(203 days)
UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.
The UNIPACK Barrier Sleeve and Barrier Film consist of various sizes and shapes of 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, etc. The devices are sold non-sterile, prepackaged, and are for single use only.
The provided document is a 510(k) premarket notification for a medical device called the UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, many of the requested items related to AI/MRMC studies, human-in-the-loop performance, and expert consensus for ground truth are not applicable to this submission. The tests are for material properties and barrier effectiveness, not for diagnostic or therapeutic efficacy involving AI or human interpretation of medical images.
Here's a breakdown of the acceptance criteria and study information available in the document:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F1670: Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood | Pass=no penetration (per ASTM F1670) | Material could not be penetrated by synthetic blood under study conditions. Meets requirements. |
| ASTM F1671: Resistance of Materials used in Protective Clothing to Penetration by Blood-Borne Pathogens using Phi-X174 Bacteriophage Penetration as a Test System | Acceptance criteria per ASTM F1671 | Material met criteria of test standard under study conditions. Meets requirements. |
| ASTM D882: Standards Test Methods for Tensile Properties of Thin Plastic Sheeting | Per ASTM D882, no acceptance criteria for this test method. | Results are for information only as there is no P/F criteria. |
| ASTM F1342: Standard Test method for protective Clothing Material Resistance to Puncture | Per ASTM F1342, no acceptance criteria for this test method. | Results are for information only as there is no P/F criteria. |
| ASTM D1004: Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting | Per ASTM D1004, no acceptance criteria for this test method. | Results are for information only as there is no P/F criteria. |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Acceptance criteria per ISO 10993-5. | Test article passed test and determined non-cytotoxic. |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Acceptance criteria for both studies per ISO 10993-10. | Study completed and test article considered non-sensitizer. Study completed and test article considered non-irritant. |
| X-Ray Effectiveness: Effectiveness of X-Ray Devices Covered with Barrier Sleeves | Expert X-Ray reader should not be able to observe differences between images of same objects captured with and w/o Barrier Sleeves covering X-Ray source. | Images were deemed to be the same by a trained X-Ray reader. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test (e.g., how many barrier sleeves were tested for penetration). It generally refers to "study conducted per [standard]" which implies adherence to the sample size requirements of those specific ASTM/ISO standards. The data provenance is not specified beyond being "non-clinical tests" supporting a US FDA 510(k) submission, suggesting the testing was likely conducted in a controlled lab environment. No information on country of origin or retrospective/prospective nature is provided, as these are material property tests rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For the "X-Ray Effectiveness" test:
- Number of experts: Singularly referred to as "a trained X-Ray reader."
- Qualifications of experts: Only stated as "a trained X-Ray reader." No specific years of experience or board certifications are mentioned.
For other tests (ASTM/ISO standards), the "ground truth" is established by the methodology and objective measurements defined by the respective standards (e.g., chemical analysis for cytotoxicity, physical measurement for tear strength, visual observation for penetration). These do not typically involve human experts establishing "ground truth" in the same way an AI diagnostic system would.
4. Adjudication method for the test set
For the "X-Ray Effectiveness" test, the adjudication method appears to be a single "trained X-Ray reader" making a judgment. There is no mention of multiple readers or an adjudication process (e.g., 2+1, 3+1).
For the other non-clinical tests, adjudication is not applicable as the results are based on objective, standardized test methodologies.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or AI-assisted devices where human interpretation plays a significant role. The device in question is a physical barrier, not a diagnostic tool or AI software.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is a physical barrier sleeve/film, not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate. The tests performed are on the physical properties and barrier effectiveness of the material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For ASTM F1670 & F1671 (Penetration): The ground truth is the objective observation of synthetic blood or bacteriophage penetration according to the standard's methodology.
- For ASTM D882, F1342, D1004 (Tensile, Puncture, Tear): The ground truth is the physical measurement obtained according to the standard's methodology.
- For ISO 10993-5 (Cytotoxicity): The ground truth is the biological response (e.g., cell viability) observed in in vitro cell culture, as interpreted by the standard's criteria.
- For ISO 10993-10 (Irritation/Sensitization): The ground truth is the observed biological response in animal models (guinea pigs, rabbits) according to the standard's criteria.
- For X-Ray Effectiveness: The ground truth is the subjective visual assessment by a "trained X-Ray reader" that images of objects with and without the barrier sleeves are the same. This is the closest to an "expert opinion" ground truth, but it's for equivalence in imaging, not for a diagnostic finding.
8. The sample size for the training set
Not applicable. This device is a physical barrier and does not involve AI or machine learning, thus 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 this device, a method for establishing its ground truth is irrelevant.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2019
UNiPACK Medical Corporation Joe Pomparelli Vice President 9830 Norwalk Blvd., Suite 100 Santa Fe Springs, California 90670
Re: K183263
Trade/Device Name: UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: May 14, 2019 Received: May 20, 2019
Dear Joe Pomparelli:
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
{1}------------------------------------------------
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 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,
For Elizabeth F. Claverie-Williams, MS Assistant Director. THT4B2: Disinfection Reprocessing and Personal Protection Acting Assistant Director, THT4B1: Sterility Devices 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
510(k) Number (if known) K183263
Device Name UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope
Indications for Use (Describe)
UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.
| Item # | Description | Designed For |
|---|---|---|
| UBC-8010E | E Tray Sleeve, 11-1/2" x 16" | Instrument trays |
| UBC-8011A | A Tray Sleeve, 11-5/8" x 14-1/2" | Instrument trays |
| UBC-8012B | B Tray Sleeve, 10-1/2" x 14" | Instrument trays |
| UBC-8013F | F Tray Sleeve, 7-1/2" x 10-1/2" | Instrument trays |
| UBC-8021 | Full Chair Cover, 29" x 80" | Chairs/Stools |
| UBC-8022 | Full Chair Cover, 48" x 56" | Chairs/Stools |
| UBC-8023 | Half Chair Cover, 27-1/2" x 24" | Chair Headrest |
| UBC-8024 | Headrest Cover, 11" x 9-1/2" x 2" | Chair Headrest |
| UBC-8025 | Headrest Cover, 14" x 9-1/2" x 2" | Chair Headrest |
| UBC-8028 | Syringe Sleeve with Opening, Clear, 2-1/2"x 10" | 3-way syringes, saliva ejectors andHVE valves |
| UBC-8029 | Syringe Sleeve with Opening, Blue, 2-1/2"x 10" | 3-way syringes, saliva ejectors andHVE valves |
| UBC-8031 | T-Handle Cover (T Shape), 4" x 5-3/4" | Most T-style dental chair lighthandles |
| UBC-8032 | Universal X-Ray Cover, 23" x 31" | X-Ray head, Extra-Long |
| UBC-8033 | Universal X-Ray Cover, 15" x 26" | X-Ray head, Regular |
| UBC-8034 | Curing Light, Pistol (Handle Only) | Curing Lights, Pen Type |
| UBC-80341-F | Curing Light, Pistol (Full Cover with VentedDesign) | Curing Lights, Pen Type |
| UBC-80342-S | Curing Light, Pen Type (Small), 2" x 12-1/2" | Curing Lights, Pen Type |
| UBC-80343-L | Curing Light, Pen (Large), 3-1/8" x 12-1/2" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8037 | Sensor Sleeve, Size 0 - Small | Digital X-Ray sensor, universal,small, 1-3/8"x8" |
| Item # | Description | Designed For |
| UBC-8038 | Sensor Sleeve, Size 2 - Large | Digital X-Ray sensor, universal, large, 1 5/8"X8" |
| UBC-80392 | Tube Sleeve, 2" x 1200', cut to length | Dental unit tubing (2") |
| UBC-80394 | Tube Sleeve, 4" x 1200', cut to length | Dental unit tubing (4") |
| UBC-820824 | X-Ray Sensor Sheath (Schick, Size 1) | Digital X-Ray sensor (Schick/Dr. SuniPlus) |
| UBC-820825 | X-Ray Sensor Sheath (Schick, Size 2) | Digital X-Ray sensor (Schick/Dr. SuniPlus) |
| UBC-820861 | X-Ray Sensor Sheath (Regam, Size 2) | Digital X-Ray sensor (Regam) |
| UBC-820978 | X-Ray Sensor Sheath (Carestream/Kodak6100, Size 1) | Digital X Ray sensor (Kodak 6100) |
| UBC-820979 | X-Ray Sensor Sheath (Carestream/Kodak6100, Size 2) | Digital X Ray sensor (Kodak 6100) |
| UBC-820999 | X-Ray Sensor Sheath (Dexis/Universal) | Digital X Ray sensor (Dexis) |
| UBC-820831 | Intraoral Camera Covers | Pro-Den Systems/Dent-X, Pro-scope1000 & Oral Scan, Easy Doc |
| UBC-820855 | Intraoral Camera Covers | Siemens, Ceracam/Minicam Ultra |
| UBC-820963 | Intraoral Camera Covers | Video Dental concepts, QuickcamSmile |
| UBC-821013 | Intraoral Camera Covers | Digital Doc, Iris |
| UBE-8160 | UNIGLIDE PSP Barrier Envelope Size O | Phosphor Plate Covers |
| UBE-8161 | UNIGLIDE PSP Barrier Envelope Size 1 | Phosphor Plates Covers |
| UBE-8162 | UNIGLIDE PSP Barrier Envelope Size 2 | Phosphor Plates Covers |
| UBE-8050 | Standard PSP Barrier Envelope Size O | Phosphor Plates Covers |
| UBE-8051 | Standard PSP Barrier Envelope Size 1 | Phosphor Plates Covers |
| UBE-8052 | Standard PSP Barrier Envelope Size 2 | Phosphor Plates Covers |
| UBE-8053 | Standard PSP Barrier Envelope Size 3 | Phosphor Plates Covers |
| UBE-8054 | Standard PSP Barrier Envelope Size 4 | Phosphor Plates Covers |
| UBC-8040-U | Keyboard sleeves | Computer keyboard, universal,22"X14" |
| UBC-8040-L | Keyboard sleeves | Computer keyboard, large, 19"X26" |
| UBC-8041 | LCD & Keyboard sleeves | Computer screen and keyboard,universal |
| UBC-8042 | Laptop sleeves | Laptop, universal |
| UBC-8043-S | Low-speed contra-angle handpiece sleevesw/paper backing | Dental low-speed contra-anglehandpiece, universal |
| UBC-8043-L | Low-speed long handpiece sleevesw/paper backing | Dental low-speed long handpiece,universal |
| UBC-8044 | Optical PC mouse barriers | Computer mouse, universal |
| UBC-8055 | Syringe sleeve w/paper backing | Air/water syringe, universal |
| UBC-8048 | Barrier film - Blue | Covers trays, accessories |
| UBC-8049 | Barrier Film - Clear | Covers trays, accessories |
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]Prescription Use (Part 21 CFR 801 Subpart D)
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Image /page/5/Picture/0 description: The image shows the logo for UniPACK Medical Corporation. The logo features the word "UniPACK" in a stylized font, with the "Uni" portion in blue and a red dot above the "i". Below the main logo, the words "UniPACK Medical Corporation" are written in a smaller, simpler font. The logo is clean and professional, suggesting a company in the medical field.
510(k) Summary for (K183263)
This is submitted in accordance with the requirements CFR 807.92.
Applicant Information:
| Owner Name: | UNIPACK Medical Corporation | |
|---|---|---|
| Address: | 9830 Norwalk Blvd., Ste. 100Santa Fe Springs, CA 90670 | |
| Contact Person: | Joe Pomparelli | |
| Phone Number: | (562) 777-8000 | |
| Email: | Joe.Pomparelli@unipackmendical.com | |
| Date Prepared: | June 13, 2019 |
Device Information:
| Trade Name: | UNIPACK Barrier Sleeve and Barrier Film and UNIGLIDE BarrierEnvelope |
|---|---|
| Common name: | Dental Barriers and Sleeves |
| Classification name: | Surgical Drape and Drape Accessories |
| Regulation: | 21 CFR 878.4370 |
| Classification: | Class II |
| Product Code: | PEM, Dental Barriers and Sleeves |
Legally Marketed Predicate Device:
| Company: | Pac-Dent International Inc. |
|---|---|
| Device: | Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film |
| 510(k): | K151123 |
| Date Cleared: | March 3, 2016 |
Device Description: 1.1
The UNIPACK Barrier Sleeve and Barrier Film consist of various sizes and shapes of 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, etc. The devices are sold non-sterile, prepackaged, and are for single use only.
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1.2 Indication for Use:
The UNiPACK Barrier Sleeve and Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.
| Item # | Description | Designed For |
|---|---|---|
| UBC-8010E | E Tray Sleeve, 11-1/2" x 16" | Instrument trays |
| UBC-8011A | A Tray Sleeve, 11-5/8" x 14-1/2" | Instrument trays |
| UBC-8012B | B Tray Sleeve, 10-1/2" x 14" | Instrument trays |
| UBC-8013F | F Tray Sleeve, 7-1/2" x 10-1/2" | Instrument trays |
| UBC-8021 | Full Chair Cover, 29" x 80" | Chairs/Stools |
| UBC-8022 | Full Chair Cover, 48" x 56" | Chairs/Stools |
| UBC-8023 | Half Chair Cover, 27-1/2" x 24" | Chair Headrest |
| UBC-8024 | Headrest Cover, 11" x 9-1/2" x 2" | Chair Headrest |
| UBC-8025 | Headrest Cover, 14" x 9-1/2" x 2" | Chair Headrest |
| UBC-8028 | Syringe Sleeve with Opening, Clear, 2-1/2"x 10" | 3-way syringes, saliva ejectorsand HVE valves |
| UBC-8029 | Syringe Sleeve with Opening, Blue, 2-1/2"x 10" | 3-way syringes, saliva ejectorsand HVE valves |
| UBC-8031 | T-Handle Cover (T Shape), 4" x 5-3/4" | Most T-style dental chair lighthandles |
| UBC-8032 | Universal X-Ray Cover, 23" x 31" | X-Ray head, Extra-Long |
| UBC-8033 | Universal X-Ray Cover, 15" x 26" | X-Ray head, Regular |
| UBC-8034 | Curing Light, Pistol (Handle Only) | Curing Lights, Pen Type |
| UBC-80341-F | Curing Light, Pistol (Full Cover with VentedDesign) | Curing Lights, Pen Type |
| UBC-80342-S | Curing Light, Pen Type (Small), 2" x 12-1/2" | Curing Lights, Pen Type |
| UBC-80343-L | Curing Light, Pen (Large), 3-1/8" x 12-1/2" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8037 | Sensor Sleeve, Size 0 - Small | Digital X-Ray sensor, universal,small, 1 3/8"X8" |
| UBC-8038 | Sensor Sleeve, Size 2 - Large | Digital X-Ray sensor, universal,large, 1 5/8"X8" |
| UBC-80392 | Tube Sleeve, 2" x 1200', cut to length | Dental unit tubing (2") |
| UBC-80394 | Tube Sleeve, 4" x 1200', cut to length | Dental unit tubing (4") |
| UBC-820824 | X-Ray Sensor Sheath (Schick, Size 1) | Digital X-Ray sensor(Schick/Dr. Suni Plus) |
| UBC-820825 | X-Ray Sensor Sheath (Schick, Size 2) | Digital X-Ray sensor(Schick/Dr. Suni Plus) |
| UBC-820861 | X-Ray Sensor Sheath (Regam, Size 2) | Digital X-Ray sensor (Regam) |
| UBC-820978 | X-Ray Sensor Sheath (Carestream/Kodak 6100,Size 1) | Digital X Ray sensor (Kodak6100) |
| Item # | Description | Designed For |
| UBC-820979 | X-Ray Sensor Sheath (Carestream/Kodak 6100,Size 2) | Digital X Ray sensor (Kodak6100) |
| UBC-820999 | X-Ray Sensor Sheath (Dexis/Universal) | Digital X Ray sensor (Dexis) |
| UBC-820831 | Intraoral Camera Covers | Pro-Den Systems/Dent-X, Pro-scope 1000 & Oral Scan, EasyDoc |
| UBC-820855 | Intraoral Camera Covers | Siemens, Ceracam/MinicamUltra |
| UBC-820963 | Intraoral Camera Covers | Video Dental concepts,Quickcam Smile |
| UBC-821013 | Intraoral Camera Covers | Digital Doc, Iris |
| UBE-8160 | UNIGLIDE PSP Barrier Envelope Size 0 | Phosphor Plate Cover |
| UBE-8161 | UNIGLIDE PSP Barrier Envelope Size 1 | Phosphor Plate Cover |
| UBE-8162 | UNIGLIDE PSP Barrier Envelope Size 2 | Phosphor Plate Cover |
| UBE-8050 | Standard PSP Barrier Envelope Size 0 | Phosphor Plate Cover |
| UBE-8051 | Standard PSP Barrier Envelope Size 1 | Phosphor Plate Cover |
| UBE-8052 | Standard PSP Barrier Envelope Size 2 | Phosphor Plate Cover |
| UBE-8053 | Standard PSP Barrier Envelope Size 3 | Phosphor Plate Cover |
| UBE-8054 | Standard PSP Barrier Envelope Size 4 | Phosphor Plate Cover |
| UBC-8040-U | Keyboard sleeves | Computer keyboard,universal, 22"X14" |
| UBC-8040-L | Keyboard sleeves | Computer keyboard, large,19"X26" |
| UBC-8041 | LCD & Keyboard sleeves | Computer screen andkeyboard, universal |
| UBC-8042 | Laptop sleeves | Laptop, universal |
| UBC-8043-S | Low-speed contra-angle handpiece sleevesw/paper backing | Dental low-speed contra-anglehandpiece, universal |
| UBC-8043-L | Low-speed long handpiece sleeves w/paperbacking | Dental low-speed longhandpiece, universal |
| UBC-8044 | Optical PC mouse barriers | Computer mouse, universal |
| UBC-8055 | Syringe sleeve w/paper backing | Air/water syringe, universal |
| UBC-8048 | Barrier Film - Blue | Cover trays, accessories |
| UBC-8049 | Barrier film - clear | Cover trays, accessories |
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1.3 Technical Characteristics:
| Descriptive Information | UNIPACK Barrier Sleeve,Barrier Film and UniGlideBarrier Envelope(Subject Device) | Pac-Dent Barrier SleeveCover-It™ Barrier Film510(k) #K151123 |
|---|---|---|
| Indication for Use | The UNIPACK Barrier Sleeve,Barrier Film and UNIGLIDEBarrier Envelopes are intendedto be used as a barrier to coverdental instruments. This deviceis non-sterile and intended forsingle patient use only. | Pac-Dent Barrier Sleeve andCover-It Barrier Film areintended to be used as a barrierto cover dental instruments. Thisdevice is non-sterile andintended for single patient useonly. |
| Regulation Number | 21 CFR 878.4370 | 21 CFR 878.4370 |
| Classification Product Code | PEM | PEM |
| Product Classification | Class II | Class II |
| Composition of Materials | LLDPE (80%)LDPE (20%) | LLDPE (80%)LDPE (20%) |
| Sterility | Non-Sterile | Non-Sterile |
| Labeling | Single Use Only, OTC | Single Use Only, OTC |
| Specifications | Film Thickness: 0.02-0.06mmTolerance: 0.01mmPaper Backing – some models | Film Thickness: 0.02-0.06mmTolerance: 0.01mmPaper Backing - some models |
| Film Thickness | Film Thickness | |
| Resistance to Penetration- ASTM F1670: Pass- ASTM F1671: Pass | Resistance to Penetration- ASTM F1670: Pass- ASTM F1671: Pass | |
| Tear Strength- ASTM D1424: Pass | Tear Strength- ASTM D1424: Pass | |
| Tensile Properties- ASTM D882: Pass | Tensile Properties- ASTM D882: Pass | |
| Performance Testing | Resistance to Puncture- ASTM F1342: Pass | Resistance to Puncture- ASTM F1342: Pass |
| Effectiveness of X-Ray DevicesCovered with Barrier Sleevesdetermined to be same aswithout Barrier Sleeves usingside-by-side visual comparisonof pictures of common dentaloffice objects. | Effectiveness of X-Ray DevicesCovered with Barrier Sleeves:Pass | |
| Biocompatibility | ISO 10933-5 (cytotoxicity): PassISO 10933-10 (irritation): PassISO 10933-10 (sensitization):Pass | ISO 10933-5 (cytotoxicity): PassISO 10933-10 (irritation): PassISO 10933-10 (sensitization):Pass |
| Descriptive Information | UNIPACK Barrier Sleeve,Barrier Film and UniGlideBarrier Envelope(Subject Device) | Pac-Dent Barrier SleeveCover-ItTM Barrier Film510(k) #K151123 |
| FDA Recognized Standards | ASTM F1670 | ASTM F1670 |
| ASTM D1004 | ASTM D1004 | |
| ASTM D882 | ASTM D882 | |
| ASTM F1342 | ASTM F1342 | |
| ASTM F1671 | ASTM F1671 | |
| ISO 10993-5 | ISO 10993-5 | |
| ISO 10993-10 | ISO 10993-10 |
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Summary of Non-Clinical Tests 1.4
The following table summarizes the non-clinical performance testing.
| Test Item | Methodology | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|
| ASTM F1670:Resistance ofMaterials Used inProtective Clothingto Penetration bySynthetic Blood | Study conducted perASTM F1670Study Endpoint:Observed for syntheticblood penetration atconclusion of study | Evaluateresistance ofprotectivematerials topenetration bysynthetic bloodunder conditions ofcontinuous liquidcontact. | Acceptance criteriaper ASTM F1670Pass/Fail based onsynthetic bloodpenetrationobservations.Pass=nopenetration | Material used forUnipack DentalBarrier Film andSleeves could notbe penetrated bysynthetic bloodunder studyconditions. Thematerial meets therequirements ofASTM F1670 inpreventingsynthetic bloodpenetration. |
| ASTM F1671:Resistance ofMaterials used inProtective Clothingto Penetration byBlood-BornePathogens usingPhi-X174BacteriophagePenetration as aTest SystemPenetration | Study conducted perASTM F1671 | Evaluate barrierperformance ofprotectivematerials whichare intended toprotect againstblood bornepathogen hazards. | Acceptance criteriaper ASTM F1671 | Material used forUnipack DentalBarrier Film andSleeves metcriteria of teststandard understudy conditions.The materialmeets therequirements ofASTM F1671 inpreventing bloodborne pathogenpenetration. |
| ASTM D882:Standards TestMethods for TensileProperties of ThinPlastic Sheeting | Study conducted perASTM D882Study Endpoint:To failure of test article | Determine tensilestrength. | Per ASTM D882,there is currentlyno acceptancecriteria for this testmethod. | The results are forinformation only asthere is no P/Fcriteria. |
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| Test Item | Methodology | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|
| ASTM F1342:Standard Testmethod forprotective ClothingMaterial Resistanceto Puncture | Study conducted perASTM F1342Study Endpoint:At the point of materialpuncture. | Determinepunctureresistance of aprotective clothingmaterial. | Per ASTM F1342,there is currentlyno acceptancecriteria for this testmethod. | The results are forinformation only asthere is no P/Fcriteria. |
| ASTM D1004:Standard TestMethod for TearResistance (GravesTear) of Plastic Filmand Sheeting | Study conducted perASTM D1004Study Endpoint:At the point of materialtearing. | Determine tearstrength of plasticfilm and sheeting. | per ASTM D1004,there is currentlyno acceptancecriteria for this testmethod. | The results are forinformation only asthere is no P/Fcriteria. |
| ISO 10993-5:Biological evaluation ofmedical devices - Part5: Tests for in vitrocytotoxicity | Study conducted incompliance to ISO10993-5: 2009 and BSEN ISO 10993-5: 2009(Tests for in vitroCytotoxicity). Test and/orcontrol article preparedin compliance to ISO10993-12: 2012 and BSEN ISO 10993-12: 2012(Sample Preparationand Reference | Purpose of MEMElution Cytotoxicitytest was todeterminecytotoxic responsefrom test articlewhich wasextracted in cellculture mediawhich was thenplated onto L-929mouse fibroblast | Acceptance criteriaper ISO 10993-5. | Test article passedtest anddetermined non-cytotoxic. |
| Test Item | Methodology | Purpose | AcceptanceCriteria | Results |
| ISO 10993-10:Biological evaluation ofmedical devices - Part10: Tests for irritationand skin sensitization | Studies (2) conducted incompliance toISO)10993-10: 2010 andBS EN ISO 10993-10:2013 (Tests for Irritationand Skin Sensitization).Test or control articleprepared in complianceto ISO 10993-12: 2012and BS EN ISO 10993-12: 2012 (SamplePreparation andReference Materials). | Study 1 purpose:To evaluatesensitization orallergenic potentialof a test article.Test is used asmethod forscreening contactallergens in guineapigs. Results areused as predictivemeasures fordetecting potentialsensitizers inhumans.Study 2 purpose:To evaluateirritation potentialof a test article.Test is used asmethod forscreening irritantsin rabbits. Resultsare used aspredictivemeasures fordetecting potentialirritants in humans. | Acceptance criteriafor both studies perISO 10993-10. | Study completedand test articleconsidered non-sensitizer.Study completedand test articleconsidered non-irritant. |
| X-RayEffectiveness:Currently nostandard isavailable. | Side-by-side visualcomparison of X-Raypictures of commondental office objects. | Determineeffectiveness of X-Ray devicescovered withBarrier Sleeves. | Expert X-Rayreader should notbe able to observedifferencesbetween images ofsame objectscaptured with andw/o Barrier Sleevescovering X-Raysource. | Images weredeemed to be thesame by a trainedX-Ray reader. |
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Clinical Performance Test 1.5
No clinical testing was performed.
1.6 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Pac-Dent Barrier Sleeve and Cover-It Barrier Film (K151123).
§ 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.