(24 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a respirator/surgical mask, with no mention of AI or ML.
No.
The device is a particulate respirator and surgical mask, intended for protection against microorganisms, body fluids, and particulate material, not for treating any medical condition or disease.
No
Explanation: The device is a particulate respirator and surgical mask, intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly outlines physical components like extruded plastic mesh, nonwoven spunbond, polypropylene melt blown filter media, a non-latex rubber head strap, and a closed cell foam nosepiece. This indicates a hardware-based device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "Healthcare Particulate Respirator and Surgical Mask." Its function is to be worn by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier device, not a device that analyzes biological samples.
- Intended Use: The intended use is for protection during surgical procedures and within healthcare facilities for TB exposure control. This aligns with personal protective equipment (PPE), not diagnostic testing.
- Performance Studies: The performance studies listed (Fluid Resistance, Flammability, Filter Efficiency, Breathing Resistance) are all related to the physical properties and protective capabilities of the mask, not to the analysis of biological samples.
Therefore, based on the provided information, this device is a medical device (specifically, a type of personal protective equipment), but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The various models of Inovel Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.
Product codes (comma separated list FDA assigned to the subject device)
MSH
Device Description
The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.
The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR Part 84. The certification numbers are TC-84A-4100 and TC-84A-4101.
The type N95 must meet the prescribed test criteria which specifies the use of 0.055 to 0.095 micron diameter challenge and requiring a 95% efficiency or better. The masks are resistant to synthetic blood as per ASTM F 1862 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood. Breathing resistance was tested by NIOSH in accordance to 42 CFR Part 84. The devices have a Bacterial Filtration Efficiency greater than 99.9%. Testing was conducted by Nelson Laboratories using the Modified Green and Vesley Mcthod for evaluation of bacterial filtration efficiency of surgical masks.
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
healthcare personnel / healthcare facilities
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)
Performance Characteristics:
- Fluid Resistance Performance: ASTM 1862 - 00a, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A, MFRN95-MLZ: 32 of 32 pass; Model MFRN95-SZ: 31 of 32 pass.
- Flammability Class: 16 CFR 1610, No flame spread on 10 of 10 samples, meets Class I.
- Filter Efficiency (%): NIOSH, 42 CFR Part 84, average 99.46% efficient of 40 samples.
- Breathing Resistance (mm H2O): NIOSH, 42 CFR Part 84, average 12.5 mm H2O @ 85 lpm of 18 samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the word "INOVEL" in a bold, sans-serif font. Below the word "INOVEL" is the phrase "Different by design." The text is black and the background is white.
10111 WEST JEFFERSON BOULEVARD, CULVER CITY, CALIFORNIA 90232 FELEPHONE 866-546-6835 FAX 310-837-0468 www.inovelmerical co
October 31, 2006
12 - 1
510(k) Summary
Submitter: Inovel LLC 10111 W. Jefferson Blvd. Culver City, CA 90232-3509
JAN 1 2 2007
Contact:
William Wawrzyniak Director Quality Assurance Telephone: 866-546-6835 Ext. 705 Fax: 310-837-0468 E-mail: .billw@inovelmedical.com.
Trade Name:
Inovel Health Care N95 Particulate Respirators and Surgical Masks, various models.
Common Name:
Health Care N95 Particulate Respirators and Surgical Masks.
Classification:
Name - Surgical Apparel, as described in 21 CFR 878.4040. Device Class - Class II Product Code - MSH CFR Section - 21 CFR 878.4040
Substantial Equivalency:
Inovel Health Care N95 Particulate Respirators and Surgical Masks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1510 (K062665), 1511,1512,1513,1517(K061859), 3000N95-XS, 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP, 3101N95-S, 3102N95-M/L, and 3104N95-LP (K051182), These products have also been tested and approved by NIOSH as N95 Respirators
1
Image /page/1/Picture/0 description: The image shows the word "inovel" in a bold, sans-serif font. Below the word "inovel" is the phrase "Different by design." The text is black and the background is white.
510(k) Summary (Continued)
Description:
The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.
The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR Part 84. The certification numbers are TC-84A-4100 and TC-84A-4101.
The type N95 must meet the prescribed test criteria which specifies the use of 0.055 to 0.095 micron diameter challenge and requiring a 95% efficiency or better. The masks are resistant to synthetic blood as per ASTM F 1862 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood. Breathing resistance was tested by NIOSH in accordance to 42 CFR Part 84. The devices have a Bacterial Filtration Efficiency greater than 99.9%. Testing was conducted by Nelson Laboratories using the Modified Green and Vesley Mcthod for evaluation of bacterial filtration efficiency of surgical masks.
Intended Use:
The various models of Inovel Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healtheare personnel from the transfer of microorganisms, body fluids and particulate material.
- I imitations:
These products do not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.
Comparison of Predicate Devices:
The configuration, materials and components are the same for both the previously cleared device and the Inovel device models for which clearance is being requested including the same color of straps.
The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks incorporate a highly efficient filter media and is 95% efficiency or better against aerosols that have a count median diameter of 0.055 - 0.095 microns which was scientifically established as the most penetrating particle size. The legally marketed devices previously cleared 510(k) are manufactured from identical materials.
12 -- 2
2
Revised Page 12-3
Image /page/2/Picture/1 description: The image is a black and white image that appears to be a highly magnified view of a surface. The surface is covered in small, dark spots or particles, which are scattered randomly across the image. The background is white, which provides a high contrast to the dark spots. The spots are of varying sizes and shapes, and they are not evenly distributed across the image.
1011 WLS FJEFFFRSON BOOLEVARD, CULVER CITY, CALIFORNIA 90232
TELEPHONE - 866 546 6835 - FAX (310 837 0468 - - www.movesmedical com
12 – 3
510(k) Summary (continued)
Device and Predicate Devices Descriptions/ Comparisons
| Description | |||
|---|---|---|---|
| Inovel Health Care N95 | |||
| Particulate Respirators and | |||
| Surgical Masks, models | |||
| MFRN95-S, MFRN95-XS, | |||
| MFRN95-ML, MFRN95-A, | |||
| MFRN95-SZ, MFRN95- | |||
| MLZ | Inovel Health Care N95 | ||
| Particulate Respirators and | |||
| Surgical Masks, models 1510 | |||
| 1511, 1512, 1513, 1517, | |||
| 3211N95-S, 3212N95-M/L | Inovel Health Care N95 | ||
| Particulate Respirators and | |||
| Surgical Masks, models | |||
| 3000N95-XS, 3001N95-S, | |||
| 3002N95-M, 3003N95-L, | |||
| 3004N95-LP, 3101N95-S, | |||
| 3102N95-M/L, 3104N95-LP | |||
| Materials | |||
| Outer Cover | |||
| Fabrics | Ethylene-Vinyl Acetate | ||
| Copolymer, extruded | Ethylene-Vinyl Acetate | ||
| Copolymer, extruded | Polypropylene Spunbond and | ||
| Ethylene-Vinyl Acetate | |||
| Copolymer, extruded | |||
| Nosepiece | Polyethylene foam | Polyethylene foam | Polyethylene foam |
| Headband | Various colors elastic, latex | ||
| free | Various colors elastic, latex free | Various colors elastic, latex free | |
| Specification & | |||
| Dimensions | Overall width: $4 5/8 - 7 3/4$ | ||
| inches | Overall width: $4 5/8 - 7 3/4$ | ||
| inches | Overall width: $4 5/8 - 7 3/4$ | ||
| inches | |||
| Overall height: $4 3/4 - 5 1/2$ | |||
| inches | Overall height: $4 3/4 - 5 1/2$ | ||
| inches | Overall height: $4 3/4 - 5 1/2$ | ||
| inches | |||
| Mask Style | Molded Cup | Molded Cup | Molded Cup |
| Design Features | Dual synthetic rubber or | ||
| single elastic head strap | Dual synthetic rubber or single | ||
| elastic head strap | Dual synthetic rubber or single | ||
| elastic head strap | |||
| NIOSH Certification# | TC-84A-4100 | ||
| TC-84A-4101 | TC-84A-4333 | ||
| TC-84A-4338 | |||
| TC-84A-0013 | TC-84A-4102 | ||
| TC-84A-4103 |
Risks to Health
| Performance
| Characteristics | Test Method | Acceptance criteria/ Results | Predicate Device Results | Predicate Device Results |
|---|---|---|---|---|
| Inovel Health Care N95 | ||||
| Particulate Respirators and | ||||
| Surgical Masks models | ||||
| MFRN95-S, MFRN95-XS, | ||||
| MFRN95-ML, MFRN95-A, | ||||
| MFRN95-SZ, MFRN95-MLZ | Inovel Health Care N95 | |||
| Particulate Respirators and | ||||
| Surgical Masks models 1510, | ||||
| 1511, 1512, 1513, 1517, | ||||
| 3211N95-S, 3212N95-M/L | Inovel Health Care N95 | |||
| Particulate Respirators and | ||||
| Surgical Masks models | ||||
| 3000N95-XS, 3001N95-S, | ||||
| 3002N95-M, 3003N95-L, | ||||
| 3004N95-LP, 3101N95-S, | ||||
| 3102N95-M/L, 3104N95-LP | ||||
| Fluid Resistance | ||||
| Performance | ASTM 1862 - 00a | Models MFRN95-S, MFRN95-XS, | ||
| MFRN95-ML, MFRN95-A, , | ||||
| MFRN95-MLZ: 32 of 32 pass | ||||
| Model MFRN95-SZ: | ||||
| 31 of 32 pass | Models 1510, 1511, 1513 and | |||
| 1517, 3211N95-S, | ||||
| 3212N95-M/L: 32 of 32 pass | ||||
| Model 1512 | ||||
| 31 of 32 pass | 32 of 32 pass | |||
| Flammability | ||||
| Class | 16 CFR 1610 | Flame spread must be within | ||
| upper and lower limits/ No flame | ||||
| spread on 10 of 10 samples, | ||||
| meets Class I | Flame spread must be within | |||
| upper and lower limits/ No | ||||
| flame spread on 10 of 10 | ||||
| samples, meets Class I | Flame spread must be within | |||
| upper and lower limits/ No flame | ||||
| spread on 10 of 10 samples, | ||||
| meets Class I | ||||
| Filter Efficiency | ||||
| (%) | NIOSH, 42 CFR | |||
| Part 84 | > 95% Efficient/ average | |||
| 99.46% efficient of 40 samples | > 95% Efficient/ average | |||
| 98.58% efficient of 17 samples | > 95% Efficient/ average | |||
| 99.11% efficient of 20 samples | ||||
| Breathing | ||||
| Resistance | ||||
| (mm H2O) | NIOSH, 42 CFR | |||
| Part 84 | ≤ 35.0 mm H2O @ 85 lpm/ | |||
| average 12.5 mm H2O @ 85 lpm | ||||
| of 18 samples | ≤ 35.0 mm H2O @ 85 lpm/ | |||
| average 10.3 mm H2O @ 85 | ||||
| lpm of 3 samples | ≤ 35.0 mm H2O @ 85 lpm/ | |||
| average 11.3 mm H2O @ 85 Ipm | ||||
| of 3 samples |
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inovel, LLC C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
JAN 1 2 2007
Re: K063747
Trade/Device Name: Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A, MFRN95-SZ, MFRN95-MLZ Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: January 2, 20067 Received: January 3, 2007
Dear Mr. Lehtonen:
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 ta2898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Lehtonen
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suttey. Michian Omd
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): KO63747
Device Name: Health Care N95 Particulate Respirators and Surgical Masks, models Health Caro 1059 Functions ML, MFRN95-ML, MFRN95-A, MFRN95-SZ, MFRN95-MLZ
Indications for Use:
The various models of Inovel Type N95 Healthcare Particulate Respirators and The Various Intodess of mover 17per for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel during "Surgiour" procedures eanisms, body fluids and particulate material.
AND/OR Prescription Use _ (Part 21 CFR 801 Subpart D)
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)
Shala H. Murphy, D
on of Anesthesiology. General H tion Control, Dental E
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