The SOPRO 225 Dual halogen light source is intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy".

Device Description

The SOPRO 225 is a light source with two 250W Halogen reflector lamps, mechanical iris light intensity control, and connections for fiber optic light cable. A switch on the front panel provides for lamp selection.

AI/ML Overview

The provided text is a 510(k) Summary for the SOPRO 225 Dual Halogen Light Source, which is a medical device. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown based on the information provided, and where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category / Performance Metric	Acceptance Criteria (Implicit by Predicate Equivalence)	Reported Device Performance
Intended Use	To be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy.	The SOPRO 225 has the same intended use as the predicate device.
Technology / Design	Dual Halogen light source.	The SOPRO 225 is a dual halogen light source with two 250W Halogen reflector lamps, mechanical iris light intensity control, and connections for fiber optic light cable. A switch on the front panel provides for lamp selection.
Safety & Effectiveness	Substantially equivalent to predicate in safety and effectiveness.	The device is deemed substantially equivalent to the WOLF LP 4251 (K010033).

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 traditional medical device (light source) submission, not an AI/software device that typically uses test sets for performance evaluation. Substantial equivalence is demonstrated through comparison of technical characteristics and intended use to a predicate device, not through a test set.

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. See point 2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 2.

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 not an AI-assisted device. The submission focuses on the technical characteristics and intended use of a physical light source.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. Substantial equivalence for this device is based on technical comparison to a predicate, not clinical performance against a "ground truth" as would be defined for diagnostic or AI/software devices. The "ground truth" in this context is the established safety and effectiveness of the existing predicate device.

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. See point 8.

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is the 510(k) premarket notification process itself, specifically the comparison to a legally marketed predicate device.

The text explicitly states:

"The SOPRO 225 is substantially equivalent to the predicate device by the Richard Wolf Instruments Corporation, the WOLF LP 4251 (K010033) previously cleared by the FDA and currently marketed."
"The SOPRO 225 dual halogen light source and the predicate device WOLF LP 4251 dual halogen light source are both in Class II Endoscope and Accessories intended for use by qualified physicians."
"The SOPRO 225 and the predicate are both dual halogen light sources intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy."

The "study" here is a comparative analysis of device characteristics and intended use against the predicate WOLF LP 4251 (K010033). The FDA's review of this comparison led to the determination of "substantial equivalence," meaning that the SOPRO 225 is as safe and effective as the predicate device. This is the mechanism by which the device "meets acceptance criteria" in the context of a 510(k) submission for this type of medical device.

Summary

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K072912

8. Summary of Safety and Effectiveness - "510(k) Summary"

A. Submitter Information SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE

Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90

NOV 1 6 2007

Contact Person: Steve Salesky SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 40 Fax: 856 222-4726 E-mail: steve.salesky@us.acteongroup.com

Date Prepared: October 11, 2007

B. Device Identification

Classification Name: Laparoscope, General & Plastic Surgery

Common Usual Name: Laparoscope and accessories

Proprietary Name: SOPRO 225 Dual halogen light source

C. Identification of Predicate Device

DeviceWOLF LP 4251	ApplicantRichard WolfMedicalInstrumentsCorp.	510(k) No.K010033	Date ClearedJanuary 10, 2002
------------------------	--------------------------------------------------------------	-----------------------	----------------------------------

The SOPRO 225 is substantially equivalent to the predicate device by the Richard Wolf Instruments Corporation, the WOLF LP 4251 (K010033) previously cleared by the FDA and currently marketed.

D. Device Description

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E. Intended Use

F. Substantial Equivalence

The SOPRO 225 dual halogen light source and the predicate device WOLF LP 4251 dual halogen light source are both in Class II Endoscope and Accessories intended for use by qualified physicians.

The SOPRO 225 and the predicate are both dual halogen light sources intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy".

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

SOPRO % ACTEON, Inc. Mr. Steve Salesky 124 Gaither Drive, Suite 140 Mt. Laurel, New Jersey 08054

Re: K072912

Trade/Device Name: SOPRO 225 DUAL HALOGEN LIGHT SOURCE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 11, 2007 Received: October 12, 2007

Dear Mr. Salesky:

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

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Page 2 - Mr. Steve Salesky

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.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 N. Molkerson

Mark N. Melkerso 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:

K072912

Device Name:

SOPRO 225 DUAL HALOGEN LIGHT SOURCE

Indications for Use:

"Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy"

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices 6072912

510(k) Number

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.