(91 days)
Not Found
No
The device is a chemical solution and foam pad for preventing fogging, with no mention of software, algorithms, or data processing.
No.
This device is an anti-fog solution for endoscopic/laparoscopic instruments, not a therapeutic agent for patients.
No
Explanation: The device is an anti-fog solution for endoscopic/laparoscopic instruments. Its function is to prevent fogging on lenses, not to diagnose medical conditions.
No
The device description clearly states it is a "clear / colorless, water soluble solution" and includes a "polyurethane foam pad" for application, indicating it is a physical product (liquid and foam) and not software.
Based on the provided information, the Unimax Anti-Fog Solution is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to prevent fogging on the lenses of endoscopic/laparoscopic instruments during use. This is a functional purpose related to the performance of a medical device (the endoscope/laparoscope), not a diagnostic purpose.
- Device Description: The description details a solution applied to a medical instrument to improve its visibility during a procedure. It does not describe a product used to examine specimens from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the anti-fogging properties, cleaning ability, and safety of the solution in relation to its intended use on the instruments, not on diagnostic accuracy or performance with biological samples.
In summary, the Unimax Anti-Fog Solution is an accessory used to improve the functionality of a medical device (endoscope/laparoscope) during a medical procedure. It does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Unimax Anti-Fog Solution 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.
Product codes
OCT, KOG
Device Description
The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.54.50.5 (LWH) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.
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
healthcare professionals only.
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
A series of safety tests were performed to assess the safety and effectiveness of the Unimax Anti-Fog Solution. The tests were conducted in accordance with ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing, ISO 10993-5 Biological Evaluation of medical devices- Part 5: Test for in vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices- Part10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-12 Biological evaluation of medical devices- Par112: Sample preparation and reference material, ISO 11137-1: 2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. All the test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses.
The result of bench testing listed below indicates that the new device is as safe and effective as the predicate device:
- Fog Resistance Test
- Cleaning Ability Test
- Extractable Test
- Prolonged Fog Resistance Test
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Unimax Medical Systems, Inc. % Aemebiotechs Co., Ltd. Mr. Michael Lee No. 45, Minshen Road Danshui Town - Taipei County Taiwan 251, China
JUL 2 7 2015
Re: K11622 Trade/Device Name: Unimax Anti-Fog Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCT Dated (Date on orig SE ltr): August 4, 2011 Received (Date on orig SE ltr): August 4, 2011
Dear Mr. Lee,
This letter corrects our substantially equivalent letter of September 9, 2011.
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
1
Page 2 -
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 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 Small Manufacturers, International and Consumer Assistance 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/Safetv/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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.
Benjamin R. Fisher -S
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
Unimax Anti-Fog Solution
..
... :: ::
:: :: ::
.
Indications for Use
510(k) Number (if known): K || 622
Device Name: Unimax Anti-Fog Solution
Indications for Use:
The Unimax Anti-Fog Solution 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (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)
Neil R.P. Ogle for 3KM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111622
-Page 1 of _
14
3
Unimax Anti-Fog Solution
KIII622
510(k) Summary
| 5.1 Type of Submission: | Traditional |
|---|---|
| 5.2 Preparation Date: | Jun 10, 2011 |
| 5.1 Revise Date: | Jul 29, 2011 |
| 5.2 Submitter: | Unimax Medical Systems Inc. |
| Address: | 8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien City, |
| Taipei, Taiwan | |
| Phone: | 886-2-89191698 |
| Fax: | 886-2-89191528 |
| Contact: | Sophia Chiu |
| Establishment Registration Number: | 3007791595 |
- ડ.3 Identification of the Device:
| Proprietary/Trade name: | Unimax Anti-Fog Solution |
|---|---|
| Common Name: | Anti-Fog Solution |
| Classification Name: | Endoscope And/ Or Accessories |
| Device Classification: | II |
| Regulation Number: | 876.1500 |
| Panel: | Gastroenterology/Urology |
| Product Code: | KOG |
5.4 Identification of the Predicate Device:
| Predicate Device Name: | Xodus Medical Anti-Fog Solution |
|---|---|
| Manufacturer: | Xodus Medical, Inc. |
| 510(k) Number or Clearance Information: | K063587 |
4
4
5.5 Intended Use and Indications for Use of the subject device.
The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic instruments which are likely to fog during use.
5.6 Device Description
The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.54.50.5 (LWH) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.
5.7 Non-clinical Testing
A series of safety tests were performed to assess the safety and effectiveness of the Unimax Anti-Fog Solution. The tests were conducted in accordance with ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing, ISO 10993-5 Biological Evaluation of medical devices- Part 5: Test for in vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices- Part10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-12 Biological evaluation of medical devices- Par112: Sample preparation and reference material, ISO 11137-1: 2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. All the test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Unimax Anti-Fog Solution is as safe and effective as the predicate devices.
5
5
Unimax Anti-Fog Solution
5.8 Safety and Effectiveness
The result of bench testing listed below indicates that the new device is as safe and effective as the predicate device:
- Fog Resistance Test .
- Cleaning Ability Test .
- Extractable Test .
- Prolonged Fog Resistance Test ●
5.9 Substantial Equivalence Determination
The Unimax Anti-Fog Solution submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Xodus Medical Anti-Fog Solution which is the subject of K063587. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | Proposed Device
(Unimax Anti-Fog Solution) | Predicate Device
(Xodus Medical Anti-Fog Solution) | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | The Unimax Anti-Fog Solution 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. | 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. | |
| Consisted | Bottled solution | Bottled solution | |
| Instruments | Foam pad | Foam pad | |
| Models | With alcohol
Alcohol free | With alcohol | |
| Comprised
Elements | With alcohol:
DPGMME (=2%)
Isopropyl alcohol
(=6%)
Deionized water
(=92%) | Alcohol free:
DPGMME (=2%)
Deionized water
(=98%) | Predominantly water (=95%)
Surfactant (