(100 days)
The DHD MedShield is a single-patient-use device. The Intended Use of the device is to reduce the taste effect of Metered Dose Inhaler (MDI) drugs by covering the tongue in the taste sensor area.
The MedShield product reduces drug deposition in the tongue when used in conjunction with metered dose inhaler (MDI) medications. The device attaches to an MDI elbow and shields the tongue of the user from the medication spray. Drug that deposits on the device would otherwise be on the users tongue. Based on this, the taste effect of the medications is reduced. This simple device includes two different features. 1. The patient end of the device covers the tongue. The patient end may vary to maximize the comfort of a wide range of users. 2. The elbow end of the device includes a universal clip, which attaches the device to all MDI elbows. To satisfy the preferences of various customers, the force required to separate (or attach) the device to various elbows can be modified by adjusting the clip or modifying the taper around the clip. The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard. The MedShield is designed for single patient use. Patients may be given the product for use either in a hospital or home environment for extended time periods. Recommendations for cleaning, in cases of extended time, are included in the instructions for use.
This K961455 submission describes the MedShield, a tongue cover or guard designed to reduce drug deposition on the tongue when used with Metered-Dose Inhalers (MDIs). The device functions by shielding the tongue from the medication spray, thereby reducing the taste effect of the medications. The data provided focuses on the physical and chemical integrity of the device material (Celcon M90 Acetal resin) rather than clinical performance metrics related to drug deposition or taste reduction.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Methodology |
|---|---|---|
| Device Safety | Small Objects (Choke Hazard): Conform to ASTM F963-92, Section 4.6.2 (Mouth-Actuated Toys), and CFR 16-1511.1, 1511.5(d) (Structural integrity for small parts). Ensure the device does not present a choke hazard. | The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard." (Statement of Conformance without specific test results provided in this document). |
| Material Resistance (Chemical) | Maintain "Excellent" or "Good" resistance to chemicals found in MDI canisters (Freon, Alcohol, Oleic Acid) and common cleaning agents (Sodium Sulfate, Sodium Carbonate, Trisodium Phosphate, Ethyl Alcohol, Methyl Alcohol, Propyl Alcohol, Oleic Acid). Resistance to other relevant chemicals at 72°F and 140°F. | Manufacturer's Data (Hoeschet Celanese Corp. - Attachment 1) and In-house Testing: |
- Alcohols (Ethyl, Methyl, Propyl), Freon, Sodium Sulfate, Trisodium Phosphate: Excellent resistance.
- Oleic Acid, Sodium Carbonate: Good resistance.
- Extensive table of "Chemical Resistance of 'Celcon' Acetal Copolymer Resin" at 72°F and 140°F (see full table in original document). |
| Durability (Cleaning) | No physical or cosmetic degradation after typical cleaning agents/conditions (e.g., alcohol, dishwashing liquid, vinegar, standard dishwasher cycles). | Cleaning Test: MedShield units were soaked for 5 days in alcohol, dishwashing liquid, and vinegar with no physical or cosmetic degradation noted. Units were subjected to 5 cycles of a standard dishwasher with no physical or cosmetic degradation noted. (Considered typical cleaning agents/conditions). |
| Durability (Impact) | Withstand repeated drops from a reasonable height without breakage. | Drop Test: MedShield units were dropped 10 times from a height of 1 meter onto a tile-covered cement floor without breakage. |
| Performance (Drug Deposition Reduction) | Reduce drug deposition on the tongue compared to no device or other devices. (Implied primary function, though not a quantifiable acceptance criterion with a specific threshold in the provided text). | Comparative Performance Testing: "In each instance tested, the medication deposited on the MedShield was less than that with other devices are cylindrical providing significantly more surface area to collect medication. The lower values for MedShield indicate that only medication that would be deposited on the tongue is affected." (Qualitative statement, no quantitative data or specific comparison devices mentioned). |
| Equivalence to Predicate Devices | Substantially equivalent to Micro Spacer and AeroChamber in terms of safety and effectiveness. | DHD believes the MedShield performs substantially equivalent to the predicate device(s) and does not adversely affect safety and effectiveness compared to the predicate device. (Conclusion based on the above tests and feature descriptions). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the number of samples (MedShield units) used for each specific test (e.g., Cleaning Test, Drop Test, Comparative Performance Testing). It refers to "MedShield units" in plural for these tests. For the chemical resistance of the raw material (Celcon M90), the data provenance is "Hoeschet Celanese Corp." (the manufacturer of the resin). For the other tests (cleaning, drop, comparative performance), the data appears to be internally generated by DHD. The data is retrospective, as it's being presented as part of a 510(k) submission after the tests were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission focuses on the material and physical properties of the device, not on clinical interpretation or diagnosis that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests performed (chemical resistance, cleaning, drop, comparative performance) are objective physical/chemical tests, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The comparative performance testing was qualitative and focused on drug deposition on the device itself, not on human reader performance or clinical outcomes.
6. 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 AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the material properties (chemical resistance) is based on manufacturer's specifications and test results for the raw material (Celcon M90 Acetal resin). For the in-house tests (cleaning, drop), the ground truth is the direct observation of physical and cosmetic degradation of the device under specific test conditions. For the "Comparative Performance Testing," the ground truth for "medication deposited" would likely be quantitative measurement of drug residue from the test setup, though specific methods are not detailed.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device; there is no AI algorithm or "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as above).
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.(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 § 868.9.