The medical device PHARAON 980 is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. PHARAON 980 includes the whole of the supplies necessary to supply the laser and to ensure its thermalisation using a Peltier element built on a ventilated radiator.

PHARAON 980 includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a TFT screen and a tactile flagstone.

PHARAON 980 is available for ENDO application (endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux) and EXO application (photocoagulation of teleangectasia of the legs).

PHARAON 980 EXO is supplied with CONTROL4+ HANDPIECE a dedicated handpiece including an auto-requlated cooling system and video allowing optimal mapping of the treatment area and screen display of the vessel on PHARAON 980.

AI/ML Overview

The provided text is a 510(k) summary for the PHARAON 980 ENDO & EXO laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the PHARAON 980 itself.

Therefore, the requested information for acceptance criteria and a study proving device conformance cannot be fully extracted from the provided document. The document states that the device "conform[s] to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)" and "conform[s] to 21 CFR part 1040.10 and 1040.11," indicating compliance with regulatory standards, not performance against specific clinical acceptance criteria.

The 510(k) summary explicitly states: "Performance data demonstrate the safety and effectiveness of PHARAON ENDO /EXO for its intended use." However, it does not provide this performance data, acceptance criteria, or details of the study in the document itself. The basis for substantial equivalence is primarily the similarity in intended use, design, and function to the predicate device, CERALAS D 980 LASER SYSTEM.

Here's what can be stated based on the provided text, and what cannot be:

1. Table of acceptance criteria and reported device performance:

Cannot be provided. The document does not list specific acceptance criteria (e.g., success rate, complication rate, accuracy, sensitivity, specificity) for the PHARAON 980 device's clinical performance. It also does not report specific device performance metrics against such criteria. The document states that "Performance data demonstrate the safety and effectiveness," but does not present the data itself.

2. Sample size used for the test set and data provenance:

Cannot be provided. The document does not describe any specific clinical "test set" for the PHARAON 980 device. The performance claims are based on substantial equivalence to the predicate device, not on a new clinical study with a specified sample size or data provenance for the PHARAON 980.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Cannot be provided. Since no specific clinical test set is described for the PHARAON 980 device, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set:

Cannot be provided. No test set is described.

5. Multi-reader multi-case (MRMC) comparative effectiveness study information:

No, an MRMC comparative effectiveness study was not done according to the provided text. This device is a laser surgical instrument, and MRMC studies are typically for imaging or diagnostic devices where human readers interpret results, often with and without AI assistance. This document does not mention any human-in-the-loop performance or AI assistance.

6. Standalone (algorithm only without human-in-the-loop performance) study information:

Not applicable in the context of this device. The PHARAON 980 is a laser surgical instrument; its "performance" is about its physical operation, safety, and effectiveness in delivering laser energy as intended, not about an algorithm's standalone diagnostic performance. The document mentions conformity to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)," which suggests software is involved, but not in a diagnostic or interpretive capacity that would typically warrant a "standalone" algorithm performance study as understood in AI/imaging contexts.

7. Type of ground truth used:

Cannot be provided as no specific clinical study data for the PHARAON 980 is presented. For a laser device, "ground truth" (if a study were conducted) would likely relate to clinical outcomes (e.g., successful coagulation, absence of reflux, teleangectasia reduction, complication rates) rather than expert consensus on an image or pathology.

8. Sample size for the training set:

Cannot be provided. This is not an AI/ML device in the sense of requiring a "training set" of data to learn from. Its safety and effectiveness are established through engineering design, adherence to standards, and substantial equivalence to a predicate device.

9. How the ground truth for the training set was established:

Cannot be provided. Not applicable.

In summary: The provided 510(k) summary is typical for a medical device seeking clearance through substantial equivalence. It confirms compliance with relevant regulations and guidance documents and asserts that performance data exists to demonstrate safety and effectiveness. However, it does not present the detailed studies, acceptance criteria, or performance results that would answer the specific questions posed, as these details are usually contained within the full 510(k) submission and not summarized in this public document to the same level of granularity.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

5 -1 GENERAL INFORMATION

人080731

Trade Name	PHARAON 980ENDO application & EXO application
Classification Name	LASER INSTRUMENT, SURGICAL, POWERED
Class	II
Product Code	GEX
CFR section	878.4810
Device panel	General & Plastic Surgery
Legally marketedpredicate devices	CERALAS D 980 LASER SYSTEM manufactured byBIOLITEC numerous 510Ks including K993911 andK024088
Submitter	OSYRIS121 Rue Chanzy, BP 9014059260 HELLEMMES FRANCE
Contacts	Pr JAQUAD ZEMMOURI CEOjaouad.zemmouri@osyris.comPhone : +33 (0)3 20 67 59 97Fax: +33 (0)3 20 04 46 24Regulatory contact : Dr Isabelle DRUBAIX (IdéeConsulting) idrubaix@nordnet.fr

5 -2. DEVICE DESCRIPTION

5 - 3. INTENDED USE

PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs.

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5 - 4. PERFORMANCE DATA

PHARAON 980 ENDO & EXO applications conform to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).

PHARAON 980 ENDO & EXO applications conform to 21 CFR part 1040.10 and 1040.11.

Performance data demonstrate the safety and effectiveness of PHARAON ENDO /EXO for its intended use.

5 - 5. SUBSTANTIAL EQUIVALENCE

PHARAON 980 ENDO & EXO applications have the same intended use, design and function as predicate devices CERALAS D980 LASER SYSTEM manufactured by BIOLITEC.

Summary preparation date: March, 7, 2008

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a bald eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2008

Osyris % Pr Jaouad Zemmouri CEO 121 Rue Chanzy B.P. 90140 Hellemmes, France

Re: K080731 Trade/Device Name: PHARAON 980 ENDO & EXO Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insgrument for use in general and plastic surgery and in चेन matology Regulatory Class: II Product Code: GEX Dated: June 12, 2008 Received: June 17, 2008

Dear Pr Jaouad Zemmouri:

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 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 comply with 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 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.

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Page 2 - Pr Jaouad Zemmouri

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems च्चा (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millican

Mark N. Melkerson 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

510(k) Number (if known): A 08073 |

Device Name: PHARAON 980 ENDO & EXO

Indications for Use:

PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs.

Prescription Use > AND/OR (Part 21 CFR 801 Subpart D)

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 Eyaluation (ODE)

Division Sta

(Division Sign-Oit) Division of General, Restorative, and Neurological Devices

510(k) Number 12080731

Regulation Number and Section

§ 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.