(191 days)
Not Found
No
The device description and performance studies focus on physical properties and barrier function, with no mention of AI or ML.
No
The device is a disposable barrier for dental instruments and equipment, designed to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is described as a barrier sleeve/film intended to cover dental instruments and equipment to provide a physical barrier during dental procedures. Its function is to prevent contamination, not to detect, diagnose, treat, or prevent disease.
No
The device description clearly states it is made of polyethylene film and is a physical barrier, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable barrier for dental instruments and equipment." This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the material (polyethylene film) and how it's used to cover instruments and equipment. There is no mention of analyzing samples from the human body or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing biological samples, detecting analytes, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on physical properties like tensile strength, puncture resistance, and barrier effectiveness against fluids and viruses. These are relevant to a physical barrier, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.
Product codes (comma separated list FDA assigned to the subject device)
PEM
Device Description
Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed focusing on Biocompatibility (In-Vitro Cytotoxicity, Sensitization, Irritation) and Performance (Tensile Strength, Puncture Resistance, Tear Resistance, Synthetic Blood Penetration, Viral Penetration, Thickness).
Key results:
- Biocompatibility: No cytotoxicity potential, Not considered a sensitizer, Irritation response classified as Negligible.
- Performance:
- Tensile Strength: Subject device is equivalent to predicate device, with results within 35-45 MPa for Transverse and 23-28 MPa for Lengthways.
- Puncture Resistance: Subject device is equivalent to predicate device, with results around 4.56N to 4.58N (acceptance criteria 4N-5N).
- Tear Resistance: Subject device is equivalent to predicate device, with results around 5.026N to 5.046N (acceptance criteria 4N-6N).
- Synthetic Blood Penetration: Pass (no visual detection of synthetic blood penetration) for material and seams.
- Viral Penetration: Pass (no visual detection of viral penetration and assay titer value
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 23, 2020
Plasdent Corporation Belen Walayat Corporate Manager 969 Price Street Pomona, California 91767
Re: K201604
Trade/Device Name: Plasdent Disposable Barrier Sleeves and Barrier Film Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: November 18, 2020 Received: November 27, 2020
Dear Belen Walayat:
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 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
1
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,
Clarence W. Murray, III, 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 0613012020 See PRA Statement below.
510(k) Number (if known) K201604
Device Name
Plasdent Disposable Barrier Sleeves and Barrier Film
Indications for Use (Describe)
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.
| Model# | Description | Designed For |
|---|---|---|
| PS201 | B Tray Sleeves w/ Lock Top | Dental Instrument Tray, 10-1/2" x 14" |
| PS202 | A Tray Sleeves w/ Lock Top | Dental Instrument Tray, 11-5/8" x 14-1/2" |
| PS204 | F Tray Sleeves w/ Lock Top | Dental Instrument Tray, 7-1/2" x 10-1/2" |
| PS3800 | Half Chair Covers or Sleeves | Half Dental Chair, 27-1/2"W x 24"L |
| PS3825 | Wide Half Chair Cover | Wide Half Chair, 32"W x 32"L |
| PS102 | Half Chair Cover | Half Chair, 24"W x 32"L |
| PS106 | Full Chair Covers or Sleeves | Wide Full Dental Chair, 44"W x 54"L |
| PS3850 | Full Chair Covers or Sleeves | X-Long Full Chair, 29"W x 80"L |
| PS650 | Headrest Cover | Headrest, 9-1/2"W x 11"W |
| PS660 | Headrest Cover | Large Headrest, 10"L x 14"W |
| PS1250C | Sticky Wraps (Barrier Film) | 4"W x 6"L, Clear Color |
| PS1250B | Sticky Wraps (Barrier Film) | 4"W x 6"L, Blue Color |
| PS400 | Computer Covers | Keyboard cover, 22"W x 14"L |
| PS400-S | Computer Covers | Small Keyboard, 12-1/2"W x 8"L |
| PF405 | Computer Covers | PC Mouse, Universal |
| PS410 | Computer Covers | LCD + Keyboard 22"W x 26"L |
| PS425 | Computer Covers | Laptop, 15-2/3"W x 24"L |
| PS1100 | X-ray Cover | X-ray 24"W x 32"L |
| PS1105 | X-ray Cover | X-ray, Universal, 15"W x 26"L |
| PS328P | Lite Handle Cover | Lite Handle for T-Style 5-3/4"W x 4"L |
| PS320A | Air/Water Syringe Covers | Air/Water Syringe, 3"W x 10"L |
| PS3720 | Air/Water Syringe Covers | Air/Water Syringe, Tube 2" Diameter |
| PS3740 | Air/Water Syringe Covers | Air/Water Syringe, Tube 4" Diameter |
| PS520 | Sensor Cover | #2 Sensor Cover, 1-5/8"W x 8-3/8"L |
| PS530 | Sensor Cover | #0 Sensor Cover, 1-3/8"W x 8-3/8"L |
| PS-SUNI-2 | X-ray Sensor Sheaths | For SUNI Size 2 Compatible TIDI: 20819 |
| PS-DEXIS-2 | X-ray Sensor Sheaths | For DEXIS Size 2 Compatible TIDI: 20999 |
| PS-6100-0 | X-ray Sensor Sheaths | For KODAK 6100 Size 0 Compatible TIDI: |
| 20977 | ||
| PS-6100-1 | X-ray Sensor Sheaths | For KODAK 6100 Size 1 Compatible TIDI: |
| 20978 | ||
| PS-6100-2 | X-ray Sensor Sheaths | For KODAK 6100 Size 2 Compatible TIDI: |
| 20979 | ||
| PS-GXDR-1 | X-ray Sensor Sheaths | For GENDEX/XDR Size 1 |
| PS-GXDR-2 | X-ray Sensor Sheaths | For GENDEX/XDR Size 2 |
| PS-SHICK-1 | X-ray Sensor Sheaths | For SCHICK Size 1 Compatible TIDI: 20824 |
| PS-SHICK-2 | X-ray Sensor Sheaths | For SCHICK Size 2 Compatible TIDI: 20825 |
| PS4550 | Curing Light Sleeves | Curing Light Handle, 5"W x 10"L |
| PS4660 | Curing Light Sleeves | Complete Curing Light Handle, 3-1/4"W x |
| 12"L | ||
| PS-DEMI | Curing Light Sleeves | Curing Light for DEMI |
| PS-LED | Curing Light Sleeves | LED Curing Light, 3-1/4"W x 12"L |
| PS700 | Handpiece Covers | Low Speed Long H.P., 1-1/2"W 7-1/2"L |
| PS710 | Handpiece Covers | Low Speed Contra-Angle, 8"W 3-1/2"L |
| PS720 | Handpiece Covers | High Speed, 1-1/6"W x 7-3/4"L |
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4
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
网 Over-The-Counter Use
(21 CFR 801 Subpart C) CONTINUE ON A SEPARATE
PAGE IF NEEDED.
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FORM FDA 3881 (7/17) PublllhiD& Senrkes (301) 443-6740
PSC
5
Image /page/5/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white shape inside, followed by the word "PLASDENT" in green, all caps. Below the word "PLASDENT" are two green lines, and below the lines is the word "CORPORATION" in smaller, green, all-caps letters.
510(K) Summary K201604
I. SUBMITTER: Plasdent Corporation 969 Price Street Pomona, CA 91767 Contact Person: Belen G. Walayat Title: Corporate Manager Phone: (909)620-0289*106 Email: belengw@plasdent.com Summary prepared: 01/30/2019 Summary revised: 08/19/2020
II. DEVICE
Name of Device: Plasdent Disposable Barrier Sleeves and Barrier Film Regulation Number: 21 CFR 878.4370 Common Name: Dental Barriers and Sleeves Classification Name: Surgical drape and drape accessories Regulatory Class: II Product Code: PEM
III. PREDICATE DEVICE
Predicate device: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film- K151123 Subject Device: Plasdent Disposable Barrier Sleeves and Barrier Film- K201604
IV. DEVICE DESCRIPTION
Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the
6
Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.
V. INDICATIONS FOR USE
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
| Model# | Description | Designed For |
|---|---|---|
| PS201 | B Tray Sleeves w/ Lock Top | Dental Instrument Tray, 10-1/2" x 14" |
| PS202 | A Tray Sleeves w/ Lock Top | Dental Instrument Tray, 11-5/8" x 14-1/2" |
| PS204 | F Tray Sleeves w/ Lock Top | Dental Instrument Tray, 7-1/2" x 10-1/2" |
| PS3800 | Half Chair Covers or Sleeves | Half Dental Chair, 27-1/2"W x 24"L |
| PS3825 | Wide Half Chair Cover | Wide Half Chair, 32"W x 32"L |
| PS102 | Half Chair Cover | Half Chair, 24"W x 32"L |
| PS106 | Full Chair Covers or Sleeves | Wide Full Dental Chair, 44"W x 54"L |
| PS3850 | Full Chair Covers or Sleeves | X-Long Full Chair, 29"W x 80"L |
| PS650 | Headrest Cover | Headrest, 9-1/2"W x 11"W |
| PS660 | Headrest Cover | Large Headrest, 10"L x 14"W |
| PS1250C | Sticky Wraps (Barrier Film) | 4"W x 6"L, Clear Color |
| PS1250B | Sticky Wraps (Barrier Film) | 4"W x 6"L, Blue Color |
| PS400 | Computer Covers | Keyboard cover, 22"W x 14"L |
| PS400-S | Computer Covers | Small Keyboard, 12-1/2"W x 8"L |
| PF405 | Computer Covers | PC Mouse, Universal |
| PS410 | Computer Covers | LCD + Keyboard 22"W x 26"L |
| PS425 | Computer Covers | Laptop, 15-2/3"W x 24"L |
|---|---|---|
| PS1100 | X-ray Cover | X-ray 24"W x 32"L |
| PS1105 | X-ray Cover | X-ray, Universal, 15"W x 26"L |
| PS328P | Lite Handle Cover | Lite Handle for T-Style 5-3/4"W x 4"L |
| PS320A | Air/Water Syringe Covers | Air/Water Syringe, 3"W x 10"L |
| PS3720 | Air/Water Syringe Covers | Air/Water Syringe, Tube 2" Diameter |
| PS3740 | Air/Water Syringe Covers | Air/Water Syringe, Tube 4" Diameter |
| PS520 | Sensor Cover | #2 Sensor Cover, 1-5/8"W x 8-3/8"L |
| PS530 | Sensor Cover | #0 Sensor Cover, 1-3/8"W x 8-3/8"L |
| PS-SUNI-2 | X-ray Sensor Sheaths | For SUNI Size 2 Compatible TIDI: 20819 |
| PS-DEXIS-2 | X-ray Sensor Sheaths | For DEXIS Size 2 Compatible TIDI: 20999 |
| PS-6100-0 | X-ray Sensor Sheaths | For KODAK 6100 Size 0 Compatible TIDI: 20977 |
| PS-6100-1 | X-ray Sensor Sheaths | For KODAK 6100 Size 1 Compatible TIDI: 20978 |
| PS-6100-2 | X-ray Sensor Sheaths | For KODAK 6100 Size 2 Compatible TIDI: 20979 |
| PS-GXDR-1 | X-ray Sensor Sheaths | For GENDEX/XDR Size 1 |
| PS-GXDR-2 | X-ray Sensor Sheaths | For GENDEX/XDR Size 2 |
| PS-SHICK-1 | X-ray Sensor Sheaths | For SCHICK Size 1 Compatible TIDI: 20824 |
| PS-SHICK-2 | X-ray Sensor Sheaths | For SCHICK Size 2 Compatible TIDI: 20825 |
| PS4550 | Curing Light Sleeves | Curing Light Handle, 5"W x 10"L |
| PS4660 | Curing Light Sleeves | Complete Curing Light Handle, 3-1/4"W x 12"L |
| PS-DEMI | Curing Light Sleeves | Curing Light for DEMI |
| PS-LED | Curing Light Sleeves | LED Curing Light, 3-1/4"W x 12"L |
| PS700 | Handpiece Covers | Low Speed Long H.P., 1-1/2"W x 7-1/2"L |
| PS710 | Handpiece Covers | Low Speed Contra-Angle, 8"W x 3-1/2"L |
| PS720 | Handpiece Covers | High Speed, 1-1/6"W x 7-3/4"L |
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VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject device, Plasdent Disposable Barrier Film, and the predicate device, Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film, have the same intended use, which are used as protective barriers intended to fit over and cover dental instruments and equipment. Both the subject device and predicate device are made of same material, which is polyethylene film (PE). Both are non-sterile, prepackaged, disposable, and are for single patient and one time use only. The main slight difference between the subject and predicate device is the material composition. The polyethylene film of the subject device is composed of 30% low density polyethylene (LDPE) and 70% linear low density polyethylene (LLDPE), while the predicate device is composed of 20% low density polyethylene (LDPE) and 80% linear low density polyethylene (LLDPE). The difference is negligible & within acceptable range.
| DEVICE | Subject Device
Plasdent Disosable Barrier
Sleeves and Barrier Film
(K201604) | Primary Predicate Device
Pac-Dent Barrier Sleeve,
Cover-ItTM Barrier Film(K151123) | Comparison |
|----------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------|
| Intended Use | To be used as a barrier for dental
instruments and equipment. | To be used as a barrier for dental
instruments and equipment. | Same |
| Classification
Product Code | PEM | PEM | Same |
| Material | Polyethylene film | Polyethylene film | Same |
| Material
Composition | LLDPE (70%)
LDPE (30%)
Blue pigment
(item#PS1250B)
Adhesive (item#PS1250B,
PS1250C) | LLDPE(80%)
LDPE (20%)
Blue pigment
(item#100B, C101B)
Adhesive (item#C101, C101B) | Similar |
| Biocompatibility | Non-cytotoxic
Non-sensitizing
Non-irritating | Non-cytotoxic
Non-sensitizing
Non-irritating | Same |
| Specifications
and Tolerances | Paper backing: none
Film thickness:0.02-0.06mm
Tolerance: 0.5 indicate
irritation. | Overall Test Group Mean: 0 | Irritation response category
of test article classified as
Negligible. |
| PERFORMANCE TESTING: | | | | | |
| Tensile Strength | ASTM D882-18 | Determine the tensile properties of
Subject device's disposable barrier
sleeve compared to that of Predicate
device disposable barrier sleeve. | Transverse: 35-45 MPa
Lengthways: 23-28 MPa | HL181201: T 39.46, L 26.26
HL20190601: T 39.84, L 26.46
HL20190605: T 40.32, L 26.52 | The tensile strength of both
products is in the same
range. |
| Puncture Resistance | ASTM F1342-05 | Determine the puncture resistance of
Subject device's disposable barrier
sleeve compared to that of Predicate
device's disposable barrier sleeve. | 4N-5N | 20190528: 4.56N
20190601: 4.58N
20190605: 4.56N | The puncture resistance of
both products is in the same
range. |
| Tear Resistance | ASTM D1004-
13 | Determine the tear resistance of
Subject device's disposable barrier
sleeve compared to that of Predicate
device's disposable barrier sleeve. | 4N-6N | HL20190605: 5.026N
HL20190610: 5.046N
HL20190615: 5.032N | The tear resistance of both
products is in the same
range. |
| Synthetic Blood
Penetration | ASTM
F1670 | Evaluate the resistance of test
material to penetration by synthetic
blood under conditions of continuous
liquid contact. | Pass determination based
on no visual detection of
synthetic blood
penetration. | Material: no synthetic blood
penetration seen | Pass. Test material resistant
to synthetic blood
penetration. |
| Synthetic blood
penetration at
seams and non-
continuous components | ASTM
F1670 | Evaluate the resistance of test
material at seams to penetration by
synthetic blood under conditions of
continuous liquid contact. | Pass determination based
on no visual detection of
synthetic blood
penetration. | Material seams: no synthetic
blood penetration seen | Pass. Test material seams
resistant to synthetic blood
penetration. |
| Viral Penetration | ASTM
F1671 | Evaluate the barrier performance of
test material which are intended to
protect against blood borne pathogen
hazards. | Pass determination based
on no visual detection of
viral penetration and assay
titer value