(71 days)
The Prestige Ameritech N95 Respirator and Surgical Mask RP88020 is a single use non-sterile disposable device intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
The Prestige Ameritech N95 Particulate Filter Respirator & Surgical mask is manufactured using ultrasonic bonding, composed of four layers of materials pouched and pleated to form the Mask. The inner layer is composed of nonwoven, the two middle layers is meltblown polypropylene filter material and the outer layer is spunbond polypropylene. Masks are held in place on wearer with latex free elastic headband and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Respirator and Surgical Masks and are being used in current legally marketed devices.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Internal Standard) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | Meets ASTM F1862 requirements (implied by "requirements") | Device samples met the ASTM F1862 fluid resistance requirements @160 mmHg. |
| Particulate Filtration Efficiency | Meets ASTM F2299 PFE requirements at 0.1 microns (implied) | Device samples met the ASTM F2299 PFE requirements at 0.1 microns. |
| Bacterial Filtration Efficiency | Meets ASTM F2101 BFE requirements (implied) | Device samples met the ASTM F2101 BFE requirements. |
| Differential Pressure | Meets Mil M36954C Delta P requirements (implied) | Device samples met the Mil M36954C Delta P requirements. |
| Flammability Class | Meets 16CFR 1610 Flammability Class 1 requirements (implied) | Device samples met the 16CFR 1610 Flammability Class 1 requirements. |
| Biocompatibility | Meets ISO-10993-10-2002 requirements (implied) | Device samples met the requirements of ISO-10993-10-2002, "Biological Evaluation of Medical Devices". |
| Sodium Chloride (NaCl) Penetration | NIOSH required sodium chloride test at ≤ 5% Penetration | Device samples met the NIOSH required sodium chloride test at ≤ 5% Penetration. |
| Inhalation Resistance | NIOSH inhalation resistance test which shall not exceed 35 mmH2O | Device samples met the requirements of NIOSH inhalation resistance test which shall not exceed 35 mmH2O. |
| Exhalation Resistance | NIOSH exhalation resistance test which shall not exceed 25 mmH2O | Device samples met the requirements of NIOSH exhalation resistance test which shall not exceed 25 mmH2O. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size used for the test set for each performance metric. It consistently uses the phrase "Subject device samples," which indicates that a representative subset of the manufactured devices was tested for each criterion. The data provenance is not specified (e.g., country of origin). The studies appear to be prospective as they are tests performed on the manufactured device to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for the performance criteria of a respirator and surgical mask is established by widely accepted international and national standards (e.g., ASTM, NIOSH, ISO, CFR). The tests are objective measurements against these predefined standards, not subjective evaluations by experts to establish a "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are objective measurements against established standards, there is no need for an adjudication method involving experts. The results are quantitative and either meet the standard or they do not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device is a physical medical product (respirator/surgical mask), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical product and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for each performance criterion is the established test methods and acceptance criteria set forth by recognized standards organizations. For example:
- Fluid Resistance: ASTM F1862
- Particulate Filtration Efficiency: ASTM F2299
- Bacterial Filtration Efficiency: ASTM F2101
- Differential Pressure: Mil M36954C
- Flammability: 16CFR 1610
- Biocompatibility: ISO-10993-10-2002
- Sodium Chloride Penetration, Inhalation Resistance, Exhalation Resistance: NIOSH standards
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product, not an AI model that requires a training set. The manufacturing process is designed to consistently produce devices that meet the specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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PRESTIGE AMERITECH
510(k) Summary K102092
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990.
Submitted for: Prestige Ameritech 7201 Iron Horse Blvd. North Richland Hills. TX 76180 Phone: 817-427-2700 Fax: 817-886-2733
Establishment Registration number: 3005022483 DCT 6 2010
Barbara McCarty, RA/QA Manager Contact Person: 7201 Iron Horse Blvd. North Richland Hills, TX 76180 817-427-2700 ext 36 barbaram@prestigeameritech.com
Date Submitted: September 21, 2010
Proprietary Name: Pro Gear N95 Particulate Filter Respirator and Surgical Mask
N95 Surgical Respirator Common Name:
Classification Name: Respirator and Surgical Mask
Classification Product Code: MSH
Regulation Number: 878.4040
Tecnol Medical Products, Inc. PFR95 Particulate Filter Respirator Predicate Devices: And Surgical Mask Regular Size K974068
The Prestige Ameritech N95 Particulate Filter Respirator & Surgical mask Device Description: is manufactured using ultrasonic bonding, composed of four layers of materials pouched and pleated to form the Mask. The inner layer is composed of nonwoven, the two middle layers is meltblown polypropylene filter material and the outer layer is spunbond polypropylene. Masks are held in place on wearer with latex free elastic headband and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Respirator and Surgical Masks and are being used in current legally marketed devices.
The Prestige Ameritech N95 Respirator and Surgical Mask RP88020 is a single Intended Use: use non-sterile disposable device intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
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Fluid Resistance: Subject device samples met the ASTM F1862 Performance Data:
fluid resistance requirements @160 mmHg.
Particulate Filtration Efficiency: Subject device samples met the ASTM F2299 PFE requirements at 0.1 microns.
Bacterial Filtration Efficiency: Subject device samples met the ASTM F2101 BFE requirements.
Differential Pressure: Subject device samples met the Mil M36954C Delta P requirements.
Flammability Class: Subject device samples met the 16CFR 1610 Flammability Class 1 requirements.
Biocompatibility: Subiect device samples met the requirements of ISO-10993-10-2002, "Biological Evaluation of Medical Devices"
Sodium Chloride (NaCl): Subject device samples met the NIOSH required sodium chloride test at ≤ 5% Penetration.
Inhalation Resistance: Subject device samples met the requirements of NIOSH inhalation resistance test which shall not exceed 35 mmH2O. Exhalation Resistance: Subject device samples met the requirements of . NIOSH exhalation resistance test which shall not exceed 25 mmH2O.
DEVICE AND PREDICATE DEVICE COMPARISON
| DESCRIPTION | PRESTIGE AMERITECHDEVICE | K974068 |
|---|---|---|
| MATERIALS;INNER | BICOMPONENT | BICOMPONENT |
| NONWOVEN | NONWOVEN | |
| MATERIALS;MIDDLE 2 LAYERS | MELTBLOWN | MELTBLOWN |
| POLYPROPYLENE | POLYPROPYLENE | |
| MATERIALS;OUTER | SPUNBOND | SPUNBOND |
| POLYPROPYLENE | POLYPROPYLENE | |
| NOSEPIECE | MALLEABLE | MALLEABLE |
| WIRE | ALUMINUM | ALUMINUM |
| SPECIFICATION | 4 PLY FILTER BODY | 4 PLY FILTER BODY |
| MASK STYLE | POUCH | POUCH |
| MASK DESIGN | HEADBAND | HEADBAND |
| MANUFACTURINGMETHOD | ULTRASONIC BONDING | ULTRASONIC BONDING |
Substantial Equivalence Conclusion: The Prestige Ameritech N95 Particulate Filter Respirator and Surgical Mask have the same intended use and technological characteristics as the predicate device K974068. When compared with data available and/or claims made on the predicate device, demonstrate that the technological characteristics do not raise any new question of safety or effectiveness. Therefore, the Prestige Ameritech N95 Particulate Filter Respirator & Surgical Mask is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Barbara McCarty Regulatory Affairs/ Quality Assurance Manager Prestige Ameritech 7201 Iron Horse Boulevard North Richland Hills, Texas 76180
OCT 6.2010
Re: K102092
Trade/Device Name: RP88020 - Pro Gear N95 Particulate Filter Respirator and Surgical Mask, Regular Size Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: July 26, 2010 Received: July 27, 2010
Dear Ms. McCarty:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2- Ms. McCarty
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K/02092
Device Name: RP88020 - Pro Gear N95 Particulate Filter Respirator and Surgical Mask, Regular Size
Indications For Use:
The Prestige Ameritech N95 Respirator and Surgical Mask RP88020 is a single use non-sterile disposable device intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from 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)
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Concurrence of DCRH, Office of Device Evaluation (ODE)
Edith F. Clausing Wills
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K | 02092
§ 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.