(26 days)
No
The description focuses on a mechanical lens cleaning device and its applier, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
This device is an accessory for cleaning endoscope lenses during surgical procedures and does not directly treat a disease or condition.
No
The device is described as an "accessory tool for laparoscopic procedures" intended for "endoscope lens cleaning for uninterrupted visualization of internal structures." Its purpose is to maintain visibility during diagnostic and therapeutic procedures, but it does not itself perform diagnosis.
No
The device description clearly outlines physical components: the EndoClear™ Lens Cleaner and the Virtual Ports Applier, which are hardware accessories used in laparoscopic procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- EndoClear™ Function: The EndoClear™ Laparoscopes Accessory is designed to clean the lens of a laparoscope during a surgical procedure. It is used inside the body to improve visualization, not to analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "endoscope lens cleaning for uninterrupted visualization of internal structures." This is a functional accessory for a surgical procedure, not a diagnostic test.
Therefore, the EndoClear™ Laparoscopes Accessory falls under the category of a surgical accessory or instrument, not an In Vitro Diagnostic device.
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
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal operating 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)
Bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Virtual Ports Ltd.
510(K) SUMMARY
510(k) Number K
MAR 1 0 2010
| Preparation Date: | January 30, 2010 |
|---|---|
| ------------------- | ------------------ |
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:
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
2-2 Virtual Ports Ltd. | EndoClear™ Special 510k Notification
1
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".
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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
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.
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
2
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.
3
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
4
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
5
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:
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 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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