Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier function of plastic covers for dental instruments, with no mention of AI or ML.

Therapeutic

No.
The device is described as a barrier to cover dental instruments and other devices, not to treat or diagnose patients.

Diagnostic

No
The device is described as a barrier to cover dental instruments, aiming to prevent contamination, and its performance studies relate to its barrier properties and biocompatibility, not its ability to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of physical polyethylene covers and films, which are hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "be used as a barrier to cover dental instruments." This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
Device Description: The description reinforces the physical barrier function, covering instruments and devices.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on the physical properties of the barrier material (penetration resistance, tensile strength, tear resistance, biocompatibility) and its effect on X-ray images, not on diagnostic accuracy or performance.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

PEM

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following non-clinical performance tests were performed:

ASTM F1670: Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood. The material used for Unipack Dental Barrier Film and Sleeves could not be penetrated by synthetic blood under study conditions. The material meets the requirements of ASTM F1670 in preventing synthetic blood penetration.
ASTM F1671: Resistance of Materials used in Protective Clothing to Penetration by Blood-Borne Pathogens using Phi-X174 Bacteriophage Penetration as a Test System Penetration. Material used for Unipack Dental Barrier Film and Sleeves met criteria of test standard under study conditions. The material meets the requirements of ASTM F1671 in preventing blood borne pathogen penetration.
ASTM D882: Standards Test Methods for Tensile Properties of Thin Plastic Sheeting. The results are for information only as there is no P/F criteria.
ASTM F1342: Standard Test method for protective Clothing Material Resistance to Puncture. The 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. The 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. Test article passed test and determined non-cytotoxic.
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Study completed and test article considered non-sensitizer. Study completed and test article considered non-irritant.
X-Ray Effectiveness: Currently no standard is available. Side-by-side visual comparison of X-Ray pictures of common dental office objects. Images were deemed to be the same by a trained X-Ray reader.

No clinical testing was performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151123

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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

2

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 and
HVE valves
UBC-8029	Syringe Sleeve with Opening, Blue, 2-1/2"x 10"	3-way syringes, saliva ejectors and
HVE valves
UBC-8031	T-Handle Cover (T Shape), 4" x 5-3/4"	Most T-style dental chair light
handles
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 Vented
Design)	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. 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 (Kodak 6100)
UBC-820979	X-Ray Sensor Sheath (Carestream/Kodak
6100, 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-scope
1000 & Oral Scan, Easy Doc
UBC-820855	Intraoral Camera Covers	Siemens, Ceracam/Minicam Ultra
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 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 sleeves
w/paper backing	Dental low-speed contra-angle
handpiece, universal
UBC-8043-L	Low-speed long handpiece sleeves
w/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

3

4

]Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

5

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. 100
Santa 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 Barrier
Envelope |
|----------------------|--------------------------------------------------------------------------|
| 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.

6

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 ejectors
and HVE valves
UBC-8029	Syringe Sleeve with Opening, Blue, 2-1/2"x 10"	3-way syringes, saliva ejectors
and HVE valves
UBC-8031	T-Handle Cover (T Shape), 4" x 5-3/4"	Most T-style dental chair light
handles
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 Vented
Design)	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 (Kodak

```
                           |
```

7

8

1.3 Technical Characteristics:

| Descriptive Information | UNIPACK Barrier Sleeve,
Barrier Film and UniGlide
Barrier Envelope
(Subject Device) | Pac-Dent Barrier Sleeve
Cover-It™ Barrier Film
510(k) #K151123 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The UNIPACK Barrier Sleeve,
Barrier Film and UNIGLIDE
Barrier Envelopes are intended
to be used as a barrier to cover
dental instruments. This device
is non-sterile and intended for
single patient use only. | 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
intended for single patient use
only. |
| 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: 0.02-0.06mm
Tolerance: 0.01mm
Paper Backing – some models | Film Thickness: 0.02-0.06mm
Tolerance: 0.01mm
Paper 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 Devices
Covered with Barrier Sleeves
determined to be same as
without Barrier Sleeves using
side-by-side visual comparison
of pictures of common dental
office objects. | Effectiveness of X-Ray Devices
Covered with Barrier Sleeves:
Pass |
| Biocompatibility | ISO 10933-5 (cytotoxicity): Pass
ISO 10933-10 (irritation): Pass
ISO 10933-10 (sensitization):
Pass | ISO 10933-5 (cytotoxicity): Pass
ISO 10933-10 (irritation): Pass
ISO 10933-10 (sensitization):
Pass |
| Descriptive Information | UNIPACK Barrier Sleeve,
Barrier Film and UniGlide
Barrier Envelope
(Subject Device) | Pac-Dent Barrier Sleeve
Cover-ItTM Barrier Film
510(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 |

9

Summary of Non-Clinical Tests 1.4

The following table summarizes the non-clinical performance testing.

| Test Item | Methodology | Purpose | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1670:
Resistance of
Materials Used in
Protective Clothing
to Penetration by
Synthetic Blood | Study conducted per
ASTM F1670
Study Endpoint:
Observed for synthetic
blood penetration at
conclusion of study | Evaluate
resistance of
protective
materials to
penetration by
synthetic blood
under conditions of
continuous liquid
contact. | Acceptance criteria
per ASTM F1670
Pass/Fail based on
synthetic blood
penetration
observations.
Pass=no
penetration | Material used for
Unipack Dental
Barrier Film and
Sleeves could not
be penetrated by
synthetic blood
under study
conditions. The
material meets the
requirements of
ASTM F1670 in
preventing
synthetic blood
penetration. |
| ASTM F1671:
Resistance of
Materials used in
Protective Clothing
to Penetration by
Blood-Borne
Pathogens using
Phi-X174
Bacteriophage
Penetration as a
Test System
Penetration | Study conducted per
ASTM F1671 | Evaluate barrier
performance of
protective
materials which
are intended to
protect against
blood borne
pathogen hazards. | Acceptance criteria
per ASTM F1671 | Material used for
Unipack Dental
Barrier Film and
Sleeves met
criteria of test
standard under
study conditions.
The material
meets the
requirements of
ASTM F1671 in
preventing blood
borne pathogen
penetration. |
| ASTM D882:
Standards Test
Methods for Tensile
Properties of Thin
Plastic Sheeting | Study conducted per
ASTM D882
Study Endpoint:
To failure of test article | Determine tensile
strength. | Per ASTM D882,
there is currently
no acceptance
criteria for this test
method. | The results are for
information only as
there is no P/F
criteria. |

10

| Test Item | Methodology | Purpose | Acceptance
Criteria | Results |
|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1342:
Standard Test
method for
protective Clothing
Material Resistance
to Puncture | Study conducted per
ASTM F1342
Study Endpoint:
At the point of material
puncture. | Determine
puncture
resistance of a
protective clothing
material. | Per ASTM F1342,
there is currently
no acceptance
criteria for this test
method. | The 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 | Study conducted per
ASTM D1004
Study Endpoint:
At the point of material
tearing. | Determine tear
strength of plastic
film and sheeting. | per ASTM D1004,
there is currently
no acceptance
criteria for this test
method. | The 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 | Study conducted in
compliance to ISO
10993-5: 2009 and BS
EN ISO 10993-5: 2009
(Tests for in vitro
Cytotoxicity). Test and/or
control article prepared
in compliance to ISO
10993-12: 2012 and BS
EN ISO 10993-12: 2012
(Sample Preparation
and Reference | Purpose of MEM
Elution Cytotoxicity
test was to
determine
cytotoxic response
from test article
which was
extracted in cell
culture media
which was then
plated onto L-929
mouse fibroblast | Acceptance criteria
per ISO 10993-5. | Test article passed
test and
determined non-
cytotoxic. |
| Test Item | Methodology | Purpose | Acceptance
Criteria | Results |
| ISO 10993-10:
Biological evaluation of
medical devices - Part
10: Tests for irritation
and skin sensitization | Studies (2) conducted in
compliance to
ISO)10993-10: 2010 and
BS EN ISO 10993-10:
2013 (Tests for Irritation
and Skin Sensitization).
Test or control article
prepared in compliance
to ISO 10993-12: 2012
and BS EN ISO 10993-
12: 2012 (Sample
Preparation and
Reference Materials). | Study 1 purpose:
To evaluate
sensitization or
allergenic potential
of a test article.
Test is used as
method for
screening contact
allergens in guinea
pigs. Results are
used as predictive
measures for
detecting potential
sensitizers in
humans.
Study 2 purpose:
To evaluate
irritation potential
of a test article.
Test is used as
method for
screening irritants
in rabbits. Results
are used as
predictive
measures for
detecting potential
irritants in humans. | 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:
Currently no
standard is
available. | Side-by-side visual
comparison of X-Ray
pictures of common
dental office objects. | Determine
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. |

11

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).