(119 days)
Minitube Dentasleeve Protective Barrier Sleeves 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
Minitube Dentasleeve Protective Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves 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 of those parts of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean up. The Minitube Dentasleeve Protective Barrier Sleeves are available in below sizes. All sizes below are provided in millimeters (mm, approx.) and excluding paper liner, i.e. actual sleeve only:
- . 1 ml Width: 29 mm Length: 148 mm
- 5 ml Width: 43 mm Length: 195 mm
- 50ml Width: 63 mm Length: 126 mm
This document, a 510(k) Premarket Notification from the FDA, details the equivalence of the Minitube Dentasleeve Protective Barrier Sleeves to a predicate device. The information provided is for a medical device (dental barrier sleeves), not an AI/algorithm-based device. Therefore, a significant portion of your request regarding AI model validation (e.g., training set, test set, ground truth for AI, MRMC studies, expert consensus, etc.) is not applicable to this document.
The acceptance criteria and study proving the device meets them are based on bench testing and material property comparisons rather than clinical performance or AI algorithm assessment.
Here's an attempt to answer your questions based on the provided document, highlighting where the information is not applicable (N/A) due to the nature of the device:
Device Name: Minitube Dentasleeve Protective Barrier Sleeves
Regulation Number: 21 CFR 878.4370 (Surgical Drape and Drape Accessories)
Regulatory Class: Class II
Product Code: PEM
1. Table of Acceptance Criteria and Reported Device Performance
This device is cleared based on substantial equivalence to a predicate device (Barrier Sleeves, K191448). The "acceptance criteria" are implied by the performance characteristics of the predicate device, which the new device must match or perform equivalently.
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (Subject Device) |
|---|---|
| Indications for Use: Disposable barrier for dental instruments and equipment; non-sterile; single patient use only. | Identical |
| Material: Polyethylene film (low density) | Identical |
| Shelf Life: 5 years | 5 years |
| Color: Clear | Clear |
| Paper backing: Yes | Yes |
| Single Use: Yes | Yes |
| Sterility: Non-sterile | Non-sterile |
| Synthetic Blood Penetration Test (ASTM F1670): Pass | Pass |
| Synthetic Blood Penetration at seams (ASTM F1670/F1670M): Pass | Pass |
| Viral Penetration Test (ASTM F1671): Pass | Pass |
| Viral Penetration at seams (ASTM F1671/F1671M): Pass | Pass |
| Biocompatibility (Cytotoxicity - ISO 10993-5): Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization - ISO 10993-10): Non-sensitizing, non-irritating | Non-sensitizing, non-irritating |
| Biocompatibility (Irritation - ISO 10993-10): Non-irritating (from Intracutaneous Study) | Non-irritating |
| Biocompatibility (Systemic Toxicity - ISO 10993-11): N/A (implied acceptable performance) | Passed Systemic Toxicity Study |
| Tensile Strength (ASTM D882): 0.03mm - acceptable | 0.03mm - identical to predicate |
| Puncture Resistance (ASTM F1342/F1342M): 0.03mm - acceptable | 0.03mm - identical to predicate |
| Tear Resistance (ASTM D1004): 0.03mm - acceptable | 0.03mm - identical to predicate |
Note on Dimensions: While the predicate device had sizes 29x148mm and 36x279mm, the subject device offers 29x148mm, 43x195mm, and 63x126mm, stating these "will fit perfectly over a 1ml, 5ml and 50ml syringe, respectively." This is deemed "SE" (Substantially Equivalent) as it still fulfills the same barrier function for dental instruments, albeit with different specific sizes.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It indicates that "samples of the proposed devices" were tested and that the "results are included in this submission."
- Data Provenance: The tests were conducted to support the 510(k) submission. The supplier (Minitube AB, Sweden) manufactures both the predicate and subject devices. This implies the bench testing was done by or for the manufacturer. The data is prospective as it's generated specifically for this premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is a physical barrier device, and its "ground truth" is established through standardized laboratory bench tests, not through expert human interpretation of medical images or data. The standards (ASTM, ISO) themselves define the methodology and "ground truth" for material performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 are relevant for subjective evaluations, typically in clinical studies or AI performance assessment. Here, the assessment is based on objective, quantitative measurements from standardized laboratory tests.
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
- N/A. This device is a physical barrier, not an AI or imaging device. Therefore, MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Testing Standards and Predicate Device Performance: The "ground truth" is established by compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, ASTM F1670, F1671, D882, F1342, D1004 for material properties) and by demonstrating identical or equivalent performance to the legally marketed predicate device.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device; therefore, there is no training set in that context.
9. How the ground truth for the training set was established
- N/A. As above, no training set for an AI model. For the device itself, the manufacturing process is regulated by Quality Systems (21 CFR Part 820), ensuring consistency and adherence to product specifications, which can be thought of as the "ground truth" for uniform product characteristics.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2021
Minitube AB % Vaibhav Arvind Rajal Official Correspondent for Minitube AB MDI Consultants Inc. 55 Northen Blvd. Suite 200 Great Neck. New York 11021
Re: K211026
Trade/Device Name: Minitube Dentasleeve Protective Barrier Sleeves Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: May 17, 2021 Received: May 21, 2021
Dear Vaibhav Arvind Rajal:
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
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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 mediation-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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
Minitube Dentasleeve Protective Barrier Sleeves
Indications for Use (Describe)
Minitube Dentasleeve Protective Barrier Sleeves 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
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for Minitube, a company that specializes in assisted reproductive technologies. The logo features a blue hexagon with a white plus sign inside, followed by the word "MINITUBE" in blue, block letters. Below the logo is the alphanumeric code "K211026".
510(k) Summary
The assigned 510(k) number is
1. Submitter's Identification:
Minitube AB Byvagen 44, 835 96 Trangsviken Sweden
Date: March 29, 2021
Contact: Mr. Bengt Myhrman President, Minitube AB Minitube AB Byvagen 44, 835 96 Trangsviken Sweden Email: bengt@minitube.se
2. Name of the Device:
| Trade Name: | Minitube Dentasleeve Protective Barrier Sleeves |
|---|---|
| Common Name: | Dental Barriers and Sleeves |
| Regulation Description: | Surgical drape and drape accessories. |
| Product Code: | PEM |
| Regulation Number: | 878.4370 |
| Device Class: | II |
3. Information on Predicate Devices:
Predicate Device:
| Trade/Device Name: | Barrier Sleeves |
|---|---|
| Regulation Number: | 21 CFR 878.4370 |
| Regulation Name: | Surgical drape and drape accessories |
| Regulatory Class: | Class II |
| Product Code: | PEM |
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4. Indications for Use Statement:
Minitube Dentasleeve Protective Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is nonsterile and intended for single patient use only.
5. Device Description:
Minitube Dentasleeve Protective Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves 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 of those parts of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean up. The Minitube Dentasleeve Protective Barrier Sleeves are available in below sizes. All sizes below are provided in millimeters (mm, approx.) and excluding paper liner, i.e. actual sleeve only:
- . 1 ml Width: 29 mm Length: 148 mm
- 5 ml Width: 43 mm Length: 195 mm
- 50ml Width: 63 mm Length: 126 mm
6. Substantial Equivalence Comparison Chart between Subject device and the Predicate devices:
The subject Minitube Dentasleeve Protective Barrier Sleeves is substantially equivalent to Barrier Sleeves device. K191448
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| Item description | MinitubeDentasleeveProtective BarrierSleevesSubject Device | Barrier SleeveK#191448PredicateDevice | SubstantiallyEquivalentor Different |
|---|---|---|---|
| Indications for UseStatement | MinitubeDentasleeveProtective BarrierSleeves areintended to serveas a disposablebarrier for dentalinstruments andequipment. Thisdevice is nonsterileand intended forsingle patient useonly. | Barrier Sleevesare intended toserve as adisposablebarrier for dentalinstruments andequipment. Thisdevice isnonsterile andintended forsingle patientuse only. | SE |
| PrecautionMeasures/Contraindications | None | None | SE |
| Summary of Indications | The indications and contraindications for thepredicate and the new device are the same. | ||
| Working principle | MinitubeDentasleeveProtective BarrierSleeves are madeof polyethylene filmand are used asaccessories todental instrumentsand equipmentused during dentalprocedures.These disposablebarrier sleeves areoffered in variousshapes and sizes | DisposableBarrier Sleevesare made ofpolyethylene filmand are used asaccessories todentalinstruments andequipment usedduring dentalprocedures.Thesedisposablebarrier sleevesare offered in | SE |
| to fit over andcover the intendeddental instrumentsand equipment.The MinitubeDentasleeveProtective BarrierSleeves slip overthe ends of therespective devices,allowing for theattachment ofthose parts of thedevices usedduring dentalprocedures.MinitubeDentasleeveProtective BarrierSleeves act as aphysical barrier,augmentingexisting infectioncontrol techniques,and facilitate clean-up. | various shapesand sizes to fitover and coverthe intendeddentalinstruments andequipment. TheDisposableBarrier Sleevesslip over theends of therespective de-vices, allowingfor theattachment ofthose parts ofthe devices usedduring dentalprocedures.DisposableBarrier Sleevesact as a physicalbarrier,augmentingexisting infectioncontroltechniques, andfacilitate clean-up. | ||
| Delivery forms/dosage | There are severalsleeves for dentalinstruments andequipment. | There areseveral sleevesfor dentalinstruments andequipment. | SEMinitubeDentasleeveProtectiveBarrierSleeves aresupposed tobe 3 articles,which differ insize of the |
| sleeve.These will fitperfectly overa 1ml, 5mland 50mlsyringe,respectively. | |||
| Shelf life | 5 years | 5 years | SE |
| Principles of operation | The disposablebarrier sleeves andcovers fit over andcover the intendeddental instrumentsand equipment. | The disposablebarrier sleevesand covers fitover and coverthe intendeddentalinstruments andequipment. | SE |
| Material | Polyethylene film | Polyethylene film | SE |
| Material composition | Low densitypolyethylene film | Low densitypolyethylene film | SEThe materialin thePredicatedevice andthe newdevice areidentical. |
| Summary of MaterialComposition | No difference. The same supplier (Minitube AB,Sweden) manufactures the predicate and the subjectdevices. Both the devices made of the identicalmaterial. | ||
| Dimensions | Size 1: 29 * 148mmSize 2: 43 * 195mmSize 3: 63 * 126mm | Size 1: 29 * 148mmSize 2: 36 * 279mm | SE |
| Film Thickness | 0.03 mm | 0.03 mm | SE |
| The materialin thePredicatedevice andthe newdevice areidentical. | |||
| Shape | Custom design tofit the intendeddental instrumentsand equipmentthey cover | Custom designto fit the intendeddentalinstruments andequipment theycover | SE |
| Dimensions | Determined by thesize and shape ofthe dentalinstruments andequipment theycover | Determined bythe size andshape of thedentalinstruments andequipment theycover | SE |
| Color | Clear | Clear | SE |
| Paper backing (y/n) | Yes | Yes | SE |
| Single use (Y/N) | Yes | Yes | SE |
| Sterility | n/a | N/a | The productis non-sterile |
| Synthetic Blood Penetrationtest (ASTM F1670) | Pass | Pass | SE |
| Synthetic Blood Penetrationat seams and non-continuoucomponents ASTMF1670/F1670M | Pass | Pass | SE |
| Viral Penetration test(ASTM F1671) | Pass | Pass | SE |
| Viral penetration at seamsand non- continuouscomponentsASTM F1671/F1671M | Pass | Pass | SE |
| Performance TestingSummary | No difference. The same supplier (Minitube AB,Sweden) manufactures the predicate and thesubject devices. Both the devices made of theidentical material. The results of Performancetesting are included in this submission. | ||
| Biocompatibility:Cytotoxicity - ISO10993-5Sensitization - ISO10993-10 | Non-cytototoxicNon-sensitizing,non-irritating | Non-cytototoxicNon-sensitizing,non-irritating | SESEThe material inthe Predicatedevice and thenew device areidentical. |
| Summary ofBiocompatibility | No difference. The same supplier (Minitube AB,Sweden) manufactures the predicate and the subjecdevices. Both the devices made of the identicalmaterial. The results of Biocompatibility testing areincluded in this submission. | ||
| Tensile strengthASTM D882 | 0.03 mm -acceptable | 0.03 mm -acceptable | SE |
| Puncture Resistance ASTMF1342/F1342M | 0.03 mm -acceptable | 0.03 mm -acceptable | SE |
| Tear Resistance ASTMD1004 | 0.03 mm -acceptable | 0.03 mm -acceptable | SE |
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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the subject device met all of the requirements of related international standards. Results of these tests demonstrate compliance with the requirements of the consensus standards.
The ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, is not applicable for the subject device, as the subject device does not come in direct contact with the tissue. The following biocompatibility testing have been conducted on the subject device:
- . ISO 10993-5: Invitro Cytotoxicity: Cytotoxicity Study Using the ISO Elution Method
- ISO 10993-10: Irritation and Skin Sensitization: ISO Guinea Pig ● Maximization Sensitization Test - Extract
- ISO 10993-10: Irritation and Skin Sensitization: ISO Intracutaneous Study in Rabbits
- ISO 10993-11: Systemic Toxicity: ISO Systemic Toxicity Study in Mice -● Extract
The performance of the proposed subject device, Minitube Dentasleeve Protective Barrier Sleeves, met the requirements of the biocompatibility testing conducted to support substantial equivalence with the predicate, Barrier Sleeves, K191448.
The performance testing (Bench) of the subject device, Minitube Dentasleeve Protective Barrier Sleeves, met the requirements of the non-clinical bench testing conducted to support substantial equivalence with the predicate, Barrier Sleeves (K191448). 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
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| MechanicalProperty | Standard | Proposed SubjectDevice | Predicate DeviceBarrier SleevesK191448 |
|---|---|---|---|
| Tensile strengt | ASTM D882 | 0.03mm – Identicalto Predicate Device | FDA 510(k) clearedwith 0.03mm result. |
| PunctureResistance | ASTMF1342/F1342M | 0.03mm – Identicalto Predicate Device | FDA 510(k) clearedwith 0.03mm result. |
| TearResistance | ASTM D1004 | 0.03mm – Identicalto Predicate Device | FDA 510(k) clearedwith 0.03mm result. |
Below is a summary of the mechanical properties testing performed on the proposed subject Minitube Dentasleeve Protective Barrier Sleeves device:
- 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
The results of the mechanical properties testing for the samples of the proposed devices, Barrier Sleeves, is identical to those reported for the predicate device, Barrier Sleeves, K191448. The results indicate the subject device passed performance testing under the conditions of the tests, and supports the substantial equivalence of the subject device, Minitube Dentasleeve Protective Barrier Sleeves to its predicate device, Barrier Sleeves K191448.
8. Product Shelf Life
The Shelf life for the predicate device is 5 years. The claimed shelf life for the new proposed subject device is also 5 years, which is identical to the predicate device.
9. Conclusion:
Based on the substantial equivalence chart and the non-clinical performance testing data the subject device was demonstrated to be as safe, as effective and substantially equivalent to the predicate device.
§ 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.