(39 days)
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.
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.
This 510(k) submission (K063587) for the Xodus Medical, Inc. Anti-Fog Solution is based on substantial equivalence to a predicate device, the Clear it Anti-Fog (K022826) by Preservation Solutions, Inc. It does not contain a study with explicitly defined acceptance criteria and device performance metrics in the typical sense of a novel medical device.
Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to a legally marketed predicate device. This means the new device has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
Here's how to break down the information based on your request, even though it's not a performance study in the traditional sense:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as demonstrated by similarity to predicate) |
|---|---|
| Intended Use: Prevent fogging on endoscopic/laparoscopic instrument lenses | Match: Anti-Fog is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use. (Identical to predicate's intended use according to Section 510(k) Summary, "Technological Characteristics Comparison") |
| Technological Characteristics: Similar physical characteristics and chemical composition to predicate device. | Match: Has the same physical characteristics, chemical composition, and packaging design as the predicate device (Clear it Anti-Fog). Chemical composition confirmed by two separate deformulations of the predicate. (Section 510(k) Summary, "Technological Characteristics Comparison") |
| Safety and Effectiveness: No new questions of safety or effectiveness raised by differences (or lack thereof) from the predicate device. | Assumed: No adverse events or safety concerns were mentioned, implying no new questions of safety or effectiveness. The similarity to a previously cleared device suggests equivalent safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" in the context of clinical or performance data collection for the new device. The "testing" was primarily analytical comparison to the predicate device.
- Sample Size: Not applicable in the sense of patient or experimental samples. The comparison was based on deformulation of the predicate device and comparison of physical characteristics of the new device.
- Data Provenance: Deformulations of the predicate device (Clear it Anti-Fog) were performed presumably by Xodus Medical, Inc. This is an internal, analytical process rather than a clinical study with patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: No "ground truth" in the sense of clinical expert assessment was established for a test set. The comparison was chemical and physical.
4. Adjudication Method for the Test Set
- Not Applicable: No adjudication method was used as there was no test set requiring multi-reader review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: This type of study (MRMC) was not performed. The device is an anti-fog solution, not an interpretive diagnostic system where human reader performance is pertinent.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable: This is a physical solution, not an algorithm. Therefore, a standalone performance study in that context was not performed.
7. Type of Ground Truth Used
The "ground truth" in this context is the established physical and chemical characteristics and performance of the predicate device.
- This was determined through:
- Deformulation (reverse engineering of chemical composition) of the predicate device.
- Direct comparison of physical characteristics (e.g., clear/colorless, water-soluble, bottling, packaging) between the new device and the predicate.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of an algorithm or machine learning. The comparison is based on the characteristics of the predicate device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there's no training set, this question is not relevant. The basis for comparison ("ground truth" of predicate device characteristics) was established through deformulation and direct observation.
In summary, K063587 is a 510(k) submission based on substantial equivalence. The "study" demonstrating this involves analytical chemistry (deformulation) and direct comparison of physical and functional characteristics to a previously cleared predicate device, rather than a clinical trial or performance study with acceptance criteria for quantitative metrics like sensitivity or specificity.
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510(k) Summary
JAN - 9 2007
510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: 724-337-5500 Fax: 724-337-0555 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 (240) 276-0115 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 (800) 638-2041 or (240) 276-3150 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 |
| 510(k) Number L063587 |
§ 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.