(130 days)
The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures.
The MicroSpot Handpiece is a handpiece with microbeam output to be used with the previously cleared MCL 31 Dermablate (K150140). The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 can be operated with a handpiece of larger spotsize or with a microbeam handpiece. The system incorporates a suction unit for the safe removal of laser plume.
This document is a 510(k) Pre-Market Notification for the Asclepion Laser Technologies GmbH MicroSpot Handpiece. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a clinical study for novel performance claims. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted from this document.
However, based on the provided text, here is what can be inferred and what information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal clinical acceptance criteria or report on device performance against such criteria. The "performance" described relates to technical characteristics and safety testing for substantial equivalence.
| Item | Acceptance Criteria (Not explicitly stated for clinical performance) | Reported Device Performance / Assessment |
|---|---|---|
| Clinical Performance | (N/A – not a novel device requiring specific clinical performance acceptance criteria) | Demonstrated substantial equivalence to predicate devices for intended use (Dermatological and Skin resurfacing procedures). |
| Technical Performance | Meets all design specifications; Conforms to specified ISO and IEC standards. | Laboratory testing validated and verified design specifications were met. Evaluated single microspot size, laser pulse duration, energy release, and energy in a duration test. |
| Safety | Safe for its intended use. | Nonclinical (standards compliance, lab testing) and animal performance data (histological study on pig skin) supported safety. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Animal Performance Data (Histological Study):
- Sample Size: 9 pigs.
- Data Provenance: Not explicitly stated, but the company is based in Germany. The study appears to be prospective (controlled experimental application of the device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified in the document. The histological samples were collected and presumably analyzed by experts, but their number and qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. 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
- Not applicable. This document describes a laser handpiece, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Animal Performance Data (Histological Study): Histological analysis of biopsied pig skin samples. This serves as a form of ground truth for assessing tissue response, ablation depth/width, and thermal damage.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare, with three human profiles incorporated into the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Asclepion Laser Technologies GmbH Mrs. Antje Katzer Product Management and International Regulatory Affairs Bruesseler Str.10, Jena, Thuringia 07747 Germanv
December 11, 2015
Re: K152153 Trade/Device Name: MicroSpot Handpiece 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: November 13, 2015 Received: November 13, 2015
Dear Mrs. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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 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.
Sincerelv vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director
For
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| Indications for Use |
| 510(k) Number (if known) | K152153 |
|---|---|
| Device Name | MicroSpot Handpiece |
| Indications for Use (Describe) | The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"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 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a dark gray sans-serif font. To the right of the word "Asclepion" are several blue circles of varying sizes, arranged in a semi-circular pattern. Below the word "Asclepion" is the phrase "Laser Technologies" in a smaller, lighter gray font.
Asclepion Laser Technologies GmbH · Brüsseler Str. 10 · 07747 Jena · Germany
Traditional 510(k) SUMMARY
MicroSpot Handpiece
This Traditional 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MicroSpot Handpiece 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 GmbHBruesseler Str. 1007747 Jena, Germany |
|---|---|
| Contact Person: | Mrs. Antje KatzerProduct Management andInternational Regulatory Affairs |
| Phone:Fax:e-mail: | +49 3641 77 00 309+49 3641 77 00 302antje.katzer@asclepion.com |
| Preparation Date: | December 10, 2015 |
| Device Name: | MicroSpot Handpiece |
| Common Name: | Microbeam Handpiece for Er:YAG Laser |
Our general terms and conditions: www.asclepion.com
Registered office: Jena Register of commerce court: Jena HRB 209648 UST ID Nr. DE 813678553 WEEE-Reg.-Nr. DE 33663120 Managing Director: Dr. Dr. Danilo Leggieri Bank Connections: Sparkasse Jena • SWIFT HELADEF1JEN • IBAN DE 3483053030000000094 Deutsche Bank Jena • SWIFT DEUTDE8EXXX • IBAN DE 67820700000397755000 Commerzbank Jena • SWIFT COBADEFF821 • IBAN DE 54820400000258272400
{4}------------------------------------------------
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and indermatology79-GEX21 CFR 878.4810Regulatory Class: Class IIProduct Code: GEX |
|---|---|
| Equivalent Devices: | K081541 Dermablate Effect (Asclepion Laser Technologies)K101306 Fotona Dynamis Er:YAG Laser System (Fotona)K132806 Fotona FS-01 Laser Handpiece (Fotona) |
| Device Description: | The MicroSpot Handpiece is a handpiece with microbeam output to beused with the previously cleared MCL 31 Dermablate (K150140). TheMCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of2940 nm. The system comprises a main console unit, a handpiece andis triggered by means of a footswitch. The MCL 31 can be operatedwith a handpiece of larger spotsize or with a microbeam handpiece.The system incorporates a suction unit for the safe removal of laserplume. |
| Intended Use: | The MicroSpot handpiece is intended for Dermatological proceduresand Skin resurfacing procedures. |
{5}------------------------------------------------
Summary of Technical Characteristics
| Proposed Modified Device | Un-Modified Predicate Device | Un-Modified Predicate Device | |
|---|---|---|---|
| Name | MCL 31 Dermablate with MicroSpotZoom Handpiece | Dermablate Effect withMicroSpot - Zoom handpiece | Dynamis Er:YAG Laser SystemFamily withFS 01-HandpieceFotona |
| Manufacturer | Asclepion Laser Technologies | Asclepion Laser Technologies | Fotona |
| 510(k) | K081541 | K101306 / K132806 | |
| Intended Use(Microbeam handpiece) | Dermatological procedures.Skin resurfacing procedures. | Dermatological procedures.Skin resurfacing procedures. | Dermatological procedures requiringresurfacing of soft tissue withfractionated handpiece. |
| Laser mediumwavelength | Er:YAG2940 nm | Er:YAG2940 nm | Er :YAG2940 nm |
| Energy, max. | 2,5 J | 1,5 J | 3,0 J |
| Power, max. | 20 W | 12 W | 20 W |
| Frequency, max. | 20 Hz | 20 Hz | 50 Hz |
| Fluence, max. | 10 J/cm²Up to 150 J/cm² with stackingpulses | 18 J/cm²Up to 162 J/cm² with stacking pulses | Up to 800 J/cm² with stacking pulses |
| Max. Energy perMicrobeam | 12 mJ | 8 mJ | 160 mJ |
| Pulse Duration | 0,1 - 1,0 ms | < 1 ms | 0,1 - 1,5 ms |
| Pulse repetition rate | Up to 20 Hz | Up to 20 Hz | Up to 50 Hz |
| Spot size of microbeams | 350 and 600 µm | 250 µm | 250 µm |
| Creation of microbeams | By microlens array | By microlens array | By microlens array |
| Treatment zones | 13 x 13 mm | 13 x 13 mm9 x 9 mm7 x 7 mm | 13 x 13 mm |
| Coverage of skin | 10 and 25 % | 5 - 17 % | 5 - 60 % |
{6}------------------------------------------------
Comparison to: The MicroSpot Handpiece of the MCL 31 Dermablate laser system is substantially equivalent to the MicroSpot Handpiece of the Dermablate Effect K081541 and the Fotona FS-01 Laser Handpiece K132806 of the Fotona Dynamis Er:YAG laser K101306 with the same principles of operation, with similar parameters and with similar indications for use. The fundamental scientific technology of the device is unchanged from the legally marketed predicates.
Nonclinical Performance Data: The MicroSpot Handpiece is designed and tested according to following standards:
ISO 14971:2009 IEC 60601-1:2005 IEC 60601-1-2:2007 IEC 60601-1-6:2010 IEC 60601-2-22:2007 IEC 60825-1:2007 IEC 62304:2006
Laboratory testing was conducted to validate and verify that the MicroSpot Handpiece met all design specifications and was substantially equivalent to the predicate devices.
The size of the single microspots was evaluated as well as the laser pulse duration, the energy release of the laser and the energy in a duration test.
The results of those testings were used to select the desired parameters with the MicroSpot handpiece.
Animal Performance Data: Histological data was submitted to support safety and effectiveness of the microbeam mode. The device was used in vivo on pig skin with low, medium and high energies, and with different pulse durations and densities. The five possible settings of the handpiece were applied to nine pigs. Three received 20 J/cm², three received 40 J/cm² and three received 60 J/cm². The histological samples have been collected at day 0, 3 and 14. The biopsied areas show the depth and width of ablation as well as the thermal damage zones and demonstrate the healing response over time. Conclusion: The MicroSpot Handpiece is another safe and effective device for Dermatological and Skin resurfacing procedures.
§ 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.