(81 days)
PRIMAGARD Delta Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and 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.
These surgical masks are deltoid shape, waterfall-pleated devices manufactured from selected non-woven materials (polypropylene and wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative to the degree of protection required during intended use.
This document is a 510(k) premarket notification for a surgical mask (PRIMAGARD Delta Surgical Mask, K092012) and, as such, does not describe the acceptance criteria, specific study details, or performance results in the way a clinical study report or a detailed validation study would.
The provided text focuses on the regulatory submission process, declaring substantial equivalence to a predicate device (K081633), and outlining the intended use and technological characteristics.
Therefore, most of the information requested in your prompt (1-9) about acceptance criteria and study details cannot be extracted directly from this 510(k) summary and the accompanying FDA letter.
However, based on the context of a surgical mask 510(k) submission, we can infer some general points and identify what is not present:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. For surgical masks, acceptance criteria would typically relate to standardized tests مثل (but not limited to) bacterial filtration efficiency (BFE), particulate filtration efficiency (PFE), differential pressure (breathability), fluid resistance, and flammability. The document only mentions "optimal breathability, particulate filtration and a fluid-penetration barrier" as design goals but provides no specific quantitative criteria or performance data.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not present in the provided document.
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)
This information is not present in the provided document. The device is a physical product (surgical mask), not an AI/diagnostic tool requiring expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present and is not applicable for a physical product like a surgical mask.
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 present and is not applicable. MRMC studies are relevant for diagnostic devices (e.g., AI algorithms for interpreting medical images), not for surgical masks. There is no AI component mentioned or implied for this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not present and is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. For surgical masks, "ground truth" would correspond to the results of standardized biological, physical, and chemical tests to measure barrier properties and breathability, not expert consensus on medical images or pathology.
8. The sample size for the training set
This information is not present and is not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not present and is not applicable for the reasons mentioned in point 8.
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KO9 2012
510 (k) Summar
| Submitted by: | priMED#900, 10707-100 Ave.Edmonton, Alberta780-497-7600 |
|---|---|
| Contact Person: | Dr. Raymond G. Marusyk |
| Date Prepared: | June 10, 2009 |
| Proprietary Name: | PRIMAGARD DELTA Surgical Mask |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Mask, 878.4040; Product code FXX |
Predicate Device:
· Surgical Mask 510(k) #K081633
Description of the Device: These surgical masks are deltoid shape, waterfall-pleated devices manufactured from selected non-woven materials (polypropylene and wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative to the degree of protection required during intended use.
Intended Use of the Device: PRIMAGARD™ Delta Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and 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.
Technological Characteristics: The PRIMAGARD™ Delta Surgical Masks are technologically similar to the predicate device (K081633) in that both devices consist of non-woven barrier materials selected and arranged in such a manner as to provide, at the time of design, and under the conditions of use, optimal breathability and particulate filtration. The PRIMAGARD™ Delta Masks incorporate a deltoid design and include an elastomeric non-woven material as piping and headband
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Raymond G. Marusyk Director, Design and Development PriMED Medical Products, Incorporated #900, 10707-100 Avenue Edmonton, Alberta CANADA T5J-3M1
SEP 2 5 2009
Re: K092012
Trade/Device Name: PRIMAGARD Delta Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: September 15, 2009 Received: September 17, 2009
Dear Mr. Marusyk: .
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 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- Mr. Marusyk
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/Reporta Problem/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,
Century 29. Nov. 62
Susan Reynolds R.R.S. M.A.
Susan Runner, D.D.S., M.A Acting 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 Statement
S10(k) Number (if known)
Device Name PRIMAGARD Delta Surgical Masks
Indications PRIMAGARD Delta Surgical Masks are surgical apparel as identified in 21 for Use CFR 878.4040 and 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 particloste material.
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
Lahip Rangubi
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092012
§ 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.