(96 days)
Not Found
No
The device description focuses on physical warming and surfactant application, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
No.
The device is intended to prevent fogging of a scope lens during endoscopic and laparoscopic procedures, which is an accessory function for the procedure itself, not a direct treatment or diagnosis for a medical condition.
No
The LaparoVue is designed to prevent fogging of scope lenses during endoscopic and laparoscopic procedures by warming the scope and applying a warmed surfactant. It does not provide any diagnostic information or interpret physiological data for diagnosis.
No
The device description clearly outlines physical components such as a warming function, surfactant application, ports for endoscopes, a scope stand, batteries, LEDs, a microfiber piece, and trocar swabs. It also mentions sterilization and electrical safety testing, which are relevant to hardware. There is no indication that the device's primary function is solely software-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent fogging of a scope lens during endoscopic and laparoscopic procedures. This is a functional purpose related to the surgical procedure itself, not to the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The device warms the scope and applies a surfactant. It also includes accessories for cleaning the scope and trocar. These are all tools used during a surgical procedure to improve visualization, not to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, urine, etc.), detecting analytes, or providing diagnostic information.
The device is clearly intended as a surgical accessory to improve the performance of endoscopic and laparoscopic equipment.
N/A
Intended Use / Indications for Use
LaparoVue is a single-use, sterile device to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, OCT
Device Description
The Laparo Vue is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile (radiation) and intended for single-use only in a healthcare facility / hospital.
The thermodynamic principle of placing a cold instrument into contact with warm, moist air results in condensation, or more commonly referred to as fogging. The LaparoVue provides the user the ability to warm the endoscope or laparoscope to a temperature very similar to what is found in the human body to mitigate the large temperature change, thus preventing the condensation, or fogging, of the lens when placed into that environment.
The LaparoVue is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by LEDs which are illuminated at each port. The LaparoVue has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 12mm in diameter. The horizontal port is the main warming port, primarily used prior to the surgical case to warm the scope before the insertion into a body cavity. A small scope stand is part of the LaparoVue, designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. The vertical port contains a sponge that is saturated with the surfactant solution and warmed when the device is active. This port allows for the user to apply the warmed surfactant prior to and during the case.
The LaparoVue is powered by alkaline batteries and has a single-use surgical life of a minimum of 5 hours.
A small piece of microfiber is attached to the main housing of the unit that would allow the user to physically wipe the lens to remove any debris throughout the surgical procedure.
The VueTip trocar swabs are an accessory that is provided in the same package with the LaparoVue. They are each a sterile, single-use accessory to be used to physically clean debris from the trocar/cannula to minimize any smudging of the scope lens when it is inserted. The trocar swabs are constructed using foam attached to a handle, where the foam is used for the mechanical wiping of the port of the trocar/cannula. Two different configurations are provided, one with a foam diameter intended for use with trocar/cannulas up to 7mm, and the other for trocar/cannula with a diameter from 7mm up to 12mm. The handle material for the VueTip trocar swab is constructed to be radiopaque for the surgical setting.
A microfiber cloth is an accessory that is provided in the same package with the Laparo Vue. The cloth is a sterile, single-use accessory to be used as an alternate method to physically wipe debris from the lens of scope during the case. The construction of the microfiber cloth is radiopaque for the surgical setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility / hospital.
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)
Biocompatibility Testing: The biocompatibility evaluation for the LaparoVue was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1. Testing included Cytotoxicity, Systemic Toxicity, Maximization Sensitization, and Intracutaneous Sensitization. The device and its accessories are considered an external device that contacts Tissue / bone / dentin for a limited contact duration (less than 24hrs).
Sterilization Testing: Sterilization validation testing completed using Method 1 as detailed in AAMI/ANSI/ISO 11137-2. Bioburden and sterility testing were performed in accordance with AAMI/ANSI/ISO 11737-1 and AAMI/ANSI/ISO 11737-2. Packaging configuration was sterilized, subjected to transportation conditions, and tested for package integrity and seal strength post conditioning, according to ASTM F2096-11.
Electrical Safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the LaparoVue. The system complies with IEC 60601-1 standard for safety and IEC 60601-1-2 standard for EMC.
Performance Testing - Bench:
- Life Expectancy Verification: Bench testing performed to verify the device operates for the labeled 5 hours. Temperatures at multiple points, including the scope body, were recorded to ensure consistent warming performance over the labeled use.
- Lens Fogging Validation: Bench testing performed to verify effectiveness in preventing lens fogging in a simulated laparoscopic environment. A laparoscope was warmed per directions for use and inserted into a chamber simulating surgical temperature and humidity. Testing utilized actual laparoscopic equipment and recorded digital images to demonstrate effectiveness.
Performance Testing - Animal: No animal testing was conducted for this submission.
Performance Testing - Clinical: No clinical testing was conducted for this submission.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2015
Buffalo Filter, LLC % Mr. Dave Yungvirt Third Party Review Group 45 Rockefeller Plaza, Suite 2000 New York, New York 10111
Re: K150569
Trade/Device Name: LaparoVue Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, OCT Dated: May 27, 2015 Received: June 1, 2015
Dear Mr. Yungvirt:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name LaparoVue
Indications for Use (Describe)
Laparo Vue is a single-use, sterile device to be used prior to and during endoscopic procedures to prevent fogging of the scope lens.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K150569 Page 1 of 5
510(k) Summary For LAPAROVUE
Submitter:
Buffalo Filter, LLC 5900 Genesee Street Phone: (716)835-7000 Fax No: (716)835-3414 FDA Registration number: 1319744
Contact:
Pamela Netzel Director of Quality & Regulatory Affairs Telephone: (716) 835-7000 Fax No:
Prepared Date: 28 May, 2015
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1. Device Name
| Trade Name: | LaparoVue, model LapVue01 |
|---|---|
| Common/Usual Name: | Endoscope Anti-Fogging Device |
| Classification Name: | Endoscope and / or accessories (21 CFR 876.1500, |
| Product Code: GCJ (primary), OCT (secondary) |
2. Predicate Device
Buffalo Filter claims substantial equivalence to:
New Wave Surgical Corporation. Defogging Heated Endoscope Lens Protector (D.H.E.L.P.) K062779
3. Description of Device
The Laparo Vue is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile (radiation) and intended for single-use only in a healthcare facility / hospital.
The thermodynamic principle of placing a cold instrument into contact with warm, moist air results in condensation, or more commonly referred to as fogging. The LaparoVue provides the user the ability to warm the endoscope or laparoscope to a temperature very similar to what is found in the human body to mitigate the large temperature change, thus preventing the condensation, or fogging, of the lens when placed into that environment.
The LaparoVue is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by LEDs which are illuminated at each port. The LaparoVue has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 12mm in diameter. The horizontal port is the main warming port, primarily used prior to the surgical case to warm the scope before the insertion into a body cavity. A small scope stand is part of the LaparoVue, designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. The vertical port contains a sponge that is saturated with the surfactant solution and warmed when the device is active. This port allows for the user to apply the warmed surfactant prior to and during the case.
The LaparoVue is powered by alkaline batteries and has a single-use surgical life of a minimum of 5 hours.
5
A small piece of microfiber is attached to the main housing of the unit that would allow the user to physically wipe the lens to remove any debris throughout the surgical procedure.
The VueTip trocar swabs are an accessory that is provided in the same package with the LaparoVue. They are each a sterile, single-use accessory to be used to physically clean debris from the trocar/cannula to minimize any smudging of the scope lens when it is inserted. The trocar swabs are constructed using foam attached to a handle, where the foam is used for the mechanical wiping of the port of the trocar/cannula. Two different configurations are provided, one with a foam diameter intended for use with trocar/cannulas up to 7mm, and the other for trocar/cannula with a diameter from 7mm up to 12mm. The handle material for the VueTip trocar swab is constructed to be radiopaque for the surgical setting.
A microfiber cloth is an accessory that is provided in the same package with the Laparo Vue. The cloth is a sterile, single-use accessory to be used as an alternate method to physically wipe debris from the lens of scope during the case. The construction of the microfiber cloth is radiopaque for the surgical setting.
4. Intended Use
The LaparoVue is designed for general minimally invasive surgery that utilizes a camera system for visualization into a body cavity. The LaparoVue enables the operator to warm the camera prior to and throughout the surgical case, along with applying a warmed surfactant to lens prior to insertion into the surgical field.
Indications for Use:
LaparoVue is a single-use, sterile device to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
5. Description of Safety and Substantial Equivalence
Minimally invasive surgery and the use of a laparoscope or endoscope for visualization during those procedures is the primary market for both the subject and predicate devices. The prevention of the condensation of moisture on the viewing lens of the scope is the technological principle for both the subject and predicate device.
At a high level, the subject and predicate devices are based on following same technological elements:
- Heat transfer - used to warm the scope to a similar temperature as the target surgical environment
- Surfactant solution warmed to aid in transfer of heat to lens ●
- Single-use, sterile device to be used during a single surgical procedure ●
6
- Battery power used to produce the heat to warm the scope ●
- . LED light - used to notify the user the device is active
The following technological differences exist between the subject and predicate device:
- Multiple ports - for warming a scope prior to or during a procedure
- Scope stand designed to support main axis of the scope, allowing it to rest . on a flat, stable surface
- Activation - removal of a non-conductive slip sheet to complete battery circuit and activate the device
Performance Data 6.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the LaparoVue was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests:
- Cytotoxicity ●
- Systemic Toxicity ●
- Maximization Sensitization ●
- Intracutaneous Sensitization ●
The LaparoVue and its accessories are considered an external device that contacts the Tissue / bone / dentin for a limited contact duration (less than 24hrs).
Sterilization Testing
Sterilization validation testing completed using Method 1 as detailed in AAMI/ANSI/ISO 11137-2. Bioburden and sterility testing were performed in accordance with FDA recognized consensus standard AAMI/ANSI/ISO 11737-1 and AAMI/ANSI/ISO 11737-2.
The packaging configuration was sterilized and subjected to transportation condition. Testing was then performed to confirm package integrity and seal
7
strength post conditioning to ensure products remain sterile, according to ASTM F2096-11.
Electrical Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LaparoVue. The system complies with IEC 60601-1 standard for safety and IEC 60601-1-2 standard for EMC.
Performance Testing - Bench
The following bench tests were performed for this submission:
Life Expectancy Verification
Life expectancy bench testing was performed to verify the device operates for the labeled (5) five hours. The device was activated and the temperatures at multiple points, including the scope body were recorded to ensure the warming operation demonstrated no change in performance over the labeled use of the product.
Lens Fogging Validation
Lens fogging bench testing was performed to verify the effectiveness of the device at preventing the lens from fogging when inserted into a simulated laparoscopic environment. Using calibrated equipment, a laparoscope was warmed per the directions for use and then inserted into a chamber with a similar environment with regards to temperature and humidity as found during actual use. The testing utilized actual laparoscopic equipment and digital images were recorded to demonstrate the effectiveness of preventing the fog from forming on the lens when the Laparo Vue was utilized.
Performance Testing - Animal
No animal testing was conducted for this submission
Performance Testing - Clinical
No clinical testing was conducted for this submission
7. Conclusion
The design, operational and technical characteristics, performance and non-clinical testing of the Laparo Vue are substantially equivalent to that of the predicate device.