(316 days)
The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
The PRECISION ECO™ Compostable / Plant Based Procedural Masks with Earloops are single use, ASTM Level 3 disposable devices, provided non-sterile. The mask has a four-layer, flat, pleated body with two earloops and a malleable nose piece. All components of the mask design are bonded together via ultrasonic welding, and it does not include any drugs, biologics, or nanoparticles. The mask comes in one configuration with two (2) different color schemes: black (100195), and white (100196).
The provided text is a 510(k) summary for the PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on laboratory performance testing rather than studies involving AI or human readers for diagnostic purposes.
Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria, in the context of an AI/human reader diagnostic device, cannot be extracted from this document. The document describes acceptance criteria and testing for a medical face mask, not a diagnostic AI device.
However, I can provide the acceptance criteria and the (laboratory) study results for the medical face mask as presented in the document:
1. A table of acceptance criteria and the reported device performance
Based on the "TABLE V: STANDARDS AND ACCEPTANCE CRITERIA" and the statement "The device met the acceptance criteria for both production lots and artificially aged samples" in the document, we can infer that the reported performance met these criteria. The document does not provide specific numerical results for each test, only that the acceptance criteria were met.
| Characteristic | Test Method | Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|---|
| Bacterial filtration Efficiency (BFE) | ASTM F2101-19: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus | ≥ 98% | Met Criteria (≥ 98%) |
| Sub-micron particulate efficiency at 0.1 µm (PFE) | ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | ≥ 98% | Met Criteria (≥ 98%) |
| Blood Penetration | ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | @160 mm Hg | Met Criteria (@160 mm Hg) |
| Differential Pressure | EN 14683:2019 Annex C: Medical face masks - Requirements and test methods | < 6.0 mm H2O/cm² | Met Criteria (< 6.0 mm H2O/cm²) |
| Flammability | 16 CFR Part 1610: Standard for the Flammability of Clothing Textiles | Class 1 (≥3.5 s flame spread) | Met Criteria (Class 1, ≥3.5 s flame spread) |
| Cytotoxicity | ISO10993-5: Biological evaluation of medical devices -Part 5: Tests for invitro cytotoxicity. | ≤ Grade 2 | Met Criteria (≤ Grade 2) |
| Irritation | ISO10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity. | Non-irritant | Met Criteria (Non-irritant) |
| Sensitization | ISO10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity. | Non-sensitizer | Met Criteria (Non-sensitizer) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "The performance testing was conducted on production lots and on artificially aged samples." It does not specify the exact sample size (the number of masks tested for each characteristic) or the country of origin of the data. It is implicitly prospective testing as new masks were produced and tested, along with artificially aged samples.
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 applicable. The device is a medical face mask, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device is based on standardized laboratory test methods for material properties and filtration efficiency.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is laboratory testing of a physical product, not diagnostic image interpretation.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device. The testing described is performance testing of the physical mask itself in a laboratory setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance claims of the medical face mask is based on the results obtained from standardized laboratory test methods, as listed in Table V (e.g., ASTM F2101-19 for BFE, ASTM F2299 for PFE, ASTM F1862 for blood penetration). These are objective, quantitative measurements derived from specific protocols.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 11, 2023
PADM Medical Inc. Pablo Batista Vice President of Engineering Operations 1595 Buffalo Place - Unit A Winnipeg, Manitoba R3T 1L9 Canada
Re: K221209
Trade/Device Name: PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX
Dear Pablo Batista:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 8, 2023. Specifically, FDA is updating this SE Letter for a typo in the trade name in the Indications for Use Form as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, brent.showalter@fda.hhs.gov.
Sincerely,
Brent Showalter -S
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
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
March 8, 2023
PADM Medical Inc. Pablo Batista Vice President of Engineering and Operations 1595 Buffalo Place - Unit A Winnipeg, Manitoba R3T 1L9 Canada
Re: K221209
Trade/Device Name: PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 12, 2023 Received: January 17, 2023
Dear Pablo Batista:
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 -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221209
K221209 Page 1 of 1
Device Name
PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops
Indications for Use (Describe)
The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Designation Under Part 61 CFR 901 Subpart F | |
|---|---|
| On-The-Ground Use Under 49 CFR 901 Subpart G |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| Date of Summary Prepared: | March 3rd, 2023 |
|---|---|
| 510(K) Number: | K221209 |
| Applicant: | PADM Medical Inc. |
| Unit A - 1595 Buffalo Place | |
| Winnipeg, MB R3T 1L9 | |
| Canada | |
| Primary Contact: | Pablo Batista |
| Phone: +1 (204) 289 4491 x233 | |
| Email: pbatista@precisionadm.com | |
| Device Name | PRECISION ECO™ Compostable / Plant Based Procedural Mask with |
| Earloops | |
| Model Number | Black: 100195 |
| White: 100196 | |
| Device Classification Name | Mask, Surgical |
| Trade Name | PRECISION ECO™ Compostable Procedural Mask with Earloops |
| PRECISION ECO™ Plant Based Procedural Mask with Earloops | |
| Classification | Class II 21 CFR 878.4040 |
| Regulatory Medical Specialty | General and Plastic Surgery |
| Product Code | FXX |
| Primary Predicate Device | K211762 |
| Company Name: Altor Safety | |
| Device Name: Altor Safety 4-Ply Surgical Mask (Model: 62232) |
Indications for Use
The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
Device Description
The PRECISION ECO™ Compostable / Plant Based Procedural Masks with Earloops are single use, ASTM Level 3 disposable devices, provided non-sterile. The mask has a four-layer, flat, pleated body with two earloops and a malleable nose piece. All components of the mask design are bonded together via ultrasonic welding, and it does not include any drugs, biologics, or nanoparticles. The mask comes in one configuration with two (2) different color schemes: black (100195), and white (100196).
TABLE / lists all materials used in the mask.
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TABLE /: MATERIALS
| Raw Material | Product Details |
|---|---|
| Inner LayerApplicable to both models: 100195 and 100196 | Spunbond nonwoven polylactide resin fabric |
| Middle LayerApplicable to both models: 100195 and 100196 | Meltblown nonwoven polylactide resin fabric |
| Outer Layers (Qty 2)(White)Applicable to white product: 100196 | Spunbond nonwoven natural polylactide resin fabric |
| Outer Layers (Qty 2)(Black)Applicable to black product: 100195 | Spunbond nonwoven black polylactide resin fabric |
| Nose PieceApplicable to both models: 100195 and 100196 | Aluminum |
| Ear Loops(White)Applicable to white product: 100196 | Round woven polyester/spandex |
| Ear Loops(Black)Applicable to black product: 100195 | Round woven polyester/spandex |
The following TABLE // outlines a comparison of the materials used for each model number (color) of mask. As evident from the materials comparison, the only difference between each device is the colorant used in the outer layers and earloops for each model.
TABLE //: COMPARISON BLACK (100195) AND WHITE (100196) MODEL(S)
| Raw Material | Black (100195) | White (100196) |
|---|---|---|
| Inner Layer | Spunbond nonwoven polylactide resinfabric | Spunbond nonwoven polylactide resin fabric |
| Middle Layer | Meltblown nonwoven polylactide resinfabric | Meltblown nonwoven polylactide resin fabric |
| Outer Layers(Quantity 2) | Spunbond nonwoven polylactide resinfabric with colorant | Spunbond nonwoven polylactide resin fabric |
| Nose Piece | Aluminum | Aluminum |
| Ear Loops | Round woven polyester/spandex withcolorant | Round woven polyester/spandex |
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Image /page/6/Picture/2 description: The image shows a diagram of a face mask with its different layers. The inner layer is white, the middle layer is meltblown, and the outer layers are black. There are two outer layers labeled as 'Outer Layer 1 Black' and 'Outer Layer 2 Black'.
FIGURE 1: DEVICE REPRESENTATIVE ILLUSTRATION (Black product 100195) Instructions for use for the mask are located on the box artwork and read as follows. Hold mask by ear loops with the nose clip at the top. Ensure the logo side or colored side is facing outward. Place one ear loop around each ear. Bend the nose clip to match the shape of the nose and ensure there are no gaps. While holding the nose clip at the bridge of your nose, pull the mask down under your chin. Properly dispose of the mask by touching only the ear loops
Technical Comparison to Primary Predicate Device
TABLE /// provides a classification comparison between the PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops and the Primary Predicate Device manufactured by Altor Safety.
| Characteristic | Subject Device | Primary Predicate Device | Result |
|---|---|---|---|
| Manufacturer | PADM Medical Inc. | Altor Safety | N/A |
| Device Name | Surgical Mask | Surgical Mask | N/A |
| Model | Black: 100195White: 100196 | 62232 | N/A |
| 510K | Pending. | K211762 | N/A |
| Device Class,product code,regulation # | Class II, FXX (21 CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Intended Use | The PRECISION ECOTMCompostable / Plant BasedProcedural Mask with Earloops isintended to be worn to protect boththe patient and healthcareprofessional from transfer ofmicroorganisms, body fluids, andparticulate material. ThePRECISION ECOTM Compostable /Plant Based Procedural Mask withEarloops is intended for use ininfection control practices to reduce | The Altor Safety 4-Ply SurgicalMask is intended to be worn toprotect both the patient andhealthcare professional fromtransfer of microorganisms,body fluids, and particulatematerial. The Altor Safety 4-PlySurgical Mask is intended foruse in infection control practicesto reduce the potential exposureto blood and body fluids. This is | Same |
|--|
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| the potential exposure to blood andbody fluids. This is a single use,non-sterile, disposable device. | a single use, non- sterile,disposable device. |
|---|---|
| -------------------------------------------------------------------------------------------------------------- | --------------------------------------------------- |
TABLE /V provides a comparison of materials used in the PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops and the Primary Predicate Device manufactured by Altor Safety.
| Characteristic | Subject Device | Primary Predicate Device | Result |
|---|---|---|---|
| Color | Black/White | Blue | Different |
| Disposable | Yes | Yes | Same |
| Mask Style | Flat pleated | Flat pleated | Same |
| Outer Layer 1Material | Polylactide resin spunbondnonwoven fabric | Spunbond polypropylene(SBPP) | Different |
| Outer Layer 2Material | Polylactide resin spunbondnonwoven fabric | Spunbond polypropylene(SBPP) | Different |
| Filter Layer Material | Polylactide resin meltblownnonwoven | Meltblown Polypropylene(MBPP) | Different |
| Inner Layer Material | Polylactide resin spunbondnonwoven fabric | Spunbond Polypropylene(SBPP) | Different |
| Nose Piece Material | Aluminum | Virgin polyethylene plastic 24gauge soft annealed carbonsteel, and kraft paper | Different |
| Earloop Material | Polyester/ spandex | Spandex/nylon | Similar |
| Earloop Style | Round knitted earloop | Round knitted earloop | Same |
| Mask Body L X W | (170mm-180mm) x(90mm-100mm) | (171.45mm-177.8mm) x(92mm) | Similar |
| Earloop | Yes | Yes | Similar |
TABLE /V: MATERIALS COMPARISON TO PRIMARY PREDICATE DEVICE(S)
The difference in materials, nose piece material, and mask dimensions does not impact the safety and effectiveness of the subject device as the subject device's performance is equivalent to the Primary Predicate Device. As evident in TABLE IV, the base materials and configuration for each product color (black/white) are identical. The colorant is not influencing the performance of the device, due to the extremely low concentration present in the device.
The performance requirements and test criteria are listed in TABLE V. The performance testing was conducted on production lots and on artificially aged samples. Accelerated aging was conducted per ASTM 1980-21: Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. The device met the acceptance criteria for both production lots and artificially aged samples.
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| Characteristic | Test Method | Acceptance Criteria |
|---|---|---|
| Bacterial filtrationefficiency (BFE) | ASTM F2101-19: Standard Test Method for Evaluating theBacterial Filtration Efficiency (BFE) of Medical Face MaskMaterials, Using a Biological Aerosol of Staphylococcusaureus | ≥ 98% |
| Sub-micronparticulateefficiency at 0.1 µm(PFE) | ASTM F2299: Standard Test Method for Determining theInitial Efficiency of Materials Used in Medical Face Masks toPenetration by Particulates Using Latex Spheres | ≥ 98% |
| Blood Penetration | ASTM F1862: Standard Test Method for Resistance ofMedical Face Masks to penetration by Synthetic Blood(Horizontal Projection of Fixed Volume at a Known Velocity) | @160 mm Hg |
| DifferentialPressure | EN 14683:2019 Annex C: Medical face masks -Requirements and test methods | < 6.0 mm H2O/cm² |
| Flammability | 16 CFR Part 1610: Standard for the Flammability ofClothing Textiles | Class 1 (≥3.5 s flamespread) |
| Cytotoxicity | ISO10993-5: Biological evaluation of medical devices -Part5: Tests for invitro cytotoxicity. | ≤ Grade 2 |
| Irritation | ISO10993-10: Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-typehypersensitivity. | Non-irritant |
| Sensitization | ISO10993-10: Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-typehypersensitivity. | Non-sensitizer |
TABLE V: STANDARDS AND ACCEPTANCE CRITERIA
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and is substantially equivalent to the legally marketed Primary Predicate Device [K211762].
§ 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.