(56 days)
When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.
Acceptance Criteria and Device Performance for 3 Layer Surgical Mask
The provided document describes the acceptance criteria and the study that proves the device, a "3 Layer Surgical Mask," meets these criteria. The study focuses on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask, K202595).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F 1862) | Evaluate resistance to penetration by synthetic blood (2ml high velocity stream). | 29 out of 32 pass at 120 mmHg | Lot 1: 32 out of 32 pass at 160 mmHg Lot 2: 32 out of 32 pass at 160 mmHg Lot 3: 31 out of 32 pass at 160 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F 2299) | Measure initial particle filtration efficiency using monodispersed aerosols (0.1 um latex spheres). | ≥ 98% PFE | Lot 1: 99.80% Lot 2: 99.83% Lot 3: 99.87% | PASS |
| Bacterial Filtration Efficiency (ASTM F 2101) | Measure Bacterial Filtration Efficiency using a biological aerosol of Staphylococcus Aureus. | > 98% BFE | Lot 1: 99.8% Lot 2: 99.8% Lot 3: 99.8% | PASS |
| Flammability (16 CFR 1610) | Determine flammability characteristics. | Class 1, Normal Flammability | Lot 1: DNI (Did Not Ignite) Lot 2: DNI Lot 3: DNI All 3 Lots met Class 1 Flammability standards | PASS |
| Differential Pressure (EN 14683:2019+AC:2019) | Determine overall breathability through the mask barrier. | < 6.0 mmH2O/cm² | Lot 1: 4.8 mmHg Lot 2: 4.7 mmHg Lot 3: 4.6 mmHg | PASS |
| Cytotoxicity (ISO 10993-5) | Determine biological reactivity of a mammalian cell culture to the test article. | Subject Article must score reactivity results not greater than 2, or a mild reactivity. | Proposed Device scored zero (0) for all reactivity. Non-cytotoxic. | PASS |
| Irritation (ISO 10993-10) | Evaluate potential skin irritation caused by extraction of the test article. | Test article subjected skin areas are graded based on reactivity after 24, 48, & 72 hours. (Implicitly, to show non-irritation) | All Scores were Zero(0). Proposed Device was determined to be Non-irritant. | PASS |
| Sensitization (ISO 10993-10) | Evaluate potential for test article extracts to cause skin sensitization in guinea pigs. | Test article subjected skin areas are graded based on reactivity after 24 & 48 hours. (Implicitly, to show non-sensitization) | All Scores were Zero(0). Proposed Device was determined to be Non-sensitizer. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For performance tests (Fluid Resistance, PFE, BFE, Flammability, Differential Pressure), the testing was conducted on three lots of the subject device. For fluid resistance, each lot involved testing 32 samples. Specific individual sample sizes for other tests within each lot are not explicitly stated but are implied to be sufficient for compliance with the specified ASTM/EN standards.
- For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the evaluations were performed on the "Proposed Device" (subject device). The specific number of individual samples or test subjects (e.g., cell cultures, rabbits, guinea pigs) used for these ISO 10993 tests is not detailed in the summary, but the results indicate compliance with the standards, which typically specify sample sizes.
- Data Provenance: The document states "Subject device has been evaluated for safety and performance by lab bench testing according to the following standards". This indicates the data is from prospective bench testing conducted in a laboratory setting for the purpose of this 510(k) submission. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, implying the tests were conducted by a lab that provides data acceptable to the FDA, likely within the US or an equivalent regulatory standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This submission relies on non-clinical bench testing and biocompatibility testing against established industry standards (ASTM, EN, ISO). Ground truth in this context is established by the specified performance thresholds defined within these standards, not by human expert interpretation of medical images or patient outcomes. Therefore, the concept of "experts establishing ground truth for a test set" as it relates to clinical diagnosis or interpretation is not applicable here. The "experts" would be the certified laboratory personnel who conducted the tests according to the defined protocols. Their qualifications would be compliance with the respective standard operating procedures and laboratory accreditation.
4. Adjudication Method for the Test Set
- Not applicable. As this is non-clinical bench testing against predefined objective criteria in standards, there is no human-in-the-loop diagnostic task requiring adjudication. The results are quantitative measurements or pass/fail determinations based on material properties and performance.
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
- No MRMC comparative effectiveness study was done. The document explicitly states: "There were no clinical studies performed or included in this submission." This device is a surgical mask, and its regulatory submission is based on bench testing of its physical properties and biocompatibility, not on a diagnostic algorithm requiring human interpretation or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone algorithm performance study was done. This device is a physical medical device (surgical mask), not an AI algorithm. Therefore, "algorithm only performance" is not relevant.
7. The Type of Ground Truth Used
- The ground truth used is based on defined performance standards and specifications from recognized organizations (e.g., ASTM, EN, ISO). These standards specify the methodology for testing and the quantitative/qualitative criteria that must be met. For example:
- Fluid Resistance: >29/32 pass at 120 mmHg.
- Filtration Efficiency (PFE & BFE): ≥ 98%.
- Flammability: Class 1.
- Differential Pressure: < 6.0 mmH2O/cm².
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): Non-cytotoxic, non-irritant, non-sensitizing outcomes based on specific grading scales within the ISO standards.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI model that requires a training set. The device itself is manufactured, and its properties are assessed against pre-defined standards.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI model.
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July 28, 2023
Original Mattress Factory Inc. Nathan Elseser Director of Personal Protective Equipment 4930 State Road Cleveland, Ohio 44134
Re: K231618
Trade/Device Name: 3 Layer Surgical Mask (134252531) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 31, 2023 Received: June 2, 2023
Dear Nathan Elseser:
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,
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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Indications for Use
510(k) Number (if known) K231618
Device Name 3 Layer Surgical Mask
Indications for Use (Describe)
When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
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
1. Submitter Information:
Company Name: The Original Mattress Factory, Inc. d.b.a. Original Medical Supply
Address: 4930 State Road, Cleveland, Ohio, USA 44134
Phone Number: 216-661-8388
Contact Person: Nathan Elseser
Email: Nelseser@OriginalMattress.com
Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical Face Mask |
| Trade Name: | 3 Layer Surgical Mask |
| Classification: | Mask, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | Class II |
Predicate Device Information:
| Sponsor: | Premier Guard USA LLC |
|---|---|
| Address: | 460 Briarwood Drive, Suite 400 |
| Common Name: | Surgical Face Mask |
| Trade Name: | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask |
| 510(k) Number: | K202595 |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | Class II |
2. Device Description
Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.
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3. Intended Use
When properly worn, the 3 Layer Surgical Mask are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
4. Test Summary
Subject device has been evaluated for safety and performance by lab bench testing according to the following standards:
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- . During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.
- o ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation Of Medical Devices Part 10: Tests O For Irritation And Skin Sensitization.
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5. Summary of Comparison and Technological Characteristics:
Table 1 - Elements of Comparison
| Elements of Comparison | Subject Device | Predicate Device (K202595) | Comments | |
|---|---|---|---|---|
| PRODUCT CODE | FXX | FXX | SAME | |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | SAME | |
| Class | II | II | SAME | |
| Product Name | 3 Layer Surgical Mask | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask | – | |
| GENERAL COMPARISON | ||||
| Intended Use | When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only. | The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from the 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 | SAME | |
| Composite | Flat Pleated, 3 Layers, ear loops | Flat Pleated, 3 Layers, ear loops | SAME | |
| MaterialS | Outer Facing | Spun-BondPolypropylene | Spun-BondPolypropylene | SAME |
| Middle | Melt BlownPolypropylenefiber | Melt Blown fiber | SAME | |
| Inner Facing | Spun-BondPolypropylene | Spun-BondPolypropylene | SAME | |
| Nose Piece | Polyethylenecoated annealedcarbon steelwire | Polyethylene coatedannealed carbonsteel wire | SAME | |
| Ear Loops | Polyester,Spandex | Nylon, Spandex | Different¹ | |
| Color | Blue, White | Blue | SIMILAR | |
| Dimensions (width) | 95.0mm (+/-5.0mm) | 95.0mm | SAME | |
| Dimensions (length) | 175mm (+/-5.0mm) | 175mm | SAME | |
| Use | Single Use | Single Use | SAME | |
| Sterility | Non-Sterile | Non-Sterile | SAME | |
| ASTM F2100 Level | Level 3 | Level 3 | SAME | |
| Fluid Resistance Performance ASTM F1862 | Lot 1: 32 out of32 pass at 160mmHgLot 2: 32 out of32 pass at 160mmHgLot 3: 31 out of32 pass at 160mmHg | Pass at 160mmHg | Both Predicateand SubjectDevice PASS | |
| Particulate Filtration Efficiency ASTM F2299 | Lot 1: 99.80%Lot 2: 99.83%Lot 3: 99.87% | ≥ 98% | Both Predicateand SubjectDevice PASS | |
| Bacterial Filtration Efficiency ASTM F 2101 | Lot 1: 99.8%Lot 2: 99.8%Lot 3: 99.8% | $\ge 98%$ | Both Predicateand SubjectDevice PASS | |
| Differential Pressure (Delta P) EN14683:2019+AC : 2019 | Lot 1: 4.8 mmHgLot 2: 4.7 mmHgLot 3: 4.6 mmHg | < 6mmH20/cm² | Both Predicateand SubjectDevice PASS | |
| Flammability 16CFR 1610 | Class 1, Non-Flammable | Class 1, Non-Flammable | Both Predicateand SubjectDevice PASS | |
| Cytotoxicity | Comply with ISO10993-5 non-cytotoxic | Comply with ISO10993-5 non-cytotoxic | SAME | |
| Irritation | Comply with ISO10993-10 non-irritating | Comply with ISO10993-10 non-irritating | SAME | |
| Sensitization | Comply with ISO10993-10 non-sensitizing | Comply with ISO10993-10 non-sensitizing | SAME |
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*Notes 1 - Different material used in the ear loops of the masks. Subject Device was tested for & passed biocompatibility and performance testing. This material difference shows no effect on performance or safety of Subject Device as compared to Predicate Device.
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6. Non-clinical Tests Performed on the Subject Device
The proposed subject device was tested and conformed to the following standards and recommendations in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission.
Table 2 - Performance Testing
| Test Methodology | Purpose | Subject Device | Acceptance Criteria | Result |
|---|---|---|---|---|
| Fluid ResistancePerformance(ASTM F 1862) | This test method is used toevaluate the resistance ofmedical face masks by theimpact of a small volume(approx 2ml) of high velocitystream of synthetic blood.Pass/Fail determinations arebased on visual detection ofsynthetic blood penetration. | Lot 1: 32 out of 32pass at 160 mmHgLot 2: 32 out of 32pass at 160 mmHgLot 3: 31 out of 32pass at 160 mmHg | 29 out of 32 pass at120 mmHg | PASS |
| ParticulateFiltrationEffeciency (ASTM F2299) | The purpose of this test is tomeasure the initial particlefiltration effeciency ofmaterials usingmonodispersed aerosolscontaining suspended latexsphere particulates of 0.1 umdiameter. | Lot 1: 99.80%Lot 2: 99.83%Lot 3: 99.87% | ≥ 98% PFE | PASS |
| Bacterial FiltrationEffeciency (ASTM F2101) | The purpose of this test is tomeasure the BacterialFiltration Effeciency of themask as specified in ASTM F2101. | Lot 1: 99.8%Lot 2: 99.8%Lot 3: 99.8% | > 98% BFE | PASS |
| Flammability 16CFR 1610 | The purpose of this testmethod is to determine theflammability characteristics ofthe mask as specified in 16CFR 1610. Materials in theconstruction of face masksshall meet the requirementsof Class 1, NormalFlammability specified by 16CFR part 1610. | Lot 1: DNILot 2: DNILot 3: DNIAll 3 Lots met Class 1Flammabilitystandards | Class 1 | PASS |
| DifferentialPressure EN14683:2019 | The purpose of this testmethod is to determine theoverall breathability throughthe mask barrier in terms ofmmH2O/cm³. The masksurface is subjected toconstant air flow of 8.0 L/minand the pressure differentialis measured. | Lot 1: 4.8mmHgLot 2: 4.7mmHgLot 3: 4.6mmHg | < 6.0 mmH20/cm² | PASS |
| Test Methodology | Purpose | Subject Device | AcceptanceCriteria | Result |
| Cytotoxicity(ISO 10993-5) | The purpose of the test is todetermine the biologicalreactivity of a mammalian cellculture in response to the testarticle. | Proposed Devicescored zero (0) forall reactivity. Non-cytotoxic. | Subject Article mustscore reactivity resultsnot greater than 2, ora mild reactivity. | PASS |
| Irritation(ISO 10993-10) | To evaluate the potential skinirritation caused by theextraction of the test articleextract contacting with the skinsurface of rabbits. | All Scores wereZero(0). ProposedDevice wasdetermined to beNon-irritant. | Test articlesubjected skin areasare graded based onreactivity after 24,48, & 72 hours. | PASS |
| Sensitization(ISO 10993-10) | To evaluate the potential testarticle extracts to cause skinsensitization in the guinea pigaccording to GPMT Method. | All Scores wereZero(0). ProposedDevice wasdetermined to beNon-sensitizer. | Test articlesubjected skin areasare graded based onreactivity after 24 &48 hours. | PASS |
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Table 3 - Biocompatibility Testing
7. Summary of Clinical Testing
There were no clinical studies performed or included in this submission.
8. Conclusion
The conclusion drawn from the nonclinical tests and substantial equivalence comparison with predicate device demonstrates that the subject device in this 510(k) submission, 3 Layer Surgical Mask, is as safe, effective, and performs as well, 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.