Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

K151123 · Pac-Dent International, Inc. · PEM · Mar 3, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K151123
• Device Name: Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
• Applicant: Pac-Dent International, Inc.
• Product Code: PEM · General, Plastic Surgery
• Decision Date: Mar 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended 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.

Device Story

Pac-Dent Barrier Sleeve and Cover-It Barrier Film are disposable, non-sterile polyethylene covers designed to protect dental equipment and surfaces from contamination. The device line includes various shapes and sizes for specific dental instruments, including handpieces, curing lights, X-ray sensors, and larger surfaces like dental chairs and trays. Used in dental clinics, the sleeves are applied by dental staff to equipment before procedures to act as a physical barrier. This simplifies clean-up and disinfection between patients by preventing direct contact between the patient/environment and the dental device. The barrier is removed and discarded after each patient use. The device does not interfere with the function of the covered equipment, such as X-ray imaging or curing light output.

Clinical Evidence

No clinical data provided. Bench testing only. Performance testing included resistance to penetration (ASTM F1670, F1671), tear strength (ASTM D1424), tensile properties (ASTM D882), and resistance to puncture (ASTM F1342). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) confirmed the device is non-cytotoxic, non-irritant, and non-sensitizing. Effectiveness of X-ray devices covered with barrier sleeves was also verified.

Technological Characteristics

Materials: 80% LLDPE, 20% LDPE; some models include blue pigment or adhesive. Film thickness: 0.02-0.06mm (tolerance <0.01mm). Form factor: various custom-shaped sleeves and films. Sterilization: non-sterile. Standards: ANSI/AAMI PB70:2012, ASTM F1670, ASTM F1671, ASTM D1004, ASTM D882, ASTM F1342, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for use as a protective barrier to cover dental instruments, equipment, and surfaces (e.g., dental chairs, trays, X-ray heads, handpieces, curing lights, sensors, keyboards) during dental procedures. Intended for single patient use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TiDiShield Curing Light Sleeve (K132953)

Reference Devices

• Cover-All, Chair Sleeve, Drape-it-All, Tray Sleeve, related products (K962288)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 during<br>procedure, 4"X6" |
| C101B | Cover It™ Barrier film, blue | Surface area that might be touched during<br>procedure, 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

| Descriptive<br>Information | Subject Device | Primary Predicate Device | Reference Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Pac-Dent Barrier Sleeve, Cover-It™<br>Barrier Film | TiDiShield Curing Light Sleeve<br>(K132953) | Cover-All (K962288) |
| Indications for<br>Use | To be used as a barrier to cover<br>dental instruments. | Use as a barrier that is used as<br>an accessory to dental<br>instrument. | To act as a physical barrier,<br>augmenting existing infection<br>control techniques and make<br>clean-up and disinfection<br>easier. |
| Classification<br>Product Code | PEM | PEM | MMP |
| Composition of<br>Materials | LLDPE (80%)<br>LDPE (20%)<br>Blue pigment (item#100B, C101B)<br>Adhesive (item#C101, C101B) | LLDPE (80%)<br>LDPE (20%) | LLDPE (80%)<br>LDPE (20%) |
| Specifications<br>and Tolerances | Paper backing: some of the model<br>Film thickness: 0.02-0.06mm<br>Tolerance: <0.01mm | Paper backing: Yes<br>Film thickness: 0.02mm<br>Tolerance: <0.01mm | Paper backing: some of the<br>model<br>Film thickness: 0.02-0.06mm<br>Tolerance: <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 -<br>ASTM F1670: pass<br>- ASTM F1671: pass<br>- Tear Strength - ASTM D1424:<br>subject device is equivalent to<br>the predicate device<br>- Tensile Properties - ASTM<br>D882: subject device is<br>equivalent to the predicate<br>device<br>- Resistance to Puncture - ASTM<br>F1342: subject device is<br>equivalent to the predicate<br>device<br>- Biocompatibility<br>- ISO10993-5 in vitro cytotoxicity<br>Under the conditions of the study,<br>the subject device was<br>non-cytotoxic.<br>- ISO 10993-10 irritation<br>Under the conditions of the study,<br>the subject device was not an<br>irritant<br>- ISO 10993-10 sensitization<br>Under the conditions of the study,<br>the subject device was not a<br>sensitizer<br>- Effectiveness of X-Ray Devices<br>Covered with Barrier Sleeves | - Synthetic Blood Resistance<br>- ASTM F1670<br>- Tear Strength - ASTM<br>D1424<br>- Tensile Properties - ASTM<br>D882<br>- Resistance to Puncture -<br>ASTM F1342 | - Synthetic Blood Resistance<br>- ASTM F1670<br>- Tear Strength - ASTM<br>D1424<br>- Tensile Properties - ASTM<br>D882<br>- Resistance to Puncture -<br>ASTM F1342 | |
| FDA-Recognized<br>Standards | 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).