XODUS MEDICAL ANTI-FOG SOLUTION

K063587 · Xodus Medical, Inc. · OCT · Jan 9, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063587
• Device Name: XODUS MEDICAL ANTI-FOG SOLUTION
• Applicant: Xodus Medical, Inc.
• Product Code: OCT · Gastroenterology, Urology
• Decision Date: Jan 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Anti-Fog is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparascopic instruments which are likely to fog during use.

Device Story

Anti-Fog solution is a clear, water-soluble liquid (water, surfactant, isopropanol, ethanol) used to reduce surface tension on endoscopic/laparascopic lenses to prevent condensation fogging. The kit includes 6cc of solution in a 10cc dropper bottle and an adhesive-backed, non-abrasive, radiopaque polyurethane foam pad. Used by healthcare professionals in clinical settings during endoscopic or laparoscopic procedures. The clinician applies the solution to the lens using the foam pad prior to or during the procedure to maintain clear visualization. This improves surgical visibility, potentially reducing procedure time and enhancing patient safety by ensuring the surgeon has an unobstructed view of the surgical site.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through chemical analysis and physical comparison to the predicate device.

Technological Characteristics

Solution: water (~95%), surfactant (<5%), isopropanol (<1%), ethanol (<0.5%). Accessory: adhesive-backed, non-abrasive, radiopaque polyurethane foam pad. Form factor: 6cc solution in 10cc plastic dropper bottle. Sterile packaging: Tyvek pouch. Mechanism: surface tension reduction. No software or electronic components.

Indications for Use

Indicated for preventing condensation-induced fogging on endoscopic/laparascopic instrument lenses during surgical procedures. For prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Clear it Anti-Fog (K022826)

Submission Summary (Full Text)

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K063587

## 510(k) Summary

JAN - 9 2007

510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: [phone] Fax: [phone] Contact: Brenda Niel (Quality Assurance Manager)

Establishment Registration Number: 2530138

Date Prepared: November 28, 2006

### Device Information

Trade/Device Name: Anti-Fog Solution Common Name: Anti-Fog Solution Classification Name: Endoscope And/ Or Accessories Regulation Number: 21 CFR 876.1500 Product Code: KOG Regulatory Class: II

#### Predicate Device

Device Name: Clear it Anti-Fog Common Name: Anti-Fog Solution 510 (k) Number: K022826 510 (k) Owner: Preservation Solutions, Inc. Classification Name: Endoscope And/Or Accessories Regulation Number: 21 CFR 876.1500 Product Code: KOG Regulatory Class: II

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## 510(k) Summary

#### Device Description

The Anti-Fog solution is a clear / colorless, water soluble solution comprised of predominantly water (~95%) with small percentages of surfactant (<5%), isopropanol (<1%) and ethanol (<0.5%). Anti-fog solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic/ laparascopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle according to approved manufacturing processes by an FDA registered establishment (See Appendix C). Included in the tyvek pouch packaging of this product is a 134" x 1 1/2" adhesive backed, non-abrasive, x-ray detectable radiopaque, polyurethane foam pad for applying the product to endoscopic / laparascopic lenses. This product is sold sterile to healthcare professionals only.

#### Intended Use

Anti-Fog is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparascopic instruments which are likely to fog during use.

#### Technological Characteristics Comparison

Xodus Medical Inc.'s Anti-Fog kit has the same physical characteristics, chemical composition and packaging design as the predicate device Preservation Solutions, Inc.'s Clear it Anti-fog kit. Chemical composition and quantification for the Xodus Medical Anti-fog solution were determined by two separate deformulations performed on the Prescrvation Solutions Clear it anti-fog solution to ensure formula accuracy. Both the Preservation Solutions, Inc. and Xodus Medical's Anti-Fog are clear/coloriess, water soluble solutions bottled in 10cc clear plastic dropper bottles and packaged in a tyvek pouch in conjunction with an adhesive backed, non-abrasive polyurethane foam pad containing an x-ray detectable radiopaque strip. Both the predicate device and Xodus Medicals' device are used to prevent fogging of endoscopic/laparascopic lenses during procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Xodus Medical, Inc. % Ms. Brenda Niel Quality Assurance Manager 702 Prominence Drive New Kensington, Pennsylvania 15068

JAN - 9 2007

Re: K063587

Trade/Device Name: Anti-Fog Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: November 28, 2006 Received: December 1, 2006

Dear Ms. Niel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Brenda Niel

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours, Mark N.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

#### cc: HFZ-401 DMC

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# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Anti-Fog Solution

Indications for Use:

Anti-Fog is intended to be used to prevent "fogging" caused by condensation on the lenses of endoscopic/laparascopic instruments which are likely to fog during use.

Prescription Use _X (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (Per 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, |
| Page 2.1 | and Neurological Devices |
| | <b>510(k) Number</b> L063587 |