(134 days)
Not Found
No
The device description and performance studies focus on mechanical and functional performance, irrigation/suction control, and equivalence to a predicate device. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device clears the end of a rigid endoscope to maintain clear visualization, facilitating endoscopic procedures, rather than directly treating a medical condition.
Yes
The device is explicitly stated to be indicated for use "during routine diagnostic procedures."
No
The device description explicitly states the system includes a reusable AC powered console with pump, a reusable footpedal, and sterile disposable single-use accessories, indicating it is a hardware-based system with software controlling some functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clear the end of a rigid rod endoscope to maintain visualization during endoscopic procedures. This is a mechanical function performed during a medical procedure on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a system with a pump, footpedal, sheaths, and tubesets used for irrigation and suction. This aligns with a device used for cleaning and maintaining visualization during surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on mechanical, functional, and cleaning performance, not on the accuracy or reliability of diagnostic results.
In summary, the InstaClear Lens Cleaner system is a medical device used to facilitate visualization during endoscopic procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Intended to clear the end of a rigid rod endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site.
The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The InstaClear Lens Cleaner system includes a reusable AC powered console with pump, a reusable footpedal, and sterile disposable single-use accessories.
The system is used to clear the end of a rigid endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery (ESS).
The system accessories include sterile sheaths to fit various sizes of 4mm Olympus and Storz endoscopes, a sterile irrigation tubeset, and a non-sterile footpedal. The console includes software to control irrigation delivery and suction.
When performing ESS the scope is inserted into the nasal passages to visualize the sinuses. During the resection of tissue the scope lens is frequently covered in debris. such as blood and mucous that limits visualization. Traditionally the surgeon has to remove the scope, clean the lens, return the scope, and resume surgery. The proposed device is intended to attach directly to the endoscope shaft and provide fluid and suction to clean the lens of unwanted debris. This provides the surgeon with better images without debris and less instrument exchanges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal passages, sinuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical site
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)
Performance tests were executed to ensure that the system functioned as intended and met design specifications. The following non-clinical and preclinical tests and usability studies were conducted:
Non-Clinical / Preclinical Performance:
- non-clinical (electrical, mechanical, functional) performance testing
- preclinical (bench) evaluations and testing
Non-clinical: Basic safety and performance testing was performed in accordance with IEC standards. In addition, verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Testing included: cleaning compatibility, noise levels, heat generation, tabletop stability, burst pressure, suction strength, hub strength, torque strength, leak testing, ship testing, and baseline performance testing.
Stability: Representative samples were subjected to accelerated aging to confirm that the disposable devices maintain functionality and continues to meet specifications over time. The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. Representative samples were also subjected to environmental conditioning and ship testing.
Preclinical: Evidence obtained from preclinical bench studies demonstrate that the system performs substantially equivalent to the predicate device in relevant aspects associated with cleaning cycle time, cleaning performance, clearing performance, and leak / drip occurrence rate. For simulated use and bench testing. the selected medium was a blood analog appropriate for testing.
Testing demonstrated that the device performs as well as or better than the predicate device.
No clinical testing was conducted. The use of the device type has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations.
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a human profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
Gyrus ACMI, Inc. Mr. Dolan Mills Sr. Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01772
Re: K152531
Trade/Device Name: InstaClear Lens Cleaner Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: September 2, 2015 Received: September 3, 2015
Dear Mr. Mills:
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 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.
1
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); 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 Industry and Consumer Education 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" (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 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 Industry and Consumer Education 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.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152531
Device Name InstaClear Lens Cleaner
Indications for Use (Describe)
Intended to clear the end of a rigid rod endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site.
The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.
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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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. InstaClear Lens Cleaner
General Information
| Manufacturer and 510(k) Submitter: | Gyrus ACMI, Inc., an Olympus company
136 Turnpike Road
Southborough, MA 01772-2104
Phone: 1-800-262-3540
Fax: 1-901-373-0260 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3003790304 |
| Manufacturing Site: | 2925 Appling Road
Bartlett , TN 38113
Phone: 1-800-262-3540
Fax: 1-901-373-0260 |
| Establishment Registration Number: | 1037007 |
| Contact Person: | Dolan Mills
Senior Specialist, Regulatory Affairs |
| Date Prepared: | September 2, 2015 |
| Device Description | |
| Classification Name: | Nasopharyngoscope and Accessories |
| Regulatory Class | Class 2 |
| Regulation Number | 21 CFR 874.4760 |
| Review Panel | Ear, Nose, & Throat Panel |
| Product Code | EOB |
| Project Name: | Lens Cleaner (12-016) |
| Trade Name(s): | InstaClear |
| Generic/Common Name: | Nasopharyngoscope (flexible or rigid)
and accessories |
4
Predicate Device
Medtronic Endo-scrub 2:
Product Description
The InstaClear Lens Cleaner system is equivalent to the predicate device cleared under K982594. The system includes a reusable AC powered console with pump, a reusable footpedal, and sterile disposable single-use accessories.
The system is used to clear the end of a rigid endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery (ESS).
The system accessories include sterile sheaths to fit various sizes of 4mm Olympus and Storz endoscopes, a sterile irrigation tubeset, and a non-sterile footpedal. The console includes software to control irrigation delivery and suction.
When performing ESS the scope is inserted into the nasal passages to visualize the sinuses. During the resection of tissue the scope lens is frequently covered in debris. such as blood and mucous that limits visualization. Traditionally the surgeon has to remove the scope, clean the lens, return the scope, and resume surgery. The proposed device is intended to attach directly to the endoscope shaft and provide fluid and suction to clean the lens of unwanted debris. This provides the surgeon with better images without debris and less instrument exchanges.
Technological Characteristics
The system is used in the same way as the predicate system (K982594). The disposable sheath is placed on the shaft of an endoscope and directs fluid to the lens of the scope for the purpose of cleaning the lens of debris. Fluid delivery is actuated by a simple footpedal. Other than the footpedal and the console there are no other capital requirements. Fluid is pressurized using a pump on the console. The flow rate may be controlled by an adjustable knob on the back of the console. Connections to the console are limited to loading the tubeset through the pump, and connecting the footpedal.
Material
The system uses the same patient-contacting materials that are utilized in predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.
The patient contacting items are classified in accordance with ISO 10993-1, as an external communicating. tissue/bone/dentin device for limited exposure (