1-6:2007 DIN EN 60601-2-22:1996 DIN EN 60825-1:2007 DIN EN 62304:2006. The device also complies with European Medical Device Directive 93/42/EEC + Amendment 2007/47/EC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN 1 0 2014
510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH K133297 QuadroStarPRO
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH QuadroStarPRO is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH
Bruesseler Str. 10
07747 Jena, Germany |
|----------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer
Product Management and
International Regulatory Affairs |
| Phone: | +49 3641 77 00 309 |
| Fax: | +49 3641 77 00 302 |
| e-mail: | antje.katzer@asclepion.com |
| Preparation Date: | June 10, 2014 |
| Device Name: | QuadroStarPRO |
| Common Name: | QuadroStarPRO |
| Classification Name: | Laser surgical instrument for use in general and plastic
surgery
79-GEX
21 CFR 878.4810 |
Equivalent Devices:
| K013940 | YellowStar Asclepion-Meditec AG
(Assignor of Asclepion Laser Technologies GmbH) |
|---------|------------------------------------------------------------------------------------|
| K060457 | QuadroStar 532 Asclepion Laser Technologies GmbH |
The QuadroStarPRO Laser system is a laser Class IV, Device Description: solid state diode laser, which emits laser radiation with a wavelength of either 577 nm or 532 nm. It`s pulse duration can be varied from millisecond pulses up to continuous operation. The laser power up to 8 Watts is transmitted to the tissue through a transfer fiber and a handpiece, optionally a scanner can be operated.
The laser system consists of:
1
Laser system including control panel (user interface) Foot switch A transfer fiber with handpiece, optional different spacers. The QuadroStarPROYELLOW (wavelength: 577nm) is Intended Use: intended for treatment of benign vascular and benign pigmented lesions. The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Comparison to:
The QuadroStarPRO with 577 nm has identical indications for use as the K013940 YellowStar, the QuadroStarPRO with 532 nm has identical indications for use as the K060457 QuadroStar 532.
Therefore the QuadroStarPRO is found to be substantially equivalent to already marketed and predicate lasers. Both predicates were developed by Asclepion or it's assignor.
With regard to technology, the QuadroStarPRO is found to be substantially equivalent to K060457 QuadroStar 532, since the basic technology, design and safety features are very similar. With the availability of multi-color diodes it became practicable also to generate wavelengths such as 577 nm by means of modern diode
technology, whereas in former times these wavelengths could only be generated with the technology of Copper Bromide or Copper Vapor lasers.
The differences between QuadroStarPRO and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
| Device | QuadroStarPRO | K013940
YellowStar | K060457
QuadroStar 532 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| | | | |
| Intended Use | 577 nm: intended for
treatment of benign
vascular and benign
pigmented lesions.
532 nm: intended for
vaporisation and
photocoagulation of benign
vascular and benign
pigmented lesions in soft
tissue. | Intended for treatment
of vascular and
pigmented lesions. | Intended for vaporization
and photocoagulation of
vascular and pigmented
lesions in soft tissue. |
| Device Type | Diode pumped solid-state
laser | Copper Bromide laser | Diode pumped solid-state
laser |
| Wavelength | 532 nm or 577 nm
(cannot be combined) | 511 nm and 578 nm
(single or combined) | 532 nm |
| Principle of
operation | Pulsed or cw
Optical excitation | Pulsed or Quasi-
continuous
High voltage
excitation | Pulsed or cw
Optical excitation |
| Maximum | 8 W (532 nm) | 5 W (511 nm) | 5 W |
2
| Power | 5 W (577 nm) | 2 W (578 nm)
7 W both/combined | |
|----------------------------|-------------------------------------------------------|-----------------------------------|----------------------|
| Energy Range | Up to 1.9 J | Up to 0.4 J | Up to 12.4 J |
| Device | | K013940 | K060457 |
| | QuadroStarPRO | YellowStar | QuadroStar 532 |
| Pulse Duration | 1 ms - 95 s and cw | 10 - 950 ms and cw | 5 ms - 2.5 s and cw |
| Max.
Repetition
Rate | 20 Hz | 16 kHz Quasi-cw | 120 Hz |
| Delivery | Transfer fiber | Transfer fiber | Transfer fiber |
| Spot
diameters | 1 mm / optional :
0.5/1.5/2.8 mm
Scanner : 1 mm | 0.2/0.4/0.6/1.0/1.5 mm | 0.5/1.0/1.5 mm |
| Device
Cooling | Internal air cooling | Internal air cooling | Internal air cooling |
| Power Supply | 100 - 240VAC, 50/60Hz | 230V 50/60Hz/10 A | 115/230V 50/60Hz |
Performance Testing:
The QuadroStarPRO laser system is tested according to following standards:
ISO 14971:2009 DIN EN 60601-1:2006 DIN EN 60601-1-2:2007 DIN EN 60601-1-6:2007 DIN EN 60601-2-22:1996 DIN EN 60825-1:2007 DIN EN 62304:2006
The device also complies with European Medical Device Directive 93/42/EEC + Amendment 2007/47/EC.
Conclusion: The QuadroStarPRO is substantially equivalent to the cited legally marked predicate devices. The minor differences between QuadroStarPRO and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2014
ASCLEPION LASER TECHNOLOGIES GmbH Ms. Antje Katzer Product Management and International Regulatory Affairs Bruesseler Str. 10 07747 Jena. Germany
Re: K133297 Trade/Device Name: QuadroStarPRO 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: May 7, 2014 Received: May 12, 2014
Dear Ms. Katzer:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Ms. Antje Katzer
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.goy/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.
for
Sincerely yours,
David Krause -S
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
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number ( if known ) | K133297 |
| Device Name | QuadroStarPRO |
| Indications for Use (Describe) | The QuadroStarPROYELLOW (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions. |
| The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue. | |
| Federal law restricts this device to sale by or on the order of a physician! | |
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Neil R Ogden | |
| 2014.06.10 15:45:00 -04'00' | For BSA |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
FORM FDA 3881 (1/14)
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PIC Publicition Scrines (1001) 40-476 EF
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