(191 days)
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.
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.
This document is a 510(k) Premarket Notification from the FDA for a medical device: "Plasdent Disposable Barrier Sleeves and Barrier Film." It is primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
It is important to note that this document does NOT describe the validation of an AI/ML powered medical device. It describes the testing of a physical barrier device. Therefore, many of the requested elements for an AI/ML device validation (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or present in this context.
However, I can extract the relevant information for the physical device based on the provided text, focusing on acceptance criteria and performance data from the non-clinical testing.
Acceptance Criteria and Device Performance (for a physical barrier device)
The document presents non-clinical testing results to demonstrate that the Plasdent Disposable Barrier Sleeves and Barrier Film are substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Standard | Purpose | Acceptance Criteria | Reported Device Performance | Results Summary |
|---|---|---|---|---|---|
| BIOCOMPATIBILITY TESTING: | |||||
| In-Vitro Cytotoxicity | ANSI/AAMI/ISO 10993-5 | Evaluate the cytotoxicity of a test article extract. | If viability is reduced to <70% of the blank, it has a cytotoxic potential. | Text extract 100%: Viab. 79.10%Test extract 75%: Viab. 83.72%Test extract 50%: Viab. 88.91%Test extract 25%: Viab. 94.10% | No cytotoxicity potential. |
| Sensitization | ISO 10993-10 | Evaluate the potential of the test article to cause delayed dermal contact sensitization in a guinea pig maximization test. | Magnusson and Kligman grades of 1 or greater in the test group indicate sensitization. | All dermal reactions for all treatment groups over 24 and 48 hours: 0 | Not considered a sensitizer in the guinea pig maximization test. |
| Irritation | ISO 10993-10 | Evaluate the potential of the test article to cause skin irritation following application on the skin or rabbits. | Cumulative irritation index mean score >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 MPaLengthways: 23-28 MPa | HL181201: T 39.46, L 26.26HL20190601: T 39.84, L 26.46HL20190605: 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: 4.56N20190601: 4.58N20190605: 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: 5.026NHL20190610: 5.046NHL20190615: 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 <1. | Visual penetration: none seenAssay Titer (PFU/mL): <1 | Pass. Test material successfully protects against blood borne pathogen hazards. |
| Viral Penetration at seams and non-continuous components | ASTM F1671 | Evaluate the barrier performance of test material at seams which are intended to protect against blood borne pathogen hazards. | Pass determination based on no visual detection of viral penetration and assay titer value <1. | Visual penetration: none seenAssay Titer (PFU/mL): <1 | Pass. Test material seam successfully protects against blood borne pathogen hazards. |
| Thickness | ASTM D6988-13 | Determine the thickness of test material. | N/A (This is a measurement, not a pass/fail criterion for this test, though it is used for comparison) | 0.018mm | Thickness: 0.018mm |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (N) for each performance test. It lists results for multiple "samples" (e.g., HL181201, HL20190601, HL20190605 for Tensile Strength) but doesn't quantify the total count per test.
- Data Provenance: The document does not specify the country of origin for the test data directly. It is inferred to be manufacturer-generated for regulatory submission. All tests appear to be retrospective in the sense that they were conducted in a lab setting, not in a live clinical environment, to characterize the device properties.
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):
- Not Applicable. This is a physical device (barrier sleeves/film), not an AI/ML device requiring expert interpretation of images or other data for ground truth establishment. The "ground truth" for these tests comes from objective measurements and standardized test methods (e.g., ASTM, ISO standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data in clinical studies, typically for establishing ground truth in image analysis or diagnostic contexts. This is a physical device undergoing lab-based performance testing.
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 type of study relates to AI-assisted human performance, which is not relevant for a physical barrier device. The study is a comparison of the subject device to a predicate device based on material properties and barrier effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This applies to AI algorithms. The device itself is a standalone physical product, and its performance was evaluated without human intervention in the loop of its function (i.e., its barrier properties were tested directly).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective measurements and adherence to recognized industry standards (ASTM, ISO) for material properties (tensile strength, puncture resistance, tear resistance, thickness) and barrier performance (synthetic blood penetration, viral penetration), as well as biocompatibility assessments (cytotoxicity, sensitization, irritation). There isn't a "clinical ground truth" in the diagnostic sense.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, 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 an AI/ML device, this question is irrelevant.
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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
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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
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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 x12"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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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
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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
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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 DevicePlasdent Disosable BarrierSleeves and Barrier Film(K201604) | Primary Predicate DevicePac-Dent Barrier Sleeve,Cover-ItTM Barrier Film(K151123) | Comparison |
|---|---|---|---|
| Intended Use | To be used as a barrier for dentalinstruments and equipment. | To be used as a barrier for dentalinstruments and equipment. | Same |
| ClassificationProduct Code | PEM | PEM | Same |
| Material | Polyethylene film | Polyethylene film | Same |
| MaterialComposition | 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-cytotoxicNon-sensitizingNon-irritating | Non-cytotoxicNon-sensitizingNon-irritating | Same |
| Specificationsand Tolerances | Paper backing: noneFilm thickness:0.02-0.06mmTolerance: <0.01mm | Paper backing: some of the modelFilm thickness:0.02-0.06mmTolerance: <0.01mm | Similar |
| MechanicalProperties | Tensile Strength -ASTM D882-Subject device is equivalent topredicate device. | Tensile Strength -ASTMD882 | SamePass |
| Resistance to Puncture -ASTMF1342-Subject device is equivalentto predicate device. | Resistance to Puncture- ASTMF1342 | SamePass | |
| Tear Strength – ASTM D1424-Subject device is equivalent topredicate device. | Tear Strength – ASTMD1424 | SamePass | |
| Effectiveness of X-Ray and SensorDevices covered with Barrierdevices. | SamePass | ||
| PerformanceProperties | Synthetic Blood Penetration-Pass | Synthetic Blood Penetration-Pass | SamePass |
| Sterility | Non-sterile | Non-sterile | Same |
| Single Use | Single use device | Single use device | Same |
| FDA-RecognizedStandards | ASTM F1670 | ASTM F1670 | Same |
| ASTM F1671 | ASTM F1671 | ||
| ASTM D882-18 | ASTM D882-18 | ||
| ASTM F1342 | ASTM F1342 | ||
| ASTM D1004-13 | ASTM D1004-13 | ||
| ISO 10993-5 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-10 | ||
| ISO 6988-13 | ISO 6988-13 |
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Image /page/9/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white outline and a white shape inside. To the right of the square is the word "PLASDENT" in green, with the word "CORPORATION" in smaller green letters below it. The logo is simple and professional, and the green color suggests that the company is environmentally friendly.
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Image /page/10/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white square cut out of the top right corner. Below the square is the word "PLASDENT" in green, with the word "CORPORATION" in smaller green letters below that. The logo is simple and modern, and the green color gives it a sense of freshness and vitality.
VII. SUMMARY OF NON-CLINICAL TESTING
Shown below is the non-clinical testing performed with the subject device can meet the acceptance criteria referenced standard or test methodology shown in the table below:
| TEST | STANDARD | PURPOSE | ACCEPTANCE CRITERIA | RESULTS | RESULTS SUMMARY |
|---|---|---|---|---|---|
| BIOCOMPATIBILITY TESTING: | |||||
| In-Vitro Cytotoxicity | ANSI/AAMI/ISO10993-5 | Evaluate the cytotoxicity of a testarticle extract. | If viability is reduced to<70% of the blank, it has acytotoxic potential. | Text extract 100%: Viab. 79.10%Test extract 75%: Viab. 83.72%Test extract 50%: Viab. 88.91%Test extract 25%: Viab. 94.10% | No cytotoxicity potential. |
| Sensitization | ISO 10993-10 | Evaluate the potential of the testarticle to cause delayed dermalcontact sensitization in a guinea pigmaximization test. | Magnusson and Kligmangrades of 1 or greater in thetest group indicatesensitization. | All dermal reactions for alltreatment groups over 24 and48 hours: 0 | Not considered a sensitizerin the guinea pigmaximization test. |
| Irritation | ISO 10993-10 | Evaluate the potential of the testarticle to cause skin irritationfollowing application on the skin orrabbits. | Cumulative irritation indexmean score >0.5 indicateirritation. | Overall Test Group Mean: 0 | Irritation response categoryof test article classified asNegligible. |
| PERFORMANCE TESTING: | |||||
| Tensile Strength | ASTM D882-18 | Determine the tensile properties ofSubject device's disposable barriersleeve compared to that of Predicatedevice disposable barrier sleeve. | Transverse: 35-45 MPaLengthways: 23-28 MPa | HL181201: T 39.46, L 26.26HL20190601: T 39.84, L 26.46HL20190605: T 40.32, L 26.52 | The tensile strength of bothproducts is in the samerange. |
| Puncture Resistance | ASTM F1342-05 | Determine the puncture resistance ofSubject device's disposable barriersleeve compared to that of Predicatedevice's disposable barrier sleeve. | 4N-5N | 20190528: 4.56N20190601: 4.58N20190605: 4.56N | The puncture resistance ofboth products is in the samerange. |
| Tear Resistance | ASTM D1004-13 | Determine the tear resistance ofSubject device's disposable barriersleeve compared to that of Predicatedevice's disposable barrier sleeve. | 4N-6N | HL20190605: 5.026NHL20190610: 5.046NHL20190615: 5.032N | The tear resistance of bothproducts is in the samerange. |
| Synthetic BloodPenetration | ASTMF1670 | Evaluate the resistance of testmaterial to penetration by syntheticblood under conditions of continuousliquid contact. | Pass determination basedon no visual detection ofsynthetic bloodpenetration. | Material: no synthetic bloodpenetration seen | Pass. Test material resistantto synthetic bloodpenetration. |
| Synthetic bloodpenetration atseams and non-continuous components | ASTMF1670 | Evaluate the resistance of testmaterial at seams to penetration bysynthetic blood under conditions ofcontinuous liquid contact. | Pass determination basedon no visual detection ofsynthetic bloodpenetration. | Material seams: no syntheticblood penetration seen | Pass. Test material seamsresistant to synthetic bloodpenetration. |
| Viral Penetration | ASTMF1671 | Evaluate the barrier performance oftest material which are intended toprotect against blood borne pathogenhazards. | Pass determination basedon no visual detection ofviral penetration and assaytiter value <1 ° | Visual penetration: none seenAssay Titer (PFU/mL): <1° | Pass. Test materialsuccessfully protects againstblood borne pathogenhazards. |
| Viral Penetration atseams and non-continuous components | ASTMF1671 | Evaluate the barrier performance oftest material at seams which areintended to protect against bloodborne pathogen hazards. | Pass determination basedon no visual detection ofviral penetration and assaytiter value <1° | Visual penetration: none seenAssay Titer (PFU/mL): <1° | Pass. Test material seamsuccessfully protects againstblood borne pathogenhazards. |
| Thickness | ASTM D6988-13 | Determine the thickness of testmaterial. | N/A | 0.018mm | Thickness: 0.018mm |
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Image /page/11/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white design inside, next to the word "PLASDENT" in green, with the word "CORPORATION" in smaller green letters below it. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
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Image /page/12/Picture/0 description: The image contains a logo for PLASDENT CORPORATION. The logo consists of a green geometric shape on the left, followed by the text "PLASDENT" in a larger, bolder font. Below "PLASDENT", the word "CORPORATION" is written in a smaller font. The overall design is simple and professional, likely representing a corporate identity.
Clinical Performance Data
No needed for this device.
VIII. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the Plasdent Disposable Barrier Sleeves and Barrier Films device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Pac-Dent Barrier Sleeve cleared under K151123, Class II (21 CFR 878.4370), product code PEM.
§ 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.