(193 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of an anti-fog solution and foam pad, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "laparoscopic accessory device" intended to "prevent condensation of the distal lenses" of surgical instruments, not to directly treat or diagnose a disease or condition in a patient. Its function is to facilitate the surgical procedure by maintaining clear visualization.
No
The device is an anti-fog solution for laparoscopic instruments, designed to prevent condensation on lenses during surgery. It does not diagnose any condition or disease.
No
The device description clearly outlines physical components (bottle, foam pad, solution) and performance studies related to material properties and physical function (biocompatibility, sterilization, fog resistance), indicating it is a physical medical device, not software-only.
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 condensation on the lenses of endoscopic/laparoscopic instruments during surgical procedures. This is a functional aid for the surgical equipment, not a test performed in vitro on biological samples to diagnose a condition.
- Device Description: The description details a solution and a foam pad used to apply the solution to the lenses. This aligns with a device used to maintain the functionality of surgical equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is clearly described as a "laparoscopic accessory device" used during a procedure to improve visualization, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/ laparoscopic instruments during the surgery. The product is intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
OCT
Device Description
The AMD Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is packaged by the Tyvek" Pouch which includes one clear plastic screw top dispenser bottle with the volume of 6 mL and one polyurethane (PU) foam pad with x-ray detectable radiopaque ribbon. The solution is a clear/colorless, odorless, and aqueous solution which comprises of surfactant (≤2%), isopropyl alcohol (≤2%), and water (≥96%). The polyurethane (PU) foam pad is an adhesivebacked sponge with radiopaque ribbon that can be used to introduce the solution into the surface of the lenses.
The device is intended to be used prior and during minimally invasive surgical operation, to prevent condensation of the distal lenses of the endoscopic instruments during the clinical operation. AMD Anti-Fog Solution is comprised of a surfactant that provides the same physical characteristics as the predicate device. The mechanism of anti-fogging function of AMD Anti-Fog Solution is to reduce the surface tension of the water, resulting in a non-scattering film of water instead of single droplets, on the lenses once the product is smeared on the lenses. Therefore, the non-scattering film of water was formed on the lenses instead of the single water droplets. This phenomenon is called "wetting".
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
Target User Population: Prescription use only
Where Used: Hospital O.R. room
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)
A series of studies were performed to evaluate the safety and effectiveness of AMD Anti-Fog Solution:
A. Biocompatibility Testing: Evaluated per FDA recognized consensus standard ISO 10993-1. Tests included Cytotoxicity Test, Sensitization Test, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, and Material-Mediated Pyrogenicity Test. All tests passed, indicating no safety issues and biocompatibility.
B. Sterilization Validation and Shelf Life Study:
a. Gamma-radiation Sterilization Validation Study: Performed per ISO 11137-2, ISO 11737-1, and ISO 11737-2. Used VDmax 25 method. Results showed the product can be sterile at a dose of no less than 25 kGy, meeting SAL
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 22, 2019
Advanced Medical Design Co., Ltd Silvia Yeh Regulatory Affairs 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City, 24888 Taiwan
Re: K181887 Trade/Device Name: AMD Anti-Fog Solution Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCT Dated: July 10, 2018 Received: December 12, 2018
Dear Silvia Yeh:
We reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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/cfpmb/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. Iisting 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.
1
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 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 mediation-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,
Mark R. Kreitz -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181887
Device Name AMD Anti-Fog Solution
Indications for Use (Describe)
AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the endoscopic/ laparoscopic instruments during the surgery. The product is intended for prescription use only.
| 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 logo for AMD Global Solutions for Medical Industry. The logo features the letters "AMD" in large, bold, blue font, with a globe graphic incorporated into the "A". Below the letters is the text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" in a smaller font. The logo is clean and professional, suggesting a company that is reliable and innovative.
I. SUBMITTER
510(k) Summary
| Company Name: | Advanced Medical Design Co., Ltd. |
|---|---|
| Mailing Address: | 4F~5F, No29, Wuquan 5th Rd., Wugu Dist., New Taipei city, 248 Taiwan |
| R.O.C. | |
| Phone: | +886-2-2290-2627 |
| Fax: | +886-2-2298-1789 |
| Contact Person: | Silvia Yeh |
| Regulatory Affair | |
| Phone: +886-2-2290-2627 Ext. 511 | |
| E-mail: silvia.yeh@amdintl.com.tw | |
| Date Prepared: | July 10, 2018 |
II. DEVICE INFORMATION
| Name of Device: | AMD Anti-Fog Solution |
|---|---|
| Common or Usual Name: | Endoscope Anti-fogging Device |
| Classification Name: | Endoscope and accessories (21 CFR 876.1500) |
| Regulatory Class: | II |
| Product Code: | OCT |
III. PREDICATE DEVICE
| Trade/Device Name | Clear-It Anti-Fog Solution |
|---|---|
| Common or Usual Name | Endoscope Anti-fogging Device |
| 510(k) Number | K022826 |
| Product Code | OCT |
| Submitter | Preservation Solution, Inc. |
IV. DEVICE DESCRIPTION
The AMD Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is packaged by the Tyvek" Pouch which includes one clear plastic screw top dispenser bottle with the volume of 6 mL and one polyurethane (PU) foam pad with x-ray detectable radiopaque
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Image /page/4/Picture/0 description: The image is a logo for AMD Global Solutions for Medical Industry. The logo is blue and white. The logo has a globe on the left side of the word AMD. The text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" is below the logo.
ribbon. The solution is a clear/colorless, odorless, and aqueous solution which comprises of surfactant (≤2%), isopropyl alcohol (≤2%), and water (≥96%). The polyurethane (PU) foam pad is an adhesivebacked sponge with radiopaque ribbon that can be used to introduce the solution into the surface of the lenses.
The device is intended to be used prior and during minimally invasive surgical operation, to prevent condensation of the distal lenses of the endoscopic instruments during the clinical operation. AMD Anti-Fog Solution is comprised of a surfactant that provides the same physical characteristics as the predicate device. The mechanism of anti-fogging function of AMD Anti-Fog Solution is to reduce the surface tension of the water, resulting in a non-scattering film of water instead of single droplets, on the lenses once the product is smeared on the lenses. Therefore, the non-scattering film of water was formed on the lenses instead of the single water droplets. This phenomenon is called "wetting".
V. INDICATIONS FOR USE
AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/laparoscopic instruments during the surgery. The product is intended for prescription use only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
AMD Anti-Fog Solution is designed to prevent condensation of the distal lenses, that is the same as the predicate device (K number: K022826). A comparison of the device features, technological characteristics, intended use, and other information demonstrates that AMD Anti-Fog Solution is substantially equivalent to the predicate device. The substantially equivalent comparison table was summarized in Table 5.1.
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Image /page/5/Picture/0 description: The image shows the logo for AMD Global Solutions for the Medical Industry. The logo is in blue and features a globe on the left side of the letters AMD. The text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" is written in a smaller font below the letters AMD.
| Device Name | Proposed Device | Predicate Device | Comment |
|---|---|---|---|
| Indication for Use | AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/laparoscopic instruments during the surgery. The product is intended for prescription use only. | Clear-It Anti-Fog Solution (K022826) | |
| Clear-It Anti-Fog Solution is indicated for use in the sterile surgical arena to eliminate condensation from endoscopic lenses, goggles and other devices that are likely to fog. | Same | ||
| Reusable / Disposable | Disposable | Disposable | Same |
| Target Patient Population | The patient who treated by minimum invasive laparoscopic surgery. | The patient who treated the surgery in the sterile surgical arena. | Similar. The patient population of the proposed device is for minimum invasive laparoscopic surgery, the predicate device included. |
| Target User Population | Prescription use only | Prescription use only | Same |
| Where Used | Hospital O.R. room | Hospital O.R. room | Same |
| Contraindications | There are no known contraindications to the patient. | N/A | Same |
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Image /page/6/Picture/0 description: The image shows the logo for AMD Global Solutions for the Medical Industry. The logo is in blue and features a globe on the left side of the letters AMD. The text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" is located below the letters AMD.
| Table 5.1. The Substantially Equivalent Comparison Table | |||
|---|---|---|---|
| Device | |||
| Name | Proposed Device | Predicate Device | |
| (K022826) | Comment | ||
| Elements | - Surfactant (≤2%) |
- Isopropyl alcohol (≤2%)
- Water (≥96%)
b. Sponge - Polyurethane (PU) foam | - Water
- Isopropyl alcohol
- Sodium Alcohol Ether
Sulfate - Ammonium
Dodecylbenzene
b. Sponge - Polyurethane (PU) foam | biological evaluation
results of the
proposed device
meet the
requirements of the
applicable
standards. |
| Method of
Introduction | Wiping distal end of the lens
by sponge with solution. | Wiping distal end of the lens
by sponge with solution. | Same |
| Compatibility
With Other
Devices | Laparoscope/Endoscope:
5 mm, 10 mm and all other
sizes | Laparoscope/Endoscope:
5 mm, 10 mm and all other
sizes | Same |
| Performance | Preventing condensation of
the distal lenses of the
endoscopic/laparoscopic
instruments during the
clinical operation. | Preventing condensation of
the distal lenses of the
endoscopic/laparoscopic
instruments during the
clinical operation. | Same |
| Safety | The following
biocompatibility tests were
conducted. - Cytotoxicity Test
- Sensitization Test
- Intracutaneous Reactivity
Test - Acute Systemic Toxicity Test
- Material-Mediated
Pyrogenicity Test
All of the tests passed the
requirements as indicated in
the applicable standards | The cytotoxicity test was
conducted. | Same. We
performed all of the
biocompatibility
tests that are
indicated in the FDA
recognized
standards. |
Table 5,1, The Substantially Equivalent Comparison Table
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Image /page/7/Picture/0 description: The image shows the logo for AMD Global Solutions for the Medical Industry. The logo is in blue and features a globe on the left side. The letters AMD are in large, bold font and are the main focus of the logo. Below the letters, the words "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" are written in a smaller font.
| Proposed Device | Predicate Device | Comment | |
|---|---|---|---|
| Device | |||
| Name | AMD Anti-Fog Solution | Clear-It Anti-Fog Solution | |
| (K022826) | |||
| Sterile | |||
| Barrier | Single Layer Of Tyvek® Pouch | Single Layer Of Tyvek® Pouch | Same |
| Sterilization | |||
| Method | Gamma-radiation Sterilization | ||
| (10-6 SAL) | Gamma-radiation Sterilization | ||
| (10-6 SAL) | Same | ||
| Energy | |||
| Source | No energy source | No energy source | Same |
Table 5.1. The Substantially Equivalent Comparison Table
Through the substantially equivalent comparison table, the differences do not raise any different issues on the safety or effectiveness of the product.
VII. PERFORMANCE DATA
A series of the studies were performed to evaluate the safety and effectiveness of AMD Anti-Fog Solution. The following test results were provided to confirm the product is safe and effective as indicated.
A. Biocompatibility Testing
The biocompatibility test was evaluated per the FDA recognized consensus standard named "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016, the biocompatibility tests include the following items since the product is classified as the classification.
| Nature of Body Contact | Contact Duration | ||
|---|---|---|---|
| Category | Contact | ||
| External communicating device | Tissue/bone/dentin | Limited (≤24 h) |
| No. | Test Name | Applicable Standards | Comment |
|---|---|---|---|
| 1 | Cytotoxicity Test | ISO 10993-5:2009 Biological Evaluation Of Medical Devices |
- Part 5: Tests For In Vitro Cytotoxicity | Pass |
| 2 | Sensitization Test | ISO 10993-10:2010 Biological Evaluation Of Medical
Devices - Part 10: Tests For Irritation And Skin Sensitization | Pass |
| 3 | Intracutaneous | ISO 10993-10:2010 Biological Evaluation Of Medical | Pass |
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| No. | Test Name | Applicable Standards | Comment |
|---|---|---|---|
| Reactivity Test | Devices - Part 10: Tests For Irritation And Skin Sensitization | ||
| 4 | Acute Systemic | ||
| Toxicity Test | ISO 10993-11:2017 Biological Evaluation Of Medical | ||
| Devices - Part 11: Tests For Systemic Toxicity | Pass | ||
| 5 | Material-Mediated | ||
| Pyrogenicity | USP Pyrogen Test | Pass |
All of the test studies listed above showed that AMD Anti-Fog Solution did not raise any safety issues and is biocompatible.
B. Sterilization Validation and Shelf Life Study
The product is designed to perform gamma-radiation sterilization prior to place into the market, therefore the following studies should be evaluated by the applicable standards/guidance.
a. Gamma-radiation Sterilization Validation Study
The gamma-radiation sterilization study was performed per the requirements of the FDA recognized consensus standards listed below.
- ISO 11137-2:2013 Sterilization of Health Care Products Radiation Part 2: Establishing the Sterilization Dose
- ISO 11737-1:2006 Sterilization of Medical Devices Microbiological Methods Part 1: Determination of A Population of Microorganisms on Products
- ISO 11737-2:2009 Sterilization of Medical Devices Microbiological Methods Part 2: Tests of Sterility Performed in The Definition, Validation And Maintenance Of A Sterilization Process
The method used for gamma-radiation sterilization study was VDmax 25 method, since the product bioburden was less than 1000 CFU/sample. The test reports showed that the product can become sterile when the routine sterilization parameter was controlled at the dose of no less than 25 kGy, which meets the regulatory requirement of sterile condition (SAL