(242 days)
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
The provided document is an FDA 510(k) premarket notification for surgical masks (Aurelia Surgical Mask ASTM Level 1 and Level 2). It focuses on demonstrating substantial equivalence to predicate devices based on performance testing against established ASTM standards for surgical masks.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD) is not directly applicable to this document. The document describes a physical medical device (surgical masks) and its performance validation, not an AI or software product.
However, I can extract and present the performance criteria and the reported performance for the surgical masks as per the ASTM standards mentioned, which function as acceptance criteria for these physical devices.
1. A table of acceptance criteria and the reported device performance
The document provides the following "Acceptance Criteria per ASTM F2100-19" and "Results" for the Aurelia Surgical Masks:
Table: Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria per ASTM F2100-19 | Reported Device Performance (Results) |
|---|---|---|---|
| For Level 1 Mask | |||
| Fluid Resistance (ASTM F1862) | This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE. | Level 1: 80mmHg | Aurelia Mask Level 1: 80mmHg |
| Differential Pressure (Delta-P) (ASTM F2100-19 EN 14683:2019) | The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device. | Level 1: < 5.0 mm H2O/cm² | Aurelia Mask Level 1: < 4.5 mm H2O/cm² |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | The BFE test is performed to determine the bacterial filtration efficiency of test articles. | Level 1: ≥ 95% | Aurelia Mask Level 1: ≥ 99.7% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | The PFE test is performed to evaluate the non-viable particle filtration efficiency of the test article. | Level 1: ≥ 95% | Aurelia Mask Level 1: ≥ 99.5% |
| Flammability (16 CFR 1610) | The purpose of this test is to ensure the subject device does not ignite when exposed to flame. | Level 1: Class 1 | Aurelia Mask Level 1: Class 1 |
| For Level 2 Mask | |||
| Fluid Resistance (ASTM F1862) | This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE. | Level 2: 120mmHg | Aurelia Mask Level 2: 120 mmHg |
| Differential Pressure (Delta-P) (ASTM F2100-19 EN 14683:2019) | The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device. | Level 2: < 6.0 mm H2O/cm² | Aurelia Mask Level 2: < 4.1 mm H2O/cm² |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | The BFE test is performed to determine the bacterial filtration efficiency of test articles. | Level 2: ≥ 98% | Aurelia Mask Level 2: ≥ 99.7% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | The PFE test is performed to evaluate the non-viable particle filtration efficiency of the test article. | Level 2: ≥ 98% | Aurelia Mask Level 2: ≥ 99.6% |
| Flammability (16 CFR 1610) | The purpose of this test is to ensure the subject device does not ignite when exposed to flame. | Level 2: Class 1 | Aurelia Mask Level 2: Class 1 |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | Not explicitly stated but implied: To evaluate potential cell toxicity. | Non-Cytotoxicity | Pass |
| Sensitization (ISO 10993-10) | Not explicitly stated but implied: To evaluate potential for allergic reaction. | Non-Sensitization | Pass |
| Irritation (ISO 10993-10) | Not explicitly stated but implied: To evaluate potential for skin irritation. | Non-Irritating | Pass |
Note: The document states that "Non-clinical performance tests and Biocompatibility were conducted to verify that the Aurelia Surgical Masks met or exceeded all the design specifications as the predicate device K082258. The results were indicated in the Predicate Comparison Section above and restated below." This acts as the "study" proving the device meets the acceptance criteria for these types of physical medical devices.
The remaining points (2-9) are typical requirements for AI/SaMD studies and are not applicable to this document, which concerns a physical surgical mask.
Therefore, for the remaining points:
- Sample size used for the test set and the data provenance: Not applicable. Performance tests (e.g., BFE, PFE, Fluid Resistance) involve standardized laboratory testing on material samples, not a "test set" of patient data as for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical mask performance is established by the test methods themselves, not expert consensus on patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI-assisted image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth is determined by standardized physical and biological test methods.
- The sample size for the training set: Not applicable. There is no "training set" for a physical surgical mask.
- How the ground truth for the training set was established: Not applicable.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2023
Supermax Healthcare Canada-Supermax Medical % Alicja Wojewnik CEO dicentra, Inc. 7 St Thomas Street, Unit 603 Toronto. Ontario M5S 2B7 Canada
Re: K231005
Trade/Device Name: Aurelia Surgical Mask ASTM Level 1: Aurelia Surgical Mask ASTM Level 2 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: November 1, 2023 Received: November 1, 2023
Dear Alicja Wojewnik:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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Indications for Use
510(k) Number (if known) K231005
Device Name
Aurelia Surgical Mask ASTM Level 1: Aurelia Surgical Mask ASTM Level 2
Indications for Use (Describe)
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 201.2 Subpart D) | ☑ |
|---|---|
| OTC Therapeutic Use (21 CFR 201.2 Subpart G) | ☐ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the Dicentra logo. The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the "d" is a purple sphere made up of interconnected dots. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in a smaller font.
510(k) Summary
Aurelia Surgical Mask
| Applicant | Supermax Healthcare Canada – Supermax Medical1001 rue Jean-Talon bureau 100Saint-Bruno-de-Montarville, Quebec, J3V 0N3Canada |
|---|---|
| Contact Person | Nicolas BergeronExecutive Vice PresidentTel. +1 (866) 428-9188Cell: +1 (514) 512-4123nbergeron@supermaxcanada.com |
| Correspondent: | dicentra, Inc.603 - 7 St. Thomas StreetToronto, Ontario M5S2B7 CanadaAlicja WojewnikTel. (416) 361-3400 Ext 228radicentra@dicentra.com |
| Summary Date | October 20, 2023 |
| Proprietary Name | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 |
| Common Name | Surgical Mask |
| Classification Regulation | 21 CFR 878.4040. |
| Product Codes | FXX |
| Device Classification | Class II |
| Predicate Device | a. Crosstex® Isofluid® Earloop Face Mask (K082258) Primary Predicateb. Crosstex® Procedural Earloop Face Mask (K082258) |
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Image /page/4/Picture/1 description: The image is a logo for "dicentra". The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the "d" is a purple graphic that resembles a network of connected dots. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in a smaller font.
Indications for Use
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Device Description
The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
| Test | ASTM 1 | ASTM 2 |
|---|---|---|
| FluidResistance | 80mmHg | 120mmHg |
| BacterialFiltrationEfficiency | ≥95% | ≥98% |
| ParticulateFiltrationEfficiency | ≥95% | ≥98% |
| DifferentialPressure | <5.0 mm H2O/cm² | <6.0 mm 2O/cm² |
| Flammability | Class 1 | Class 1 |
Table 1: ASTM Standards
The device is single use and provided non-sterile. Both masks are blue in color and have the following dimensions: Length: 17.5 cm, Height: 9.5 cm, Ear loop Length: 15.2 cm, Nosepiece: 11.5 cm
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Image /page/5/Picture/1 description: The image is a logo for "dicentra". The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the "d" is a purple graphic that resembles a network of interconnected nodes. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in a smaller font.
Table 2: Material Information
| Raw Material | Product Details | Supplier | ChemicalComposition | Colorant |
|---|---|---|---|---|
| Inner Layer | White 25 gsm Spunbondednon-woven fabric | Anhui MedysenImport & ExportCo., LTD | PolypropyleneCAS:9003-07-0 | N/A |
| Middle Layer | White 25 gsm Melt-Blown non-woven fabric | Anhui MedysenImport & ExportCo., LTD | PolypropyleneCAS:9003-07-0IrganoxCAS:6683-19-8 | N/A |
| Outer Layer | Blue 25 gsm Spun-bondednonwoven fabric | Anhui MedysenImport & ExportCo., LTD | PolypropyleneCAS:9003-07-0 | Phthalocyanineblue CAS:147-14-8 |
| Nose Piece | 3mm Aluminum Flat WireNose Strip | Anhui MedysenImport & ExportCo., LTD | AluminumCAS:7429-90-5 | N/A |
| Ear Loops | White 4MM Elastic Ear Loop | Anhui MedysenImport & ExportCo., LTD | Nylon CAS:32131-17-2PolyurethaneCAS:51852-81-4 | N/A |
Table 3: Comparison to Predicate Device (LV1)
| Comparison toPredicate Device | Predicate Device:Crosstex® Isofluid® Earloop Face Mask(K082258) | Candidate Device:Aurelia Surgical Mask Lv. 1 | Conclusion |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Fluid Resistance | 80mmHg | 80mmHg | Same |
| Particulate FiltrationEfficiency | 95% | 99.5% | Different |
| Bacterial FiltrationEfficiency | 95% | 99.7% | Different |
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Image /page/6/Picture/1 description: The image shows the Dicentra logo. The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the "d" is a purple graphic that resembles a network of connected dots. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in a smaller font.
| Differential Pressure | <4.0 mm H2O/cm² | 4.5 mm H2O/cm² | Different |
|---|---|---|---|
| Flammability | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Irritation | No Irritation | No Irritation | Same |
Table 4: Comparison to Predicate Device (LV2)
| Comparison toPredicate Device | Predicate Device:Crosstex® Procedural Earloop FaceMask (K082258) | Candidate Device:Aurelia Surgical Mask Lv. 2 | Conclusion |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Fluid Resistance | 120mmHg | 120mmHg | Same |
| Particulate FiltrationEfficiency | 98% | 99.6% | Different |
| Bacterial FiltrationEfficiency | 98% | 99.8% | Different |
| Differential Pressure | <5.0 mm H2O/cm² | 4.1 mm H2O/cm² | Different |
| Flammability | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Irritation | No Irritation | No Irritation | Same |
| Test | Purpose | AcceptanceCriteriaper ASTM F2100-19 | Results |
| Fluid Resistance(ASTM F1862) | FXX This test is performedtoEvaluate PersonalProtective Equipmentagainst fluid penetration.An arterial spray issimulated to test thePPE. | Level1:80mmHg | Aurelia Mask Level 1:80mmHg |
| Level 2:120mmHg | Aurelia Mask Level 2:120 mmHg | ||
| Differential Pressure(Delta-P)(ASTM F2100-19EN 14683:2019) | The purpose of this testis to ensure the dropin pressure is not toogreat so the user maybreathe through thesubject device. | Level1:< 5.0 mm H2O/cm | Aurelia Mask Level 1:< 4.5 mm H2O/cm² |
| Level 2:< 6.0 mm H2O/cm² | Aurelia Mask Level 2:< 4.1 mm H2O/cm² | ||
| Bacterial FiltrationEfficiency (BFE)(ASTM F2101) | The BFE test isperformed to determinethe bacterial filtrationefficiency of test articles. | Level1:≥ 95% | Aurelia Mask Level 1:≥ 99.7% |
| Level 2:≥ 98% | Aurelia Mask Level 2:≥ 99.7% | ||
| ParticulateFiltration Efficiency(PFE)(ASTM F2299) | The PFE test isperformed to evaluatethe non-viable particlefiltration efficiency of thetest article. | Level1:≥ 95% | Aurelia Mask Level 1:≥ 99.5% |
| Level 2:≥ 98% | Aurelia Mask Level 2:≥ 99.6% | ||
| Flammability(16 CFR 1610) | The purpose of this testis to ensure the subjectdevice does not ignitewhen exposed to flame. | Level1:Class 1 | Aurelia Mask Level 1:Class 1 |
| Level 2:Class 1 | Aurelia Mask Level 2:Class 1 | ||
| Biocompatibility | Test Method/ Standard | Acceptance Criteria | Results |
| Cytotoxicity | ISO 10993-5 | Non- Cytotoxicity | Pass |
| Sensitization | ISO 10993-10 | Non- Sensitization | Pass |
| Irritation | ISO 10993-10 | Non- Irritating | Pass |
Performance Testing Summary
Non-clinical performance tests and Biocompatibility were conducted to verify that the Aurelia Surgical Masks met or exceeded all the design specifications as the predicate device K082258.The results were indicated in the Predicate Comparison Section above and restated below.
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Image /page/7/Picture/1 description: The image shows the Dicentra logo. The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the word is a purple sphere made up of interconnected dots. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in smaller, black font.
Table 5: Summary of Performance Testing
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Image /page/8/Picture/1 description: The image is a logo for "dicentra". The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the "d" is a purple graphic that resembles a network of interconnected nodes. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in a smaller font.
Shelf-Life
The proposed shelf life for the Aurelia Surgical masks is 5 years. An accelerated aging test was performed to support this claim and a real time aging study has been underway since December 2021.
The Accelerated Aging Test was initiated on 10th January 2022 and completed on 16th September 2022. The test was conducted in compliance with USFDA regulations (21 CFR Parts 58, 210, 211, and 820). 60 boxes/samples were subjected to an incubation temperature of 50°C ± 20°C for 229 days (5 years simulated shelf life)
The test report does not specify any failures of the packaging or loss of sterile integrity after the accelerated aging. Therefore, the results indicate the packaging, maintained integrity and sterile barrier properties up to 5 years of simulated shelf life under the test conditions.
Conclusion
The Aurelia Surgical masks are substantially equivalent to the predicate device [K082258]. The design and technological characteristics of the devices are the same and the proposed device meets or exceeds the efficacy and safety tests results of the 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.