(10 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.
A therapeutic device is one that treats or mitigates a disease or condition. This device is a mask for protection and prevention, not treatment.
No
The device is a N95 Healthcare Particulate Respirator and Surgical Mask, which is a protective barrier worn by healthcare personnel. Its intended use is to prevent the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly outlines physical components like nonwoven spunbond, polypropylene melt blown filter media, head straps, and a nosepiece, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a respirator and surgical mask worn by healthcare personnel to protect against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and construction of a mask, not components of a diagnostic test kit or instrument.
- Performance Studies and Key Metrics: The performance studies and metrics focus on the physical properties and filtration capabilities of the mask (fluid resistance, filtration efficiency, breathing resistance, flammability, biocompatibility). These are relevant to a personal protective device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The various models of Inovel/Cardinal 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 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 (for double headband) and polyester elastic (for single head strap) which is sewn 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 84. The certification numbers are TC-84A-4101 and TC-84A-4103 (for single head strap) and TC-84A-4100 and TC-84A-4102 (for double head straps) for a type N95 Particulate Respirator.
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 1863 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood, conducted by Nelson Laboratories. Breathing resistance was tested by NIOSH in accordance to 42 CFR 84.
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 (mmHg):
- Test Method: ASTM 1862 - 00a @ 160 mm Hg
- Acceptance criteria/ Results: 29 of 32 pass / 32 of 32 pass
- Flammability Class:
- Test Method: 16 CFR 1610
- Acceptance criteria/ Results: Flame spread must be within upper and lower limits/ No flame spread on 10 of 10 samples, meets Class I
- Filter Efficiency (%):
- Test Method: NIOSH, 42 CFR Part 84
- Acceptance criteria/ Results: > 95% Efficient/ average 99.11% efficient of 20 samples (model 3000N95-XS)
- Breathing Resistance (mm H2O):
- Test Method: NIOSH, 42 CFR Part 84
- Acceptance criteria/ Results: ≤ 35.0 mm H2O @ 85 lpm/ average 3.5 mm H2O @ 85 lpm of 3 samples
- Biocompatibility:
- Test Method: ISO 10993 — 1
- Cytotoxicity: Acceptance criteria/ Results: Cytotoxicity, score of 2 or less/ Score of 0
- Sensitization: Acceptance criteria/ Results: Sensitization, Grade 1 (no different than control)/ Grade 1
- Primary Skin Irritation: Acceptance criteria/ Results: Primary Skin Irritation, Negligible/Negligible
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance: 29 of 32 pass / 32 of 32 pass
- Filter Efficiency: average 99.11% efficient of 20 samples
- Breathing Resistance: average 3.5 mm H2O @ 85 lpm of 3 samples
- Cytotoxicity: Score of 0
- Sensitization: Grade 1
- Primary Skin Irritation: Negligible
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 logo for "iNovel" with the tagline "Different by design." The logo is in a sans-serif font and appears to be slightly pixelated. The tagline is in a smaller, italicized font and is located below the main logo.
MAY 1 9 2005
10111 WEST JEFFERSON ROULEVARD, CULVER CITY, CALIFORNIA 90232 TELEPHONE BRE BRACHARTSTAR FAX 240-337 -0468 www.inevelmsdici31.com
April 29, 2005
12 - 1
510(k) Summary
Submitter:
Inovel LLC 10111 W. Jefferson Blvd. Culver City, CA 90232-3509
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.
| Model Numbers: | 3000N95-XS, 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP, 3101N95-S, 3102N95-M/L, 3104N95-LP, FRN95-SEZ, FRN95-MLEZ, FRN95-AEZ, FRN95-XS, FRN95-S, FRN95-ML and FRN95-A |
|---|---|
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Common Name:
Health Care N95 Particulate Respirator and Surgical Mask.
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 the Aearo Co. Pleats Plus mask model 1050 and 1050S [(510(k)K041855] and Gerson Isolair APR type N95 mask model 2735 [510(k)K960778)]. These two products have also been tested and approved by NIOSH as N95 Respirators.
1
Image /page/1/Picture/1 description: The image shows the logo for "inovEL" in a bold, sans-serif font. The letters are blocky and geometric, with a pixelated texture. Below the main logo, in a smaller font, is the tagline "Different by design."
10111 WEST JEFFERSON BOULEVARD, CULVER CITY, CALIFORNIA 90232 TELEPHONE 866-546-6835 FAX 310-837-0468 www.inovelmedical.com
12-2
Description:
The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from 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 (for double headband) and polyester elastic (for single head strap) which is sewn to the mask. The inside nosepiece is a closed cell foam.
510(k) Summary (Continued)
The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR 84. The certification numbers are TC-84A-4101 and TC-84A-4103 (for single head strap) and TC-84A-4100 and TC-84A-4102 (for double head straps) for a type N95 Particulate Respirator.
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 1863 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood, conducted by Nelson Laboratories. Breathing resistance was tested by NIOSH in accordance to 42 CFR 84.
Intended Use:
The various models of Inovel/Cardinal 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.
Limitations:
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 outside cover color of the previously cleared devices are white and the Inovel are blue or multi-color. The head strap color of the cleared device is vellow and the Inovel device models are various colors as described in pages 2 - 2 through 2 - 5.
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 similar materials.
2
K 051182
Image /page/2/Picture/1 description: The image shows the word "inovel" in a stylized font. Below the word "inovel" is the phrase "Different by design." The text is in black and white.
10111 WEST JEFFERSON BOULEVARD, CUI.VER CITY, CALIFORNIA 90282
TELEPHONE 800-640-8835 FAX 310-837-0468 www.shovelmedical.com
12 - 3
510(k) Summary (continued)
Device and Predicate Devices Descriptions/ Comparisons
| Description | Inovel Health Care N95
Particulate Respirators and
Surgical Masks, various models
(15) | Gerson Isolair APR Type N95
model 2735, 510(k) K960778 | Aearo Co. Pleats Plus 1050 and
1050S, 510(k) K041855 |
|-------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------|
| Materials | | | |
| Fabrics | Spunbond polypropylene,
Meltblown polypropylene | White nonwoven polyester,
Meltblown polypropylene | White spundbond polypropylene,
Meltblown polypropylene |
| Nosepiece | Polyethylene foam | Closed cell foam | Tie wire |
| Headband | Various colors elastic, latex free | Yellow elastic, latex free | White Elastic, latex free |
| Specification &
Dimensions | Various sizes (14.75" - 15.625"
circumference) | Small (13.75" circumference) | Small ( 13.5" circumference)
Large (15.5" circumference) |
| Mask Style | Molded Cup | Molded Cup | Flat pleated |
| Design Features | Dual synthetic rubber or single
elastic head strap | Dual elastic head strap | Dual elastic head strap |
| NIOSH
Certification# | TC-84A-4100 thru TC-84A-4103 | TC-84A-160 | TC-84A-2630 |
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 various models
(15) | Gerson Isolair APR
Type N95 model
2735, 510(k)
K960778 | Aero Co. Pleats
Plus 1050 and
1050S, 510(k)
K041855 |
| Fluid Resistance
Performance
(mmHg) | ASTM 1862 - 00a @
160 mm Hg | 29 of 32 pass/
32 of 32 pass | 32/32 pass | 31/32 pass @ 120
mmHg |
| 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 | Meets Class I | Meets Class I |
| Filter Efficiency
(%) | NIOSH, 42 CFR
Part 84 | > 95% Efficient/ average
99.11% efficient of 20 samples
(model 3000N95-XS) | Average 98.86%
efficient of 20
samples | Average 99.11%
efficient of 20
samples |
| Breathing
Resistance
(mm H2O) | NIOSH, 42 CFR
Part 84 | ≤ 35.0 mm H2O @ 85 lpm/
average 3.5 mm H2O @ 85 lpm
of 3 samples | Average 15.2 mm
H2O on 3 samples | Average 3.5 mm
H2O on 3 samples |
| Biocompatibility | ISO 10993 — 1 | Cytotoxicity, score of 2 or less/
Score of 0 | N/A | Score of 0 |
| | | Sensitization, Grade 1 (no
different than control)/ Grade 1 | N/A | Score of 0 (closed
patch test) |
| | | Primary Skin Irritation,
Negligible/Negligible | N/A | Negligible |
,在线上的
3
Image /page/3/Picture/1 description: The image shows the logo for "iNovel" with the tagline "Different by design." The logo is in a blocky, pixelated font, giving it a retro or digital feel. The tagline is in a smaller, more cursive font, positioned below the main logo.
10111 WEST JEFFERSON ROULEVARD, CUILVER CITY, CALIFORNIA 90232 TELEPHONE 685-546-6835 FAX 3 16-337 -0468 www.inovelmedical.com
12 - 4
510(k) Summary (Continued)
Performance Tests:
These products were tested and certified by NIOSH as an approved N95 Respirator. It meets all the requirements prescribed in 42 CFR Part 84 and is assigned TC-84A-4100 through TC-84A-4103.
| Tests Performed | Laboratory | |
|---|---|---|
| 1. | Fluid Resistance - Resistance of Liquid | |
| (Synthetic Blood Penetration Resistance) | ||
| ASTM F 1862. | Nelson Laboratories | |
| 2. | Filtration Efficiency (Particulate and | |
| Bacterial) 42 CFR Part 84 | NIOSH | |
| 3. | Differential Pressure (Delta P) - Breathing | |
| Resistance 42 CFR Part 84 | NIOSH | |
| 4. | Flammability 16 CFR 1610 (Class 1) | Nelson Laboratories |
| 5. | Biocompatibility | |
| • Cytotoxicity ISO 10993 – 5 | Nelson Laboratories | |
| • Sensitization ISO 10993 – 10 | Northview Pacific Laboratories, Inc. | |
| (Coordinated by Nelson Laboratories | ||
| • Irritation ISO 10993 – 10 | Northview Pacific Laboratories, Inc. | |
| (Coordinated by Nelson Laboratories |
Safety/ Effectiveness:
The devices have a filtration equivalent to the previously cleared Aearo Co. Pleats Plus model 1050 and 1050S and Gerson Isolair APR model 2735 Particulate Respirator and Surgical mask. They are NIOSH approved and meet the CDC guidelines for TB.
Conclusion:
The basic construction and material used in the cleared devices is basically the same as in the new devices. The cleared devices and the new devices are also approved by NIOSH, and meets all other required tests. The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are substantially equivalent to those listed on page 2 - 7.
... ... ... ...
4
Image /page/4/Picture/1 description: The image shows the logo for the United States 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2005
Inovel, LLC C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779
Re: K051182
Trade/Device Name: Inovel Health Care N95 Particulate Respirators and Surgical Masks, Various Models Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: May 6, 2005 Received: May 9, 2005
Dear Mr. Devine:
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 Amendinently, or or us as a cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Nr.), it may be basyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Devine
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 modified in any Federal statutes and regulations administered by other Federal agencies. or the Act of all - outs 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 ting (2) 02 1 0 1 1 1 1 1 1 1 1 4 quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrent 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) Prinstet notification. The FDA finding of substantial equivalence of your device to a premiaries included 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), rr you don't 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 may obtain 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,
Chih-Lin, Ph.D.
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
6
Indications for Use
510(k) Number (if known): KO51 | 82
Device Name: Inovel Health Care N95 Particulate Respirators and Surgical Masks, various models.
Indications for Use:
The various models of Inovel/Cardinal 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
X Over-The-Counter Use ________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Bvaluation (ODE)
Shirley A. Murphy, R
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ._