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 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.

AI/ML Overview

This FDA 510(k) summary for the LaparoVue device primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for the LaparoVue itself. The document describes types of performance tests conducted but does not provide specific acceptance criteria or reported device performance values from those tests in a way that allows for a direct comparison as requested.

Therefore, many of the requested sections cannot be fully populated from the provided text.

Here is an attempt to address your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes types of performance tests but does not explicitly state numerical acceptance criteria or provide quantitative reported device performance values for the LaparoVue device for fogging prevention. The "Lens Fogging Validation" section notes that "digital images were recorded to demonstrate the effectiveness of preventing the fog from forming on the lens when the Laparo Vue was utilized," implying a qualitative assessment rather than a specific numerical metric.

Criteria Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1 for biological evaluation; passing results for Cytotoxicity, Systemic Toxicity, Maximization Sensitization, and Intracutaneous Sensitization. (As an external device with limited contact duration <24hrs).	The battery of testing (Cytotoxicity, Systemic Toxicity, Maximization Sensitization, Intracutaneous Sensitization) was completed indicating acceptable results, as it was provided in support of substantial equivalence.
Sterilization	Compliance with AAMI/ANSI/ISO 11137-2 (Method 1), AAMI/ANSI/ISO 11737-1/2 for bioburden and sterility, and ASTM F2096-11 for package integrity and seal strength post-conditioning.	Sterilization validation testing was completed using Method 1; Bioburden and sterility testing were performed; Packaging configuration was sterilized and subjected to transportation conditions with testing performed to confirm package integrity and seal strength. This implies compliance.
Electrical Safety/EMC	Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).	The system complies with IEC 60601-1 and IEC 60601-1-2.
Life Expectancy	Device operates for a minimum of 5 hours with no change in warming performance over the labeled use.	Performance testing was performed to verify the device operates for the labeled (5) five hours. 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. This implies acceptable performance met the 5-hour minimum.
Lens Fogging Validation	Effectiveness at preventing fogging when inserted into a simulated laparoscopic environment (qualitative assessment based on digital images).	Digital images were recorded to demonstrate the effectiveness of preventing the fog from forming on the lens when the Laparo Vue was utilized in a simulated laparoscopic environment. This phrasing suggests qualitative effectiveness was demonstrated, rather than a specific quantitative metric. No "failure" or "inadequate" result is reported.

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

Test Set Sample Size: Not explicitly stated for any of the performance tests. The document mentions "digital images" for fogging, but not the number of tests/scopes.
Data Provenance: All listed performance data (Biocompatibility, Sterilization, Electrical Safety/EMC, Life Expectancy, Lens Fogging Validation) appear to be from bench testing conducted by Buffalo Filter, LLC. No information is provided regarding the country of origin of the data beyond the manufacturer's location in the US. The studies are prospective in the sense that they were conducted for this 510(k) submission.

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

Not applicable for the bench studies described. These studies did not involve human interpretation or a "ground truth" derived from expert consensus. For the "Lens Fogging Validation," the assessment appears to be a direct physical observation or image analysis, not expert medical opinion.

4. Adjudication Method for the Test Set

Not applicable, as no expert review or adjudication process is described for the bench performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The document explicitly states:

"No animal testing was conducted for this submission"
"No clinical testing was conducted for this submission"

This indicates that no studies involving human readers or clinical cases were performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance tests described (Biocompatibility, Sterilization, Electrical Safety/EMC, Life Expectancy, Lens Fogging Validation) are all standalone bench tests focused on the device's intrinsic performance characteristics without human interaction beyond operating the device for the test. The "Lens Fogging Validation" assessed the device's ability to prevent fogging directly.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The closest concept to "ground truth" for the performance tests would be:

Established standards: For Biocompatibility (ISO 10993), Sterilization (AAMI/ANSI/ISO 11137, 11737; ASTM F2096), and Electrical Safety/EMC (IEC 60601-1, 60601-1-2).
Direct physical measurement/observation: For Life Expectancy (recording temperatures over time) and Lens Fogging Validation (qualitative observation/recording of fog presence in a simulated environment).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm requiring a training set.

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

Not applicable, as there is no training set for this device.

Summary

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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

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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)

K150569

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 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.

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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 ●

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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

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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.

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.