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 a sterile, single patient use system consisting of: EndoClear™ Lens Cleaner and the EndoClear™ Introducer. The EndoClear Lens Cleaner is an internally anchored hands-free, laparoscope lens cleaning device which is attached to the internal abdominal cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the lens of blood, fat, fog, and secretions without removing it from the cavity. The Virtual Ports EndoClear™ Lens Cleaner is introduced via a cannula using the EndoClear™ Introducer, which also removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.

AI/ML Overview

The Virtual Ports EndoClear™ system is a sterile, single-patient use system designed to clean the lens of a laparoscope internally during surgery without removing it from the abdominal cavity. This allows for uninterrupted visualization of internal structures during diagnostic and therapeutic laparoscopic procedures.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device performs safely. Materials in contact with the human body are biocompatible.	The animal study demonstrated that "no safety and effectiveness questions were raised." All materials in contact with the human body are biocompatible in accordance with ISO 10993-1.
Effectiveness: Device effectively cleans the laparoscope lens of blood, fat, fog, and secretions without removal from the cavity, enabling uninterrupted visualization.	Bench tests and an animal study were performed. The document states: "All testing results demonstrated satisfactory performance." The animal study showed that "the EndoClear™ system performs as intended." The overall conclusion is that "the device performs safely and efficiently in accordance with its intended use."
Substantial Equivalence: Device is substantially equivalent to predicate devices.	Preclinical and bench performance data were supplied to demonstrate that the EndoClear™ meets its labeled performance claims and to establish substantial equivalence to the predicate devices (Laparoscope and Monopolar laparoscopic instruments; Instrumed International, Inc. K040855 and g-Lix™ Tissue Grasper; USGI Medical K061268).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Bench Tests: The document does not specify a numerical sample size for the bench tests. It states "Series of bench tests were performed."
- Animal Study: The document does not specify a numerical sample size (e.g., number of animals) for the animal study. It just states "An animal study was performed."
Data Provenance: The document does not explicitly state the country of origin for the studies. Given the applicant's address (Israel), it's highly probable the studies were conducted in Israel or a location collaborating with the applicant. The studies described are prospective in nature, as they involve testing the device to evaluate its performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information regarding the number of experts, their qualifications, or the method used to establish ground truth for the test set in either the bench tests or the animal study. The evaluation of performance in the animal study would typically involve veterinary surgeons or researchers, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or conducted, as this device is a physical tool for cleaning a laparoscope lens, not an imaging or diagnostic algorithm used by multiple human readers.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was conducted. The EndoClear™ system is a physical medical device, not an algorithm, and it is intended for human-in-the-loop use by a surgeon during laparoscopic procedures.

7. Type of Ground Truth Used

Bench Tests: The ground truth for bench tests would be defined by pre-established engineering specifications or performance metrics for lens cleaning effectiveness (e.g., clarity measurements after cleaning, removal of specific contaminants).
Animal Study: The ground truth for the animal study would likely be a combination of direct observation by the surgical team/researchers on the safety (e.g., lack of device-related injury) and effectiveness (e.g., visual clarity through the endoscope, ability to complete the intended surgical task). The document implies a qualitative assessment ("performs as intended," "no safety and effectiveness questions were raised").

8. Sample Size for the Training Set

This information is not applicable as the EndoClear™ system is a physical device and does not involve a "training set" in the context of machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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Virtual Ports Ltd.

510(K) SUMMARY

510(k) Number K Q8 005 |

MAR 2 1 2008

Applicant's Name:	Virtual PortsTeradion Industrial Park6 Kahol StreetD.N Misgav 20179ISRAELTel: (972)4-999-0189Fax: (972)4-999-1901
Contact Person:	Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	EndoClear™ system
Common name:	Accessory to a Laparoscope
Classification:	Name: Endoscope and accessoriesProduct Code: GCJRegulation No: 876.1500Class: IIClassification Panel: General and Plastic Surgery
Predicate Devices:	Substantial equivalence to the following predicate device is claimed:
	1. Laparoscope and Monopolar laparoscopic instruments; InstrumedInternational, Inc. K040855.2. g-Lix™ Tissue Grasper; USGI Medical K061268
Device Description:	The Virtual Ports EndoClear™ system is a sterile, single patient usesystem consisting of: EndoClear™ Lens Cleaner and the EndoClear™Introducer. The EndoClear Lens Cleaner is an internally anchoredhands-free, laparoscope lens cleaning device which is attached to theinternal abdominal cavity wall and remains in position until

Virtual Ports Ltd. | EndoClear™ 510k Notification

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Virtual Ports Ltd.

completion of the surgery, enabling the surgeon to effectively clean the lens of blood, fat, fog, and secretions without removing it from the cavity.

The Virtual Ports EndoClear™ Lens Cleaner is introduced via a cannula using the EndoClear™ Introducer, which also removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.

Intended Use Statement:

Performance Validation: Performance Testing - bench tests

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

Performance Testing - animal

An animal study was performed in order to evaluate the safety and effectiveness of using the Virtual Ports EndoClear™ System as an internal endoscope lens cleaner. This study demonstrated that the EndoClear™ system performs as intended and that no safety and effectiveness questions were raised.

Tests conclusion:

Both bench tests and the animal study were shown that the device performs safely and efficiently in accordance with its intended use.

Materials:

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Virtual Ports Ltd.

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

Substantial Equivalence:

Preclinical and bench performance data was supplied to demonstrate that the EndoClear ™ meets its labeled performance claims, and to demonstrate substantial equivalence to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2008

Virtual Ports % Osite Yoram Levy General Manager 31 Haavoda Street Binyamina, Israel

Re: K080051 Trade/Device Name: EndoClear™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 5, 2008 Received: March 10, 2008

Dear Yoram 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.

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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forth in the quality systems (OS) 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 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 of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (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 N Millman

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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1080051

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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 Division of General, Restorative and Neurological Devices

510(k) Number

Mark A. Melhem

Division Sig - Off Division of General. Restorative, and Neurological Devices

*510(k) Number K080051

1-2 Virtual Ports Ltd. | EndoClear™ 510k Notification

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.