(35 days)
The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.
MeDioStar XT Laser System is a pulsed diode laser with a wavelength of 808µm. It consists a laser enclosure and optic delivery system (fiber bundle and handpiece).
The provided text is a 510(k) summary for the Asclepion Laser Technologies GmbH MeDioStar XT Laser System. It is a premarket notification to the FDA for a new medical device, aiming to demonstrate substantial equivalence to a predicate device. This type of document does not typically contain detailed acceptance criteria or a study proving that the device meets specific performance metrics in the way a clinical trial report would.
Here's an analysis based on the provided text, highlighting what's missing and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to MeDioStar H Laser System | Claimed substantial equivalence |
| Same principles of operation as predicate | Same principles of operation confirmed |
| Same wavelength as predicate | Same wavelength (808µm) confirmed |
| Essentially the same power range as predicate | Essentially the same power range confirmed |
| Safety and effectiveness for unwanted body hair removal | Deemed safe and effective (by FDA K050900 letter) |
| Safety and effectiveness for vascular lesion treatment | Deemed safe and effective (by FDA K050900 letter) |
Explanation:
The document does not state explicit, quantitative acceptance criteria for performance parameters such as hair reduction percentage, number of treatments, or lesion clearance rates. Instead, the "acceptance criteria" here are implied by the 510(k) process, which focuses on demonstrating substantial equivalence to a predicate device. The performance is "reported" by stating that the device is substantially equivalent and therefore safe and effective for its stated indications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no new test set of data (clinical or nonclinical) was generated or used for this 510(k) submission to demonstrate performance a new.
- Data Provenance: Not applicable, as no new data was submitted or analyzed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Since no new clinical or non-clinical performance data was generated or analyzed for this submission, there was no need for experts to establish ground truth from such data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As no test set data was provided, no adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: None."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, this device is a physical laser system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant or mentioned.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for performance data related to the MeDioStar XT itself. The "ground truth" for the 510(k) submission relies on the established safety and effectiveness of the predicate device (MeDioStar H Laser System). The new device is claimed to be safe and effective because it is substantially equivalent to the predicate, not based on new, direct evidence from the MeDioStar XT itself.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This document does not describe the development or training of an algorithm, but rather the regulatory submission for a physical laser device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. No algorithm training set is mentioned or relevant to this type of device submission.
In Summary:
The provided 510(k) summary is for a device seeking market clearance based on substantial equivalence to an already approved predicate device. For such submissions, detailed performance studies with acceptance criteria and clinical data are often not required if the new device can demonstrate very close similarity in design, function, and intended use to an existing device. The FDA's acceptance of this 510(k) indicates their agreement that the MeDioStar XT Laser System is substantially equivalent to the MeDioStar H Laser System and is therefore safe and effective for its intended uses without new clinical data.
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MAY 1 6 2005
Image /page/0/Picture/1 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a bold, sans-serif font, with a cluster of black dots of varying sizes above and to the right of the word. Below "Asclepion" is the phrase "Laser Technologies" in a smaller font.
Asclepion Laser Technologies GmbH • Göschwitzer Str. 51-52 • D-07745 Jena
510(k) SUMMARY
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ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar XT Laser System
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MeDioStar XT Laser System 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 GmbHGoeschwitzer Str. 51-5207745 Jena, Germany |
|---|---|
| Contact Person: | Mr Reinhard ThiemeQuality Assurance andInternational Regulatory Affairs |
| Phone: | +49 3641 220 211 |
| Fax: | +49 3641 220 322 |
| e-mail: | reinhard.thieme@asclepion.com |
| Preparation Date: | March 23, 2005 |
| Device Name: | MeDioStar XT Laser System |
| Common Name: | MeDioStar XT |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.481 |
| Equivalent Device: | MeDioStar H Laser Sytsem(with and without skin cooling system) |
| Device Description: | MeDioStar XT Laser System is a pulsed diode laser with awavelength of 808µm. It consists a laser enclosure and opticdelivery system (fiber bundle and handpiece). |
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| Intended Use: | The MeDioStar XT Laser System is intended to removeunwanted body hair and vascular lesions. |
|---|---|
| Comparison to: | The MeDioStar XT Laser System is substantially equivalent tothe MeDioStar H Laser System (with and without skin cooling),with the same principles of operation, the same wavelength andessentially the same power range as the predicate device for thesame indications for uses. |
| NonclinicalPerformance Data: | None |
| ClinicalPerformance Data: | None |
| Conclusion: | The MeDioStar XT Laser System is another safe and effectivedevice for the removal of unwanted body hair and the treatmentof vascular lesions. |
| Additional Information: | None |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Mr. Reinhard Thieme Quality Assurance and International Regulatory Affairs Asclepion Laser Technologies GmbH Goeschwitzerstrasse 51-52 Jena, Germany 07745
Re: K050900
Trade/Device Name: MeDioStar XT 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: II Product Code: GEX Dated: April 26, 2005 Received: April 28, 2005
Dear Mr. Thieme:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of 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, de nees mat have been 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 or any I catala all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N 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.
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Page 2 – Mr. Reinhard Thieme
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your ntial equivalence of your device to a legally premarket notification. "The PDF Intering of our device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your 2001 276-0115 . Also, please note the regulation entitled, Colliact the Office of Comphalled at (217) = 16 = 16 = 18 = 1 = 1 = 1 = 0 may obtain Missuranting of Icrerchee to premantonibilities under the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consults. 1/10:2018. 1/2 1/2017 1/2017 1/10/11/10 1/1
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 长6 So 960
Device Name: MeDioStar XT Laser System
Indications for Use:
The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.