(642 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical compression and physical adjustments, with no mention of AI or ML algorithms for operation, analysis, or decision-making.
Yes.
The device is indicated to "reduce outflow through the nasolacrimal ducts," which is a physiological effect intended to treat a condition or symptom.
No
The device is indicated to temporarily occlude the nasolacrimal ducts to reduce outflow, which is a therapeutic function, not a diagnostic one. While a dye disappearance test is mentioned in relation to fitting the device, the device itself is not performing the diagnostic test.
No
The device description clearly outlines physical components made of materials like PVC, carbon steel wire, silicone rubber, and nylon fabric, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The Nasolacrimal Compression Device is a physical device that is applied to the body (specifically, the nose bridge) to physically occlude the nasolacrimal ducts. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is to "temporarily occlude the nasolacrimal ducts," which is a physical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a physical device used for a therapeutic or management purpose (reducing outflow), not for diagnosing a condition by analyzing a sample.
N/A
Intended Use / Indications for Use
Nasolacrimal Compression Device (NCD) is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.
Product codes (comma separated list FDA assigned to the subject device)
PLX
Device Description
The Nasolacrimal Compression Device is a modified spectacle frame made of polyvinyl chloride (PVC) coated soft carbon steel wire covered with silicone rubber where the device contacts the nose bridge (See Figure 1 below). The fastening bands are made from flame-retardant nylon hook and loop fabric. The following differences exist between the subject device and a "normal" spectacle frame:
- The frame width, nose bridge width, and nose pad shape of the subject device may be adiusted.
- . The nose pad is contoured such that it lies over the nasal aspect of the orbital rims where the nasolacrimal systems are underneath.
- . There are fastening bands attached to each temple that allow the user to adjust pressure applied to the nasolacrimal system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasolacrimal ducts, orbital rim
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Prescription-use device intended for home use. Clinician for fitting.
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 included a leak test, spring test, pressure testing, and device endurance testing.
Spring Test:
- Expected Outcome: No deformation of the spring under normal use, when the imposed force is smaller than the yield force of the spring.
- Conclusions: Fyield (W1): b(4) CCL; Fnormal (W2): b(4) CCI.
Pressure Tests:
- Expected Outcome: 1. Pressure applied on the nasolacrimal ducts under the normal use is ≤ the pressure exerted by a standard eyeware 2. No discomfort
- Conclusions: Pnormal: b(4) CCI below safety limit from the literature. Maximum pressure point is at center of the nose pad (where it directly overlays the nasolacrimal ducts) is below b(4). Yield pressure does not exceed 3.9 psi.
Metal Fatigue Test of NCD:
- Expected Outcome: NCD frame can sustain repeated twisting spring motions during normal use.
- Conclusions: The nose pad section can sustain repeated twisting spring motions 1,000 times during normal use. None of the tested devices broke at the end of the test. For multiple eyedrop users, this amount of usage would cover half of a year of device use.
Hook and Loop Bands Test:
- Expected Outcome: Determine the number of attaching/detaching operations for hook and loop bands without compromising their gripping capability.
- Conclusions: The hook and loop bands can maintain their gripping capability for 600 times of repeated use.
Demonstration of Clinical Effectiveness (Dye Disappearance Test):
- Study Type: Clinical evaluation on a single subject.
- Sample Size: One subject, two eyes.
- Key Results: Performance of the simplified dye disappearance test by an eye care professional is the most effective means to ensure proper fit. The test revealed that NCD was able to occlude nasolacrimal drainage. Persistence of dye was achieved bilaterally for 5 minutes. No adverse events were reported.
Fitness Adjustment Validation:
- Study Type: Validation of user instructions for device fitting.
- Sample Size: Seven subjects of different ethnicity and age (2 Asian females, 2 white females, one white male).
- Key Results: Subjects could follow verbal and written instructions for fitting the device to the proper position on the face. A simplified dye disappearance was performed on one subject to demonstrate that nasolacrimal drainage was obstructed. No adverse events were reported in this study.
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.
Not Found
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
§ 886.5838 Nasolacrimal compression device.
(a)
Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.(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 the limitations in § 886.9.
0
DE NOVO CLASSIFICATION REQUEST FOR NASOLACRIMAL COMPRESSION DEVICE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Nasolacrimal Compression Device. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
NEW REGULATION NUMBER: 886.5838
CLASSIFICATION: Class I (Exempt from premarket notification review, subject to the limitations in 21 CFR 886.9)
PRODUCT CODE: PLX
BACKGROUND
DEVICE NAME: NASOLACRIMAL COMPRESSION DEVICE
SUBMISSION NUMBER: DEN140022
DATE OF DE NOVO: JULY 18, 2014
CONTACT: INNOVATEX, INC. STEPHEN C. CHEN, PRESIDENT 150 Buckskin Drive WESTON, MA 02403
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS I
INDICATIONS FOR USE
Nasolacrimal Compression Device (NCD) is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.
LIMITATIONS
The Nasolacrimal Compression Device is for prescription use only.
Select Warnings and Precautions
- . Serious injury may result if the device is used in cases of open globe, post-surgery, infection, and inflammation.
1
- . This device has not been evaluated for pediatric use.
- . Do not use this device if you are on anti-coagulants as use of this device may cause bruising.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
RATIONALE FOR EXEMPTION
The technology of a non-invasive, nasolacrimal compression device is limited to mechanicalbased pressure. Thus, the risks associated with use of the device are low. Therefore, a noninvasive compression device for the nasolacrimal ducts, when indicated for prescription use, is appropriate for exemption from premarket notification and is also subject to the limitations of exemptions identified in 21 CFR 886.9. Given the simplicity of the design, including the lack of any electrical components, general controls provide reasonable assurance of safety and effectiveness if device manufacturers comply with such requirements, which includes current good manufacturing practice requirements (21 CFR part 820), and general labeling (21 CFR part 801).
An example of exceeding the limitations of the class I exemption could include a significant change in the technological characteristics used to apply pressure to the nasolacrimal ducts (e.g., electronically controlled pressure).
Indications for increased adsorption or effectiveness of eye drop medications or efficacy for specific diseases or indications would exceed the scope of the regulation and would require submission of a new de novo application with data to support the new intended use.
DEVICE DESCRIPTION
The Nasolacrimal Compression Device is a modified spectacle frame made of polyvinyl chloride (PVC) coated soft carbon steel wire covered with silicone rubber where the device contacts the nose bridge (See Figure 1 below). The fastening bands are made from flame-retardant nylon hook and loop fabric. The following differences exist between the subject device and a "normal" spectacle frame:
- The frame width, nose bridge width, and nose pad shape of the subject device may be adiusted.
- . The nose pad is contoured such that it lies over the nasal aspect of the orbital rims where the nasolacrimal systems are underneath.
- . There are fastening bands attached to each temple that allow the user to adjust pressure applied to the nasolacrimal system.
2
Image /page/2/Picture/0 description: The image shows a pair of glasses with a unique design. The glasses have a loop fabric tape and a hook fabric tape that connect to a fabric fastening ring. The glasses also have soft silicone nose pads and temple sleeves for comfort. The frame is made of PVC coated steel wire.
Figure 1. Components of the Nasolacrimal Compression Device (used by permission).
Principle of Operation and Design Goals
Occlusion of the nasolacrimal system may reduce drainage through the ducts, allowing fluid to remain on the surface of the eye for a longer period of time. One such application of the device could be with the administration of eye drops, as the current standard-of-care is to manually occlude the nasolacrimal ducts by pressing on the nasal aspect of the orbital rim with a finger for 5 minutes after adding eye drops. The Nasolacrimal Compression Device is designed to substitute for this manual occlusion of the nasolacrimal ducts.
SUMMARY OF NONCLINICAL/BENCH STUDIES
Bench testing included a leak test, spring test, pressure testing, and device endurance testing, which are summarized in Table 1 below:
| Test
| Performed | Expected Outcome | Test Details | Conclusions |
|---|---|---|---|
| Spring Test | No deformation of the | ||
| spring under normal | |||
| use, when the imposed | |||
| force is smaller than | |||
| the yield force of the | |||
| spring. | 1. The temple is fixed and | ||
| the force is applied at | |||
| the center of the nose | |||
| pads. As the weight | |||
| reached W1, the device | |||
| frame will begin to | |||
| deform and will not | Fyield (W1): b(4) | ||
| CCL | |||
| Test | |||
| Performed | Expected Outcome | Test Details | Conclusions |
| return to its original | |||
| shape when the weight | |||
| is removed. |
- The W2 (force at center
of nose pads) is defined
as the person feels that
both nose pads begin to
separate from the skin. | Fnormal (W2):
b(4) CCI |
| Pressure
Tests | 1. Pressure applied
on the
nasolacrimal ducts
under the normal
use is ≤ the
pressure exerted
by a standard
eyeware - No discomfort | See details of calculation
below. | Pnormal: b(4) CCI
below safety limit
from the literature |
| Metal Fatigue
Test of NCD | NCD frame can
sustain repeated
twisting spring
motions during normal
use. | Alternate 1000 times
between yield weight, W1,
with the normal use weight,
W2. | The nose pad section
can sustain repeated
twisting spring
motions 1,000 times
during normal
use. None of the
tested devices broke
at the end of the test.
For multiple
eyedrop users, who
administer eyedrops
3 times a day, this
amount of usage
would cover half of
a year of device use. |
| Hook and
Loop Bands
Test | Determine the number
of attaching/detaching
operations for
hook and loop bands
without compromising
their gripping
capability. | The hook and loop bands
are manually attached with
1 inch overlap and then
detached from each other. | The hook and loop
bands can maintain
their gripping
capability for 600
times of repeated
use. |
Table 1. Summary of Bench Testing for the NCD.
3
Pressure Tests
Objective and Pass/fail Criteria
4
The maximum pressure the NCD can apply to the nasolacrimal ducts was determined. The pressure applied on the nasolacrimal ducts under normal use conditions should be below 6 psi (the skin tolerable pressure under bony prominences as supported by literature articles provided by the applicant).
Test Method
The maximum pressure applied on the nasolacrimal ducts was evaluated analytically using a 3D model of the NCD. For their analysis, the applicant used yield and separation force values obtained in the spring test. In their analysis of pressure distribution along the nose pad they determined that the nose pad skin contact length is between b(4) CCI and the outer diameter of the silicone rubber tube(4) The results showed that the maximum pressure point is at center of the nose pad (where it directly overlays the nasolacrimal ducts) is belowb(4) . The analysis also showed that the yield pressure (i.e., the maximal pressure for deformation of the device) does not exceed 3.9 psi.
Pressure Test Conclusion
With regard to the comfort level of wearing NCD under the normal use condition, the normal pressure applied on the nasolacrimal systems by wearing NCD is about 1.6 psi. The risk of excessive pressure is mitigated by design limitations of a yield pressure of 3.9 psi. This amount of yield pressure should not cause adverse effects.
BIOCOMPATIBILITY/MATERIALS
The primary patient contacting material is silicone rubber tubing. The PVC coated carbon steel wire used to construct the device frame and the nylon hook and loop fabric fastener straps mav also contact intact skin. The materials used to construct the NCD were not manufactured or modified by the device manufacturer. Since the materials are widely used for medical devices and the duration of contact is for less than 24 hours, biocompatibility testing was not needed for this device.
SHELF LIFE/STERILITY
The NCD is not intended for use in any sterile application. It is not to be used by any individual who is maintaining, entering, or contacting any sterile field. In addition, this device is intended to be used by a single patient. The labeling recommends weekly cleaning with an alcohol wipe or moistened facial tissue.
SUMMARY OF CLINICAL INFORMATION
Demonstration of Clinical Effectiveness
Clinical evaluations were performed on a single subject to demonstrate the effectiveness of the device to occlude the nasolacrimal ducts. This is acceptable to demonstrate reasonable assurance of safety and effectiveness for the limited use of for the tool claim for the NCD. However, any claims of clinical effectiveness for a nasolacrimal compression device would require extensive clinical data.
Dye Disappearance Test
5
Performance of the simplified dye disappearance test by an eve care professional is the most effective means to ensure proper fit. The simplified dye disappearance test used a moistened fluorescein strip to instill fluorescein into the conjunctival fornices of each eve and the tear film was observed using the cobalt blue filter of a slit lamp. This test was performed on one subject and it revealed that NCD was able to occlude nasolacrimal drainage.
Clinical Study
Two eves were tested on one subject with this simplified dye disappearance test by a boardcertified ophthalmologist to verify temporary nasolacrimal duct occlusion. The outcome was that persistence of dye was achieved bilaterally for 5 minutes. No adverse events were reported.
Fitness Adjustment Validation
Seven subjects of different ethnicity and age were recruited to determine how well patients could follow verbal and written instructions for fitting the device to the proper position on the face. The subjects performed the fitness adjustments with assistance. A simplified dye disappearance was performed on one subject to demonstrate that nasolacrimal drainage was obstructed. The trial group for fitness testing consisted of 2 Asian females, 2 white females, and one white male.
The conclusions from the fitness adjustment validation were that patients could fit the device to their face following instructions as would be provided by a clinician. No adverse events were reported in this study.
LABELING
The Nasolacrimal Compression Device is a prescription-use device intended for home use. The labeling for the Nasolacrimal Compression Device consists of the User Guide. In addition to the precautions, warnings, and contraindications mentioned above, the guide provides fitting instructions for the user and the clinician with a description of the dye disappearance test to be used by a clinician when fitting the device to the patient. Other information provided to the user includes pressure adjustments, maintenance, storage, and use life for the device.
RISKS TO HEALTH
The risks to health that may be associated with use of the Nasolacrimal Compression Device are:
- improper fit of the device; extended or aggressive use of this device may cause sequelae . such as bruising and/or soreness, and
- . improper use of the device; for the uncoordinated, a corneal abrasion may occur inadvertently.
General controls are sufficient to mitigate these risks.
BENEFIT/RISK DETERMINATION
The risks of the device are based on data collected in a clinical study and a fitness adjustment validation study described above. No adverse events were reported in the fitness adjustment validation study (7 participants) or in the clinical use study involving a single subject who used
6
the device for 3 years. Possible complications from use of the Nasolacrimal Compression Device include:
- Particularly in the elderly on anticoagulants, prolonged and/or "too tight" use of this device (i.e., 5 hours instead of 5 minutes) may cause sequelae such as bruising.
The probable benefits of the device are also based on data collected in a clinical study as described above. Limited effectiveness has been demonstrated because it appears that only a single subject was tested with a simplified dye disappearance. While we do believe there is probable benefit with this device. it is unclear whether the test device may be used in a widescale by other patients and physicians with similar results due to the limited data and experience with this device.
In conclusion, given the available information, the sponsor has demonstrated that the device has utility to occlude the nasolacrimal duct in adults. Based on known information about the device, the probable benefits outweigh the probable risks for the Nasolacrimal Compression Device. Furthermore, the risks can be adequately mitigated by the use of general controls alone, which includes labeling requirements (i.e., 21 CFR 801) in accordance with a Class I device.
CONCLUSION
The de novo for the Nasolacrimal Compression Device is granted and the device is classified under the following:
Product Code: PLX Device Type: Nasolacrimal Compression Device Class: I (Exempt from premarket notification, subject to the limitations in 21 CFR 886.9) Regulation: 886.5838