(117 days)
The Surgical Earloop Face Mask with Bottom Gap Shield 7410E and Surgical Tie-On Face Mask with Bottom Gap Shield 7410T are single use disposable devices 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.
Not Found
{
"1. A table of acceptance criteria and the reported device performance": {
"Fluid Resistance": {
"Acceptance Criteria (mmHg)": "120",
"Reported Device Performance (mmHg)": "Pass at 120"
},
"Bacterial Filtration Efficiency (BFE)": {
"Acceptance Criteria (%)": "≥98",
"Reported Device Performance (%)": "≥98"
},
"Particulate Filtration Efficiency (PFE)": {
"Acceptance Criteria (%)": "≥98",
"Reported Device Performance (%)": "≥98"
},
"Breathability (Delta P)": {
"Acceptance Criteria (mm H2O/cm²)": "<5.0",
"Reported Device Performance (mm H2O/cm²)": "<5.0"
},
"Flammability": {
"Acceptance Criteria": "Class 1",
"Reported Device Performance": "Class 1"
},
"Biocompatibility (Cytotoxicity)": {
"Acceptance Criteria": "Non-cytotoxic",
"Reported Device Performance": "Non-cytotoxic"
},
"Biocompatibility (Sensitization)": {
"Acceptance Criteria": "Non-sensitizing",
"Reported Device Performance": "Non-sensitizing"
},
"Biocompatibility (Irritation)": {
"Acceptance Criteria": "Non-irritating",
"Reported Device Performance": "Non-irritating"
}
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not specified in the provided text. The document refers to the general conformity to regulations rather than a specific clinical study with a test set.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. This is a medical device regulation document, not a study evaluating an AI algorithm or diagnostic device requiring expert ground truth.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This is a medical device regulation document, not a study evaluating an AI algorithm or diagnostic device.",
"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": "Not applicable. This is a medical device regulation document; the device is a surgical face mask, not an AI-powered diagnostic tool.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device regulation document; the device is a surgical face mask, not an algorithm.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not applicable. The performance criteria are physical and biological characteristics of the face mask, evaluated through specific standardized tests (e.g., ASTM F2100-11 for masks).",
"8. The sample size for the training set": "Not applicable. This is a medical device regulation document for a physical device, not an AI/ML product that requires a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This is a medical device regulation document for a physical device."
}
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2017
Prestige Ameritech Rex Reese Advanced Technologies Engineer 7201 Iron Horse Blvd. North Richland Hills, Texas 76180
Re: K171162
Trade/Device Name: Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 20, 2017 Received: July 24, 2017
Dear Rex Reese:
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.
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
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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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tara A. Ryan -S
for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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): K171162
Device Name: Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
Indications for Use (Describe):
The Surgical Earloop Face Mask with Bottom Gap Shield 7410E and Surgical Tie-On Face Mask with Bottom Gap Shield 7410T are single use disposable devices 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.
Type of Use: ______________________________________________________________________________________________________________________________________________________________________________ Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
§ 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.