(78 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
Aearo Surgical N95 Respirators protect against the transfer of microorganisms and particulate materials by acting as a barrier, rather than providing therapy for a medical condition.
No
The device is described as an N95 respirator intended to protect against the transfer of microorganisms, blood, and airborne particulate materials, functioning as a barrier rather than for diagnosis.
No
The device description clearly indicates a physical product (molded cup masks with layers of material and headbands) and the performance studies focus on physical properties like fluid resistance, flammability, and filtration efficiency. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the respirators are for protecting healthcare workers and patients from the transfer of microorganisms, blood and body fluids, and airborne particulate materials. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask, which is consistent with a personal protective equipment (PPE) device, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and protective capabilities of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility), not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This respirator does not perform any such function.
N/A
Intended Use / Indications for 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.
Aearo Surgical N95 Respirators, N9508C and N9511 are NIOSH approved N95 respirators 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.
Product codes
MSH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel or general health care workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis was conducted as recommended in the Guidance Document for Surgical Masks. Adequacy of the fluid resistance was evaluated using ASTM-F 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 16 CFR 1610 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid resistance: 32 of 32 pass (Acceptance criteria: 29 of 32 must pass)
Flammability class: No flame spread on 10 of 10 samples, meets Class I (Acceptance criteria: Flame spread must be within upper and lower control limits)
Filter efficiency: >95% Efficient (NIOSH, 42CFR Part 84)
Breathing resistance: ≤ 25 mm H2O@85 lpm (exhalation) ≤ 35 mm H2O@85 lpm (inhalation) (NIOSH 42CFR Part 84)
Bacterial Filtration Efficiency: >99.9% (ASTM F2101-01)
Biocompatibility: Cytotoxicity, score of 0 (Acceptance criteria: score of 2 or less); Sensitization, No visible change, Score of 0; Primary Skin Irritation/ Negligible, Score of 0.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Abbreviated 510(K) For Aearo Company N9508C and N9511C Surgical N95 Respirators
ll 510(k) Summary
NOV 0 8 2007
Company Name and Address
Aearo Company 90 Mechanic Street Southbridge, MA 01550
Contact Person
Ann Phillips Quality Assurance Manager Telephone 508-764-5713 Fax 508-764-5242 E-Mail ann phillips@aearo.com
Manufacturing Facility
Available from Company
Date Prepared
August 14, 2007
Device Name
Trade Name - N9508C and N9511C 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 N9508C and N9511C Surgical N95 Respirators
ll 510(k)Summary (cont.)
N95 Respirators, N9508C and N9511C have been used in the industrial setting for over a year. They are NIOSH approved N95 respirators, approval numbers TC-84A-4268 and TC-84A-4261. OSHA requlations 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-F 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 16 CFR 1610 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.
These N95 Respirators are substantially equivalent to the N9504C and N9514C. Surgical N95 Respirators, 510(k) K070168, which are marketed for use as a Surgical Mask.
Aearo Company 510(k) revised 10/18/07
2
Abbreviated 510(K) N9508C and N9511C Surgical N95 Respirators
ll 510(k) Summary (cont.)
Devi e and Predicate Device Descriptions/Comparisons
| Description | N9508C and N9511C Type N95 Masks | N9504C, N9504CS and N9514C Type N95 Masks, 510(k) K070168 |
|---|---|---|
| Fabrics | White nonwoven polyester, meltblown polypropylene | White nonwoven polyester, meltblown polypropylene |
| Nosepiece | Aluminum | Aluminum |
| Headband | White braided Elastic | Yellow Elastic |
| Specification and Dimensions | N9508C 4.7" diameter | |
| N9511C 5.0" diameter | Small 5.0" diameter | |
| Large 5.5" diameter | ||
| Mask Style | Cup | Cup |
| Design Features | Dual elastic head strap | Dual elastic head strap |
| NIOSH Certification # | TC-84A-4268 (N9508C) | |
| TC-84A-4261 (N9511C) | TC-84A-3715 (N9504C & N9504CS) | |
| TC-84A-4272 (N9514C) |
Risks to Health
| Performance
Characteristics | Test Method | Acceptance Criteria/ Results | Predicate Device
Results |
|-----------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | | N9504C, N9504CS and N9514C
Type N95 Masks | N9504C, N9504CS and
N9514C Type N95
Masks, 510(k)
K070168 |
| Fluid resistance
Performance ( mmHg) | ASTM F-1862
@ 80 mmHg | 29 of 32 must pass/
32 of 32 pass | 32/32 pass |
| Flammability class | 16 CFR 1610 | Flame spread must be within upper
and lower control limits/No flame
spread on 10 of 10 samples, meets
Class I | Meets Class I |
| Filter efficiency | NIOSH, 42CFR Part
84 | >95% Efficient /
PASS | PASS |
| Breathing resistance: | NIOSH 42CFR Part
84 | $≤$ 25 mm H20@85 lpm(exhalation)
$≤$ 35 mm H2O@85 lpm(inhalation/
PASS | PASS |
| Bacterial Filtration
Efficiency | ASTM F2101-01 | >99.9% | >99.9% |
| Biocompatibility | ISO-10993-1 | Cytotoxicity, score of 2 or less/
score of 0 | Cytotoxicity, score of 2
or less/ score of 0 |
| | | Sensitization, / No visible change,
Score of 0 | Sensitization, / No
visible change, Score
of 0 |
| | | Primary Skin Irritation/ Negligible,
Score of 0 | Primary Skin Irritation/
Negligible, Score of 0 |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 8 2007
Ms. Ann L. Phillips Quality Assurance Manager Acaro Company 90 Mechanic Street Southbridge, Massachusetts 01550
Re: K072359
Trade/Device Name: Surgical N95 Respirators N9508C and N9511C Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: October 4, 2007 Received: October 9, 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Neil Ro. Ogl
Chiu Lin, Ph.D., fyc
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: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Aearo Surgical N95 Respirators, N9508C and N9511 are NIOSH approved N95 respirators 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
677 354 510(k) Number:
Page 1 of 1
Aearo Company 510(k)
8/14/07
Page 6