(310 days)
Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
Device Name: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Testing Category | Acceptance Criteria (from predicate/recognized standards) | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Film Thickness | Predicate: 0.02mm, Tolerance: <0.01mm (TiDiShield) | Subject Device: 0.02-0.06mm, Tolerance: <0.01mm (This indicates a range for the subject device, which aligns with the predicate's tolerance for variations, but the base thickness can be higher. The document states it is "equivalent" or "as well as the predicate devices.") |
| Protective Barrier Performance | ||
| Resistance to Penetration (Synthetic Blood) | Pass (ASTM F1670) | Pass (ASTM F1670) |
| Resistance to Penetration (Viral/Bacterial) | Pass (ASTM F1671) | Pass (ASTM F1671) |
| Tear Strength | Equivalent to predicate device (ASTM D1424) | Subject device is equivalent to the predicate device (ASTM D1424) |
| Tensile Properties | Equivalent to predicate device (ASTM D882) | Subject device is equivalent to the predicate device (ASTM D882) |
| Resistance to Puncture | Equivalent to predicate device (ASTM F1342) | Subject device is equivalent to the predicate device (ASTM F1342) |
| Biocompatibility | ||
| In vitro cytotoxicity | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic under the conditions of the study (ISO 10993-5) |
| Irritation | Not an irritant (ISO 10993-10) | Not an irritant under the conditions of the study (ISO 10993-10) |
| Sensitization | Not a sensitizer (ISO 10993-10) | Not a sensitizer under the conditions of the study (ISO 10993-10) |
| Functional Performance | ||
| Effectiveness of X-Ray Devices Covered with Barrier Sleeves | No impact on function of dental x-ray devices | Performed to demonstrate the subject device does not impact the function of dental x-ray devices (implies successful demonstration, as it supported the conclusion of substantial equivalence). |
Study Details:
-
Sample sizes used for the test set and data provenance:
The document does not explicitly state the specific sample sizes for each test in terms of the number of individual barrier sleeves or films tested. It mentions "Performance test including resistance to penetration, tear strength, tensile properties, resistance to puncture was performed in comparison to the predicate device." Similarly, it notes "Biocompatibility test in accordance with ISO10993-5, ISO10993-10 has been performed" and "Effectiveness of X-Ray Devices Covered with Barrier Sleeves was performed".The data provenance is not specified. It's typical for premarket notifications to be based on studies conducted by the manufacturer or third-party labs on behalf of the manufacturer, likely in the country of manufacture or where testing facilities are located. The document implies these were non-clinical tests (lab-based, not involving human patients), so the concept of "retrospective or prospective" as it applies to patient data is not directly relevant here.
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This question is not applicable to the type of studies described. The "ground truth" here is based on objective, standardized laboratory test methods (e.g., ASTM, ISO standards) and comparison with a predicate device, not on expert human interpretation of results like in medical image analysis. -
Adjudication method for the test set:
This is not applicable. The tests performed are objective, quantitative laboratory tests with defined pass/fail criteria or comparative measurements against a predicate device. There is no element of human judgment or adjudication in the sense of consensus building for a diagnosis or interpretation. -
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, an MRMC comparative effectiveness study was not done. This device is a physical barrier (barrier sleeve/film), not an AI-powered diagnostic or assistive tool for human readers. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. Again, this is not an AI/software device. The studies focused on the physical and protective properties of the barrier sleeves and films. -
The type of ground truth used:
The "ground truth" for this device's performance is established by:- Adherence to recognized standards: ASTM F1670, ASTM F1671, ASTM D1424, ASTM D882, ASTM F1342, ISO 10993-5, ISO 10993-10. These standards define the test methodologies and often the performance thresholds.
- Comparison to predicate device: The subject device's performance characteristics (e.g., tear strength, tensile properties, resistance to puncture) were shown to be "equivalent" to the predicate device (TiDiShield Curing Light Sleeve - K132953). This implies that the predicate's established performance serves as a benchmark for substantial equivalence.
- Functional demonstration: For the x-ray sleeves, the "ground truth" was that the barrier did not negatively impact the function of the dental x-ray devices, which is a functional test.
-
The sample size for the training set:
This question is not applicable. This device is not an AI/machine learning device, so there is no concept of a "training set" in the context of data used for algorithm development. The tests are physical and biological property evaluations of the manufactured product. -
How the ground truth for the training set was established:
This question is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Pac-Dent International, Inc. Wenying Zhu Materials Engineer 670 Endeavor Circle Brea, CA 92821
Re: K151123
Trade/Device Name: Pac-Dent Barrier Sleeve, Cover-It110 Barrier Film Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: PEM Dated: February 1, 2016 Received: February 4, 2016
Dear Ms. Zhu:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Zhu
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151123
Device Name
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Indications for Use (Describe)
Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
| Item# | Model | Designed for |
|---|---|---|
| 101 | B tray sleeves | Dental instrument tray (size B) |
| 101A | A tray sleeves | Dental instrument tray (size A) |
| 102 | Headrest cover | Dental chair headrest, 11"X9 1/2" |
| 103 | Headrest cover | Dental chair headrest, jumbo, 14"X9 1/2" |
| 104 | F tray sleeves | Dental instrument tray (size F) |
| 109 | X-Ray sleeves | X-Ray head, universal, 15"X26" |
| 110 | Universal X-Ray sleeves | X-Ray head, universal, extra-long, 23"X31" |
| 111 | Full chair sleeves | Dental chair, universal, 29"X80" |
| 111SG | S&G full chair sleeves | Dental chair, Slip and Grip, 48"X56" |
| 112 | Half chair sleeves | Half dental chair, universal, 27 1/2"X24" |
| 100 | Syringe sleeve w. opening, clear | Air/water syringe HVE, universal |
| 100B | Syringe sleeve w. opening, blue | Air/water syringe HVE, universal |
| 100L | Digital sensor sleeve | Digital X-Ray sensor, universal, large, 1 5/8"X8" |
| 100S | Digital sensor sleeve | Digital X-Ray sensor, universal, small, 1 3/8"X8" |
| 103HP | High-speed handpiece sleeves | Dental high-speed handpiece, universal |
| 104HP | Low-speed handpiece sleeves | Dental low-speed handpiece, universal |
| 106 | "T" handle sleeves | T-style light handles, universal |
| 190LED | Sleeves for L.E. Demetron | Dental curing light (L.E. Demetron) |
| D250 | LED Curing light sleeves for Demi | Dental curing light (Demi) |
| S121 | Keyboard sleeves | Computer keyboard, universal, 22"X14" |
| S122 | Keyboard sleeves | Computer keyboard, large, 19"X26" |
| S123 | LCD & Keyboard sleeves | Computer screen and keyboard, universal |
| S124 | Laptop sleeves | Laptop, universal |
| LCH500 | Low-speed contra-angle handpiece sleeves w/paper backing | Dental low-speed contra-angle handpiece, universal |
| LLH500 | Low-speed long handpiece sleeves w/paper backing | Dental low-speed long handpiece, universal |
| CM500 | Optical PC mouse barriers | Computer mouse, universal |
| AWP400 | Syringe sleeve W/paper backing | Air/water syringe, universal |
| DX-405 | X-ray sensor sheaths, Gender,XDR® Size 1 | Digital X-Ray sensor (Gender,XDR® Size 1) |
| DX-406 | X-ray sensor sheaths, Gender,XDR® Size 2 | Digital X-Ray sensor (Gender,XDR® Size 2) |
| DX-819 | X-ray sensor sheaths, Suni/Lightyear | Digital X-Ray sensor (Suni/Lightyear) |
| DX-824 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-825 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-890 | X-ray sensor sheaths, Sirona Size 2 | Digital X-Ray sensor (Sirona Size 2) |
| DX-904 | X-ray sensor sheaths, Sirona Size 1 | Digital X-Ray sensor (Sirona Size 1) |
| DX-977 | X-ray sensor sheaths, Kodak 6100 Size 0 | Digital X-Ray sensor (Kodak 6100 Size 0) |
| DX-978 | X-ray sensor sheaths, Kodak 6100 Size 1 | Digital X-Ray sensor (Kodak 6100 Size 1) |
| DX-979 | X-ray sensor sheaths, Kodak 6100 Size 2 | Digital X-Ray sensor (Kodak 6100 Size 2) |
| DX-999 | X-ray sensor sheaths, Dexis | Digital X-Ray sensor (Dexis) |
| PIC250 | Complete iCure curing light sleeves | Dental curing light (iCure) |
| CS250 | Complete curing light sleeves | Dental curing light, universal |
| P3720 | Tube sleeves(2") | Dental unit tubing (2") |
| P3740 | Tube sleeves(4") | Dental unit tubing (4") |
| P4550 | Curing Light Handle Sleeves | Curing light handle, universal |
| C101 | Cover It Barrier film, clear | Surface area that might be touched during |
| procedure, 4"X6" | ||
| C101B | Cover It Barrier film, blue | Surface area that might be touched during |
| procedure, 4"X6" |
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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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Image /page/4/Picture/0 description: The image shows the logo for PacDent. The logo features the company name in a bold, blue font. Above the company name is an orange swoosh that curves over the top of the text. The logo is simple and modern, and the colors are eye-catching.
Pac-Dent International, Inc.
510(k) Summary
Submitter:
Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821 Contact Person: Wenying Zhu Materials Engineer 909-839-0888 ext.111 Date Summary Prepared: 02/15/2016
Device Name
Trade Name: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film Common Name: Dental Barriers and Sleeves Device Classification: Class II Classification Product Code: PEM Classification Name: Surgical drape and drape accessories per 21 CFR 878.4370
Predicate Device
Primary predicate device: TiDiShield Curing Light Sleeve - K132953 Reference Device: Cover-All, Chair Sleeve, Drape-it-All, Tray Sleeve, related products - K962288
Description of Device
Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
Indications for Use
Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
| Item# | Model | Designed for |
|---|---|---|
| 101 | B tray sleeves | Dental instrument tray (size B) |
| 101A | A tray sleeves | Dental instrument tray (size A) |
| 102 | Headrest cover | Dental chair headrest, 11"X9 1/2" |
| 103 | Headrest cover | Dental chair headrest, jumbo, 14"X9 1/2" |
| 104 | F tray sleeves | Dental instrument tray (size F) |
| 109 | X-Ray sleeves | X-Ray head, universal, 15"X26" |
| 110 | Universal X-Ray sleeves | X-Ray head, universal, extra-long, 23"X31" |
| 111 | Full chair sleeves | Dental chair, universal, 29"X80" |
| 111SG | S&G full chair sleeves | Dental chair, Slip and Grip, 48"X56" |
| 112 | Half chair sleeves | Half dental chair, universal, 27 1/2"X24" |
| 100 | Syringe sleeve w. opening, clear | Air/water syringe HVE, universal |
| 100B | Syringe sleeve w. opening, blue | Air/water syringe HVE, universal |
| 100L | Digital sensor sleeve | Digital X-Ray sensor, universal, large, 1 5/8"X8" |
| 100S | Digital sensor sleeve | Digital X-Ray sensor, universal, small, 1 3/8"X8" |
| 103HP | High-speed handpiece sleeves | Dental high-speed handpiece, universal |
| 104HP | Low-speed handpiece sleeves | Dental low-speed handpiece, universal |
| 106 | "T" handle sleeves | T-style light handles, universal |
| 190LED | Sleeves for L.E. Demetron | Dental curing light (L.E. Demetron) |
| D250 | LED Curing light sleeves for Demi | Dental curing light (Demi) |
| S121 | Keyboard sleeves | Computer keyboard, universal, 22"X14" |
| S122 | Keyboard sleeves | Computer keyboard, large, 19"X26" |
| S123 | LCD & Keyboard sleeves | Computer screen and keyboard, universal |
| S124 | Laptop sleeves | Laptop, universal |
| LCH500 | Low-speed contra-angle handpiece sleeves w/paper backing | Dental low-speed contra-angle handpiece, universal |
| LLH500 | Low-speed long handpiece sleeves w/paper backing | Dental low-speed long handpiece, universal |
| CM500 | Optical PC mouse barriers | Computer mouse, universal |
| AWP400 | Syringe sleeve w/paper backing | Air/water syringe, universal |
| DX-405 | X-ray sensor sheaths, Gender,XDR® Size 1 | Digital X-Ray sensor (Gender,XDR® Size 1) |
| DX-406 | X-ray sensor sheaths, Gender,XDR® Size 2 | Digital X-Ray sensor (Gender,XDR® Size 2) |
| DX-819 | X-ray sensor sheaths, Suni/Lightyear | Digital X-Ray sensor (Suni/Lightyear) |
| DX-824 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-825 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-890 | X-ray sensor sheaths, Sirona Size 2 | Digital X-Ray sensor (Sirona Size 2) |
| DX-904 | X-ray sensor sheaths, Sirona Size 1 | Digital X-Ray sensor (Sirona Size 1 |
| DX-977 | X-ray sensor sheaths, Kodak 6100 Size 0 | Digital X-Ray sensor (Kodak 6100 Size 0) |
| DX-978 | X-ray sensor sheaths, Kodak 6100 Size 1 | Digital X-Ray sensor (Kodak 6100 Size 1) |
| DX-979 | X-ray sensor sheaths, Kodak 6100 Size 2 | Digital X-Ray sensor (Kodak 6100 Size 2) |
| DX-999 | X-ray sensor sheaths, Dexis | Digital X-Ray sensor (Dexis) |
| PIC250 | Complete iCure curing light sleeves | Dental curing light (iCure) |
| CS250 | Complete curing light sleeves | Dental curing light, universal |
| P3720 | Tube sleeves(2") | Dental unit tubing (2") |
| P3740 | Tube sleeves(4") | Dental unit tubing (4") |
| P4550 | Curing Light Handle Sleeves | Curing light handle, universal |
| C101 | Cover It™ Barrier film, clear | Surface area that might be touched duringprocedure, 4"X6" |
| C101B | Cover It™ Barrier film, blue | Surface area that might be touched duringprocedure, 4"X6" |
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Image /page/5/Picture/0 description: The image contains the logo for PacDent. The logo features the company name in a bold, blue font. Above the company name is an orange swoosh design.
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Image /page/6/Picture/0 description: The image contains the logo for Pac-Dent International, Inc. The logo features the company name in a combination of blue and gray text. To the left of the company name is an orange graphic element that appears to be a stylized swoosh or arc.
Comparison of Technological Characteristics and Performance
| DescriptiveInformation | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Pac-Dent Barrier Sleeve, Cover-It™Barrier Film | TiDiShield Curing Light Sleeve(K132953) | Cover-All (K962288) | |
| Indications forUse | To be used as a barrier to coverdental instruments. | Use as a barrier that is used asan accessory to dentalinstrument. | To act as a physical barrier,augmenting existing infectioncontrol techniques and makeclean-up and disinfectioneasier. |
| ClassificationProduct Code | PEM | PEM | MMP |
| Composition ofMaterials | LLDPE (80%)LDPE (20%)Blue pigment (item#100B, C101B)Adhesive (item#C101, C101B) | LLDPE (80%)LDPE (20%) | LLDPE (80%)LDPE (20%) |
| Specificationsand Tolerances | Paper backing: some of the modelFilm thickness: 0.02-0.06mmTolerance: <0.01mm | Paper backing: YesFilm thickness: 0.02mmTolerance: <0.01mm | Paper backing: some of themodelFilm thickness: 0.02-0.06mmTolerance: <0.01mm |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Labeling | Single Use Only | Single Use Only | Single Use Only |
| Performance | · Film Thickness | · Film Thickness | · Film Thickness |
| Testing | |||
| Resistance to Penetration -ASTM F1670: pass- ASTM F1671: pass- Tear Strength - ASTM D1424:subject device is equivalent tothe predicate device- Tensile Properties - ASTMD882: subject device isequivalent to the predicatedevice- Resistance to Puncture - ASTMF1342: subject device isequivalent to the predicatedevice- Biocompatibility- ISO10993-5 in vitro cytotoxicityUnder the conditions of the study,the subject device wasnon-cytotoxic.- ISO 10993-10 irritationUnder the conditions of the study,the subject device was not anirritant- ISO 10993-10 sensitizationUnder the conditions of the study,the subject device was not asensitizer- Effectiveness of X-Ray DevicesCovered with Barrier Sleeves | - Synthetic Blood Resistance- ASTM F1670- Tear Strength - ASTMD1424- Tensile Properties - ASTMD882- Resistance to Puncture -ASTM F1342 | - Synthetic Blood Resistance- ASTM F1670- Tear Strength - ASTMD1424- Tensile Properties - ASTMD882- Resistance to Puncture -ASTM F1342 | |
| FDA-RecognizedStandards | ANSI/AAMI PB70:2012 | ANSI/AAMI PB70:2012 | ANSI/AAMI PB70:2012 |
| ASTM F1670 | ASTM F1670 | ASTM F1670 | |
| ASTM D1004 | ASTM D1004 | ASTM D1004 | |
| ASTM D882 | ASTM D882 | ASTM D882 | |
| ASTM F1342 | ASTM F1342 | ASTM F1342 | |
| ASTM F1671 | |||
| ISO 10993-5 | |||
| ISO 10993-10 |
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Image /page/7/Picture/0 description: The image shows the logo for PacDent. The logo features the company name in a bold, blue font. Above the company name is an orange swoosh design.
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Image /page/8/Picture/0 description: The image shows the logo for Pac-Dent International, Inc. The logo features the company name in a combination of blue and gray text. To the left of the name is an orange graphic element that resembles a swoosh or curved line, adding a visual accent to the logo.
The product code PEM (Dental Barriers and Sleeves) better describes the subject device than MMP (Cover, Barrier, Protective). Therefore, the subject device uses PEM as its product code.
Non-Clinical Tests
Performance test including resistance to penetration, tear strength, tensile properties, resistance to puncture was performed in comparison to the predicate device. Effectiveness of X-Ray Devices Covered with Barrier Sleeves was performed to demonstrate the subject device does not impact the function of dental x-ray devices.
Biocompatibility test in accordance with ISO10993-5, ISO10993-10 has been performed.
Clinical Performance Test
No clinical testing was provided.
Summary of Non-Clinical and Clinical Performance Testing
The performance test result shows that the subject device performs as well as the predicate devices. The biocompatibility test result shows that the subject device was found to be not an irritant or a sensitizer and non -cytotoxic under the conditions of the studies.
Conclusion
The performance data support the conclusion that the subject device is as safe and as effective and performs as well as the legally marketed devices identified TiDiShield Curing Light Sleeve (K132953) and Cover-All, Chair Sleeve, Drape-it-All, Tray Sleeve, related products (K962288).
§ 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.