EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.

Device Description

The Virtual Ports EndoClear™ system is an accessory tool for laparoscopic procedures that consists of the EndoClear™ Lens Cleaner and the Virtual Ports Applier. The EndoClear™ Lens Cleaner is an internally anchored, hands-free, laparoscope lens cleaning device that is attached to the internal operating cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the laparoscope lens of blood, fat, fog, and secretions without removing it from the cavity. The EndoClear™ Lens Cleaner is introduced via a cannula using the Virtual Ports Applier, which introduces the EndoClear™ Sens Cleaner into the cavity, enables positioning of the device under endoscopic guidance, anchors it to the internal cavity wall, and removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.

AI/ML Overview

The provided document is a 510(k) summary for the Virtual Ports Ltd. EndoClear™ System. It focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and bench testing. Crucially, this document does not contain information about a study proving the device meets specific acceptance criteria in the context of AI performance or clinical efficacy.

Instead, it states that "Bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance." This suggests a verification of engineering specifications rather than a comparative study for acceptance criteria related to clinical outcomes or AI performance, as the original request implies.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Device performs as intended	"All testing results demonstrated satisfactory performance."
Materials are biocompatible (in contact with human body)	"Materials of the EndoClear™ System that are in contact with the human body are biocompatible in accordance with ISO 10993-1"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be determined from the provided text. The document only mentions "bench tests."

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):

Cannot be determined from the provided text. This information is typically relevant for studies involving human interpretation or clinical data.

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

Cannot be determined from the provided text.

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:

No, an MRMC study was not described. The device is a physical accessory for laparoscopic procedures, not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone AI algorithm performance study was not described. The device is a physical accessory.

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

For the "bench tests," the ground truth would likely be engineering specifications and test protocols designed to verify the device's mechanical, material, and functional performance as intended. The document states "device performs as intended," indicating adherence to pre-defined functional requirements.

8. The sample size for the training set:

Not applicable / Cannot be determined. This device is hardware, not an AI algorithm requiring a training set.

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

Not applicable / Cannot be determined. This device is hardware, not an AI algorithm.

Summary of Device and Performance Information Available from the Text:

The EndoClear™ System is an accessory for laparoscopic procedures designed to clean endoscope lenses internally. The performance validation cited in this 510(k) summary relies on:

Bench tests: These tests were performed to ensure the device performs "as intended," and all results were "satisfactory." The specific criteria for "satisfactory performance" in these bench tests are not detailed.
Biocompatibility testing: The materials in contact with the human body were confirmed to be biocompatible in accordance with ISO 10993-1.

The document's primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (K080051) based on having the "same intended use" and incorporating the "same technology," despite some engineering and material changes, and a labeling change. The "performance validation" described serves to support this claim of substantial equivalence for mechanical and material aspects, not a clinical effectiveness study or AI performance evaluation.

Summary

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10003/6

Virtual Ports Ltd.

510(K) SUMMARY

510(k) Number K

MAR 1 0 2010

Preparation Date:	January 30, 2010
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Applicant's Name: Virtual Ports Ltd. 17 Tchelet Street Misgav Business Park D.N Misgav 20174, ISRAEL Tel: (972)4-999-0189 Fax: (972)4-999-1901 Yoram Levy, Osite Contact Person: 31 Haavoda Street Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com

Trade Name: EndoClear™ System
Common name: Accessory to a Laparoscope

Classification: Name: Endoscope and accessories Product Code: GCJ Regulation No: 876.1500 Class: II Classification Panel: General and Plastic Surgery

Substantial equivalence to the following predicate device is Predicate Device: claimed:

Device Name	510k No	Clearance Date
EndoClear™ System	K080051	21 Mar, 2008

Device Description:

2-2 Virtual Ports Ltd. | EndoClear™ Special 510k Notification

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Image /page/1/Picture/0 description: The image shows the logo for "Virtual Ports Laparoscopy Systems". The logo features a stylized graphic to the left of the text, resembling a curved line with a dot. The text "Virtual Ports" is prominently displayed, with the words "Laparoscopy Systems" written in a smaller font size below it. A horizontal line underlines the words "Laparoscopy Systems".

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Virtual Ports Ltd.

cleaning device that is attached to the internal operating cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the laparoscope lens of blood, fat, fog, and secretions without removing it from the cavity. The EndoClear™ Lens Cleaner is introduced via a cannula using the Virtual Ports Applier, which introduces the EndoClear™ Sens Cleaner into the cavity, enables positioning of the device under endoscopic guidance, anchors it to the internal cavity wall, and removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.

Intended Use Statement: 1

Technical Characteristics:

Both the modified EndoClear™ System and its predicate device (EndoClear™ System; K080051) are internally anchored, handsfree, laparoscope lens cleaning devices. Both devices are attached to the internal operating cavity and remain in position until completion of the surgery.

Technical Modifications from Predicate Device:

The modifications between the modified EndoClear™ System and its predicate device EndoClear™ System; (K080051) are:

. Engineering changes
Changes in materials .

2-3 Virtual Ports Ltd. | EndoClear™ Special 510k Notification

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aparoscopy Sys

Virtual Ports Ltd.

The Virtual Ports Applier is reusable .
Labeling change (Introducer to Applier) .

Substantial Equivalence:

The modified EndoClear™ System:

. has the same intended use
incorporates the same technology .

As the EndoClear™ System, cleared in K080051.

Performance Validation:

Performance Testing - bench tests

Bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.

Materials:

Materials of the EndoClear™ System that are in contact with the human body are biocompatible in accordance with ISO 10993-1

Conclusion:

Virtual Ports Ltd. believes that, based on the information provided in this submission, the modified EndoClear™ System is substantially equivalent to its predicate device without raising any new safety and/or effectiveness concerns.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, overlaid with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the figure. The figure is composed of three curved lines that suggest a person in motion. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Virtual Ports Ltd. % Osite Mr. Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

MAR 1 0 2010

Re: K100346

Trade/Device Name: EndoClear™ System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: February 02, 2010 Received: February 18, 2010

Dear Mr. Levy:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 - Mr. Yoram Levy

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/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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

ely yours,

for

N. Melkerson

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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Image /page/5/Picture/0 description: The image shows the logo for Virtual Ports Laparoscopy Systems. The logo features a stylized "V" shape with a dot above it, followed by the words "Virtual Ports" in bold, and "Laparoscopy Systems" in a smaller font below. The logo is simple and modern, and the text is clear and easy to read.

Virtual Ports Ltd.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _

Device Name: EndoClear™ System

Indications for Use:

Prescription Use X (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

510(k) Number

Anh

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100346

Virtual Ports Ltd. | EndoClear™ Special 510k Notification

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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.