(134 days)
Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
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 is operated with a handpiece of larger spotsize. The system incorporates a suction unit for the safe removal of laser plume.
This document is a 510(k) summary for the MCL 31 Dermablate laser system. It does not describe a study to prove the device meets specific acceptance criteria in the context of AI/ML device performance. Instead, it demonstrates substantial equivalence to predicate devices through technical characteristics and adherence to recognized standards.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typically relevant for AI/ML device evaluations) are not applicable to this document.
However, I can extract the relevant information regarding performance and testing that is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for metrics like sensitivity, specificity, etc. Instead, acceptance is implied by demonstrating substantial equivalence to predicate devices, focusing on:
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (MCL 31 Dermablate) |
|---|---|---|
| Intended Use | Similar to predicate devices | Coagulation, vaporization, ablation or cutting of soft tissue (skin) in various medical fields (matching predicate K101306 and expanding on K081541 due to larger spot size). |
| Laser medium | Er:YAG | Er:YAG |
| Wavelength | 2940 nm | 2940 nm |
| Interaction with skin | Ablation, Coagulation | Ablation, Coagulation |
| Energy, max. | Similar range to predicate (1.5 - 3.0 J) | 2.5 J |
| Power, max. | Similar range to predicate (12 - 20 W) | 20 W |
| Frequency, max. | Similar range to predicate (20 - 50 Hz) | 20 Hz |
| Spot size | Similar range to predicate (1-12 mm) | 1-12 mm |
| Fluence, max. | Similar range to predicate (100 - 250 J/cm^2) | 250 J/cm^2 |
| Pulsewidth | Similar range to predicate (100 - 1500 µs) | 100 - 1000 µs |
| Safety Standards | Adherence to recognized medical device standards | Tested according to ISO 14971, DIN EN 60601-1, DIN EN 60601-1-2, DIN EN 60601-1-6, DIN EN 60601-2-22, DIN EN 60825-1, DIN EN 62304. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a non-clinical submission based on comparison to predicate devices and adherence to standards. No "test set" of clinical data for AI/ML performance is mentioned.
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 applicable. No ground truth establishment for a test set of clinical data is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is mentioned.
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 is a laser surgical instrument, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (laser system), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices and compliance with recognized standards, not a specific ground truth for a performance study.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Asclepion Laser Technologies GmbH Ms. Antje Katzer Regulatory Affairs Manager Bruesseler Straße 10 07747 Jena, Thuringia Germany
Re: K150140 Trade/Device Name: MCL 31 Dermablate 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 5, 2015 Received: May 8, 2015
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
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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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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) K150140
Device Name
MCL 31 Dermablate
Indications for Use (Describe)
Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
| 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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Asclepion Laser Technologies GmbH • Brüsseler Str. 10 • 07747 Jena • Germany
Traditional 510(k) SUMMARY
MCL 31 Dermablate
This Traditional 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MCL 31 Dermablate 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: | June 3, 2015 |
| Device Name: | MCL 31 Dermablate |
| Common Name: | 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. Danilo Leggieri
Bank Connections: Sparkasse Jena • SWIFT HELADEF1JEN • IBAN DE 348305303000000000094 Deutsche Bank Jena • SWIFT DEUTDE8EXXX • IBAN DE 67820700000397755000 Commerzbank Jena • SWIFT COBADEFF821 • IBAN DE 54820400000258272400
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| Classification Name: | Laser surgical instrument for use in general and plastic surgery and indermatology79-GEX21 CFR 878.4810Regulatory Class: Class IIProduct Codes: GEX |
|---|---|
| Equivalent Devices: | K081541 Dermablate Effect (Asclepion Laser Technologies)K101306 Fotona Dynamis Er:YAG Laser System (Fotona) |
| Device Description: | The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of2940 nm. The system comprises a main console unit, a handpiece and istriggered by means of a footswitch. The MCL 31 is operated with ahandpiece of larger spotsize. The system incorporates a suction unit for thesafe removal of laser plume. |
| Intended Use: | The MCL 31 Dermablate laser system is intended for coagulation,vaporization, ablation or cutting of soft tissue (skin) in Dermatology, PlastiSurgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry andOphthalmology (skin around the eyes). |
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Summary of Technical Characteristics
| Proposed Modified Device | Un-Modified Predicate Device | Un-Modified Predicate Device | |
|---|---|---|---|
| Name | MCL 31 Dermablate | Dermablate Effect with | Dynamis Er:YAG Laser |
| Manufacturer | Asclepion Laser Technologies | Handpiece of larger spot sizeAsclepion Laser Technologies | Fotona |
| 510(k) | K081541 | K101306 | |
| Intended Use(handpiece with largerspot size) | Coagulation, vaporization, ablationor cutting of soft tissue (skin) inDermatology, Plastic Surgery, OralSurgery, ENT, Gynecology, GeneralSurgery, Podiatry andOphthalmology (skin around theeyes). | Coagulation, vaporization, ablationor cutting of soft tissue (skin) indermatology, plastic surgery, oralsurgery and ophthalmology (skinaround the eyes). | Surgical incision/excision,vaporization and coagulation of softtissue during any general surgeryapplication where skin incision, tissuedissection, excision of lesions,complete or partial resection ofinternal organs, lesions, tissueablation and vessel coagulation isnecessary.Dermatology and Plastic Surgery,ENT Surgery, Oral/MaxillofacialIndications, Ophthalmology,Gynecology, General Surgery,Podiatry. |
| Laser mediumwavelength | Er:YAG2940 nm | Er:YAG2940 nm | Er:YAG2940 nm |
| Principle of interactionwith skin | Ablation, Coagulation | Ablation, Coagulation | Ablation, Coagulation |
| Energy, max. | $2,5 J$ | $1,5 J$ | $3,0 J$ |
| Power, max. | $20 W$ | $12 W$ | $20 W$ |
| Frequency, max. | $20 Hz$ | $20 Hz$ | $50 Hz$ |
| Spot size | $1-12 mm$ | $1-6 mm$ | $0,3-12 mm$ |
| Fluence, max. | $250 J/cm^2$ | $100 J/cm^2$ | $250 J/cm^2$ |
| Pulsewidth | $100 - 1000 μs$ | $350 μs$ | $100 - 1500 μs$ |
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| Comparison to: | The MCL 31 Dermablate laser system is substantially equivalent to the Dermablate Effect K081541 and the Fotona Dynamis Er:YAG laser K101306, with the same principles of operation, with similar parameter and the same indications for use. The fundamental scientific technology of the device is unchanged from the legally marketed predicates. |
|---|---|
| Nonclinical Performance Data: | The MCL 31 Dermablate 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 | |
| Clinical Performance Data: | None |
| Conclusion: | The MCL 31 Dermablate laser system is another safe and effective device for Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General |
Surgery, Podiatry and Ophthalmology (skin around the eyes).
§ 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.