(92 days)
Intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material.
These disposable surgical masks are formed of three layers and are flat-fold disposable face masks comprised of two segments which form a comfortable mask covering the nose and mouth areas of the face. The outer mask surface is of non-woven polypropylene. The middle layer, between the non-woven outer and inner lavers, is made of "meltblown" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate breathing and minimize spectacle fogging. The facial layer is of non-woven polypropylene. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing.
Drawings of the Defend Surgical Mask appear in Attachment I. These are intended to be exemplary rather than exhaustive. The mask is formed of three layers and is a flat-fold disposable face mask comprised of pleated segments which open to form a comfortable mask covering the nose and mouth areas of the face. The sides are secured by binding tapes to which is attached the elastic band to secure the mask to the face. The top and bottom of the mask are fused to prevent fabric delamination.
The outer mask surface is of Spunbond non-woven polypropylene (20 g/m'). The middle layer, between the non-woven outer and inner layers, is made of meltblown air filtration media. The characteristics of this media are listed in Attachment VI, This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate breathing and minimize spectacle fogging. The facial layer is of Thermobond non-woven polypropylene (15 g/m²). The characteristics of the two outer layers are also listed in Arachment VI. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing.
The mask has a light aluminum strip which bends readily to fit closely over the nose, diminishing fogging of spectacles. It also has a light foam strip fused to this edge to provide more effective coverage and user comfort. Two woven elastic ear loops complete the mask.
The products will be sold non-sterile, prepackaged, and are disposable, for single use only.
The provided text describes a 510(k) summary for the DEFEND™ Surgical Mask, focusing on its substantial equivalence to other legally marketed devices. It details the device's description and the tests performed to demonstrate this equivalence.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "Performance Standard: None established under section 514." Therefore, explicit acceptance criteria in terms of specific threshold values are not provided within the document. Instead, the study aims to show "substantial equivalence" to predicate devices. The "reported device performance" is essentially that the device performed comparably to predicate devices in the listed tests.
| Test Name | Acceptance Criteria (Not explicitly stated as numerical values; implied substantial equivalence) | Reported Device Performance (Implied substantial equivalence to predicate devices) |
|---|---|---|
| Penetration by Water Impact | Performance similar to predicate devices | Test data supplied showed equivalence |
| Sensitization | Performance similar to predicate devices | Test data supplied showed equivalence |
| Primary Dermal Irritation | Performance similar to predicate devices | Test data supplied showed equivalence |
| Particulate Shedding analysis | Performance similar to predicate devices | Test data supplied showed equivalence |
| Flammability | Performance similar to predicate devices | Test data supplied showed equivalence |
| Cytotoxicity | Performance similar to predicate devices | Test data supplied showed equivalence |
| Filtration Efficiency | Performance similar to predicate devices (highly efficient bacterial filter) | Test data supplied showed equivalence |
| Breathability | Performance similar to predicate devices (very low pressure drop) | Test data supplied showed equivalence |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the tests. It only states, "Test data supplied to show the equivalence of this device to Technol and others cited below included..."
The data provenance (country of origin, retrospective/prospective) is not mentioned. Given the nature of a 510(k) submission for a surgical mask, these tests are typically prospective laboratory tests conducted on samples of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant or typically included in a 510(k) submission for a surgical mask. The "ground truth" for material performance tests is established by standardized testing methodologies, not expert consensus in the diagnostic sense. The tests themselves provide objective measurements.
4. Adjudication Method for the Test Set
Not applicable. As mentioned above, the assessment is based on objective laboratory tests against established standards or predicate device performance, not on expert adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. These types of studies are relevant for medical imaging or diagnostic devices where human interpretation plays a significant role. This submission pertains to a surgical mask, where performance is evaluated through physical and material tests.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical product (surgical mask), not an algorithm or software. Therefore, the concept of "standalone performance" in that context does not apply. The tests described are inherently "standalone" in the sense that they measure the device's intrinsic properties.
7. The Type of Ground Truth Used
For the performance tests listed (e.g., penetration, filtration efficiency, breathability), the "ground truth" is based on objective measurements derived from standardized laboratory testing protocols. These protocols aim to quantify specific physical and material properties of the surgical mask in a controlled environment. The comparison is then made against "predicate devices" (other surgical masks already on the market) which are presumed to be safe and effective.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.