VIRTUAL PORTS ENDOCLEAR SYSTEM

K080051 · Virtual Ports, Ltd. · GCJ · Mar 21, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080051
• Device Name: VIRTUAL PORTS ENDOCLEAR SYSTEM
• Applicant: Virtual Ports, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 Story

EndoClear™ system is a sterile, single-patient-use accessory for laparoscopes. It consists of an internally anchored, hands-free lens cleaner and an introducer. The lens cleaner is inserted into the abdominal cavity via a cannula using the introducer and anchored to the internal abdominal wall. It remains in position throughout the surgery, allowing the surgeon to clean the laparoscope lens of blood, fat, fog, and secretions without removing the scope from the cavity. The introducer is also used to remove the cleaner at the end of the procedure. Used in clinical settings by surgeons to maintain uninterrupted visualization, potentially reducing procedure time and improving surgical efficiency.

Clinical Evidence

Bench testing and an animal study were conducted. Bench tests confirmed the device performs as intended. The animal study evaluated safety and effectiveness as an internal lens cleaner, demonstrating that the system functions as designed with no safety or effectiveness concerns identified.

Technological Characteristics

Sterile, single-patient-use system. Materials are biocompatible per ISO 10993-1. Mechanical device consisting of an internally anchored lens cleaner and an introducer cannula. No electronic, software, or energy-based components.

Indications for Use

Indicated for use by qualified physicians for endoscope lens cleaning during diagnostic and therapeutic laparoscopic procedures to maintain visualization.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Laparoscope and Monopolar laparoscopic instruments; Instrumed International, Inc. (K040855)
• g-Lix™ Tissue Grasper; USGI Medical (K061268)

Submission Summary (Full Text)

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Virtual Ports Ltd.

# 510(K) SUMMARY

# 510(k) Number K Q8 005 |

MAR 2 1 2008

| Applicant's Name: | Virtual Ports<br>Teradion Industrial Park<br>6 Kahol Street<br>D.N Misgav 20179<br>ISRAEL<br>Tel: [phone]<br>Fax: [phone] |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda Street<br>Binyamina, Israel 30500<br>Tel [phone]; Fax [phone]<br>[e-mail] |
| Trade Name: | EndoClear™ system |
| Common name: | Accessory to a Laparoscope |
| Classification: | Name: Endoscope and accessories<br>Product Code: GCJ<br>Regulation No: 876.1500<br>Class: II<br>Classification Panel: General and Plastic Surgery |
| Predicate Devices: | Substantial equivalence to the following predicate device is claimed: |
| | 1. Laparoscope and Monopolar laparoscopic instruments; Instrumed<br>International, Inc. K040855.<br>2. g-Lix™ Tissue Grasper; USGI Medical K061268 |
| Device Description: | The Virtual Ports EndoClear™ system is a sterile, single patient use<br>system consisting of: EndoClear™ Lens Cleaner and the EndoClear™<br>Introducer. The EndoClear Lens Cleaner is an internally anchored<br>hands-free, laparoscope lens cleaning device which is attached to the<br>internal 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:

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.

### 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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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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# Virtual Ports Ltd.

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: EndoClear™ System

Indications for Use:

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.

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

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