(12 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of the respirator/mask, with no mention of AI or ML.
No
The device is described as a particulate respirator and surgical mask, intended to protect from microorganisms and particulate matter, not to treat a disease or medical condition.
No
This device is a particulate respirator and surgical mask used for protection against the transfer of microorganisms, body fluids, and particulate material, not for diagnosing medical conditions.
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. The performance studies also focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices.
Based on the provided information, 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 for protecting healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical construction of a mask, including materials like plastic mesh, nonwoven fabric, filter media, and straps. This aligns with a personal protective equipment (PPE) device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, 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 screening purposes. This device does not perform any such function.
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 is TC-84A-0013.
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 Method 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. Inovel Health Care N95 Particulate Respirators and Surgical Masks various models (4) Models 1511, 1513 and 1517 32 of 32 pass; Model 1512 31 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.
Filter Efficiency (%): NIOSH, 42 CFR Part 84. > 95% Efficient/ average 98.58% efficient of 17 samples.
Breathing Resistance (mm H2O): NIOSH, 42 CFR Part 84. ≤ 35.0 mm H2O @ 85 lpm/ average 10.3 mm H2O @ 85 lpm of 3 samples.
Biocompatibility: ISO 10993 - 1. Cytotoxicity: Same as predicate device; Sensitization: Same as predicate device; Primary Skin Irritation: Same as predicate device.
Bacterial Filtration Efficeincy: Modified Greene and Vesley Method. J Bacteriol 83:663-667. Test results show a bacterial filtration efficiency greater than 99.9%.
Tests Performed:
- Fluid Resistance - Resistance of Liquid (Synthetic Blood Penetration Resistance) ASTM F 1862. Laboratory: Inovel LLC.
- Filtration Efficiency (Particulate and Bacterial) 42 CFR Part 84. Laboratory: NIOSH.
- Differential Pressure (Delta P) - Breathing Resistance 42 CFR Part 84. Laboratory: NIOSH.
- Flammability 16 CFR 1610 (Class 1). Laboratory: Nelson Laboratories.
- Biocompatibility (tested on predicate devices) Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation (ISO 10993-10). Laboratory: Nelson Laboratories; Northview Pacific Laboratories, Inc (Coordinated by Nelson Laboratories); Northview Pacific Laboratories, Inc (Coordinated by Nelson Laboratories).
- Bacterial Filtration Efficiency Modified Greene and Vesley Method. J Bacteriol 83:663-667. Laboratory: Nelson Laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Filter Efficiency: > 95% Efficient/ average 98.58% efficient of 17 samples.
Bacterial Filtration Efficiency: greater than 99.9%.
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
K061859
JUL 1 2 2006
June 27, 2006
12 - I
510(k) Summary
Submitter:
lnovel 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.
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 model 3001N95-S, 3002N95-M, 3003N95-L and 3004N95-LP [(510(K) K051182] These products have also been tested and approved by NIOSH as N95 Respirators.
1
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 is TC-84A-0013.
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 Method 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 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 of the previously cleared devices incorporate a nonwoven polypropylene material with a layer of an extruded plastic mesh and the Inovel models 1511, 1512. 1513 and 1517 incorporate an extruded plastic mesh without the nonwoven material on the outer cover. The head strap color of the cleared device is the same as the Inovel device models for which clearance is being requested.
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 061859
510(k) Summary (continued)
Device and Predicate Devices Descriptions/ Comparisons
| Description | Inovel Health Care N95 Particulate
Respirators and Surgical Masks, models
1511, 1512, 1513, 1517 | Inovel Health Care N95 Particulate
Respirators and Surgical Masks, models
3001N95-S, 3002N95-M, 3003N95-L,
3004N95-LP |
|----------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Materials | | |
| Outer Cover Fabrics | Spunbond polypropylene, Meltblown
polypropylene | Spunbond polypropylene, Meltblown
polypropylene |
| Nosepiece | Polyethylene foam | Polyethylene foam |
| Headband | Various colors elastic, latex free | Various colors elastic, latex free |
| Specification & | Overall width: 5 - 5 5/8 inches | Overall width: 5 - 5 5/8 inches |
| Dimensions | Overall height: $4 \frac{1}{4}$ - $5 \frac{1}{2}$ inches | Overall height: $4 \frac{1}{4}$ - $5 \frac{1}{2}$ inches |
| Mask Style | Molded Cup | Molded Cup |
| Design Features | Dual synthetic rubber | Dual synthetic rubber |
| NIOSH Certification# | TC-84A-0013 | TC-84A-4102 |
Risks to Health
| Performance
| Characteristics | Test Method | Acceptance criteria/ Results | Predicate Device Results |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | ASTM 1862 - 00a | Inovel Health Care N95 Particulate | |
| Respirators and Surgical Masks | |||
| various models (4) | |||
| Models 1511, 1513 and 1517 | |||
| 32 of 32 pass | |||
| Model 1512 | |||
| 31 of 32 pass | Inovel Health Care N95 Particulate | ||
| Respirators and Surgical Masks | |||
| various models (4) | |||
| Models 3001N95-S, 3002N95-M, | |||
| 3003N95-L, 3004N95-LP | |||
| 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 | |||
| Filter Efficiency (%) | NIOSH, 42 CFR | ||
| Part 84 | > 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 | ||
| 10.3 mm H2O @ 85 lpm of 3 | |||
| samples | ≤ 35.0 mm H2O @ 85 lpm/ average | ||
| 11.3 mm H2O @ 85 lpm of 3 | |||
| samples | |||
| Biocompatibility * | ISO 10993 - 1 | Cytotoxicity | |
| Same as predicate device |
Sensitization
Same as predicate device
Primary Skin Irritation
Same as predicate device | Cytotoxicity, score of 2 or less/
Score of 0
Sensitization, Grade 1 (no different
than control)/ Grade 1
Primary Skin Irritation,
Negligible/Negligible |
| Bacterial Filtration
Efficeincy | Modified Greene
and Vesley
Method. J
Bacteriol 83:663-
667 | Test results show a bacterial
filtration efficiency greater than
99.9% | Greater than 99.9% |
- Tests were conducted on Predicate Devices which are made from the same material as models
identified in this 510(k) submission.
12 - 3
3
K061859
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-0013
| Tests Performed | Laboratory |
|---|---|
| 1. Fluid Resistance - Resistance of Liquid | |
| (Synthetic Blood Penetration Resistance) | |
| ASTM F 1862. | Inovel LLC |
| 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* (tested on | |
| predicate devices) | |
| Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation (ISO 10993-10) | Nelson Laboratories |
| Northview Pacific Laboratories, Inc | |
| (Coordinated by Nelson Laboratories) | |
| Northview Pacific Laboratories, Inc | |
| (Coordinated by Nelson Laboratories) | |
| 6. Bacterial Filtration Efficiency | |
| Modified Greene and Vesley | |
| Method. J Bacteriol 83:663-667. | Nelson Laboratories |
- Tests were conducted on Predicate Devices which are made from the same material as models identified in this 510(k) submission.
Safety/ Effectiveness:
The devices have a filtration equivalent to the previously cleared Inovel LLC N95 Particulate Respirator and Surgical mask models 3001N95-M, 3003N95-L and 3004N95-LP 510(k) number K051182. They are NIOSH approved and meet the CDC guidelines for TB and Avian Flu exposure control.
Conclusion:
The basic construction and material used in the cleared devices are 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 - 4.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Inovel LLC C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Twinsburg, Ohio 44087
Rc: K061859
Trade/Device Name: Health Care N95 Respirators and Surgical Masks Inovel Models 1511,1512,1513, & 1517
Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: June 29, 2006 Received: June 30, 2006
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 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.
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 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 vours.
Quy Solom for
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
KO61859 510(k) Number (if known):
Device Name: Health Care N95 Particulate Respirators and Surgical Masks Inovel Models 1511,1512,1513 & 1517 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.
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)
Page 1 of 1
Shade N. Murphy 1/2/04
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of Anesthesiology, General Hospital, Jon Control. Dental Devices ) Number.