(156 days)
No
The device description and performance studies focus on basic light emission and mechanical properties, with no mention of AI/ML algorithms or data processing.
No
The device is used to locate, illuminate, and transilluminate nasal and sinus structures for visualization, not to treat a condition.
No
The device is used to locate, illuminate within, and transilluminate across nasal and sinus structures, which are functions for assisting a medical procedure (guidance/visualization) rather than diagnosing a condition.
No
The device description explicitly states it is a sterile, single-use device consisting of a flexible light fiber, protective sheath, integrated battery-powered LED light source, and mentions bench testing for physical characteristics and performance, indicating it is a hardware device.
Based on the provided information, the VenSure™ LightGuide is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "locate, illuminate within, and transilluminate across, nasal and sinus structures." This describes a device used for visualization and guidance during a medical procedure, not for testing samples from the human body to diagnose a condition.
- Device Description: The description details a light-emitting device used as an accessory for another device (VenSure™ Balloon). It focuses on its physical characteristics and function in providing light for visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VenSure™ LightGuide is used in vivo (within the body) for visualization.
N/A
Intended Use / Indications for Use
The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
Product codes
LRC
Device Description
VenSure™ LightGuide is a sterile, single-use device designed to emit light from the distal end. The device is an accessory to the VenSure™ Balloon device and used to locate, illuminate within and transilluminate across nasal and sinus structures. The device consists of a flexible light fiber, a protective sheath and an integrated battery-powered LED light source. When activated, the light fiber will emit red light from the distal tip for two (2) hours. It has a fiber nominal working length of 20mm (0.79 inch) with an outer diameter of 0.5mm (0.02 inch). The VenSure™ LightGuide is packaged separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and sinus structures
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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)
Bench testing was conducted to ensure that the VenSure™ LightGuide met the predefined acceptance criteria to demonstrate safety and performance. Testing included the following:
- Dimensional and Slider Characterization
- Light Output and Run Time Test .
- Slider Separation Force
- Advancement and Retraction Force ●
- Light Fiber Tensile ●
- Comparative Light Output Testing against the predicate device ●
All tests met the predefined acceptance criteria. The test results demonstrated that differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.
The biocompatibility evaluation for the VenSure™ LightGuide was conducted in accordance with ISO 10993-1. Biocompatibility testing included cytotoxicity, irritation, sensitization and acute systemic toxicity testing. All tests successfully met the required acceptance criteria, demonstrating that the patient contacting materials used in the subject device are biocompatible.
Sterilization validation testing was performed to demonstrate compliance with ISO 11135-1. Shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
Electromagnetic Compatibility (EMC) and Electrical Safety testing was conducted per IEC 60601-1 and IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PathAssist LED Light Fiber (K141916)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
February 4, 2022
Intersect ENT Yoko Enrile Advisor, Regulatory Affairs 1555 Adams Dr. Menlo Park, California 94025
Re: K212774
Trade/Device Name: VenSure LightGuide Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: January 7, 2022 Received: January 10, 2022
Dear Yoko Enrile:
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. 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/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212774
Device Name VenSure™ LightGuide
Indications for Use (Describe)
The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Intersect ENT. The logo consists of a colorful, abstract symbol resembling an infinity sign or a stylized flower, followed by the word "intersect" in bold, black letters. Below "intersect" is the abbreviation "ENT" in smaller, black letters.
510(k) Summary
510(k) Number: K212774
Date prepared: February 2, 2022
1.Submitter Information
| Submitter: | Intersect ENT |
|---|---|
| Address: | 1555 Adams Dr. |
| Menlo Park, CA 94025, USA | |
| Telephone: | (650) 681 3143 |
| Fax: | (650) 641 2065 |
| Contact: | Yoko Enrile |
| Advisor, Regulatory Affairs |
2.Device Information
| Trade Name: | VenSure™ LightGuide |
|---|---|
| Common Name: | Sinus Guidewire |
| Classification: | Class I per 21 CFR 874.4420 |
| Classification Name: | Ear, nose and throat manual surgical instrument |
| Product Code: | LRC |
3.Predicate Device Information
The VenSure™ LightGuide is substantially equivalent to PathAssist LED Light Fiber (K141916).
4.Device Description
VenSure™ LightGuide is a sterile, single-use device designed to emit light from the distal end. The device is an accessory to the VenSure™ Balloon device and used to locate, illuminate within and transilluminate across nasal and sinus structures. The device consists of a flexible light fiber, a protective sheath and an integrated battery-powered LED light source. When activated, the light fiber will emit red light from the distal tip for two (2) hours. It has a fiber nominal working length of 20mm (0.79 inch) with an outer diameter of 0.5mm (0.02 inch). The VenSure™ LightGuide is packaged separately.
4
Image /page/4/Picture/0 description: The image shows the logo for Intersect ENT. The logo consists of a colorful, abstract shape resembling four interconnected loops or petals, with a black dot in the center. To the right of the shape, the word "intersect" is written in a bold, sans-serif font, and below that, the letters "ENT" are written in a smaller font.
5. Intended Use
The VenSure™ LightGuide and the predicate device have the same Intended Use, which is to locate, illuminate within, and transilluminate across, nasal and sinus structures.
Indications for Use for VenSure™ LightGuide and Predicate Device
| Device | Indications for Use |
|---|---|
| VenSureTM LightGuide – Subject device | The VenSureTM LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults. |
| PathAssist LED Light Fiber (K141916) – | |
| Predicate device | To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over. |
6. Comparison of Technological Characteristics
The VenSure™ LightGuide is substantially equivalent to PathAssist LED Light Fiber (K141916). The VenSure™ LightGuide has the same intended use and fundamental scientific technology as the predicate device (K141916). The subject device has the same technological characteristics; in particular, basic design, energy source, performance, and principle of operation.
| Description | VenSure™ LightGuide - Subject Device | PathAssist LED Light Fiber (K141916) - Predicate Device |
|---|---|---|
| Device Classification | Class I, LRC, 21 CFR 874.4420 | Class I, LRC, 21 CFR 874.4420 |
| Indications for use | See above | See above |
| Light fiber dimensions | OD: 0.5mm | |
| Length: 304mm | OD: 0.375mm | |
| Length: 276mm | ||
| Device Design | Device consists of a flexible light fiber, a protective sheath/housing and an integrated battery-powered LED light source | Device consists of a flexible light fiber, a protective sheath and an integrated battery-powered LED light source |
| Biocompatibility | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Battery Type | Lithium Manganese Dioxide, CR2, 3 Volts | Lithium Manganese Dioxide, CR2, 3 Volts |
| Light Source Type | LED (Red) | LED (Red) |
| Maximum LED Power Output | 1 W | 1 W |
| Light Source Wavelength / Color | 625nm / Red | 625nm / Red |
| Medical Safety Standards | Complied with IEC 60601-1 | Complied with IEC 60601-1 |
5
Image /page/5/Picture/0 description: The image shows the logo for Intersect ENT. The logo consists of a colorful abstract symbol on the left, followed by the word "intersect" in black font. Below the word "intersect" is the word "ENT" in a smaller black font. The abstract symbol is made up of four overlapping circles in different colors: pink, yellow, blue, and purple.
| Description | VenSure™ LightGuide - Subject Device | PathAssist LED Light Fiber (K141916) - Predicate Device |
|---|---|---|
| Medical EMC Standard | Complied with IEC 60601-1-2; Type BF applied part | Complied with IEC 60601-1-2; Type BF applied part |
| Illumination and activation time | Emits red LED light from the distal end of light fiber for 2 hours | Emits red LED light from the distal end of light fiber for over 60 minutes |
| Use | Single use, disposable | Single use, disposable |
| Operation Method | Load the light fiber into Sinus Dilation Device (VenSure Balloon Sinus Dilation System) and attach the light fiber housing to the luer lock fitting on the VenSure Balloon device. Pull the tab to activate the LED light. | Load the light fiber into Sinus Dilation Device (XprESS Multi-Sinus Dilation System) and attach the LED light fiber housing to the barbed fitting of XprESS device. Pull the tab to activate the LED light. |
The performance testing including mechanical integrity, functionality, EMC and Electrical Safety testing / evaluation support that the difference in the fiber dimensions and activation time between the subject device and the predicate device do not raise any new concerns of safety or effectiveness.
7. Performance Data
Bench Testing
Bench testing was conducted to ensure that the VenSure™ LightGuide met the predefined acceptance criteria to demonstrate safety and performance. Testing included the following:
- Dimensional and Slider Characterization
- Light Output and Run Time Test .
- Slider Separation Force
- Advancement and Retraction Force ●
- Light Fiber Tensile ●
- Comparative Light Output Testing against the predicate device ●
All tests met the predefined acceptance criteria. The test results demonstrated that differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.
6
Image /page/6/Picture/0 description: The image shows the logo for Intersect ENT. The logo features a colorful, abstract symbol to the left of the word "intersect" in black, with a small circle above the "t". Below "intersect" is the word "ENT" in a smaller font size, also in black. The symbol is made up of four overlapping circles in different colors: pink, yellow, green, and blue.
Biocompatibility
The biocompatibility evaluation for the VenSure™ LightGuide was conducted in accordance with ISO 10993-1. Biocompatibility testing included cytotoxicity, irritation, sensitization and acute systemic toxicity testing. All tests successfully met the required acceptance criteria, demonstrating that the patient contacting materials used in the subject device are biocompatible.
Sterilization & Stability
Sterilization validation testing was performed to demonstrate compliance with ISO 11135-1. Shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
Electromagnetic compatibility and Electrical Safety
Electromagnetic Compatibility (EMC) and Electrical Safety testing was conducted per IEC 60601-1 and IEC 60601-1-2.
8. Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, it is concluded that the VenSure™ LightGuide performs as its intended use, is substantially equivalent to the predicate device identified in this submission and does not present any new issues of safety or effectiveness.