(73 days)
Not Found
No
The device description and performance studies focus on mechanical lens cleaning and do not mention any AI/ML components or image processing.
No
The device is described as an accessory for cleaning endoscope lenses during laparoscopic procedures, specifically for maintaining visualization. While used during therapeutic procedures, its function is for visualization and not directly therapeutic in itself.
No
The device is described as an accessory for endoscope lens cleaning, which helps provide uninterrupted visualization during diagnostic and therapeutic procedures. It does not perform diagnostic functions itself.
No
The device description clearly states it is a "sterile, single patient use system consisting of: EndoClear™ Lens Cleaner and the EndoClear™ Introducer." These are physical components, not software. The performance studies also describe bench and animal testing, which are typical for hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EndoClear™ Laparoscopes Accessory is a physical device used during a surgical procedure to clean the lens of a laparoscope inside the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to provide "endoscope lens cleaning for uninterrupted visualization of internal structures." This is a functional aid during surgery, not a diagnostic test performed on a biological sample.
The device is a surgical accessory designed to improve visualization during laparoscopic procedures, which falls under the category of surgical instruments or accessories, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for "Virtual Ports Laparoscopy Systems". The logo features a stylized checkmark-like symbol on the left, followed by the words "Virtual Ports" in a bold, sans-serif font. Below "Virtual Ports", the words "Laparoscopy Systems" are written in a smaller, less bold font.
Virtual Ports Ltd.
510(K) SUMMARY
510(k) Number K Q8 005 |
MAR 2 1 2008
| Applicant's Name: | Virtual Ports
Teradion Industrial Park
6 Kahol Street
D.N Misgav 20179
ISRAEL
Tel: (972)4-999-0189
Fax: (972)4-999-1901 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 30500
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@qsitemed.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 |
| Predicate Devices: | Substantial equivalence to the following predicate device is claimed: |
| | 1. Laparoscope and Monopolar laparoscopic instruments; Instrumed
International, Inc. K040855.
2. g-Lix™ Tissue Grasper; USGI Medical K061268 |
| 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 |
Virtual Ports Ltd. | EndoClear™ 510k Notification
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Ko8oosi
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Image /page/1/Picture/2 description: The image shows the logo for Virtual Ports Laparoscopy Systems. The logo features a stylized figure on the left, followed by the words "Virtual Ports" in a bold, sans-serif font. Below "Virtual Ports" are the words "Laparoscopy Systems" in a smaller font.
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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jc040051
. 30 r.
Image /page/2/Picture/2 description: The image shows a logo with the words "Virtual Ports" in a bold, sans-serif font. Below "Virtual Ports" is the text "Laparoscopy Systems" in a smaller font. To the left of the text is a stylized graphic that resembles a check mark or a stylized letter V. There is a small dot above the graphic.
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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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 eagle with three stripes extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
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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Page 2 - Yoram Levy
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
p. lot l
Image /page/5/Picture/2 description: The image shows the logo for "Virtual Ports Laparoscopy Systems". The logo features a stylized "V" shape on the left, with a dot above the center of the "V". To the right of the "V" is the text "Virtual Ports" in a bold font. Below "Virtual Ports" is the text "Laparoscopy Systems" in a smaller font.
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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