(161 days)
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4).
The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3.
The mask is sold non-sterile and intended to be a single-use, disposable device.
The requested information pertains to a medical surgical mask, which is a physical device, not an AI/ML powered device. Therefore, acceptance criteria and study details relevant to AI/ML powered devices are not applicable.
However, based on the provided document, I can extract the acceptance criteria and performance data for the physical medical surgical mask for Level 1 and Level 3 performance, as well as biocompatibility testing.
Here's the relevant information about the acceptance criteria and the study that proves the device meets these criteria, focusing on the available context for a physical medical surgical mask:
1. A table of acceptance criteria and the reported device performance
Medical Surgical Mask (Level 1)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 95% | 32/32 Passed at ave. 99.3% |
| Differential Pressure (Delta-P) | < 5.0 mm H2O/cm² | 32/32 Passed at ave. 3.7 mm H2O/cm² |
| Particulate Filtration Efficiency | ≥ 95% | 32/32 Passed at ave. 98.12% |
| Resistance to penetration by synthetic blood | Fluid resistant claimed at 80 mmHg | 32/32 Passed at 80 mmHg |
| Flame Spread | Class 1 | 32/32 Passed ≥ 3 Seconds burn Time - Class 1 |
Medical Surgical Mask (Level 3)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 98% | 32/32 Passed at ≥ 99.8% |
| Differential Pressure (Delta-P) | < 6.0 mm H2O/cm² | 32/32 Passed at < 4.24 mm H2O/cm² |
| Particulate Filtration Efficiency | ≥ 98% | 32/32 Passed at ≥ 99.58% |
| Resistance to penetration by synthetic blood | Fluid resistant claimed at 160 mmHg | 32/32 Passed at 160 mmHg |
| Flame Spread | Class 1 | 32/32 Passed ≥ 3 Seconds burn Time - Class 1 |
Biocompatibility Testing
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| In vitro Cytotoxicity Test | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: For the performance tests (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Resistance to penetration by synthetic blood, and Flame Spread), the reported sample size is 32/32 Passed, which implies 32 samples were tested for each performance criterion. The number of samples for biocompatibility tests is not explicitly stated but would typically involve biological samples.
- Data Provenance: Not explicitly stated in terms of country of origin. The submitter is "GUANGDONG KINGFA SCI.&TECH. CO., LTD." from China. The tests are non-clinical (laboratory-based) performance tests, not human data. The tests are prospective in nature, as they are performed on manufactured masks to ensure they meet standards.
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 is not applicable for this type of device. The "ground truth" for the performance tests is established by adhering to recognized international standards (e.g., ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, ASTM F1862/F1862M-17, 16 CFR Part 1610, and ISO 10993 series for biocompatibility). These standards define the test methodologies and pass criteria. The testing would be performed by qualified laboratory technicians in accordance with these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The tests performed are objective, quantitative laboratory tests with defined pass/fail criteria from international standards. There is no subjective interpretation requiring expert adjudication in the manner of medical image analysis.
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 a physical medical device (mask), not an AI/ML powered device, and therefore does not involve human readers interpreting output or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device without any algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is defined by adherence to established international standards and their specified methodologies and acceptance limits. For example, the Bacterial Filtration Efficiency testing is conducted according to ASTM F2101-14, and biocompatibility according to ISO 10993-5 and ISO 10993-10.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for a physical device, this question is irrelevant.
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April 5, 2022
Guangdong Kingfa Sci.&Tech. Co., Ltd. Yu Xiaoge Product Certification Engineer 28 Delong Avenue, Shijiao Town, Qingcheng District Qingyuan City, Guangdong 511500 China
Re: K213450
Trade/Device Name: Medical surgical mask (Black mask, Level 1 and Level 3) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 25, 2022 Received: March 1, 2022
Dear Yu Xiaoge:
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.
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
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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,
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K213450
Device Name
Medical surgical mask (Black mask, Level 1 and Level 3)
Indications for Use (Describe)
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K213450
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: GUANGDONG KINGFA SCI.&TECH. CO., LTD. Establishment Registration Number: 3016785267 Address: No.28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China Postal Code:511500 Tel: +86 2632 8999 Fax: +0763-3203108 Contact Person (including title): Yu Xiaoge (Product certification engineer) E-mail: yuxiaoge@kingfa.com.cn
Date of the summary prepared: April 4, 2022
2. Subject Device Information
Common Name: Medical surgical mask Classification Name: Mask, Surgical Trade Name: Medical surgical mask (Black mask, Level 1 and Level 3) Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
3. Predicate Device Information
3.1. Predicate Device Information
Sponsor: Guangdong KINGFA Sci.&Tech.Co.,Ltd. Trade/Device Name: Medical surgical mask Classification Name: Mask, Surgical Common Name: Mask, Surgical 510(K) Number: K201622 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040
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Regulation Class: II
3.2. Predicate Device Information
Sponsor: Guangdong KINGFA Sci.&Tech.Co.,Ltd. Trade/Device Name: Medical surgical mask Classification Name: Mask, Surgical Common Name: Mask, Surgical 510(K) Number: K202139 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II
4. Device Description
The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4).
The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3.
The mask is sold non-sterile and intended to be a single-use, disposable device.
5. Intended Use / Indications for Use
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorqanisms, bodily fluids, and particulate matters This device is single use and provided non-sterile.
6. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
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| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict | |
|---|---|---|---|---|---|
| Company | GuangdongKINGFASci.&Tech.Co.,Ltd. | Guangdong KINGFASci.&Tech.Co.,Ltd. | Guangdong KINGFASci.&Tech.Co.,Ltd. | -- | |
| Trade Name | Medical surgicalmask | Medical surgicalmask | Medical surgicalmask | -- | |
| ClassificationName | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same | |
| 510(k) Number | K213450 | K201622 | K202139 | -- | |
| Product Code | FXX | FXX | FXX | Same | |
| Classification | Class II | Class II | Class II | Same | |
| Intended Use /Indications forUse | Medical surgicalmask is intended foruse by healthcareworkers duringprocedures toprotect both patientsand healthcareworkers againsttransfer ofmicroorganisms,bodily fluids, andparticulate mattersThis device is singleuse and providednon-sterile. | Medical surgicalmask is intended foruse by healthcareworkers duringprocedures toprotect both patientsand healthcareworkers againsttransfer ofmicroorganisms,bodily fluids, andparticulate mattersThis device is singleuse and providednon-sterile. | This product isindicated for infectioncontrol practices inthe health careindustry. When wornproperly, the MedicalSurgical Mask isintended to protectboth patient andwearer from thetransfer ofmicroorganisms,body fluids andparticulate material. | Same | |
| Material | |||||
| Outer facinglayer | Polypropylene | Polypropylene | Polypropylene | Same | |
| Middle layer | Polypropylene melt-blown | Polypropylene melt-blown | Polypropylene melt-blown | Same | |
| Inner facinglayer | Polypropylene | Polypropylene | Polypropylene | Same | |
| Nose clip | Polypropylene andmetallic iron | Polypropylene andmetallic iron | Iron corepolypropylene strip | Same | |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict | |
| Ear loops | Polypropylene | Polyester andspandex elasticband | Polyester andspandex elasticbands | DifferentNote 1 | |
| Designfeatures | Color: black | Color: blue | Color: blue | DifferentNote 1 | |
| Mask Style | Ear loop flat | Ear loop Flat | Ear loop flat | Same | |
| SpecificationandDimension | 17.59.5; 14.59.5cm;Ear loops:150-185mm | 17.5cmx9.5cm | 17.5cmx9.5cm | DifferentNote 1 | |
| OTC use | Yes | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use,Disposable | Single Use,Disposable | Single Use,Disposable | Same | |
| Product performance (Level 1) | |||||
| PerformanceTesting(according toASTM-2100:2019) | Level 1 | Level 1 | -- | Same | |
| BacterialFiltrationEfficiency | Passed atave.99.3% | 99.2% | -- | SimilarNote 2 | |
| DifferentialPressure | Passed at ave.3.7mmH2O/ cm² | <5.0 mmH2O/ cm² | -- | SimilarNote 2 | |
| Resistance topenetration bysynthetic blood | Pass at 80 mmHg | Pass at 80 mmHg | -- | Same | |
| ParticulateFiltrationEfficiency | Passed atave.98.12% | 99.46% | -- | SimilarNote 2 | |
| Flammability | Class 1 | Class 1 | -- | Same | |
| Product performance (Level 3) | |||||
| PerformanceTesting | Level 3 | -- | Level 3 | Same | |
| Elements ofComparison(according toASTM-2100:2019) | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict | |
| BacterialFiltrationEfficiency | Passed atave.99.8% | -- | >99.9% | SimilarNote 2 | |
| DifferentialPressure | Passed at ave.4.27mmH2O/ cm² | -- | 3.72 mm H2O/ cm² | SimilarNote 2 | |
| Resistance topenetration bysynthetic blood | Pass at 160 mmHg | -- | Pass at 160 mmHg | Same | |
| ParticulateFiltrationEfficiency | Passed atave.99.58% | -- | 99.65% | SimilarNote 2 | |
| Flammability | Class 1 | -- | Class 1 | Same | |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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Comparison in Detail(s):
Note 1:
Although the Ear loops", "Design features" and "Specification and Dimension" of subject device are different from the predicate devices, all of them meet the requirement of safety and essential performance standard ISO 10993-5 and ISO 10993-10. So, the differences between the predicate devices and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
Although the "Bacterial Filtration Efficiency" "Differential Pressure" and "Particulate Filtration Efficiency" of subject device are different from the predicate devices, all of them meet the requirement of safety and essential performance standard ASTM F2100-19. So, the differences between the predicate devices and subject device will not affect the safety and effectiveness of the subject device.
7. Summary of Non-Clinical Performance Testing
Medical surgical mask (Level 1)
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| Test item(PerformanceLevel 1) | Test method | Passcriteria | Test results |
|---|---|---|---|
| Bacterial filtrationefficiency | ASTM F2101-14 Standard TestMethod for Evaluating theBacterial Filtration Efficiency(BFE) of Medical Face MaskMaterials, Using a BiologicalAerosol of Staphylococcusaureus according to ASTMF2100:2019 | ≥ 95% | 32/32 Passed at ave.99.3% / Pass |
| Differentialpressure (Delta-P) | EN 14683: 2019, Annex CMedical face masks -Requirements and test methodsaccording to ASTM F2100:2019 | <5.0 mmH2O/cm2 | 32/32 Passed at ave.3.7mmH2O/cm2/ Pass |
| ParticulateFiltrationEfficiency | ASTM F2299-03 Standard TestMethod for Determining the InitialEfficiency of Materials Used inMedical Face Masks toPenetration by ParticulatesUsing Latex Spheres accordingto ASTM F2100:2019 | ≥ 95% | 32/32 Passed at≥ave.98.12% / Pass |
| Resistance topenetration bysyntheticblood, minimumpressure inmmHgfor pass result | ASTM F1862/F1862M-17Standard Test Method forResistance of Medical FaceMasks to Penetration bySynthetic Blood (HorizontalProjection of Fixed Volume at aKnown Velocity) according toASTM F2100:2019 | Fluidresistantclaimedat 80mmHg | 32/32 Passed at 80 mmHg/Pass |
| Flame spread | 16 CFR Part 1610 Standard forthe Flammability of Clothingaccording to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3 SecondsburnTime-Class 1 / Pass |
| Medical surgical mask (Level 3) | |||
|---|---|---|---|
| Test item | Test method | Pass | Test results |
| (Performance) | criteria | ||
| Level 3) | |||
| Bacterial filtrationefficiency | ASTM F2101-14 Standard TestMethod for Evaluating theBacterial Filtration Efficiency(BFE) of Medical Face MaskMaterials, Using a BiologicalAerosol of Staphylococcusaureus according to ASTMF2100:2019 | ≥ 98% | 32/32 Passed at ≥99.8% /Pass |
| Differentialpressure (Delta-P) | EN 14683: 2019, Annex CMedical face masks -Requirements and test methodsaccording to ASTM F2100:2019 | <6.0 mmH2O/cm2 | 32/32 Passed at <4.24 mmH2O/cm2/ Pass |
| ParticulateFiltrationEfficiency | ASTM F2299-03 Standard TestMethod for Determining the InitialEfficiency of Materials Used inMedical Face Masks toPenetration by ParticulatesUsing Latex Spheres accordingto ASTM F2100:2019 | ≥ 98% | 32/32 Passed at ≥99.58% /Pass |
| Resistance topenetration bysyntheticblood, minimumpressure inmmHgfor pass result | ASTM F1862/F1862M-17Standard Test Method forResistance of Medical FaceMasks to Penetration bySynthetic Blood (HorizontalProjection of Fixed Volume at aKnown Velocity) according toASTM F2100:2019 | Fluidresistantclaimedat160mmHg | 32/32 Passed at 160mmHg/ Pass |
| Flame spread | 16 CFR Part 1610 Standard forthe Flammability of Clothingaccording to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3 SecondsburnTime-Class 1 / Pass |
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8. Biocompatibility Testing Summary
According to ISO 10993-1: 2018, the nature of body contact for the subject device is direct surface contact with skin and indirect contact with the respiratory tract, and the duration of the contact is A-Limited (<24 h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
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| Title of the test | Purpose of the test | The source of references (Test method) | Acceptance criteria | Test results |
|---|---|---|---|---|
| In vitroCytotoxicity Test | Under the research conditions, determine whether the target device extract is cytotoxic. | ISO 10993-5:2009Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| SkinSensitizationTest | Under the research conditions, determine whether the non-polar and polar extracts of the target device are sensitive. | ISO 10993-10:2010Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin IrritationTest | Under the research conditions, determine whether the non-polar and polar extracts of the target device are irritating. | ISO 10993-10:2010Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10. Final Conclusion
The conclusions drawn from the nonclinical tests that demonstrate that the subject device Medical surgical mask (Black mask, Level 1 and Level 3) is as safe, as effective, and performs as well as or better than the legally marketed device K201622 and K202139.
§ 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.