(398 days)
Dermatology, Plastic & General Surgery
The CO2 laser, model MedArt 610, is intended to be used by physicians in the performatice of the following specialities:
The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:
- Skin Resurfacing .
- . Treatment of wrinkles and rhytids
- Treatment of furrows .
- Soft tissuc ablation .
The MedArt 610 system comprises the following major parts:
- A laser console containing a CO2 laser module capable of providing a laser beam having a wave-. length of 10,600 nm.
- A scanner that is intended to manipulate and place a pulsed beam received from the laser console in . a pre-specified pattern on the skin being treated.
- An optical fiber providing a beam path from the laser to the scanner. .
The MedArt 610 Laser system is identified as substantially equivalent to the Uni-Laser 450P (K991297) manufactured by ASAH Medico A/S. The submission demonstrates substantial equivalence through a side-by-side comparison of device specifications and indications for use, rather than a primary clinical study with predefined acceptance criteria. Therefore, the information provided focuses on the comparative data rather than a direct performance study against specific acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device, Uni-Laser 450P. This implies that the MedArt 610 is expected to perform at least as safely and effectively as the predicate device for its stated indications. The document does not provide explicit numerical acceptance criteria, but rather a direct comparison of features and performance parameters.
| Acceptance Criteria (Implied by Predicate Equivalence) | MedArt 610 Performance (Reported Device Performance) | Predicate Device (Uni-Laser 450P) Performance |
|---|---|---|
| Indications for Use: | ||
| Skin Resurfacing | Yes (Identical application) | Yes |
| Treatment of wrinkles and rhytids | Yes (Identical application) | Yes |
| Treatment of furrows | Yes (Identical application) | Yes |
| Soft tissue ablation | Yes (Identical application) | Yes |
| Technology: | ||
| CO2 laser module | Yes | Yes |
| Scanner for pattern production | Yes | Yes |
| Beam delivering system (fiber) | Yes | Yes |
| Physical Parameters: | ||
| Length of beam delivering system | 165cm | 165cm |
| Type of beam delivering system | Fiber providing full freedom of movement | Fiber providing full freedom of movement |
| Wavelength | 10,600nm | 10,600nm |
| Max power | 0.1 - 12W | 0.1 - 12W |
| Minimum scanner spot size | Ø400µm | Ø400µm |
| Max power density | 17 kW/cm2 (Computed from 12W/Ø300µm) | 17 kW/cm2 (Computed from 12W/Ø300µm) |
| Aiming beam | 635nm, max 5mW | 635nm, max. 2mW |
| Scanning speed | 0.3-100 Hz | Not specified, but "In the range of 1 sec. Actual time is depending on scan pattern chosen" for full scan time. |
| Time for a full scan | In the range of 1 sec. Actual time is depending on scan pattern chosen | In the range of 1 sec. Actual time is depending on scan pattern chosen |
| Beam activation | Foot switch | Foot switch |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical data is provided for the MedArt 610 within this 510(k) summary. The submission relies on a comparison to a legally marketed predicate device (Uni-Laser 450P) to demonstrate substantial equivalence. Therefore, there is no sample size for a test set or data provenance from a new study provided for the MedArt 610.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The submission does not involve a test set requiring expert ground truth establishment for the MedArt 610. The equivalence is based on engineering specifications and comparison to the predicate device's cleared indications and performance characteristics.
4. Adjudication Method for the Test Set
Not applicable. There was no test set or clinical study requiring an adjudication method presented in this 510(k) summary.
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 device is a laser system for surgical and dermatological procedures, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study and
effect size related to AI assistance for human readers is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical laser system operated by physicians, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the MedArt 610's substantial equivalence determination is the previously cleared performance and indications for use of the predicate device, the Uni-Laser 450P. This is based on the regulatory clearance of a similar device with known safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This submission does not involve training data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This submission does not involve a training set or ground truth establishment for an algorithm.
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NUV 2 4 2009
MedArt A/S .
MedArt 610 Laser system
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92.
A. Contact information and device identification:
| Date of the summary: | 23 November 2009 | ||
|---|---|---|---|
| Submitted by/manufacturer: | MedArt A/SValseholmen 11-132650 Hvidovre, DenmarkTel: + 45 3634 2300Fax: + 45 3634 2323 | ||
| Contact person: | Olav Balle-Petersen | ||
| Device Trade Name: | MedArt 610 | ||
| Device Model number: | 610.000 | ||
| Common Name: | Laser treatment system. | ||
| Classification name: | Laser surgical instrument for use in general and plastic surgery andin dermatology (per 21 CFR Part 878.4810). | ||
| Device classification: | Class II. | ||
| Product code: | GEX | ||
| Predicate devices legallymarketed to which MedArtA/S claims equivalence: | Uni-Laser 450P (K991297) manufactured by ASAH Medico A/S,Denmark.(Laser surgical instrument for use in general and plastic surgeryand in dermatology (per 21 CFR Part 878.4810)). |
B. Description of MedArt 610 system:
The MedArt 610 system comprises the following major parts:
- A laser console containing a CO2 laser module capable of providing a laser beam having a wave-. length of 10,600 nm.
- A scanner that is intended to manipulate and place a pulsed beam received from the laser console in . a pre-specified pattern on the skin being treated.
- An optical fiber providing a beam path from the laser to the scanner. .
C. Indications for Use of MedArt 610 system:
The CO2 laser, model MedArt 610, is intended to be used by physicians in the performance of the following specialities:
The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:
- Skin Resurfacing .
- Treatment of wrinkles and rhytids
- Treatment of furrows
- Soft tissue ablation
Sec 9 ver3 510(k) Summary 610: 510(k) OBP November 23, 2009
Image /page/0/Picture/21 description: The image shows the word "MedArt" with a circled "R" symbol next to it. The letters are drawn in a simple, outlined font. The word appears to be a logo or brand name.
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D. Comparison of MedArt 610 to predicate devices:
| Issue/data compared | MedArt 610 | Uni-Laser 450P(Asah Medico A/S) |
|---|---|---|
| FDA clearance / statusIndications for predicate device | Being submitted (this submission) | K991297This predicate device under K991297 is cleared for: (copy from 510(k) clearence):Dermatology, Plastic & General SurgeryThe ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:a. Laser Skin Resurfacingb. Treatment of wrinkles, rhytids and furrowsc. Blepharoplastyd. HemorrhoidsAblation and/or vaporization of soft tissue in dermatology and plastic surgery and for the reduction , removal and/or treatment of;actinic keratosis skin tags solar/actinic elastosis actinic cheilitis lentigines uneven pigmentation, dyschromaia acne scars surgical scars keloids hermangiomes tattoos telangiectasia squamous and basel cell carcinoma spider and epidermal naevi xanthelasma palpebrarum syringoma verrucae and seborrhoecae valugares (warts) Soft Tissue DentalIncision and vaporization of soft tissue in dentistry and oral surgery.Applications include; |
| Issue/datacompared | MedArt 610 | Uni-Laser 450P(Asah Medico A/S) |
| gingivectomy- removal of hyperplasia gingivoplasty and incisions and excision frenectomy incisional and excisional biopsy incision and excision of aphthous ulcers excision and ablations of benign and malignant lesions homeostatis operculectomy | ||
| PodiatryLaser ablations, vaporization and/or excision of soft tissue in podiatry for Reduction, removal and/or treatment of verrucae valugares Matrixectomy | ||
| Otorhinolaryngology (ENT)Laser Incision, excision, ablations and/or va-porization of soft tissue in otorhinlaryngology for the treatment of; | ||
| Choanal atresia Leukoplakia of larynx Nasal obstructions UPP Rhinohyma Adult and juvenile papillomatosis polyps Rhinophyma Verruce valares | ||
| GynecologyLaser Incision, excision, ablations and/or va-porization of soft tissue in gynecology for the treatment of; | ||
| Cervical intraepithelial neoplasty Condolyome acuminate Leukoplakia (vulvar dystrophies) Vulvar and vaginal intraepithelial neoplasty | ||
| Issue/datacompared | MedArt 610 | Uni-Laser 450P(Asah Medico A/S) |
| NeurosurgeryLaser Incision, excision, ablations and/or va-porization of soft tissue in neurology for thetreatment of; | ||
| Basal tumor-meningioma Posterior fossa tumors Peripheral neurectomy Lipomas/large tumors | ||
| Indication com-parison | ||
| Skin resurfacing | Identical application - a | |
| Wrinkels and rhytids | Identical application - b | |
| Furrows | Identical application - b | |
| Soft tissue ablation | Identical application | |
| Technology | The system comprises:a) A laser console containing aCO2 laser moduleb) A scanner for producing a pat-tern of light spots on the skinc) a beam delivering system con-necting the laser console and thescanner. | The system comprises:a) A laser console containing a CO2 lasermoduleb) A scanner for producing a pattern of lightspots on the skinc) a beam delivering system connecting thelaser console and the scanner. |
| Length of beamdelivering sys-tem | 165cm | 165cm |
| Type of beamdelivering sys-tem | Fiber providing full freedom ofmovement | Fiber providing full freedom of movement |
| Wavelength | 10,600nm | 10,600nm |
| Max power | 0.1 - 12W | 0.1-12W |
| Minimum scan-ner spot size | Ø400µm | Ø400µm |
| Max power den-sity (computedas max powerdivided by min-imum scannerspot size) | 12W/ Ø300µm =17 kW/cm2 | 12W / Ø300µm =17 kW/cm2 |
| Aiming beam | 635nm, max 5mW | 635nm, max. 2mW |
Image /page/1/Picture/4 description: The image shows the word "MedArt" with a circled R symbol next to it. The word is written in a simple, sans-serif font, and the letters are outlined in black. The circled R symbol indicates that the word is a registered trademark. The overall design is clean and professional.
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Sec 9 ver3 510(k) Summary 610: 510(k)
OBP November 23, 2009
.
Image /page/2/Picture/3 description: The image shows the word "MedArt" with a registered trademark symbol. The word is written in a simple, sans-serif font, with each letter outlined in black. The registered trademark symbol is located to the upper right of the word.
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Korsica
SEC 9 Vers 510(K) 3, 2009
MedArt®
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| K083123 | |||
|---|---|---|---|
| Issue/data compared | MedArt 610 | Uni-Laser 450P (Asah Medico A/S) | |
| Scanning speed (light spots on the skin per second) | 0.3-100 Hz | ||
| Time for a full scan | In the range of 1 sec. Actual time is depending on scan pattern chosen | In the range of 1 sec. Actual time is depending on scan pattern chosen | |
| Beam activation | Foot switch | Foot switch |
Conclusion:
MedArt 610 applications and indications are evaluated to be within the scope of the previously cleared devices. The same counts for the essential treatment parameters, the protective conditions for the skin during treatment, and the working conditions of the physician.
Based on this side-by-side comparison of the overall performance characteristics of the predicate devices under consideration MedArt A/S concludes that no significant differences exist. The MedArt 610 should not raise any new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices.
(Signature)
Olav Balle-Petersen
(Typed Name)
23-November-2009
(Date)
(Premarket Notification 510(k) Number)
Sec 9 ver3 510(k) Summary 610: 510(k) OBP November 23, 2009
Image /page/4/Picture/11 description: The image shows the word "MedArt" with a circled R symbol next to it. The word is written in a simple, sans-serif font, with each letter outlined in black. The overall design is clean and straightforward, suggesting a professional or medical context.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NUV 2 4 2009
MedArt A/S % Olav Balle-Petersen VP, R&D, Innovation, QA Valseholmen 11-13 2650 Hvidovre, Denmark
Re: K083123
Trade/Device Name: MedArt 610 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 24, 2009 Received: November 24, 2009
Dear Olav Balle-Petersen:
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.
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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Page 2 – Olav Balle-Petersen
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 of 1
510(k) Number (if known): K083123
MedArt 610 Device Name:
Indications for Use:
Dermatology, Plastic & General Surgery
The CO2 laser, model MedArt 610, is intended to be used by physicians in the performatice of the following specialities:
The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:
- Skin Resurfacing .
- . Treatment of wrinkles and rhytids
- Treatment of furrows .
- Soft tissuc ablation .
Contraindications for MedArt® 610
The MedArt® 610 may not be used for hard tissue dental applications such as tooth enamel, dentin or fillings and other indications not cleared by the FDA.
The system has not been evaluated for safety and effectiveness as a fractionated scanner
Mark A. Millener
vi non Sign-O cal. Orthopedic,
K08 31
510(k) Number
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sec 7v5 Statement of indication for use 610: 510(k) OBP Ver 5 August 27, 2009
§ 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.