(22 days)
Perfetta Moderate Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene. The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex. A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose. The subject device is provided in blue color. The blue colorant is made of polypropylene master batch. This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable device, provided non-sterile.
The provided text is related to the FDA 510(k) premarket notification for a medical face mask, not an AI/ML medical device. Therefore, a direct response to your detailed questions regarding acceptance criteria, study design for AI/ML devices, and ground truth establishment is not applicable. The information describes the performance testing of a physical product (medical face mask) against established industry standards.
However, I can extract the acceptance criteria and the device's performance based on the provided document as it pertains to the Perfetta Moderate Medical Face Mask.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥29 out of 32 passed in 120 mmHg (Level 2) | ≥29 out of 32 passed in 120 mmHg (Level 2) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% at 0.1µm | ≥98% at 0.1µm | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | ≥98% | Pass |
| Differential Pressure (Delta P) | < 6 mmH2O/cm² | < 6 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 (≥ 3.5 seconds) | Class 1 (≥ 3.5 seconds) | Pass |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | The device is non-cytotoxic | Under the conditions of the studies, the device is non-cytotoxic. | Pass |
| Skin Sensitization (ISO 10993-10) | The device is non-sensitizing | Under the conditions of the studies, the subject device is non-sensitizing. | Pass |
| Skin Irritation (ISO 10993-23) | The device is non-irritating | Under the conditions of the studies, the device is non-irritating. | Pass |
Since this document describes a physical medical device (face mask) rather than an AI/ML-driven diagnostic or treatment device, the following questions are not directly applicable. I will indicate where the information is not present or not relevant to this type of submission.
2. Sample size used for the test set and the data provenance
- Sample size: The document states that "Performance testing were performed on three non-consecutive lots." For fluid resistance, the test involved 32 samples (≥29 out of 32 passed). For other performance attributes, the specific sample size per test, beyond "three non-consecutive lots," is not detailed but states that the sample size "is complied with ISO 2859-1, general inspection level II as FDA recommendation and acceptance quality limit (AQL) of 4%."
- Data provenance: Not explicitly stated regarding country of origin or retrospective/prospective for the testing of the device itself. The applicant and factory are based in Vietnam.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a physical product directly tested against objective, measurable performance standards (e.g., filtration efficiency, fluid resistance) defined by consensus standards (ASTM, ISO, CFR). There is no "ground truth" established by experts in the sense of interpreting medical images or data.
4. Adjudication method for the test set
- Not applicable for performance testing of a physical product against numerical standards. Results are pass/fail based on meeting the quantitative criteria.
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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Not applicable in the AI/ML context. For this medical device, the "ground truth" is established by direct physical, chemical, and biological testing against predefined, objective performance standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration efficiency, ISO 10993 for biocompatibility).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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September 2, 2022
Phu Bao Group Company Limited % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K222426
Trade/Device Name: Perfetta Moderate Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 9, 2022 Received: August 11, 2022
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222426
Device Name Perfetta Moderate Medical Face Mask
Indications for Use (Describe)
Perfetta Moderate Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
This 510(k) Summary as per 21 CFR 807.92
Date of submission: July 25, 2022
(1) Applicant information
| 510(k) Owner/ Applicant: | PHU BAO GROUP COMPANY LIMITED |
|---|---|
| Address: | Head office: |
| PHU BAO GROUP COMPANY LIMITED | |
| 5 floor, CJ Building, 02Bis-4-6 Le Thanh Ton Street, | |
| Ben Nghe Ward, District 1, Hochiminh city, Vietnam, 70000 | |
| Factory: | |
| PHU BAO MEDICAL CO., LTD | |
| Lot C21, D2 Road, Cau Tram Industrial Park, | |
| Long Trach Ward, Can Duoc Dist., | |
| Long An province, Vietnam. | |
| Contact: | Le Pham Minh Ngoc (Ms.) |
| Email: | info@phubaogroup.com.vn; |
| consultant.fda@phubaomedical.com | |
| Phone: | +84-28-3914 2980 |
| Owner/Operator Number: | 10074628 |
| FEI Number: | 3016615220 |
| US Agent: | THANH PHONG KIEM NGUYEN GOLUS LLC at address: |
| 421 Sletten Drive, Lawrenceville, GA US 30046 | |
| Contact of US agent: | THANH PHONG KIEM NGUYEN, Phone: 470 4189790, |
| Email: golus@gol.vn | |
| Correspondent: | Regulatory Technology Services at address: 1000 |
| Westgate Drive, Suite #510, Saint Paul, Minnesota, 55114 | |
| Contact of Correspondent: Ms. Prithul Bom - Accredited Person, Reviewer | |
| Phone 612-963-0379 |
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Email: prithul.bom@rts3pro.com
(2) Subject device
| Trade name: | Perfetta Moderate Medical Face Mask |
|---|---|
| Model number: | PT3B50 |
| Common Name: | Surgical Face Mask |
| Classification Name: | Masks, Surgical |
| Review Panel: | General Hospital |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
(3) Predicate device
| Submitter: | MEGASOFT(CHINA) CO., LTD |
|---|---|
| Device name: | Surgical Face Mask |
| 510(k) number: | K213617 |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
(4) Description of device
The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene.
The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex.
A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose.
The subject device is provided in blue color. The blue colorant is made of polypropylene master batch.
This subject device is provided with size 17.5 cm ± 0.5 cm.
The subject device is single-use, disposable device, provided non-sterile.
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(5) Indications for use
Perfetta Moderate Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 510 (k)number | - | K213617 | Notapplicable |
| Applicant | PHU BAO GROUPCOMPANY LIMITED | MEGASOFT(CHINA) CO.,LTD | Notapplicable |
| ProductName | Perfetta Moderate MedicalFace Mask | Surgical Face mask | Notapplicable |
| Modelnumber | PT3B50 | MGSM-01 | Notapplicable |
| Device class | Class II Device, FXX(21 CFR 878.4040) | Class II Device, FXX(21 CFR 878.4040) | Same |
| Indicationsfor Use | Perfetta Moderate MedicalFace Mask is intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Thissurgical face mask isintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. This issingle use, disposabledevice, provided non-sterile. | The Surgical Face Mask isintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is single use,disposable device(s),provided non-sterile. | Same |
| Material | |||
| Outer layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Meltblown polypropylene | Meltblown polypropylene | Same |
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Nose piece | Zinc wire with polypropylenecoating | Polypropylene, iron and zinc | Different |
| DesignFeatures | Ear loops: 80% polyester20% spandex | Ear loops: elastics film | Similar |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Color | Blue | Blue | Same |
| SpecificationandDimension | Length: 17.5cm±0.5cmWidth: 9.5cm±0.5cm | Length: 17.5cm±0.5cmWidth: 9.5cm±0.5cm | Same |
| Dimensionear loops | Length: 17.5cm±0.5cmWidth: 0.40cm±0.02cm | - | Different |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance Characteristics | |||
| FluidResistancePerformanceASTMF1862 | Pass at 120 mmHg(Level 2 Fluid Resistance) | Pass at 120 mmHg(Level 2 Fluid Resistance) | Same |
| ParticulateFiltrationEfficiencyASTMF2299 | ≥98% at 0.1µm | ≥98% at 0.1µm | Same |
| BacterialFiltrationEfficiencyASTMF2101-19 | ≥98% | ≥98% | Same |
| DifferentialPressure(Delta P) | < 6 mmH2O/cm² | < 6 mmH2O/cm² | Same |
| Flammability16 CFR1610 | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudies, the subject device isnon-cytotoxic | Under the conditions of thestudy, the device is non-cytotoxic | Same |
| Irritation | Under the conditions of thestudies, the subject device isnon-irritant | Under the conditions of thestudy, the device is non-irritating | Same |
| Sensitization | Under the conditions of thestudies, the subject device isnon-sensitizer | Under the conditions of thestudy, the device is non-sensitizing | Same |
(6) Comparison of Technological Characteristics and Performance testing with the Predicate device
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The subject device is same indication for use, design style, dimension of size, component of material (except nose piece), performance characteristics and biocompatibility with predicate device.
The subject device is different material of nose piece to predicate device. The subject device which was included the nose piece had been tested and the result was complied with acceptance criteria. This result demonstrates that the difference on material of nose piece do not affect the safety performance and effectiveness of subject device.
The component of ear loop of subject device is similar with predicate device but clearly claim the percent of composition.
The subject device is provided with detail dimension of ear loops but cannot compare with predicate device because no information about dimension of ear loops of predicate device is mentioned in its 510(k) summary. The subject device which was included the ear loop with its dimension had been tested and the result was complied with acceptance criteria. This result demonstrates that the difference on dimension of ear loop do not affect the safety performance and effectiveness of subject device.
| Performance characteristics | |||
|---|---|---|---|
| Test Method | Subject Device | Acceptance Criteria | Conclusion |
| Fluid ResistancePerformanceASTM F1862 | ≥29 out of 32 passed in120 mmHg(Level 2) | ≥29 out of 32 passed in120 mmHg(Level 2) | Pass |
| Particulate FiltrationEfficiencyASTM F2299 | ≥98% at 0.1µm | ≥98% at 0.1µm | Pass |
(7) Summary of Non-clinical test
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| Bacterial FiltrationEfficiencyASTM F2101-19 | ≥98% | ≥98% | Pass |
|---|---|---|---|
| DifferentialPressure (Delta P) | < 6 mmH2O/cm² | < 6.0 mm H2O/cm² | Pass |
| Flammability16 CFR 1610 | Class 1 (≥ 3.5 seconds) | Class 1 (≥ 3.5 seconds) | Pass |
Performance testing were performed on three non-consecutive lots to support that the performance specification are maintained cross production lots and the lot-to-lot variability in performance is acceptable.
Sample size of each lot is complied with ISO 2859-1, general inspection level II as FDA recommendation and acceptance quality limit (AQL) of 4%.
The results of performance testing of subject device demonstrate that the subject device met all design specification as was same to predicate device, complied with requirements in quidance: "Surgical Masks – Premarket Notification [510(k)] Submissions", complied with standard ASTM F2100 at level 2.
| Biocompatibility | |||||
|---|---|---|---|---|---|
| Standard | Subject Device | AcceptanceCriteria | Conclusion | ||
| CytotoxicityISO 10993-5 | Under the conditions of the studies,the device is non-cytotoxic. | The device isnon-cytotoxic | Pass | ||
| SkinSensitizationtest ISO10993-10 | Under the conditions of the studies,the subject device is non-sensitizing | The device isnon-sensitizing | Pass | ||
| Skin Irritationtest ISO10993-23 | Under the conditions of the studies,the device is non-irritating. | The device isnon-irritating | Pass |
The biocompatibility evaluation of this subject device was conducted according to ISO 10993-1: nature of body contact of the subject device is belonged to category Surface device, intact skin, with contact duration A-limited (≤24h)
The subject device was evaluated in its final finished form, in blue color.
The results of biocompatibility testing of subject device demonstrate that the subject device is biocompatible and safe for its intended use.
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(8) Summary of Clinical test
No clinical study is included in this submission.
(9) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
§ 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.