The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.

Device Description

The SightFix consists of a rigid endoscope and a flexible holding arm. The rigid endoscope of the SightFix contains an optic and a light fiber. The SightFix endoscope is designed to be used with the camera SightCam and the light source SightLight manufactured by WORLD OF MEDICINE Lemke GmbH. In addition, the use of adapters allows an easy attachment of standard 180W endoscopic light sources (halogen, xenon, quartz) to the endoscope. The holding arm of the SightFix is a manually operated endoscope holder to ensure an optimal positioning of the endoscope. Both the rigid endoscope and some components of the holding arm are autoclavable.

AI/ML Overview

The provided text describes a 510(k) submission for a device called "SightFix." This submission primarily focuses on establishing substantial equivalence to predicate devices rather than detailing independent performance criteria and an accompanying study with specific acceptance criteria that would typically be found in a primary clinical trial or performance evaluation.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance cannot be directly extracted from the provided text. The document primarily relies on compliance with international and European safety standards for its performance data.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with International Standard IEC 60601-2-18:1996 (Particular requirements for the safety of endoscopic equipment)	The device complies with IEC 60601-2-18:1996.
Compliance with European Standards EN 554:1994, EN 556:2001-01, and EN 1174-1:1996 (Sterilization of Medical Devices) for some components	Some components of the SightFix comply with EN 554:1994, EN 556:2001-01, and EN 1174-1:1996.
Bearing the CE mark in accordance with the European Medical Device Directive 93/42/EEC	The device bears the CE mark in accordance with the European Medical Device Directive 93/42/EEC.
Safety and effectiveness (implied by substantial equivalence to predicate devices)	Determined to be substantially equivalent to predicate devices, implying similar safety and effectiveness.

Study Information

1. Sample sizes used for the test set and the data provenance:

Not explicitly stated. The document refers to compliance with standards, which would involve testing, but the specific sample sizes for such tests or the provenance of any performance data are not provided. The strategy is based on substantial equivalence, not a direct clinical performance study.

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

Not applicable/Not stated. This information would typically be relevant for a clinical performance study with human interpretation (e.g., imaging studies), which is not the primary basis of this 510(k) submission.

3. Adjudication method for the test set:

Not applicable/Not stated. See point above.

4. 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:

No. This is not an AI-assisted device. The device is an endoscope and holder.

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

Not applicable. This device is a medical instrument (endoscope and holder), not an algorithm or AI system. Its performance is inherent to its physical design, materials, and manufacturing, tested against standards for safety and function, not as a standalone algorithmic performance.

6. The type of ground truth used:

Compliance with recognized standards and substantial equivalence. The "ground truth" here is that the device meets established safety and sterilization standards and is functionally similar to legally marketed predicate devices, which are presumed safe and effective.

7. The sample size for the training set:

Not applicable/Not stated. This concept is typically relevant for machine learning algorithms, which this device is not.

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

Not applicable/Not stated. See point above.

Summary of Approach:

The 510(k) submission for SightFix relies on demonstrating substantial equivalence to existing predicate devices (MGB LAPALUX Telescope, Robotrac™ Retractor Arm, and KSEA Endoscope Holder) in terms of intended use, design, material, and technological characteristics. Additionally, it highlights compliance with relevant international and European safety and sterilization standards. This approach, common for medical devices, means that a detailed, independent clinical study with specific performance acceptance criteria and associated sample sizes, expert ground truth, and comparative effectiveness (as one might see for diagnostics or AI devices) is generally not required or presented in such a submission. The performance is assessed against the established safety and functional profiles of the predicate devices and the relevant standards.

Summary

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K024251

510(K) SUMMARY SightFix

MAR 1 8 2003

I. Submitter:

WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany

II. Device Names:

1 . Classification Name: Endoscope and Accessory
1. Common or Usual Name: Laparoscope and Endoscope Holder
1. Proprietary Name:

SightFix

III. Classification:

Class II. The device is described in 21 C.F.R. § 876.1500. The product code for the device is GCJ.

IV. Predicate Device:

MGB LAPALUX Telescope (K982013) manufactured by MGB Endoskopische . Geräte GmbH
Robotrac ™ Retractor Arm (Unitrac) (K893121) manufactured by Aesculap Instruments Corp.
KSEA Endoscope Holder (K990334) manufactured by Karl Storz Endoscopy-● America, Inc.

V. Intended Use:

The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.

VI. Device Description:

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VII. Substantial Equivalence:

The SightFix described in this notification is similar in intended use, design, material and technological characteristics to the MGB LAPALUX Telescope (K982013) manufactured by MGB Endoskopische Geräte GmbH, the Robotrac TM Retractor Arm (Unitrac) (K893121) manufactured by Aesculap Instruments Corp. and the KSEA Endoscope Holder (K990334) manufactured by Karl Storz Endoscopy-America, Inc.

Both the endoscope of the SightFix and the predicate device MGB LAPALUX Telescope (K982013) are intended to allow access and observation of body cavities during diagnostic and therapeutic procedures in laparoscopy. In addition, both devices are rigid and autoclavable.

The holding arm of the SightFix and the predicate devices Robotrac ™ Retractor Arm (Unitrac) (K893121) and KSEA Endoscope Holder (K990334) are devices all intended to hold an endoscope during diagnostic and therapeutic endoscopic procedures. Moreover, the SightFix holding arm and the Robotrac TM Retractor Arm (Unitrac) (K893121) are both intended to be used during open surgery. All three devices contain stainless steel and aluminum and can be sterilized.

The differences between the SightFix and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the SightFix is substantially equivalent to the predicate devices currently on the market.

VIII. Performance Data:

The device complies with the International standards IEC 60601-2-18:1996 (Particular requirements for the safety of endoscopic equipment). Some Components of the SightFix comply with the European Standards EN 554:1994, EN 556:2001-01 and EN 1174-1:1996 (Sterilization of Medical Devices). In addition, the device bears the CE mark in accordance with the European Medical Device Directive 93/42/EEC.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2003

World of Medicine Lemke GmbH c/o Ms. Susanne Raab 91 Trowbridge Street Cambridge, Massachusetts 02138

Re: K024251

Trade/Device Name: SightFix Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 13, 2002 Received: December 23, 2002

Dear Ms. Raab:

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. Iisting 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 - Ms. Susanne Raab

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

APPLICANT:	WORLD OF MEDICINE Lemke GmbH
510(K) NUMBER (if known):	K024251
DEVICE NAME:	SightFix

INDICATIONS FOR USE:

The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number K024251

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.