N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C

K070168 · Aearo Company · MSH · Apr 18, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070168
• Device Name: N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
• Applicant: Aearo Company
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Apr 18, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Aearo Surgical N95 Respirators, N9504C, N9504CS and N9514 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask. isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

Device Story

Molded cup-style N95 respirator; consists of center layer of polypropylene meltblown material sandwiched between nonwoven polyester layers; features aluminum nosepiece and dual elastic headbands. Used by operating room personnel and healthcare workers to provide respiratory protection and fluid resistance. Device acts as physical barrier against airborne particulates, microorganisms, and body fluids. Performance verified via NIOSH certification (42 CFR Part 84) for filtration efficiency and breathing resistance; fluid resistance tested per ASTM F-1862 at 80 mmHg; flammability tested per 21 CFR Part 58 (Class I). Biocompatibility evaluated per ISO-10993 for cytotoxicity, skin irritation, and sensitization. Single-use device.

Clinical Evidence

No clinical data. Bench testing only. Fluid resistance (ASTM F-1862 @ 80 mmHg): 32/32 passed. Bacterial Filtration Efficiency (ASTM F2101-01): >99.9%. Flammability: Class I. Biocompatibility (ISO-10993): No cytotoxicity, no skin irritation, no sensitization. NIOSH certification (42 CFR Part 84): Average filter efficiency 97.36%-97.83%; average breathing resistance 6.2-8.0 mm H2O @ 85 lpm.

Technological Characteristics

Molded cup design; materials: nonwoven polyester, meltblown polypropylene, aluminum nosepiece, elastic headbands. NIOSH-certified N95 (42 CFR Part 84). Fluid resistance tested per ASTM F-1862. Biocompatibility per ISO-10993. Flammability per 21 CFR Part 58 (Class I). No fiberglass media.

Indications for Use

Indicated for operating room personnel and health care workers for protection against microorganisms, blood, body fluids, and airborne particulates; includes use as procedure, isolation, or dental mask; meets CDC guidelines for TB exposure control.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Gerson Isolair APR, type N95, Model 2735 (K960778)

Submission Summary (Full Text)

{0}------------------------------------------------

## Abbreviated 510(K) For Aearo Company

K070168

N9504C, N9504CS and N9514C Surgical N95 Respirators

#### ll 510(k) Summary

APR 1 0 2007

## Company Name and Address

Aearo Company 90 Mechanic Street Southbridge, MA 01550

# Contact Person

Ann Phillips Quality Assurance Manager Telephone [phone] Fax [phone] E-Mail ann [e-mail]

#### Manufacturing Facility

Available from Company

#### Date Prepared

January 12, 2007

#### Device Name

Trade Name - N9504C, N9504CS and N9514C N95 Respirators Common Name - Surgical Mask or Surgical N95 Respirator

#### Classification

CFR Section - 21 CFR 878,4040 Device Class - Class II Product Code - MSH - Surgical N95 Respirator

## Device Description

These masks are molded cup masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 elastic headbands. No fiberglass media is used in this product.

#### Intended Use

These masks are intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. This would include use as a procedure mask, isolation mask or dental face mask.

{1}------------------------------------------------

# Abbreviated 510(K) For Aearo Company N9504C, N9504CS and N9514C Surgical N95 Respirators

#### ll 510(k)Summary (cont.)

N95 Respirators, N9504C, N9504CS and N9514C have been used in the industrial setting for over a year. They are NIOSH approved N95 respirators. approval numbers TC-84A-3715 and TC-84A-4272. OSHA regulations and the concerns relating to exposure of health care personnel to bloodborne pathogens have brought these types of products into the medical and dental care arenas.

Risk analysis was conducted as recommended in the Guidance Document for Surgical Masks. Adequacy of the fluid resistance was evaluated using ASTM 1862-00a. Testing was conducted at 80 mmHg. Acceptance criteria for this test is that 29 of 32 show no fluid penetration. Test results for these masks showed 32 of the 32 masks tested had no fluid penetration. Adequacy of the Mask for air exchange and as a respiratory barrier for bacteria were evaluated at the time of NIOSH certification. In addition, we conducted tests according to ASTM F2101-01, Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureas at Nelson Laboratories which showed a percent BFE of greater than 99.9% on all samples tested. Assessment of flammability of the mask was conducted according to 21 CFR Part 58 and it met Class I requirements showing no flame spread in the tests conducted by Nelson Laboratories. This conforms to the recommendation in the Guidance Document that only class I and class II flammability materials be used in surgical masks intended for use in the operating room. Finally, since surgical masks have parts that come into contact with the skin, biocompatibility was evaluated as described in ISO-10993. Three tests were conducted. Cytotoxicity was evaluated by Nelson Laboratories using the agar overlay method. None of the mask samples tested showed any detectable reactivity. Primary skin irritation was evaluated by AppTec Laboratory Services using rabbits, according to 16 CFR 1500 modified to use 3 animals instead of 6. No irritation was evident on intact or abraded skin after 24 or 72 hours. Delayed Hypersensitivity was evaluated by Northview Pacific Laboratories using the closed patch test NV SOP 16G-60. Albino guinea pigs were used for the test as required by ISO 10993-10, 2002. None of the Pleats Plus patched animals had any visible change at the test site 48 hours after the challenge dose.

This product meets the requirements of the tests recommended for evaluation and risk analysis outlined in the Guidance Document for Surgical Masks. Summary tables with test results for Pleats Plus and the predicate device (including acceptance criteria) and a comparison of the construction of Pleats Plus vs. the predicate device can be found on page 5. Copies of the test reports are in the appendix.

Pleats Plus N95 Respirators are substantially equivalent to the Gerson Isolair APR, type N95, Model 2735, 510(k) K960778, which is marketed for use as a Surgical Mask.

Aearo Company 510(k) 1/12/07

Page 4

{2}------------------------------------------------

# Abbreviated 510(K) For Aearo Company N9504C, N9504CS and N9514C Surgical N95 Respirators

| 510(k) Summary (cont.)<br>Device and Predicate Device Descriptions/Comparisons | | | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Description | N9504C, N9504CS and N9514C<br>Type N95 Masks | Gerson Isolair APR<br>Type N95 Model 2735, 510(K) K960778 | |
| Fabrics | White nonwoven polyester, meltblown polypropylene | White nonwoven polyester, meltblown polypropylene | |
| Nosepiece | Aluminum | Aluminum | |
| Headband | Yellow Elastic | Yellow Elastic | |
| Specification and Dimensions | Small (13.5" circumference),<br>Large (15.5" circumference) | Small (13.75" circumference) | |
| Mask Style | Cup | Cup | |
| Design Features | Dual elastic head strap | Dual elastic head strap | |
| NIOSH Certification # | TC-84A-3715 (N9504C & N9504CS)<br>TC-84A-4272 (N9514C) | TC-84A-160 | |
| Risks to Health | | | |
| Performance<br>Characteristics | Test Method | Acceptance Criteria/ Results | Predicate Device Results |
| | | N9504C, N9504CS and N9514C<br>Type N95 Masks | Gerson Isolair APR<br>Type N95 Model 2735,<br>510(K) K960778 |
| Fluid resistance<br>Performance ( mmHg) | ASTM F-1862<br>@ 80 mmHg | 32 of 32 pass/ 32 of 32 pass | 32/32 pass |
| Flammability class | 21 CFR Part 58 | Flame spread must be within<br>upper and lower control limits/No<br>flame spread on 10 of 10 samples,<br>meets Class I | Meets Class I |
| Filter efficiency | NIOSH, 42CFR Part 84 | ≥95% Efficient /<br>Average 97.36% (N9514C),<br>97.66%(N9504C), and<br>97.83%(N9504CS)<br>efficient of 20 samples | Average 96.86% efficient<br>of 20 samples |
| Breathing resistance: | NIOSH 42CFR Part 84 | ≤35.0 mm H20 @ 85 lpm/<br>average 6.2 mm H20 (N9514C),<br>7.6 mm H20 (N9504C), and<br>8.0 mm H20 (N9504CS) @85 lpm<br>average of 3 samples each | Average 15.2 mm H20 on<br>3 samples |
| Biocompatibility | ISO-10993-1 | Cytotoxicity, score of 2 or less/<br>score of 0 | N/A |
| | | Sensitization, / No visible change,<br>Score of 0 | N/A |
| | | Primary Skin Irritation/<br>Negligible, Score of 0 | N/A |

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its wings, symbolizing strength and progress. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann L. Phillips Quality Assurance Manager Aearo Company 90 Mechanic Street Southbridge, Massachusetts 01550

APR 1 8 2007

Re: K070168

Trade/Device Name: Surgical N95 Respirators N9504C, N9504CS and N9514C Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: March 22, 2007 Received: March 23, 2007

Dear Ms. Phillips:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

# Page 2 -- Ms. Phillips

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

#### Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: Surgical N95 Respirators N9504C, N9504CS and N9514C

Indications For Use:

Aearo Surgical N95 Respirators, N9504C, N9504CS and N9514 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask. isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A. Murphy, M.D.

Contri

ospital.

k) Alumber

Page 1 of 1

Aearo Company 510(k)

1/12/07

Page 6