(127 days)
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.
The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.
The document provided is a 510(k) premarket notification for "Disposable Barrier Sleeves and Covers" (K160232) by DENTSPLY International. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information requested regarding acceptance criteria and studies proving a device meets them for a complex AI/ML device is largely not applicable in this context.
However, I can extract the relevant information from the provided document as it pertains to the substantial equivalence determination for this non-AI medical device.
Here's a breakdown based on the provided document and the nature of a 510(k) submission for a non-AI device:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established by recognized standards for medical device materials and performance. The document defines the "Proposed Device" as "Disposable Barrier Sleeves and Covers" and compares its performance against a "Predicate Device," "TIDIShield™ Curing Light Sleeve (K132953)".
| Element / Test | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Material | Polyethylene film | Polyethylene film |
| Material Composition | Ethylene methyl acrylate copolymer and low density polyethylene film (Predicate) | Supplier #1 (PacDent): low density polyethylene and linear low-density polyethylene film |
| Supplier #2 (MiniTube AB): low-density polyethylene film | ||
| Biocompatibility - In-Vitro Cytotoxicity | Pass (based on ANSI/AAMI/ISO 10993-5) | Pass |
| Biocompatibility - Sensitization | Pass (based on ISO 10993-10) | Pass |
| Biocompatibility - Irritation | Pass (based on ISO 10993-10) | Pass |
| Performance - Synthetic Blood Penetration | Pass (based on ASTM F1670/F1670M) | Pass |
| Performance - Synthetic Blood Penetration at seams and non-continuous components | Pass (based on ASTM F1670/F1670M) | Pass |
| Performance - Viral Penetration | Pass (based on ASTM F1671/F1671M) | Pass |
| Performance - Viral Penetration at seams and non-continuous components | Pass (based on ASTM F1671/F1671M) | Pass |
| Mechanical - Tensile Strength | Acceptable for 0.05mm (Predicate) | 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate |
| Mechanical - Puncture Resistance | Acceptable for 0.05mm (Predicate) | 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate |
| Mechanical - Tear Resistance | Acceptable for 0.05mm (Predicate) | 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate |
| Thickness | 0.05mm (Predicate) | PacDent: 0.02mm, 0.03mm, 0.05mm; MiniTube AB: 0.03mm |
| Shape | Custom design to fit the intended instrument (Predicate) | Custom design to fit the intended dental instruments and equipment they cover (Reference Table 5.3) |
| Dimensions | Determined by the size and shape of the instruments they cover (Predicate) | Determined by the size and shape of the dental instruments and equipment they cover (Reference Table 5.3) |
| Color | Clear (Predicate) | Clear, with some RINN Tight Cover barrier sleeves being clear with white and blue tabs |
| Sterile | Not sterile (Predicate) | Not sterile |
| Single Use | Single use device (Predicate) | Single use device |
2. Sample size 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 the mechanical and performance tests. It refers to "samples" being tested. For biocompatibility, it states "the proposed devices, Disposable Barrier Sleeves and Covers" underwent testing.
The data provenance is not specified beyond "testing conducted to support substantial equivalence." It's common for such bench testing to be conducted in-house by the manufacturer or by contract labs. There is no indication of country of origin or whether it was retrospective or prospective, as these are typically not relevant for a 510(k) submission for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable. For a physical barrier device like this, ground truth is established by standardized material and performance testing against recognized industry standards (e.g., ASTM, ISO). There are no "experts" establishing a subjective "ground truth" in the way one would for diagnostic imaging.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in clinical studies, typically for diagnostic devices. This device is a physical barrier, and its performance is evaluated by objective laboratory tests, not by expert adjudication of subjective assessments.
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
This is entirely not applicable.
* This device is a disposable physical barrier, not an AI/ML-powered diagnostic device.
* No human "readers" are involved.
* No "cases" are being interpreted.
* No AI assistance is provided or claimed.
* No MRMC study was conducted or is relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is entirely not applicable.
* This device is a physical product, not an algorithm.
* There is no "human-in-the-loop" concept for this device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on the objective outcomes of standardized laboratory tests as defined by international standards (e.g., ISO, ASTM). For example:
- Biocompatibility: Demonstrated non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993 series.
- Performance (Barrier): Demonstrated resistance to synthetic blood and viral penetration as per ASTM F1670/F1670M and ASTM F1671/F1671M.
- Mechanical Properties: Measured tensile strength, puncture resistance, and tear resistance as per ASTM D882, F1342/F1342M, and D1004.
These are quantitative measurements against defined criteria, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
This is not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2016
DENTSPLY International Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K160232
Trade/Device Name: Disposable Barrier Sleeves and Covers Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: PEM Dated: May 6, 2016 Received: May 9, 2016
Dear Ms. Lewis:
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
{1}------------------------------------------------
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,
Susan Runno, DDS, MA
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160232
Device Name Disposable Barriers Sleeves and Covers
Indications for Use (Describe)
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
See the attached table for the product names, trade names and model numbers.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 complete 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."
{3}------------------------------------------------
| Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instrumentsand equipment. This device is non-sterile and intended for single patient use only. | |||
|---|---|---|---|
| Models: | |||
| Part Number(SKU) | Description | Designed For | |
| A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | Low Speed, Contra-Angle Handpieces | |
| 65090003 | DISPOSA-SHIELD® No. 3 Air Turbines andCavitron, A88005 | Fits Cavitron HandpieceLow Speed, Contra-Angle HandpiecesFits Cavitron Handpiece | |
| A88006 | Disposable Barrier for Low Speed, Long Handpiece | Low Speed, Long HandpiecesFits: SmartLite PS, Tulsa 6:1,Contra Angle Handpiece by Sirona,e³ Torque Control Motor, MIDWEST Handpiece | |
| A88007 | Disposable Barrier for Universal Air/Water Syringe | Universal Air/Water Syringe(syringe type delivery system) | |
| 65090002 | DISPOSA-SHIELD® No. 2 Air Motors, A88007 | Universal Air/Water Syringe(syringe type delivery system) | |
| A88008 | Disposable Barrier for Light Handle (T-Bar) | Light Handle (T-Bar) | |
| A88013 | Disposable Barrier for Standard Type DeliverySystems | Syringe Type Delivery SystemsFits Delton FS+ Syringe | |
| A880095 | Disposable Barrier for Dental Hose | Dental Hose | |
| A880105 | Disposable Barrier for Universal Chair/X-Ray Head | Universal Chair / X-Ray Head | |
| A880115 | Disposable Barrier for Multi-Purpose Use | Multi-Purpose Use | |
| 65090001 | DISPOSA-SHIELD® No. 1 Light Handles and ControlPanels, A880115 | Multi-Purpose Use | |
| A88014 | Disposable Barrier for Tray Size 10 ½" x 14½" | Tray Size 10-1/2" x 14-1/2" | |
| A88015 | Disposable Barrier for Tray Size 12" x 17" | Tray Size 12" x 17" | |
| A88016 | Disposable Barrier for Dental Chair Head Rest | Dental Chair Head Rest | |
| 65090004 | DISPOSA-SHIELD® No. 4 Headrest Cover, A88016 | Dental Chair Head Rest | |
| A88018 | Disposable Barrier for Midwest RDH Freedom InnerModule | Midwest RDH Freedom Inner Module | |
| A88019 | Disposable Barrier for Midwest RDH Freedom withSmartMode Technology Inner Module | Midwest RDH Freedom Cordless Prophy System withSmartMode Technology | |
| Part Number (SKU) | Description | Designed For | |
| 737007 | Disposable Barrier for Standard Type Delivery Systems, Trial Pack for A88013 | Syringe Type Delivery SystemsFits Delton FS+ Syringe | |
| 90736 | Disposable Barrier for Midwest RDH Freedom Inner Module, Trial Pack for A88018 | Midwest RDH Freedom Inner Module | |
| 978079 | Bebop Barrier Sleeve | Impression Material Dispenser | |
| RINN® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only. | |||
| Models:Part Number (SKU) | Description | Designed For | |
| 050500 | Universal Digital Sensor Covers (Bulk) | RINN® Digital Sensor Covers, Size 1 and Size 2 | |
| 550500 | Universal Digital Sensor Covers | RINN® Digital Sensor Covers, Size 1 and Size 2 | |
| 550200 | Large Sensor Cover(Soft Overbag Cover) | RINN® Large Digital SensorsSized to overbag sensor and sensor holder (such as Snap-A-Ray DS) | |
| 550143 | Tight Digital Sensor Cover –Size 1.5/2, 300-pack | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2 sensors:Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 055574 | Tight Digital Sensor Cover –Size 1.5/2, 25-pack | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2 sensors:Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 055629 | Tight Digital Sensor Cover –Size 1.5/2 | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2 sensors:Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 550149 | Tight Sensor Cover –Size 1, 300-pack | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick, Gendex, Kodak, Dentex | |
| Part Number(SKU) | Description | Designed For | |
| 055575 | Tight Digital Sensor Cover -Size 1, 25-pack | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick, Gendex, Kodak,Dentex | |
| 055630 | Tight Sensor Covers –Size 1 | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick, Gendex, Kodak,Dentex | |
| Sani-Shield® and Sani-Tip® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dentalinstruments and equipment. This device is non-sterile and intended for single patient use only.Models: 120126, 130010 and 1300105 Disposable Barrier for Air/Water Syringes air designed for Sani-Tipair/water syringe tips. | |||
| Smartlite® Max Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instrumentsand equipment. This device is non-sterile and intended for single patient use only.Model:644060 SmartLite® Max Disposable Barrier Sleeves is designed for SmartLite® Max L.E.D Curing Light.644.50.030 SmartLite Focus Sleeve Refill is designed for Caulk K-156 SL Focus, SL PS. | |||
| Endo® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments andequipment. This device is non-sterile and intended for single patient use only.Model: EAPB100 (EAS100) EndoActivator Protective Barrier is designed for EAD100 EndoActivatorHandpiece/Driver. | |||
| digit® power Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instrumentsand equipment. This device is non-sterile and intended for single patient use only.Model: 678079 digit® power Disposable Barrier Sleeves Refill is designed for Aquasil Ultra cordless TissueManaging Impression System and Fits digit® power Dispenser. |
{4}------------------------------------------------
{5}------------------------------------------------
{6}------------------------------------------------
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
Image /page/6/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a leaf or a curved form in gray. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a simple, sans-serif font and in the same gray color as the abstract shape. The overall design is clean and modern.
SECTION 5. 510(k) SUMMARY for Disposable Barrier Sleeves and Covers
1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: 29 January 2016
2. Device Name:
-
Proprietary Name: Disposable Barrier Sleeves and Covers ●
II -
Classification Name: Dental Barriers and Sleeves
-
CFR Number: 878.4370
-
Device Class: ●
-
. Product Code: PEM
3. Predicate Device:
.
.
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| TIDIShield™ CuringLight Sleeve | K132953 | TIDI Products, LLC |
4. Description of Device:
The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.
The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.
{7}------------------------------------------------
5. Indications for Use:
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
See the attached table for the product names, trade names and model numbers.
Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only. Models:
| PartNumber(SKU) | Description | Designed For |
|---|---|---|
| A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | Low Speed, Contra-Angle HandpiecesFits Cavitron Handpiece |
| 65090003 | DISPOSA-SHIELD® No. 3 Air Turbines andCavitron, A88005 | Low Speed, Contra-Angle HandpiecesFits Cavitron Handpiece |
| A88006 | Disposable Barrier for Low Speed, LongHandpiece | Low Speed, Long HandpiecesFits:SmartLite PSTulsa 6:1,ContraAngle Handpiece by Sironae3 Torque Control MotorMIDWEST Handpiece |
| A88007 | Disposable Barrier for Universal Air/WaterSyringe | Universal Air/Water Syringe(syringe type delivery system) |
| 65090002 | DISPOSA-SHIELD® No. 2 Air Motors,A88007 | Universal Air/Water Syringe(syringe type delivery system) |
| A88008 | Disposable Barrier for Light Handle (T-Bar) | Light Handle (T-Bar) |
| A88013 | Disposable Barrier for Standard Type DeliverySystems | Syringe Type Delivery SystemsFits Delton FS+ Syringe |
| A880095 | Disposable Barrier for Dental Hose | Dental Hose |
| A880105 | Disposable Barrier for Universal Chair/X-RayHead | Universal Chair / X-Ray Head |
| A880115 | Disposable Barrier for Multi-Purpose Use | Multi-Purpose Use |
| 65090001 | DISPOSA-SHIELD® No. 1 Light Handles andControl Panels, A880115 | Multi-Purpose Use |
| A88014 | Disposable Barrier for Tray Size 10 $^{1}!/{2}$ " x 14$^{1}!/{2}$ " | Tray Size 10-1/2" x 14-1/2" |
| PartNumber(SKU) | Description | Designed For |
| A88015 | Disposable Barrier for Tray Size 12" x 17" | Tray Size 12" x 17" |
| A88016 | Disposable Barrier for Dental Chair Head Rest | Dental Chair Head Rest |
| 65090004 | DISPOSA-SHIELD® No. 4 Headrest Cover,A88016 | Dental Chair Head Rest |
| A88018 | Disposable Barrier for Midwest RDH FreedomInner Module | Midwest RDH Freedom Inner Module |
| A88019 | Disposable Barrier for Midwest RDH Freedomwith SmartMode Technology Inner Module | Midwest RDH Freedom CordlessProphy System with SmartModeTechnology Inner Module |
| 737007 | Disposable Barrier for Standard Syringe TypeDelivery Systems, Trial Pack for A88013 | Syringe Type Delivery SystemsFits Delton FS+ Syringe |
| 90736 | Disposable Barrier for Midwest RDH FreedomInner Module, Trial Pack for A88018 | Midwest RDH Freedom Inner Module |
| 978079 | Bebop Barrier Sleeve | Impression Material Dispenser |
{8}------------------------------------------------
RINN® Universal Digital Sensor Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Models:
| PartNumber(SKU) | Description | Designed For |
|---|---|---|
| 050500 | Universal Digital Sensor Covers (Bulk) | RINN® Digital Sensor Covers, Size 1and Size 2 |
| 550500 | Universal Digital Sensor Covers | RINN® Digital Sensor Covers, Size 1and Size 2 |
| 550200 | Large Sensor Cover(Soft Overbag Cover) | RINN® Large Digital SensorsSized to overbag sensor and sensorholder (such as Snap-A-Ray DS) |
| PartNumber(SKU) | Description | Designed For |
| 550143 | Tight Digital Sensor Cover -Size 1.5/2, 300-pack | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2sensors:Schick CDR, Schick 33, Dexis, Kodak6100, Gendex eHd, Gendex GXS-700 |
| 055574 | Tight Digital Sensor Cover -Size 1.5/2, 25-pack | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2sensors:Schick CDR, Schick 33, Dexis, Kodak6100, Gendex eHd, Gendex GXS-700 |
| 055629 | Tight Digital Sensor Cover -Size 1.5/ 2 | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2sensors:Schick CDR, Schick 33, Dexis, Kodak6100, Gendex eHd, Gendex GXS-700 |
| 550149 | Tight Sensor Cover -Size 1, 300-pack | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick,Gendex, Kodak, Dentex |
| 055575 | Tight Digital Sensor Cover -Size 1, 25-pack | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick,Gendex, Kodak, Dentex |
| 055630 | Tight Sensor Covers –Size 1 | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick,Gendex, Kodak, Dentex |
{9}------------------------------------------------
Sani-Shield® and Sani-Tip® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Models: 120126, 130010 and 1300105 Disposable Barrier for Air/Water Syringes air designed for Sani-Tip air/water syringe tips.
{10}------------------------------------------------
Smartlite® Max Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Model:
644060 SmartLite® Max Disposable Barrier Sleeves is designed for SmartLite® Max L.E.D Curing Light.
644.050.030 SmartLite Focus Sleeve Refill is designed for Caulk K-156 SL Focus, SL PS.
Endo® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Model: EAPB100 (EAS100) EndoActivator Protective Barrier is designed for EAD100 EndoActivator Handpiece/Driver.
digit® power Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Model: 678079 digit® power Disposable Barrier Sleeves Refill is designed for Aquasil Ultra cordless Tissue Managing Impression System and Fits digit® power Dispenser.
{11}------------------------------------------------
6. Substantial Equivalence:
Table 5.2 Technological Characteristics
| Element | Proposed Device | Predicate Device |
|---|---|---|
| Disposable Barrier Sleeves and Covers | TIDIShield™ CuringLight Sleeve (K132953) | |
| 510(k) | To be assigned | K132953 |
| Indications forUse | Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.See the attached table for the product names, trade names and model numbers. | TIDIShield™ CuringLight Sleeves areindicated for use as abarrier that is used as anaccessory to dentalinstrument. These sleevesare non-sterile and areintended for single patientonly. |
{12}------------------------------------------------
| Element | Proposed DeviceDisposable Barrier Sleeves and Covers | Predicate Device | |
|---|---|---|---|
| Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposablebarrier for dental instruments and equipment. This device is non-sterile and intendedfor single patient use only.Models: | TIDIShield™ CuringLight Sleeve (K132953) | ||
| PartNumber(SKU) | Description | Designed For | |
| A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | Low Speed, Contra-Angle HandpiecesFits Cavitron Handpiece | |
| 65090003 | DISPOSA-SHIELD® No. 3 Air Turbinesand Cavitron, A88005 | Low Speed, Contra-Angle HandpiecesFits Cavitron Handpiece | |
| A88006 | Disposable Barrier for Low Speed, LongHandpiece | Low Speed, Long HandpiecesFits: SmartLite PS,Tulsa 6:1,ContraAngle Handpiece by Sirona,e³ Torque Control Motor, MIDWESTHandpiece | |
| A88007 | Disposable Barrier for UniversalAir/Water Syringe | Universal Air/Water Syringe(syringe type delivery system) | |
| 65090002 | DISPOSA-SHIELD® No. 2 Air Motors,A88007 | Universal Air/Water Syringe(syringe type delivery system) | |
| A88008 | Disposable Barrier for Light Handle (T-Bar) | Light Handle (T-Bar) | |
| A88013 | Disposable Barrier for Standard TypeDelivery Systems | Syringe Type Delivery SystemsFits Delton FS+ Syringe | |
| A880095 | Disposable Barrier for Dental Hose | Dental Hose | |
| A880105 | Disposable Barrier for Universal Chair/X-Ray Head | Universal Chair / X-Ray Head | |
| A880115 | Disposable Barrier for Multi-Purpose Use | Multi-Purpose Use | |
| 65090001 | DISPOSA-SHIELD® No. 1 Light Handlesand Control Panels, A880115 | Multi-Purpose Use | |
| Element | Proposed Device | Predicate Device | |
| Disposable Barrier Sleeves and Covers | TIDIShield™ Curing Light Sleeve (K132953) | ||
| PartNumber(SKU) | Description | Designed For | |
| A88014 | Disposable Barrier for Tray Size 10 ½" x14 ½" | Tray Size 10-1/2" x 14-1/2" | |
| A88015 | Disposable Barrier for Tray Size 12" x 17" | Tray Size 12" x 17" | |
| A88016 | Disposable Barrier for Dental Chair HeadRest | Dental Chair Head Rest | |
| 65090004 | DISPOSA-SHIELD® No. 4 HeadrestCover, A88016 | Dental Chair Head Rest | |
| A88018 | Disposable Barrier for Midwest RDHFreedom Inner Module | Midwest RDH Freedom Inner Module | |
| A88019 | Disposable Barrier for Midwest RDHFreedom with SmartMode TechnologyInner Module | Midwest RDH Freedom Cordless ProphySystem with SmartMode Technology | |
| 737007 | Disposable Barrier for Standard TypeDelivery Systems, Trial Pack for A88013 | Syringe Type Delivery SystemsFits Delton FS+ Syringe | |
| 90736 | Disposable Barrier for Midwest RDHFreedom Inner Module, Trial Pack forA88018 | Midwest RDH Freedom Inner Module | |
| 978079 | Bebop Barrier Sleeve | Impression Material Dispenser | |
| Element | Proposed DeviceDisposable Barrier Sleeves and Covers | Predicate DeviceTIDIShield™ CuringLight Sleeve (K132953) | |
| Models: | |||
| PartNumber(SKU) | Description | Designed For | |
| 050500 | Universal Digital Sensor Covers (Bulk) | RINN® Digital Sensor Covers, Size 1 andSize 2 | |
| 550500 | Universal Digital Sensor Covers | RINN® Digital Sensor Covers, Size 1 andSize 2 | |
| 550200 | Large Sensor Cover(Soft Overbag Cover) | RINN® Large Digital SensorsSized to overbag sensor and sensor holder(such as Snap-A-Ray DS) | |
| 550143 | Tight Digital Sensor Cover -Size 1.5/2, 300-pack | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2 sensors:Schick CDR, Schick 33, Dexis, Kodak6100, Gendex eHd, Gendex GXS-700 | |
| 055574 | Tight Digital Sensor Cover -Size 1.5/2, 25-pack | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2 sensors:Schick CDR, Schick 33, Dexis, Kodak6100, Gendex eHd, Gendex GXS-700 | |
| 055629 | Tight Digital Sensor Cover -Size 1.5/ 2 | Digital Sensors, size 1.5/2Fits the following size 1.5 and 2 sensors:Schick CDR, Schick 33, Dexis, Kodak6100, Gendex eHd, Gendex GXS-700 | |
| 550149 | Tight Sensor Cover –Size 1, 300-pack | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick,Gendex, Kodak, Dentex | |
| 055575 | Tight Digital Sensor Cover -Size 1, 25-pack | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick,Gendex, Kodak, Dentex | |
| 055630 | Tight Sensor Covers –Size 1 | Digital Sensors, size 1Fits the following size 1 sensors:Planmeca, Instrumentarium, Schick,Gendex, Kodak, Dentex | |
| Element | Proposed DeviceDisposable Barrier Sleeves and Covers | Predicate Device | |
| Sani-Shield® and Sani-Tip® Barrier Sleeves and Covers are intended to serve as adisposable barrier for dental instruments and equipment. This device is non-sterile andintended for single patient use only.Models: 120126, 130010 and 1300105 Disposable Barrier for Air/Water Syringes airdesigned for Sani-Tip air/water syringe tips. | TIDIShield™ CuringLight Sleeve (K132953) | ||
| Smartlite® Max Barrier Sleeves and Covers are intended to serve as a disposablebarrier for dental instruments and equipment. This device is non-sterile and intendedfor single patient use only.Model:644060 SmartLite® Max Disposable Barrier Sleeves is designed for SmartLite® MaxL.E.D Curing Light.644.50.030 SmartLite Focus Sleeve Refill is designed for Caulk K-156 SL Focus, SLPS. | |||
| Endo® Barrier Sleeves and Covers are intended to serve as a disposable barrier fordental instruments and equipment. This device is non-sterile and intended for singlepatient use only.Model: EAPB100 (EAS100) EndoActivator Protective Barrier is designed forEAD100 EndoActivator Handpiece/Driver. | |||
| digit® power Barrier Sleeves and Covers are intended to serve as a disposable barrierfor dental instruments and equipment. This device is non-sterile and intended for singlepatient use only.Model: 678079 digit® power Disposable Barrier Sleeves Refill is designed for AquasilUltra cordless Tissue Managing Impression System and Fits digit® power Dispenser. | |||
| Element | Proposed Device | Predicate Device | |
| Disposable Barrier Sleeves and Covers | TIDIShield™ CuringLight Sleeve (K132953) | ||
| Material | Polyethylene film | Polyethylene film | |
| MaterialComposition | Supplier #1 (PacDent): low density polyethylene and linear low density polyethylene film | Ethylene methyl acrylatecopolymer and low densitypolyethylene film | |
| Supplier #2 (MiniTube AB): low density polyethylene film | |||
| Biocompatibility | Supplier #1 (PacDent):Non-cytotoxicNon-sensitizingNon-irritating | Non-cytotoxicNon-sensitizingNon-irritating | |
| Supplier #2 (MiniTube AB):Non-cytotoxicNon-sensitizingNon-irritating | |||
| PerformanceProperties | Synthetic Blood Penetration- PassSynthetic Blood Penetration at seams and non-continuous components-PassViral Penetration- PassViral Penetration at seams and non-continuous components-Pass | Synthetic Blood Penetration-PassViral Penetration-Pass | |
| MechanicalProperties | Tensile Strength• 0.02mm-Acceptable• 0.03mm-Acceptable• 0.05mm-Comparable to predicatePuncture Resistance• 0.02mm-Acceptable• 0.03mm-Acceptable• 0.05mm-Comparable to predicateTear Resistance• 0.02mm-Acceptable• 0.03mm-Acceptable• 0.05mm-Comparable to predicate | Tensile Strength• 0.05mm- AcceptablePuncture Resistance• 0.05mm- AcceptableTear Resistance• 0.05mm- Acceptable |
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
{16}------------------------------------------------
{17}------------------------------------------------
| Element | Proposed Device | Predicate Device | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Disposable Barrier Sleeves and Covers | TIDIShield™ Curing Light Sleeve (K132953) | |||||||||||||||||||
| Thickness | PacDent: 0.02mm, 0.03mm, 0.05mmMiniTube AB: 0.03mm | 0.05mm | ||||||||||||||||||
| Shape | Custom design to fit the intended dental instruments and equipment they cover(Reference Table 5.3). | Custom design to fit the intended instrument. | ||||||||||||||||||
| Dimensions | Determined by the size and shape of the dental instruments and equipment they cover(Reference Table 5.3). | Part # Length(in) Width(in) 21103 10 1/8" 2 3/16" 21102 10 1/8" 2 ¼" 21101 10 1/8" 2 ½" 21100 10 1/8" 2 3/16" Difference in Dimensions isdue to the difference in sizeof the instruments theycover. | ||||||||||||||||||
| Color | Clear, except for RINN Tight Cover barrier sleevesRINN Tight Cover barrier sleeves are clear with white tabs and blue tabs. Part numbers550143, 055574, 055629, 550149, 05575, and 055630. | Clear | ||||||||||||||||||
| Sterile | Not sterile | Not sterile | ||||||||||||||||||
| Single Use | Single use device | Single use device |
{18}------------------------------------------------
| Part Number | Device Description | Size |
|---|---|---|
| A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | 4.91 in. x 8.90 in. |
| 65090003 | DISPOSA-SHIELD® No. 3 Air Turbines and Cavitron, A88005 | 4.91 in. x 8.90 in. |
| A88006 | Disposable Barrier for Low Speed, Long Handpiece | 1.56 in. x 7.60 in. |
| A88007 | Disposable Barrier for Universal Air/Water Syringe | 2.30 in. x 5.63 in. |
| 65090002 | DISPOSA-SHIELD® No. 2 Air Motors, A88007 | 2.30 in. x 5.63 in. |
| A88008 | Disposable Barrier for Light Handle (T-Bar) | 2.94 in. x 6.81 in. |
| A88013 | Disposable Barrier for Standard Type Delivery Systems | 1.37 in. x 7.60 in. |
| A880095 | Disposable Barrier for Dental Hose | 2.1 in. x 24.0 in. |
| A880105 | Disposable Barrier for Universal Chair/X-Ray Head | 15 in. x 27.25 in. |
| A880115 | Disposable Barrier for Multi-Purpose Use | 4 in. x 6 in. |
| 65090001 | DISPOSA-SHIELD® No. 1 Light Handles and Control Panels,A880115 | 4 in. x 6 in. |
| A88014 | Disposable Barrier for Tray Size 10 ½" x 14½" | 10.5 in. x 14.5 in. |
| A88015 | Disposable Barrier for Tray Size 12" x 17" | 12 in. x 17 in. |
| A88016 | Disposable Barrier for Dental Chair Head Rest | 13 in. x 13 in. |
| 65090004 | DISPOSA-SHIELD® No. 4 Headrest Cover, A88016 | 13 in. x 13 in. |
| A88018 | Disposable Barrier for Midwest RDH Freedom Inner Module | 59 mm x 178 mm |
| A88019 | Disposable Barrier for Midwest RDH Freedom with SmartModeTechnology Inner Module | 56.6 mm x 178 |
| 737007 | Disposable Barrier for Standard Type Delivery Systems, Trial Packfor A88013 | 1.37 in. x 7.60 in. |
| 90736 | Disposable Barrier for Midwest RDH Freedom Inner Module, TrialPack for A88018 | 59 mm x 178 mm |
| 978079 | Bebop Barrier Sleeve | 2.5 in. x 8.016 in. |
| 050500 | Universal Digital Sensor Covers – Bulk Pack | 1.574 in. x 7.00in. |
| 550500 | Universal Digital Sensor Covers | 1.574 in. x 7.00in. |
| 550200 | Large Sensor Cover (Soft Overbag Cover) | 4.02 in. x 9.4 in. |
| 550143 | Tight Digital Sensor Cover -Size 1.5/2, 300-pack | 8.881 in. x 1.772in |
| 055574 | Tight Digital Sensor Cover -Size 1.5/2, 25-pack | 8.881 in. x 1.772in |
| 055629 | Tight Digital Sensor Cover -Size 1.5/2 | 8.881 in. x 1.772in |
| 550149 | Tight Sensor Cover -Size 1, 300-pack | 8.881 in. x 1.713in |
| Part Number | Device Description | Size |
| 055575 | Tight Sensor Cover - Size 1, 25-pack | 8.881 in. x 1.713 in |
| 055630 | Tight Sensor Cover -Size 1 | 8.881 in. x 1.713 in |
| 120126 | Sani-Shield® Disposable Barrier for Air/Water Syringe -Single Packs of 250 | 2.25 in. x 8.50 in. |
| 130010 | Sani-Shield® Disposable Barrier for Air/Water Syringe – 40 Single Packs of 250 | 2.25 in. x 8.50 in. |
| 1300105 | Sani-Shield® Disposable Barrier for Air/Water Syringe -Single Packs of 250 | 2.25 in. x 8.50 in. |
| 644060 | SmartLite® Max Disposable Barrier Sleeves | 2.125 in. x 10.813 in. |
| 644.50.030 | SmartLite Focus Sleeve Refill | 11 in. x 1.75 in. |
| EAPB100 | Endo Activator Protective Barrier | |
| 678079 | digit® power Disposable Barrier Sleeves Refill | 2.189 in. x 8.5 in. |
Table 5.3 Overall Dimensions (by Inches and Millimeters)
{19}------------------------------------------------
7. Non-Clinical Performance Data
| Test | Standard | Proposed DevicesDisposable BarrierSleeves and Covers | Predicate DeviceTIDIShield™ CuringLight Sleeve(K132953) |
|---|---|---|---|
| Biocompatibility Testing: | |||
| In-VitroCytotoxicity | ANSI/AAMI/ISO10993-5 | Pass | Pass |
| Sensitization | ISO 10993-10 | Pass | Pass |
| Irritation | ISO 10993-10 | Pass | Pass |
| Performance Testing: | |||
| Synthetic BloodPenetration | ASTMF1670/F1670M | Pass | Pass |
| Synthetic BloodPenetration at seamsand non-continuouscomponents | ASTMF1670/F1670M | Pass | Pass |
| Viral Penetration | ASTMF1671/F1671M | Pass | Pass |
| Viral Penetration atseams and non-continuouscomponents | ASTMF1671/F1671M | Pass | Pass |
{20}------------------------------------------------
Biocompatibility testing focused on cytotoxicity, levels of skin sensitization and oral mucosa irritation of the proposed devices, Disposable Barrier Sleeves and Covers. Below is a summary of the testing performed:
- ANSI AAMI ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: ● Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for . Irritation and Skin Sensitization
The performance of the proposed devices. Disposable Barrier Sleeves and Covers, met the requirements of the biocompatibility testing conducted to support substantial equivalence with the predicate, TIDIShield™ Curing Light Sleeve (K132953).
The performance testing (Bench) of the proposed devices, Disposable Barrier Sleeves and Covers, met the requirements of the non-clinical bench testing conducted to support substantial equivalence with the predicate, TIDIShield™ Curing Light Sleeve (K132953). Below is a summary of the testing performed:
- ASTM F1670/F1670M Standard Test Method for Resistance of Materials Used in . Protective Clothing to Penetration by Synthetic Blood
- ASTM F1671/ F1671M Standard Test Method for Resistance of Materials Used . in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
| MechanicalProperty | Standard | Proposed DevicesDisposable BarrierSleeves and Covers | Predicate DeviceTIDIShield™ CuringLight Sleeve(K132953) |
|---|---|---|---|
| Tensile Strength | ASTM D882 | 0.02mm Acceptable0.03mm Acceptable0.05mm Comparable toPredicate | Acceptable for0.05mm |
| Puncture Resistance | ASTMF1342/ F1342M | 0.02mm Acceptable0.03mm Acceptable0.05mm Comparable toPredicate | Acceptable for0.05mm |
| Tear Resistance | ASTM D1004 | 0.02mm Acceptable0.03mm Acceptable0.05mm Comparable toPredicate | Acceptable for0.05mm |
The range of mechanical properties for the samples is reported for the proposed devices. Disposable Barrier Sleeves and Covers. Below is a summary of the testing performed:
- . ASTM D882 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
- ASTM F1342/ F1342M Standard Test Method for Protective Clothing Material . Resistance to Puncture
- ASTM D1004 Standard Test Method for Tear Resistance (Graves Tear) of Plastic . Film and Sheeting
{21}------------------------------------------------
The range of mechanical properties for the samples of the proposed devices. Disposable Barrier Sleeves and Covers, are comparable to those reported for the predicate device, TIDIShield™ Curing Light Sleeve (K132953), and support substantial equivalence with the predicate device, TIDIShield™ Curing Light Sleeve (K132953).
Clinical Performance Data.
No data from human clinical studies have been included to support the substantial equivalence of the proposed devices, Disposable Barrier Sleeves and Covers, as clinical studies are not required for this medical device.
8. Conclusion Regarding Substantial Equivalence
The proposed devices, Disposable Barrier Sleeves and Covers, are dental barrier sleeves and covers which are intended to serve as a disposable barrier for dental instruments and equipment. These disposable barrier sleeves and covers are non-sterile and are intended for single patient use only. The proposed devices, Disposable Barrier Sleeves and Covers, have the same intended use and indications for use and incorporate the same fundamental technology, as the predicate device, TIDIShield™ Curing Light Sleeve, cleared under premarket notification K132953. Test data to verify the performance of the proposed devices, Disposable Barrier Sleeves and Covers, have been provided including cytotoxicity, skin sensitization, oral mucosa irritation, synthetic blood penetration, synthetic blood penetration at seams and non-continuous components, viral penetration and viral penetration at seams and non-continuous components. The range of mechanical properties has been provided for puncture resistance, tear resistance, and tensile strength. The results of this testing, combined with the design, intended use and mechanical property comparison with the predicate device, support substantial equivalence with the predicate device, TIDIShield™ Curing Light Sleeve (K132953).
§ 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.