Nasolacrimal Compression Device (NCD) is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.

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. The fastening bands are made from flame-retardant nylon hook and loop fabric. The frame width, nose bridge width, and nose pad shape of the subject device may be adjusted. 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.

AI/ML Overview

The provided text does not describe acceptance criteria for a study demonstrating device performance. Instead, it outlines bench testing and limited clinical observations to support the classification of a Nasolacrimal Compression Device as Class I (exempt from premarket notification).

The document is primarily a regulatory submission (DE NOVO CLASSIFICATION REQUEST), not a detailed study report with formal acceptance criteria and a comprehensive study to prove those criteria were met.

However, based on the information provided, I can extract the closest equivalents to acceptance criteria and performance as presented in the document:

Acceptance Criteria and Reported Device Performance (Bench Testing & Limited Clinical Observations)

Acceptance Criteria (Implied from "Expected Outcome" or "Objective and Pass/fail Criteria")	Reported Device Performance
Spring Test: No deformation of the spring under normal use, when the imposed force is smaller than the yield force of the spring.	Fyield ($W_1$): b(4) CCL (Specific numerical value redacted)Fnormal ($W_2$): b(4) CCI (Specific numerical value redacted)
Pressure Tests:
1. Pressure applied on the nasolacrimal ducts under normal use is $\le$ the pressure exerted by a standard eyewear.	Pnormal: b(4) CCI (Specific numerical value redacted) below safety limit from literature
2. No discomfort.	Not explicitly quantified, but implied by "Pnormal... below safety limit" and "should not cause adverse effects."
3. Maximum pressure applied to nasolacrimal ducts $\le$ 6 psi (skin tolerable pressure).	Maximum pressure point (at center of nose pad) is below b(4) (Specific numerical value redacted, but stated to be < 6 psi). Yield pressure does not exceed 3.9 psi.
Metal Fatigue Test: NCD frame can sustain repeated twisting spring motions during normal use.	The nose pad section can sustain repeated twisting spring motions 1,000 times during normal use. None of the tested devices broke.
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 can maintain their gripping capability for 600 times of repeated use.
Dye Disappearance Test (Clinical Observation): Device is able to occlude nasolacrimal drainage.	Persistence of dye was achieved bilaterally for 5 minutes in one subject.
Fitness Adjustment Validation (Clinical Observation): Patients can fit the device to their face following instructions.	Patients could fit the device to their face following instructions with assistance.

Study Details Based on Provided Information:

The provided text describes several non-clinical/bench studies and limited clinical information/observations, rather than a single, comprehensive "study proving the device meets acceptance criteria."

1. Sample size used for the test set and the data provenance:

Bench Testing:
- No specific sample size (N) for devices tested is stated for the Spring, Pressure, Metal Fatigue, or Hook and Loop Bands tests, other than "None of the tested devices broke" for Metal Fatigue.
- Data Provenance: Implied to be prospective controlled testing performed by the applicant (Innovatex, Inc.) in a lab setting. Country of origin not specified, but the applicant is based in Weston, MA, USA.
Clinical Information/Observations:
- Dye Disappearance Test: One subject.
- Fitness Adjustment Validation: Seven subjects. The trial group consisted of 2 Asian females, 2 white females, and one white male (total 5 specific individuals mentioned, implying the remaining 2 are not detailed or were part of a different subgroup).
- Data Provenance: Prospective clinical observations/validation. Country of origin not specified, but assumed to be local to the testing facility or applicant.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Bench Testing: For the Pressure Test, the definition of "skin tolerable pressure" (6 psi) was established from "literature articles provided by the applicant." No specific expert count or qualifications mentioned for these literature articles. The analysis itself was performed by the applicant.
Clinical Information/Observations:
- Dye Disappearance Test & Clinical Study: "a board-certified ophthalmologist" performed the test and verified occlusion. This implies at least one expert (the ophthalmologist). Qualifications: Board-certified ophthalmologist.
- Fitness Adjustment Validation: "patients could fit the device to their face following instructions as would be provided by a clinician." This suggests a clinician was involved in assessing the fit, but their specific number or qualifications are not explicitly stated, other than for the Dye Disappearance Test within this validation, which was noted to be performed by "a simplified dye disappearance... performed on one subject to demonstrate that nasolacrimal drainage was obstructed." It is reasonable to infer the board-certified ophthalmologist also performed this.

3. Adjudication method for the test set:

Bench Testing: Not applicable. These were direct physical measurements and analytical assessments.
Clinical Information/Observations: Not applicable. Given the very small sample sizes (1 and 7 subjects) and the nature of the observations (dye persistence, ability to fit), formal adjudication methods like 2+1 or 3+1 (common in image-based diagnostic studies) were not described or likely employed. The ophthalmologist's assessment served as the primary clinical judgment.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. This device is a mechanical compression device, not an AI-powered diagnostic or assistive tool. The concept of "human readers improve with AI" is not relevant to this device or its evaluation as described.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

Bench Testing: Engineering measurements and calculations (e.g., force, pressure, cycles to failure). Some criteria were derived from "literature articles."
Clinical Information/Observations:
- Dye Disappearance Test: Direct observation of fluorescein dye persistence in the eye by a board-certified ophthalmologist. This is a clinical observation/assessment recognized as a standard method for assessing nasolacrimal drainage.
- Fitness Adjustment Validation: Direct observation of subjects' ability to follow instructions and achieve proper fit, confirmed by a simplified dye disappearance test on one subject.

7. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The device's design was based on engineering principles and existing medical understanding.

8. How the ground truth for the training set was established:

Not applicable. As above, there is no training set. The "ground truth" for the device's design and operation principles would be established through ophthalmological and anatomical knowledge, and general engineering practices.

Summary

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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.

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. 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 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.

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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:

TestPerformed	Expected Outcome	Test Details	Conclusions
Spring Test	No deformation of thespring under normaluse, when the imposedforce is smaller thanthe yield force of thespring.	1. The temple is fixed andthe force is applied atthe center of the nosepads. As the weightreached W1, the deviceframe will begin todeform and will not	Fyield (W1): b(4)CCL
TestPerformed	Expected Outcome	Test Details	Conclusions
		return to its originalshape when the weightis removed.2. The W2 (force at centerof nose pads) is definedas the person feels thatboth nose pads begin toseparate from the skin.	Fnormal (W2):b(4) CCI
PressureTests	1. Pressure appliedon thenasolacrimal ductsunder the normaluse is ≤ thepressure exertedby a standardeyeware2. No discomfort	See details of calculationbelow.	Pnormal: b(4) CCIbelow safety limitfrom the literature
Metal FatigueTest of NCD	NCD frame cansustain repeatedtwisting springmotions during normaluse.	Alternate 1000 timesbetween yield weight, W1,with the normal use weight,W2.	The nose pad sectioncan sustain repeatedtwisting springmotions 1,000 timesduring normaluse. None of thetested devices brokeat the end of the test.For multipleeyedrop users, whoadminister eyedrops3 times a day, thisamount of usagewould cover half ofa year of device use.
Hook andLoop BandsTest	Determine the numberof attaching/detachingoperations forhook and loop bandswithout compromisingtheir grippingcapability.	The hook and loop bandsare manually attached with1 inch overlap and thendetached from each other.	The hook and loopbands can maintaintheir grippingcapability for 600times of repeateduse.

Table 1. Summary of Bench Testing for the NCD.

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Pressure Tests

Objective and Pass/fail Criteria

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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

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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

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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

Regulation Number and Section

§ 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.