(70 days)
Paneffort 3-ply Surgical and Procedural Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on. Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later. Paneffort 3-ply Surgical and Procedural masks are available in blue colour.
The provided text is a 510(k) Premarket Notification for Paneffort 3-Ply Surgical and Procedural Masks. It details the device's technical specifications, intended use, and comparative testing against predicate devices to demonstrate substantial equivalence.
Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:
Device: Paneffort 3-Ply Surgical and Procedural Masks
Regulatory Class: Class II
Product Code: FXX
Regulation Name: Surgical Apparel (21 CFR 878.4040)
The study focuses on non-clinical performance and biocompatibility testing, primarily against ASTM F2100 standards for surgical masks. It does not describe a study involving human readers or AI-assisted performance analysis, as the device is a physical medical mask, not a diagnostic AI system or image analysis tool. Therefore, questions 2, 3, 4, 5, 8, and 9 are largely not applicable as they pertain to clinical studies, AI performance evaluation, and ground truth establishment for such studies, which are not relevant to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM F2100-19e1, an FDA-recognized consensus standard for medical face mask materials. The performance results show that the Paneffort masks meet or exceed these criteria for both Level 2 and Level 3 masks.
| Parameters | Acceptance Criteria (ASTM F2100-19e1) | Reported Device Performance (Paneffort 3-Ply Surgical/Procedural Masks) | Comments |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥98% | Pass at >98% (for Level 2 and Level 3) | Meets criteria. Table 5 (page 5) lists ">99.9 %" for subject device and predicate, while Table 3 (page 9) states ">98%". The most stringent stated passing result for the subject device is ">99.9 %". The crucial point is that it Passes at > 98%. |
| Differential Pressure (Delta-P) (EN 14683 Annex C) | <6mm H2O/cm² | <6mm H2O/cm² (specifically 3.175 mmH2O/cm²) | Meets criteria. |
| Sub-micron Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥98% | Pass at >99% (for Level 2 and Level 3) | Meets criteria. Table 5 (page 5) lists "≥ 99.20%" for subject device and predicate, while Table 3 (page 9) states ">99%". The crucial point is that it Passes at > 98%. |
| Resistance to Penetration by Synthetic Blood (ASTM F1862) | ≥120 mm Hg (for Level 2) | Pass at ≥120 mm Hg (specifically ≥120 mm Hg, and tested at 160 mm Hg) | Meets criteria for both Level 2 and Level 3. The test result for the subject device is "Pass at 160 mm Hg", exceeding the 120 mm Hg requirement for Level 2 and meeting the 160 mm Hg requirement for Level 3. |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Meets criteria. |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Pass - Non-cytotoxic | Meets criteria. |
| Biocompatibility - Irritation (ISO 10993-10) | Non-irritating | Pass - Non-irritating | Meets criteria. |
| Biocompatibility - Sensitization (ISO 10993-10) | Non-sensitizing | Pass - Non-sensitizing | Meets criteria. |
2. Sample Size and Data Provenance
- Sample Size: The document does not specify the exact sample size for each performance test (e.g., how many masks were tested for BFE, PFE, etc.). It only provides the acceptance criteria and whether the tested product met them.
- Data Provenance: The data is gathered from non-clinical laboratory testing of the subject device (Paneffort 3-Ply Surgical and Procedural Masks). The manufacturer is Paneffort (Cambodia) Garment Co. Ltd. (Cambodia), and the legal manufacturer is PANEFFORT, LLC (USA). The testing was conducted in accordance with FDA-recognized consensus standards (ASTM and ISO). The document does not specify if the tests were performed retrospectively or prospectively, but typically, these are prospective tests conducted on representative samples of the manufactured product.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This is a non-clinical performance and biocompatibility study of a physical device (surgical mask), not an AI or image analysis system requiring expert review for ground truth establishment. The "ground truth" is the objective measurement defined by the standards (e.g., a BFE of >98%).
4. Adjudication Method for Test Set
- Not applicable. This is a non-clinical performance and biocompatibility study. Adjudication methods are relevant for clinical studies, especially those involving subjective assessments or disagreements among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This study does not involve human readers or AI assistance. It is a technical performance assessment of a surgical mask.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device and study type is established by objective, standardized test methods and criteria defined by international consensus standards (ASTM F2100-19e1, ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured directly against these established physical and biological benchmarks.
8. Sample Size for Training Set
- Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How Ground Truth for Training Set was Established
- Not applicable. As there is no training set for an AI model, this question is not relevant.
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Image /page/0/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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
July 25, 2022
Paneffort, LLC % Vardhini Kirthivas Regulatory Correspondent Freyr Solutions Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli Hyderabad, Telangana 500081 India
Re: K221409
Trade/Device Name: Paneffort 3-ply Surgical and Procedural Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 8, 2022 Received: June 10, 2022
Dear Vardhini Kirthivas:
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 medical devices and radiation-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.
for 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) K221409
Device Name Paneffort 3-Ply Surgical and Procedural Masks
Indications for Use (Describe)
Paneffort 3-Ply Surgical and Procedural Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a 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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Traditional 510(k) Paneffort 3-Ply Surgical and Procedural Masks
K221409 Page 1 of 8 PANEFFORT, LLC
510(k) Summary
Submitter Information:
Application Correspondent (US agent): Vardhini Kirthivas
| Freyr Global Regulatory Solutions and ServicesLevel 4, Building No. H-08, Phoenix SEZ,Phase 2, Gachibowli, Hyderabad,Telangana, India, 500081 | |
|---|---|
| Phone: | +91 - 9940445965 |
| E-mail: | usagent@freyrsolutions.com |
| Manufacturer: | Paneffort (Cambodia) Garment Co. Ltd.,National Road No.2, Kleang Sambatt,Pot Sar Ward, Bati District,Takeo 21309, Cambodia |
| Legal Manufacturer: | PANEFFORT, LLC700 Elmridge Center DriveRochester, NY 14626 |
| Phone: | +855 12284810 |
| Contact Person: | Harry |
E-mail: Fax Number (including area code): Date Prepared:
Phil@paneffort.com +855 12284810 11 May 2022
Device Identification:
| Device Trade Name: | Paneffort 3-ply Surgical and Procedural Masks |
|---|---|
| Device Classification name: | Surgical Mask |
| Regulation Name: | Surgical Apparel |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
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Predicate Devices:
Table 1 List of Predicate Devices
| Device Name | 510(k) Number | |
|---|---|---|
| Medical surgical Masks-Non-sterile | K202594 | Primary Predicate |
| Surgical Face Masks (Ear loops and Tie-on) | K160269 | Additional Predicate Device |
Device Description
The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on.
Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later.
Paneffort 3-ply Surgical and Procedural masks are available in blue colour.
| Sr.No. | Variants | ASTMLevel | Mask style | Colors | Item Number |
|---|---|---|---|---|---|
| 1. | PaneffortProcedure Masks | Level 2 | 3-ply Earloop Mask | Blue | (3PML2-EXEL-11) |
| 2. | PaneffortProcedure Masks | Level 3 | 3-ply Earloop Mask | Blue | (3PML3-EXEL-11) |
| 3. | Paneffort SurgicalMasks | Level 2 | 3-ply Tie-On Mask | Blue | (3PML2-SRTB-11) |
| 4. | Paneffort SurgicalMasks | Level 3 | 3-ply Tie-On Mask | Blue | (3PML3-SRTB-11) |
Models:
Intended Use & Indications for Use
Paneffort 3-ply Surgical and Procedural masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
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Comparison of Technological Characteristics
Table 2 Substantial Equivalence Table
| S.No | Parameters | Subject device | Primary Predicate | Additional Predicate Device | Comments | ||
|---|---|---|---|---|---|---|---|
| 1. | Product Name | Paneffort 3-ply Surgical andProcedural mask | Medical surgical Masks-Non-sterile | Surgical Face Masks (Earloops and Tie-on) | N/A | ||
| 2. | 510(k) Number | To be assigned | K202594 | K160269 | N/A | ||
| 3. | Manufacturer | PANEFFORT(CAMBODIA) GARMENTCO. LTD. | Shandong T&F Nonwoven Co.Ltd | SAN - M PACKAGE CO.,LTD | N/A | ||
| 4. | Product Code | FXX | FXX | FXX | Same | ||
| 5. | Regulation Number | 878.4040 | 878.4040 | 878.4040 | Same | ||
| 6. | Intended Use/Indications of Use | Paneffort 3-ply Surgical andProcedural Masks areintended 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 a single use,disposable device providednon-sterile. | The Medical Surgical Masks-Non-Sterile is intended to be wornto protect both the patient andhealthcare personnel from thetransfer of microorganisms, bodyfluids, and particulate material.The Medical Surgical Masks -Non-Sterile is intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile | The Surgical face masks areintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potential exposureto blood and body fluids thisis a single use, disposabledevice, provided non-sterile. | Same | ||
| 7. | Material ofConstruction | InnerLayer | Spunbound polypropylene | Polypropylene non-woven fabric | Polypropylene | Same | |
| OuterLayer | Spunbound polypropylene | Polypropylene non-woven fabric | Polypropylene | Same | |||
| MiddleLayer | Melt blown polypropylenefilter | Polypropylene meltblown fabric | 1. Polypropylene Spunbound2. Polypropylene Meltblown | Same | |||
| S.No | Parameters | Subject device | Primary Predicate | Additional Predicate Device | Comments | ||
| Ear loops | Spandex and polyamide | Polyamide and Polyurethane | Ear loops: Polyester, polyurethane | Different, does not raise any concerns with safety and effectiveness. Note 1 | |||
| Tie-On/Tie strip | Spunbound polypropylene | NA | Tie tapes: Polypropylene Spunbound or polyester Spunbound | Same | |||
| Nose Piece | Iron wire+Polypropylene+Zinc | PP + Iron wire | Polyethylene coated steel wire | Different, does not raise any concerns with safety and effectiveness. Note 2 | |||
| 8. | Dimensions | $(9.5 ±3) cm x (17.5 ± 5) cm$ | Length 17.5±5mmWidth 9.5±5mm | Length : 90± 3 mmWidth : 175± 5 mmLength : 90 ± 3 mmWidth : 180 ± 5 mm | Similar, does not raise any concerns with safety and effectiveness. Note 1 | ||
| 9. | Mask Style | Flat pleated | Flat Pleated | Flat - pleated | Same | ||
| 10. | Design Features | Ear loop, tie-on | Ear loops | Ear loop and Tie-On | Same | ||
| 11. | Sterility | Non- Sterile | Non-sterile | Non- Sterile | Same | ||
| 12. | Use | Single Use | Single use | Single Use | Same | ||
| 13. | Latex | Not made with Natural Rubber Latex | Not made with Natural Rubber Latex | Not made with Natural Rubber Latex | Same | ||
| 14. | ASTM E2100 Level | Level 2 and Level 3 | Level 2 | Level 2 and Level 3 | Same | ||
| S.No | Parameters | Subject device | Primary Predicate | Additional Predicate Device | Comments | ||
| Level 2 | Level 3 | ||||||
| 15. | Bacterial filtration efficiency | Pass at >99.9 %(ASTMF2101) | Pass at >99.9 %(ASTMF2101) | >99%(ASTM F2101) | Pass at > 98%(ASTMF2101) | Similar, Note3 | |
| 16. | Differential pressure (Delta-P) | 3.175mmH2O/cm²(EN 14683) | 3.182mmH2O/cm²(EN 14683) | < 4.8 mmH2O/cm²(MIL-M36945C) | Pass at 1.6mmH2O/cm²(MIL-M36945C) | Different,Note 4 | |
| 17. | Sub-micron particulate filtrationefficiency | Pass at ≥99.20%(ASTMF2299) | Pass at ≥99.20 %(ASTMF2299) | >99% | Pass at 99.6%(ASTMF2299) | Similar, Note5 | |
| 18. | Resistance to penetration bysynthetic blood, minimumpressure in mm Hg for passresult | ≥ 120 mmHg (ASTMF1862) | ≥ 160 mmHg(ASTMF1862) | Pass at 120mm Hg (ASTMF1862) | Pass at 120mm Hg(ASTMF1862) | Same | |
| 19. | Flammability | Class 1 as per 16 CFR Part1610 | Class 1(16 CFR Part 1610) | Class 1 (16 CFR Part 1610) | Same | ||
| 20. | Biocompatibility | Cytotoxicity,ISO 10993-5:2009 | Pass ISO 10993-5:2009/under the conditions ofstudy the subject device wasnon-cytotoxic | Not Cytotoxic | Pass ISO 10993-5:2009/under the conditions of studythe subject device was non-cytotoxic. | Same | |
| Irritation,ISO 10993-10:2010 | Pass ISO 10993-10:2010/under the conditions of thestudy, the subject devicewas non-irritating | Not an irritant | Pass ISO 10993-10:2010/under the conditions of thestudy, the subject device wasnon-irritating. | Same | |||
| Sensitization,ISO 10993-10:2010 | Pass ISO 10993-10:2010/under the conditions ofstudy, the subject devicewas non-sensitizing | Not Sensitive | Pass ISO 10993-10:2010/under the conditions of study,the subject device was non-sensitizing. | Same |
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PANEFFORT, LLC
Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks
{7}------------------------------------------------
PANEFFORT, LLC
Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks
Notel & Note2: The differences in the materials do not any and effectiveness. Performance testing including biocompatibility evaluation mentioned in Section 14 has been performed on the final finished device which includes all construction materials.
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PANEFFORT, LLC
Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks
Note 3: The performance requirement for BPE as per ASTM F2100 is >9%. The subject device meets the requirements of FDA recognized consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria.
Note 4: We understand that ML-M-36945C is the FDA recommended standard for differential pressure. However, the conformance to FDA Recognized conservass standard [Rec# 6-425], ASTM F2100-19 requires that Differential pressure be performed as per EN 14683:2019, Annex C.
We also understand that as per ASTM F2100-19, passing criteria for and Level 2 mask with respect to differential pressure is <6.0mm HJ0cm² when tested in accordance with EN 14683:2019, Annex C. The subject device meets the criteria.
Note 5: The performance requirement for PFE as per ASTM F2100 is ≥98% when tested in accordance with ASTM F2299. The performance of the subject device meets the requirements of FDA recognized consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria
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Non-Clinical Testing
The following performance tests, in accordance with ASTM F2100 were conducted for the subject device:
- . Bacterial filtration efficiency - ASTM F2100-19e1 Clause 9.1
- o ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus aureus.
- Differential Pressure ASTM F2100-19e1 Clause 9.2 ●
- EN 14683:2019 Medical face masks Requirements and test methods o Annex C - Method for determination of breathability (differential pressure)
- Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2100-19e1 ● Clause 9.3
- o ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- Resistance to Penetration by Synthetic Blood- ASTM F2100-19e1 Clause 9.4
- ASTM F1862 Standard test method for resistance of medical face masks to o penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- Flammability - ASTM F2100-19e1 Clause 9.5
- 16 CFR Part 1610 Standard for The Flammability of Clothing Textiles о
| S.No | TestMethod/Standard | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|
| 1. | ASTM F2100-19e1 Clause 9.4 | Resistance to penetration bysynthetic blood | 160mm Hg | Pass at 160mmHg |
| 2. | ASTM F2100-19e1 Clause 9.5 | Flammability of ClothingTextiles | Class I | Class I |
| 3. | ASTM F2100-19e1 Clause 9.2 | Differential Pressure (Delta-P) | ΔP <6mmH2O/cm² | ΔP <6mmH2O/cm² |
| 4. | ASTM F2100-19e1 Clause 9.3 | Sub-micron particulate filtrationefficiency | ≥98% | Pass at >99% |
| 5. | ASTM F2100-19e1 Clause 9.1 | Bacterial filtration efficiency | ≥98% | Pass at >98% |
Table 3 Table of Non-clinical Testing Standards
FDA's guidance, "Surgical Masks - Premarket Notification [510(k)] Submissions ", recommends evaluating the biocompatibility as described in the standard ISO10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for limited contact devices, contacting intact skin.
The following Biocompatibility End points have been identified and tested in accordance appropriate biocompatibility standards.
- -Cytotoxicity (ISO 10993-5)
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Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks
- Irritation or Intracutaneous Reactivity (ISO 10993-10) -
- -Sensitization (ISO 10993-10)
| Biologicalendpoint | TestMethod/Standard | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | Verify Cytotoxicitypotential of the subjectdevice | Non-cytotoxic | Pass - ISO 10993-5:2009/ under theconditions of studythe subject devicewas non-cytotoxic. |
| IrritationandSensitization | ISO 10993-10 | Verify irritation andsensitization potential ofthe subject device | Non-irritatingand non-sensitizing | Pass ISO 10993-10:2010/ under theconditions of thestudy, the subjectdevice was non-irritating. |
Table 4 Biocompatibility Testing – Summary
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than 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.