(161 days)
The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a no fiberglass, fluid resistant single-use mask 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. This device also meets CDC Guidelines for TB Exposure Control.
The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside noseviece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
Here's a breakdown of the acceptance criteria and study information for the Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Performance Requirement (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Particulate Filtration Efficiency (NIOSH N95 Certification) | 95% efficiency against 0.3 micron diameter challenge | Meets requirements for TC-84A-3323 (N95 certification) |
| Resistance to Synthetic Blood Penetration (ASTMF1862-00) | Resistant to synthetic blood | Resistant to synthetic blood |
| Breathing Resistance (NIOSH 30 CFR11 section 11.140-9 / 42CFR84) | Meets prescribed test criteria for breathing resistance | Meets prescribed test criteria |
| Irritation: Primary Skin FHSA & Skin Sensitization | Not explicitly stated, but passes the test | Passes the tests (implied by inclusion in performance tests and conclusion) |
| Meets CDC Guidelines for TB Exposure Control | Meets CDC Guidelines | Meets CDC Guidelines for TB Exposure Control |
Note: The document emphasizes substantial equivalence to a predicate device (Gerson Isolair APR Type N95 Mask Model 2735, K960778) as the primary proof of safety and effectiveness, meaning the new device performs comparably to an already approved device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "the use of 0.3 micron diameter challenge" for filtration efficiency testing, and tests performed by NIOSH and Nelson Laboratories. It does not specify the number of masks or trials involved in these tests.
- Data Provenance: The tests were conducted by recognized testing laboratories: NIOSH (National Institute for Occupational Safety and Health) and Nelson Laboratories. The data is prospective, as it involves active testing of the Makrite device. The country of origin for these testing bodies is the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical product, and its performance is assessed through objective, standardized laboratory tests, not subjective expert evaluation of data. Therefore, there is no "ground truth" established by human experts in the context of image interpretation or medical diagnosis. The "ground truth" is defined by the objective measurement standards of the relevant test protocols (e.g., 95% filtration efficiency for N95).
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation relies on objective laboratory test results, not expert consensus or adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, where the goal is to evaluate the impact of a new tool (like AI) on physician performance. The Makrite Model 910-N95 is a physical protective device, not a diagnostic tool requiring human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense, the performance of the device itself (the "algorithm" in this analogy) was tested in a standalone manner. The tests reported (filtration efficiency, breathing resistance, synthetic blood penetration, irritation) are all direct measurements of the mask's physical properties and performance without human interaction beyond conducting the test.
7. The Type of Ground Truth Used
The ground truth used is based on objective, standardized test criteria and regulatory requirements. For example:
- NIOSH N95 certification: The ground truth is defined by the NIOSH 42 CFR 84 standard, which specifies 95% efficiency against 0.3 micron particles.
- Synthetic Blood Penetration: The ground truth is defined by the ASTMF1862-00 standard for resistance.
- Breathing Resistance: The ground truth is defined by NIOSH 30 CFR11 section 11.140-9.
These are established benchmarks for performance, not subjective expert opinions or clinical outcomes.
8. The Sample Size for the Training Set
Not applicable. The Makrite Model 910-N95 is a manufactured product, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. Its performance is inherent in its design and manufacturing materials, verified through testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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JUL 2 3 2002
510(K) Summary
Submitter Joseph Z. Zdrok & Associates 24 Tower St. Webster, MA 01570
Contact Joseph Z. Zdrok President 508-943-4895 Telephone 508-671-9144 FAX E-Mail jzzdrok@aol.com
Date Jan. 31, 2002
Trade Name Makrite Type N-95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95
Common Name: Healthcare Particulate Respirator and Surgical Mask
Classification Device Class - Class II CFR Section - 21 CFR 878.4040
Substantial Equivalency:
The Makrite Model 910-N95 Heathcare Particulate Respirator and Surgical Mask is found to be substantially equivalent to the Gerson Isolair APR Type N95 Mask Model 2735 (510(K)K960778). Both products have been tested and approved by NIOSH as N-95 respirators.
2
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510(K) Summary (Continued)
USE
Description:
The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside noseviece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
The Makrite Type N95 Healthcare Respirator and Surgical Mask Model 910-N95 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-3323 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is resistant to synthetic blood as per ASTMF1862-00 Standard Test Method for Resistance of Medical Face Mask to Penetration by Synthetic Blood, conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9.
Intended Use:
The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-95 is 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.
This device also meets CDC Guidelines for TB Exposure Control.
Limitations:
This product does 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 Device
The outside cover stock color of the preciously cleared device is white. The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask Model is also white. The headband color of the cleared device is green and the Makrite Model 910-N95 is yellow.
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The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask incorporates a highly efficient filer media and is 95% efficient against a .3 micron particulate which was scientifically established as the most penetrating particle size. The legally marketed Gerson device previously cleared 510 (k) K960778 is manufactured from similar materials.
Performance Tests:
This product was tested and certified by NIOSH as an approved N95 respirator. It meets all the requirements prescribed in 42 CFR 84 and is assigned TC-84A-3323.
| Tests Performed | Laboratory | |
|---|---|---|
| 1. | Department of Health and HumanServices 42CFR 84 Type N95Requirements | NIOSH |
| 2. | Resistance of Liquid (SyntheticBlood Penetration Resistance)ASTMF 1862-00 | Nelson Laboratories |
| 3. | Breathing Resistance 42CFR84 | NIOSH |
| 4. | Filtration Efficiency NIOSH 42 CFR 11 | NIOSH |
| 5. | Irritation: Primary Skin FHSASkin Sensitization | Nelson Laboratories |
Conclusion:
Since the basic construction is used in the cleared device as in the new device and approved by NIOSH, the Makrite 910-95 Healthcare Particulate Respirator and Surgical Mask is substantially equivalent to the Gerson Model 2735 Healthcare and Particulate Respirator and Surgical Mask.
Safety/Effectiveness
The device has a filtration equivalent to the previously cleared Gerson Model 2735 Surgical Mask Respirator. It is NIOSH approved and meets the CDC guidelines for TB Exposure Control.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2002
Makrite Industries, Incorporated C/O Mr. Joseph Zdrok Joseph Z. Zdrok & Associates 24 Tower Street Webster, Massachusetts 01570
Re: K020474
Trade/Device Name: Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: May 28, 2002 Received: May 31, 2002
Dear Mr. Zdrok:
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.
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.
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Page 2 - Mr. Zdrok
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Nunber (if known): __ K020474_
Device Name: Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask
Indications For Use:
The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a no fiberglass, fluid resistant single-use mask 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. This device also meets CDC Guidelines for TB Exposure Control.
FDA/CDRH/ODE/DHG
MAR 25 'L 20 PM '02
RECEIVED
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formst 1-2-96)
Rassidy for Clan
Division of Dental, Infection Control, and General Hospital Devices E10(k) Number K020474
§ 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.