(48 days)
Not Found
No
The description details a simple electromechanical device for warming and applying an antifogging solution. There is no mention of data processing, algorithms, or learning capabilities.
Yes
The device is used prior to and during medical procedures (endoscopic and laparoscopic) to prevent fogging of instruments, which aids in visualization for medical interventions. While not directly treating a condition, it facilitates the therapeutic process by improving the clarity of the surgical field.
No
The device is designed to prevent fogging of endoscope and laparoscope lenses and to warm them. It does not collect or interpret any physiological data or images for the purpose of diagnosis.
No
The device description clearly outlines physical components including a housing, a circuit, a battery power source, a port, and included solutions and cloths. It also describes bench testing and animal testing, which are typical for hardware devices. There is no mention of software as a component or function of the device.
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 endoscope and laparoscope lenses during surgical procedures. This is a function related to the surgical equipment itself, not to the analysis of biological samples from the human body.
- Device Description: The device applies a solution and warms the scope lens. It does not interact with or analyze any biological material from the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This device's function is purely to improve the visualization during a surgical procedure by preventing lens fogging.
N/A
Intended Use / Indications for Use
The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, OCT
Device Description
The Scope Antifogging System is a single use, sterile device that is designed to apply an antifogging solution (surfactant) and warm the scope at or above the human body temperature when used prior to and during procedures that utilize an endoscope or laparoscope.
The Scope Antifogging System provides antifogging of the lens of the endoscope and laparoscope when inserted into the Scope Antifogging System for use in a laparoscopic procedure. Fogging occurs when the ambient temperature of the lens of the endoscope/laparoscope is cooler than the temperature of the human body and condensation forms on the lens. This is especially important in a surgical procedure where a surgeon must have a clear view of the operative site to safely perform surgery.
The Scope Antifogging System is controlled by an on switch to activate the circuit containing battery power source to indicate the activation of the antifogging solution warming circuit. The activation of the warming circuit life expectancy is 5 hours.
The antifogging solution is retained in the device and warmed when the device is activated in the "on" position. Subsequently, the endoscope/laparoscope is inserted into the device port for application of the warmed antifogging solution. The device's single scope insertion port of the endoscope/laparoscope accepts scopes up to 12mm in diameter.
The antifogging solution is included in with the Scope Antifogging System as fluid contained in two separate bottles. The solution is dispensed into the single port opening of the housing of the Scope Antifogging System prior to use.
Included with the Scope Antifogging System in the same packaging is a pair of sponge-tipped, trocar wipes. The trocar wipes are a single-use, radiopaque accessory used to wipe debris from the inside of the trocar during the surgical procedure. The trocar wipe sponge tip diameters are 7mm and 12mm.
Also included with the Scope Antifogging System in the same packaging is a single-use, microfiber cloth. The microfiber cloth is an accessory used as a method to wipe the endoscope/laparoscope lens of any debris buildup.
This product is sold sterile to healthcare professionals only.
The Scope Antifogging System has not been previously submitted for 510(k) clearance. However, the Xodus Medical Scope Antifogging System component, Antifog solution. is also a separately sold product, and is currently marketed by Xodus Medical with FDA clearance under 510k number K063587.
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
Hospitals and/or surgery centers on or by the order of a physician. Physicians, Nurses, Health Care Professionals, General Surgery.
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)
7.1 Performance Testing - Bench
- 7.1.1 Scope Lens Fogging Validation: Lens fogging validation testing was performed using the Xodus Medical Scope Antifogging System and the predicate device. The testing performed was to verify the effectiveness of the Scope Antifogging System at preventing fogging from occurring on simulated equipment. A laparoscope and a glass mirror plate were used in the testing and subjected to a high humidity source. Using a control, the antifogging solutions of both products were applied to the simulated equipment, the laparoscope and glass mirror plate. The testing conclusions were the Xodus Medical Scope Antifogging System demonstrated the effectiveness of preventing the fogging of the simulated equipment consistently, as with the predicate device.
- 7.1.2 Life Expectancy Validation: Testing of the duration of activation of the warming circuit was performed. The Scope Antifogging System was activated and observed for duration of the activation period. Thermal characteristics were observed during the activation period and determined the activation to be a minimum for five (5) hours.
- 7.1.3 Trocar Wiping Validation: Testing of the wiping of the inside of the trocar to clear any debris following application of blood and tissue (general smudging) from beef liver and extracting the scope was conducted. The blood and tissue were applied to the scope interior of the trocar and successfully wiped away on three test cases using the trocar wipes of the Scope Antifogging System and the Covidien Clearify Visualization system trocar wipes. There were no visible signs of any debris left behind following the wiping of the inside of the trocar.
7.2 Performance Testing -Animal
- 7.2.1 Scope Lens Fogging Validation: Testing of the Xodus Medical Scope Antifogging System and the predicate device was conducted with a live, anesthetized pig. A Karl Storz endoscopy system was used with a 5mm and 10mm Storz laparoscope. A series of exploratory procedures with four different Storz laparoscope types were used. Cleaning and application of antifogging solution to the scopes for determination of fogging prevention was performed in several instances. In all cases, the Scope Antifogging System demonstrated effectiveness of preventing the fogging of the laparoscopes consistently, as with the predicate device.
- 7.2.2 Scope Lens Wiping of Debris Validation: Testing of the wiping of the scope lens following application of bile, blood, and tissue was conducted. The matter was applied to the scope lens and subsequently successfully wiped away successfully on all occasions using the microfiber cloth and the foam pad on the Scope Antifogging System.
7.3 Biocompatibility
The Scope Antifogging System was successfully conducted to the ISO 10993-1 standard, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a Risk Management System". The biocompatibility tests performed are shown below. These tests were determined to be applicable to the product according to the device classification according to ISO 10993-1 Appendix A. Table A.1. The product category was determined to be "External Communicating Device": Contact determined to be "Tissue/Bone/Dentin; with Contact Duration "A-limited, ≤24hr"; and Biological Effect determined to be "Cytotoxicity, Sensitization, and Intracutaneous Reactivity". Additional biocompatibility tests included were include in the biocompatibility testing, the Acute Systemic Toxicity, and Pyrogenicity.
7.4 Sterilization
The Scope Antifogging System shall be sterilized by gamma radiation based on the ISO 11137-2 standard; "Sterilization of Health Care Products - Part 2: Establishing the Sterilization Dose". The process shall be validated to ensure 10-6 sterility assurance or better is achieved. The sterilization shall follow the same processes as currently marketed Xodus Medical FDA 510(k) cleared sterile products to include Antifog Solution 510(k) K063587, ES Pencils and Electrodes 510(k) K081647; Cautery Tip Cleaner 510(k) K053433, and Light Guard Light Handle 510(k) K053321.
7.5 Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC compatibility testing was successfully conducted on the Scope Antifogging System. The system complies with the IEC 60601-1-2 standard for EMC. The Scope Antifogging system shall be electrical safety tested to the standard IEC 60601-1.
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The logo is simple and professional, and it is easily recognizable.
September 19, 2018
Xodus Medical, Inc. Mr. Paul Lloyd Vice President, Global QA/RA & Technology 702 Prominence Drive New Kensington, Pennsylvania 15068
Re: K182080
Trade/Device Name: Scope Antifogging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, OCT Dated: July 27, 2018 Received: August 2, 2018
Dear Mr. Lloyd:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -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
2
Indications for Use
510(k) Number (if known) K182080
Device Name Scope Antifogging System
Indications for Use (Describe)
The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope 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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Image /page/3/Picture/0 description: The image is a company logo for Xodus Medical. The logo has a symbol on the left that is made up of two overlapping shapes, one in black and one in blue. To the right of the symbol is the company name, "XODUS MEDICAL", in bold black letters. Below the company name is the tagline "Making Surgery Safer" in blue letters.
SECTION 5 - 510(k) Summarv
- 510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: 724-337-5500 Fax: 724-337-1131 Contact: Paul Lloyd (Vice President, Global QA/RA & Technology)
Establishment Registration Number: 2530138
Date Prepared: July 27, 2018
1. Device Information:
Trade/Device Name: Scope Antifogging System Common Name: Endoscope Antifogging Device Classification Name: Endoscope and/or Accessories Regulation Number: 21 CFR 876.1500 Product Code: GCJ; OCT Regulatory Class: II
2. Legally Marketed Devices to which Xodus Medical claims Substantial Equivalence:
Device Name: Clearify Visualization System Common Name: Endoscope Antifogging Device 510(k) Number: K062779 510(k) Owner: Covidien LLC Classification Name: Endoscope and/or Accessories Regulation Number: 21 CFR 876.1500 Product Code: GCJ; OCT Regulatory Class: II
*The Covidien predicate device is formerly known as New Wave Surgical's DHELP, FDA 510k K062779, acquired by Medtronic/Covidien and marketed as Clearify Visualization System under a name change only.
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Image /page/4/Picture/0 description: The image is a logo for Xodus Medical. The logo features a stylized "X" formed by two overlapping shapes, one in black and the other in blue. To the right of the symbol is the text "XODUS MEDICAL" in bold, black letters, with the tagline "Making Surgery Safer" in a smaller, lighter blue font underneath.
3. Device Description
The Scope Antifogging System is a single use, sterile device that is designed to apply an antifogging solution (surfactant) and warm the scope at or above the human body temperature when used prior to and during procedures that utilize an endoscope or laparoscope.
The Scope Antifogging System provides antifogging of the lens of the endoscope and laparoscope when inserted into the Scope Antifogging System for use in a laparoscopic procedure. Fogging occurs when the ambient temperature of the lens of the endoscope/laparoscope is cooler than the temperature of the human body and condensation forms on the lens. This is especially important in a surgical procedure where a surgeon must have a clear view of the operative site to safely perform surgery.
The Scope Antifogging System is controlled by an on switch to activate the circuit containing battery power source to indicate the activation of the antifogging solution warming circuit. The activation of the warming circuit life expectancy is 5 hours.
The antifogging solution is retained in the device and warmed when the device is activated in the "on" position. Subsequently, the endoscope/laparoscope is inserted into the device port for application of the warmed antifogging solution. The device's single scope insertion port of the endoscope/laparoscope accepts scopes up to 12mm in diameter.
The antifogging solution is included in with the Scope Antifogging System as fluid contained in two separate bottles. The solution is dispensed into the single port opening of the housing of the Scope Antifogging System prior to use.
Included with the Scope Antifogging System in the same packaging is a pair of sponge-tipped, trocar wipes. The trocar wipes are a single-use, radiopaque accessory used to wipe debris from the inside of the trocar during the surgical procedure. The trocar wipe sponge tip diameters are 7mm and 12mm.
Also included with the Scope Antifogging System in the same packaging is a single-use, microfiber cloth. The microfiber cloth is an accessory used as a method to wipe the endoscope/laparoscope lens of any debris buildup.
This product is sold sterile to healthcare professionals only.
The Scope Antifogging System has not been previously submitted for 510(k) clearance. However, the Xodus Medical Scope Antifogging System component, Antifog solution. is also a separately sold product, and is currently marketed by Xodus Medical with FDA clearance under 510k number K063587.
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Image /page/5/Picture/0 description: The image is a logo for Xodus Medical. The logo consists of a stylized "X" made up of two overlapping parallelograms, one in black and one in blue. To the right of the "X" is the text "XODUS MEDICAL" in bold, black letters. Below that, in a smaller blue font, is the tagline "Making Surgery Safer™".
4. Intended Use:
The Xodus Medical Scope Antifogging System intended use is identified to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
5. Indications for Use:
The Scope Antifogging System is a single use, sterile device to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
6. Description of Safety and Substantial Equivalence
The Xodus Medical Scope Antifogging System has the same intended use as the predicate device, Covidien Clearify Visualization System, which is, "Use prior to and during endoscopic and laparoscopic procedures to prevent the fogging of the scope lens". The Xodus Medical Scope Antifogging System and Covidien Clearify Visualization System are based on the same technological elements shown in the table below.
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Image /page/6/Picture/0 description: The image shows the logo for Xodus Medical. The logo consists of a blue and black abstract symbol on the left, followed by the text "XODUS MEDICAL" in black, bold letters. Below the company name, the tagline "Making Surgery Safer" is written in a smaller, blue font with a trademark symbol.
Comparison Table to Predicate Device
| Name of Device | Xodus Medical Inc.'s Scope | Covidien's Clearify |
|---|---|---|
| Antifogging System | Visualization System | |
| Intended Use | Scope Antifogging System | |
| intended to be used prior to and | ||
| during endoscopic and | ||
| laparoscopic procedures to prevent | ||
| the fogging of the scope lens. | Clearify Visualization System | |
| intended to be used prior to and | ||
| during endoscopic and | ||
| laparoscopic procedures to | ||
| prevent the fogging of the scope | ||
| lens. | ||
| Usage | Hospitals and/or surgery centers | |
| on or by the order of a physician | Hospitals and/or surgery centers | |
| on or by the order of a physician | ||
| Materials | Antifogging Solution: Water, | |
| Isopropanol, Ethanol, Surfactant. | ||
| Material difference in housing | ||
| using polycarbonate plastic. | FDA approved ShurClens, a | |
| wound cleaning surfactant; | ||
| Water, alcohol, and surfactant. | ||
| Material difference in housing | ||
| using polyurethane foam. | ||
| Physical | ||
| Characteristics | Antifogging Solution of Clear/ | |
| colorless, odorless, water soluble | ||
| liquid. | ||
| Similar physical footprint-Xodus | ||
| lower profile; Shape is triangular | ||
| design. | Antifogging Solution of Clear/ | |
| colorless, odorless, water soluble | ||
| liquid. | ||
| Physical footprint with rounded, | ||
| oval design, higher profile. | ||
| Sterilization | Gamma radiation | Gamma radiation |
| Design/Packaging | Sterile barrier of polyethylene | |
| plastic and Tyvek | Sterile barrier of polyethylene | |
| plastic and Tyvek | ||
| Mechanism of | ||
| Action | Heating and dipping of distal end | |
| of endoscope/laparoscope into | ||
| solution | Heating and dipping of distal | |
| end of endoscope/laparoscope | ||
| into solution | ||
| Biocompatibility | ||
| Standards | ||
| Compliant | Yes, per ISO 10993-1 | Yes |
| Target Population | Physicians, Nurses, Health Care | |
| Professionals, General Surgery | Physicians, Nurses, Health Care | |
| Professionals, General Surgery | ||
| Power Source | Battery | Battery |
| Single Use | Yes | Yes |
| Sterility | Sterile | Sterile |
| 510(k) Number | TBD | K062779 |
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Image /page/7/Picture/0 description: The image shows the Xodus Medical logo. The logo consists of a stylized "X" formed by two intersecting blue and black shapes. To the right of the "X" is the text "XODUS MEDICAL" in bold, black letters. Below "XODUS MEDICAL" is the tagline "Making Surgery Safer" in a smaller, blue font, with a trademark symbol next to the word "Safer".
7. Performance Data:
7.1 Performance Testing - Bench
The following bench tests were performed for this submission:
7.1.1 Scope Lens Fogging Validation:
Lens fogging validation testing was performed using the Xodus Medical Scope Antifogging System and the predicate device. The testing performed was to verify the effectiveness of the Scope Antifogging System at preventing fogging from occurring on simulated equipment. A laparoscope and a glass mirror plate were used in the testing and subjected to a high humidity source. Using a control, the antifogging solutions of both products were applied to the simulated equipment, the laparoscope and glass mirror plate. The testing conclusions were the Xodus Medical Scope Antifogging System demonstrated the effectiveness of preventing the fogging of the simulated equipment consistently, as with the predicate device.
7.1.2 Life Expectancy Validation
Testing of the duration of activation of the warming circuit was performed. The Scope Antifogging System was activated and observed for duration of the activation period. Thermal characteristics were observed during the activation period and determined the activation to be a minimum for five (5) hours.
7.1.3 Trocar Wiping Validation
Testing of the wiping of the inside of the trocar to clear any debris following application of blood and tissue (general smudging) from beef liver and extracting the scope was conducted.
The blood and tissue were applied to the scope interior of the trocar and successfully wiped away on three test cases using the trocar wipes of the Scope Antifogging System and the Covidien Clearify Visualization system trocar wipes. There were no visible signs of any debris left behind following the wiping of the inside of the trocar.
7.2 Performance Testing -Animal
The following animal tests were performed for this submission:
7.2.1 Scope Lens Fogging Validation
Testing of the Xodus Medical Scope Antifogging System and the predicate device was conducted with a live, anesthetized pig. A Karl Storz endoscopy system was used with a 5mm and 10mm Storz laparoscope. A
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Image /page/8/Picture/0 description: The image shows the Xodus Medical logo. The logo consists of a stylized "X" formed by two intersecting shapes, one in black and one in blue. To the right of the "X" is the text "XODUS MEDICAL" in bold, black letters. Below "XODUS MEDICAL" is the tagline "Making Surgery Safer" in a smaller, blue font, with a trademark symbol next to the word "Safer".
series of exploratory procedures with four different Storz laparoscope types were used. Cleaning and application of antifogging solution to the scopes for determination of fogging prevention was performed in several instances. In all cases, the Scope Antifogging System demonstrated effectiveness of preventing the fogging of the laparoscopes consistently, as with the predicate device.
7.2.2 Scope Lens Wiping of Debris Validation
Testing of the wiping of the scope lens following application of bile, blood, and tissue was conducted. The matter was applied to the scope lens and subsequently successfully wiped away successfully on all occasions using the microfiber cloth and the foam pad on the Scope Antifogging System.
7.3 Biocompatibility
The Scope Antifogging System was successfully conducted to the ISO 10993-1 standard, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a Risk Management System". The biocompatibility tests performed are shown below. These tests were determined to be applicable to the product according to the device classification according to ISO 10993-1 Appendix A. Table A.1.
The product category was determined to be "External Communicating Device": Contact determined to be "Tissue/Bone/Dentin; with Contact Duration "A-limited, ≤24hr"; and Biological Effect determined to be "Cytotoxicity, Sensitization, and Intracutaneous Reactivity". Additional biocompatibility tests included were include in the biocompatibility testing, the Acute Systemic Toxicity, and Pyrogenicity.
7.4 Sterilization
The Scope Antifogging System shall be sterilized by gamma radiation based on the ISO 11137-2 standard; "Sterilization of Health Care Products - Part 2: Establishing the Sterilization Dose". The process shall be validated to ensure 10-6 sterility assurance or better is achieved.
The sterilization shall follow the same processes as currently marketed Xodus Medical FDA 510(k) cleared sterile products to include Antifog Solution 510(k) K063587, ES Pencils and Electrodes 510(k) K081647; Cautery Tip Cleaner 510(k) K053433, and Light Guard Light Handle 510(k) K053321.
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Image /page/9/Picture/0 description: The image shows the logo for Xodus Medical. The logo consists of a stylized "X" formed by two overlapping blue shapes on the left. To the right of the "X" is the text "XODUS MEDICAL" in black, with the tagline "Making Surgery Safer" in blue below it. The logo is clean and modern, with a focus on the company's name and mission.
7.5 Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC compatibility testing was successfully conducted on the Scope Antifogging System. The system complies with the IEC 60601-1-2 standard for EMC.
The Scope Antifogging system shall be electrical safety tested to the standard IEC 60601-1.
8. Conclusion:
The design, characteristics, and performance of the Scope Antifogging System substantiate that the device is working as intended (use prior to and during endoscopic and laparoscopic procedures to prevent the fogging of the scope lens). The Xodus Medical Scope Antifogging System is substantially equivalent to its predicate device, Covidien's Clearify Visualization System.