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.

Device Description

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.

AI/ML Overview

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.

Summary

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K971130 JUN 27 1997

XII. 510(k) SUMMARY FOR K-971130, DBFEND4 SURGICAL MASK

A. Submitter: Andrew Parker, Carl Parker Assoc. Inc., 275 Oser Ave., Hauppauge, NY 11788

I. Classification Names and numbers: Surgical Mask, 79FXX

II. Common/Usual Name: Surgical Mask
III. Proprietary Names: DEFEND™ Surgical Mask
IV. Establishment Registration Number: 2433028
V. Classification: Surgical masks were classified by the General and Plastic Surgery Panel in Class II under code 79FXX and are listed in CFR 878,4040 as "Surgical Apparel." Most examples are Class I except for surgical gowns and masks which are Class II.
VI. Performance Standard: None established under section 514.
VII. Description of the Device: 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.
VIII. Labels of the product and competitive devices are provided.

IX. Substantial Equivalence Statement. The "510(k) "Substantial Equivalence" Decision process

(Detailed) from ODE Guidance Memorandum #86-3 was followed as described below: 1. These products have the same intended use, to act as physical barner including fluidresistant properties, provide only very low impediment to breathing, avoid fogging of surgeons glasses, effective filtration of particles, droplets, not hinder speech. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.

The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.
Descriptive information provided shows that the materials from which the Fluid Resistant Pleated Mask is made are substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market.
Test data supplied to show the equivalence of this device to Technol and others cited below included:

a. Penetration by Water Impact Test;
b. Sensitization test:

c. Primary Dermal Irritation test;

d. Particulate Shedding analysis,

e. Flammability: and
f. Cytotoxicity.

g. Filtration Efficiency, Breathability

Repl. p. 8

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VI. Performance Standard:

None established under section 514.

VII. Description of the Device:

The products will be sold non-sterile, prepackaged, and are disposable, for single use only.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carl Parker Associates, Incorporated ·C/O Mr. Neal Dunning Neal Dunning Associates, Incorporated 8309 Byrant Drive Bethesda, Maryland 20817

K971130 Re : Defend Surqical Mask Trade Name: Requlatory Class: II Product Code: FXX May 20, 1997 Dated: Received: June 10, 1997

JUN 2 7 1997

Dear Mr. Dunning:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Dunning

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
L. Alturist

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VIII.1 Indications for Use: [Separate Page]

510(k) Number: Not Applicable

Device Name: DEFEND™ Surgical Mask

1. 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.

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K971130

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use X (Optional Format 1-2-96)
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Regulation Number and Section

§ 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.