(654 days)
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
Non-sterile surgical face mask, white, yellow, pink, blue and green.
Here's a breakdown of the acceptance criteria and study information based on the provided documents:
Acceptance Criteria and Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance | ASTM F-1862-00a | No visual detection of penetration | No visual detection of penetration |
| Filter Efficiency Performance (Microns) | Not explicitly stated | Passed 2.0 Micron Test | Passed 2.0 Micron Test |
| Bacterial Filtration Efficiency (BFE) (%) | ASTM F-2101-01 | Not explicitly stated (implied >96.4% from predicate) | 97.9% |
| Differential Pressure (Delta-P) | MIL M 36945C4.4.1.1.1 | Not explicitly stated (implied <3 from predicate) | 1.8 |
| Flammability Class | 16 CFR 1610 | Flammability Class 2 | Flammability Class 2 |
Study Details
The provided document describes a 510(k) Premarket Notification for a surgical face mask (K022256). This type of submission in the US regulatory framework for medical devices does not involve clinical trials or studies like those typically conducted for AI/software devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device already on the market.
Therefore, many of the requested details, such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this type of device and submission.
Here's what can be inferred or explicitly stated based on the provided text:
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the face mask undergoing standardized laboratory tests. The data provenance is from tests conducted on samples of the manufactured device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical performance tests is established by the standardized test methods themselves and measured by laboratory equipment, not by human experts.
- Adjudication method for the test set: Not applicable. Results are quantitative or visually assessed according to the standard.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a diagnostic device involving human interpretation of cases.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable. This is a physical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is defined by the objective measurements and criteria within the specified ASTM and MIL standards. For example, "no visual detection of penetration" is a direct observational outcome of the ASTM F-1862-00a fluid resistance test.
- The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device testing in this context.
- How the ground truth for the training set was established: Not applicable.
Summary of the "study" for this device:
The "study" involved performing a series of standardized laboratory tests on the surgical face mask (K022256) and comparing its performance characteristics to both pre-defined acceptance criteria (where available) and the performance of a legally marketed predicate device (K970835). The goal was to demonstrate that the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, based on its physical performance.
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APR 2 6 2004
510(k) SUMMARY K022256
| Submitted For: | TUCKER & ASSOCIATES198 Ave. de la D'emeraldSparks, Nevada 89434-9550 |
|---|---|
| Submitted by: | JANNA P. TUCKER, President - CEOAnd Official Correspondent forTucker & Associates198 Avenue de la D'emeraldSparks, NV 89434Phone: 775-342-2612Fax: 775-342-2613E-mail: Tuckerjan@aol.com |
| Date of Submission: | Original: 12 July 2002, "Add to File" revisions andadditions 2 April 2004 |
| Classification Name: | Surgical Face Mask, FXX, Class 2 Device |
| Proprietary Name:Common Name:Regulatory Reference:Predicate Device: | (Multiple Labels)Face Mask, Surgical21 CFR 878.Face Mask, Surgical Mask, K970835 |
| Labels/Labeling: | This device will be marketed to medical device suppliers,Dentist and Doctor Offices, Clinics, Emergency ResponseProfessionals, Hospitals and other healthcare professionalsfor the Intended Use purposes below. |
| Intended Use: | This device is intended to be worn to protect both thepatient and healthcare personnel from transfer ofmicroorganisms, body fluids and particulate material. |
| Description: | Non-sterile surgical face mask, white, yellow, pink, blueand green. |
| Substantial Equivalence: | This device is equivalent to one in commercial distributionapproved K970835, but specifically, and most importantly,it has passed all recommended standards and/or tests asfollows: |
| Standards and/or tests: | |
| ASTM F2299-03 | ...materials used in Face Masks |
| ASTM F1862-00a | ...Resistance of Medical Face Masks to Penetration |
| By Synthetic Blood | |
| ASTM F2101-01 | |
| Medical Face Mask Materials. | |
| MIL M 36945C4.4.1.1.1 | |
| 15 CFR 1610.4 | Flammability Class - tested at flammability Class 2 |
| Biocompatibility and Agar Diffusion Tests successfully completed. |
EXHIBIT J
Page 73 of 88
Revised 04-02-04
gk
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Page 2, 510(k) Summary K022256
Performance Characteristics Test Method Acceptance Criteria/Results
| Fluid Resistance Performance | ASTM F-1862-00a | No visual detection of penetration |
|---|---|---|
| Filter Efficiency Performance | 2.0 Microns | Passed 2.0 Micron Test |
| Bacterial Filtration EfficiencyPerformance (%) (BFE) | ASTM F-2101-01 | Passed at 97.9% |
| Differential Pressure (Delta-P) | MIL M 36945C4.4.1.1.1 | Passed at 1.8 |
| Flammability Class | 16 CFR 1610 | Passed at Flammability Class 2 |
EQUIVALENCY COMPARISONS:
| Current Device | ||
|---|---|---|
| K970835 | K022256 | |
| Fluid Resistance | Fluid Resistant | No visual penetration |
| Filter Efficiency Performance (microns) | 2.9 microns | 2.0 microns |
| BFE % | 96.4% | 97.9% |
| Delta-P | 1.7 | 1.8 |
| Flammability Class | 3 | 2 |
Conclusion:
This device is substantially equivalent to the device approved as K970835
EXHIBIT J
Page 74 of 88
Revised 04-02-04
gt.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is a symbol that looks like three stylized waves or lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Tucker & Associates Ms. Janna Tucker Official Correspondents 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K022256
Trade/Device Name: Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: April 2, 2004 Received: April 6, 2004
Dear Ms. Tucker:
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.
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Page 2 - Ms. Tucker
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
TUCKER AND ASSOCIATES APPLICANT: -KO22256 510(k) NUMBER:
DEVICE NAME: SURGICAL FACE MASK Colors: White, Yellow, Pink, Blue And Green
This device is intended to be worn 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 (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kevin Mulvey
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K022254
Page 1 of
§ 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.