Who is the manufacturer of Minitube Dentasleeve Protective Barrier Sleeves?

Minitube AB filed the 510(k) submission for Minitube Dentasleeve Protective Barrier Sleeves (K211026).

What is the FDA product code for Minitube Dentasleeve Protective Barrier Sleeves?

PEM. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Minitube Dentasleeve Protective Barrier Sleeves?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Minitube Dentasleeve Protective Barrier Sleeves?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Minitube Dentasleeve Protective Barrier Sleeves

K211026 · Minitube AB · PEM · Aug 3, 2021 · General, Plastic Surgery

Device Facts

Record ID	K211026
Device Name	Minitube Dentasleeve Protective Barrier Sleeves
Applicant	Minitube AB
Product Code	PEM · General, Plastic Surgery
Decision Date	Aug 3, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

Indications for Use

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.

Device Story

Disposable polyethylene film sleeves; designed to fit over dental instruments and equipment; act as physical barrier to augment infection control and facilitate cleanup. Used in dental clinics; operated by dental staff. Sleeves slip over device ends; provide protection against blood-borne pathogens and synthetic blood. Benefits include reduced cross-contamination risk and simplified equipment maintenance.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity) and mechanical/barrier performance (synthetic blood and viral penetration resistance, tensile strength, puncture resistance, tear resistance) per ASTM and ISO standards.

Technological Characteristics

Material: Low-density polyethylene film (0.03 mm thickness). Form factor: Disposable sleeves in various sizes (1ml, 5ml, 50ml). Non-sterile. Single-use. Standards: ASTM F1670/F1670M, ASTM F1671/F1671M, ASTM D882, ASTM F1342/F1342M, ASTM D1004, ISO 10993-5, ISO 10993-10, ISO 10993-11.

Indications for Use

Indicated for use as a disposable barrier for dental instruments and equipment in a dental procedure setting. No specific patient population or contraindications identified.

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

Barrier Sleeves (K191448)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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 {2}------------------------------------------------ 510(k) Number (if known) K211026 #### 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) | |--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and 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}------------------------------------------------ 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 | {4}------------------------------------------------ ## 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 {5}------------------------------------------------ | Item description | Minitube Dentasleeve Protective Barrier Sleeves Subject Device | Barrier Sleeve K#191448 Predicate Device | Substantially Equivalent or Different | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | 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. | 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. | SE | | Precaution Measures/Contraindications | None | None | SE | | Summary of Indications | The indications and contraindications for the predicate and the new device are the same. | | | | Working principle | 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 | Disposable 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 | SE | | | to fit over and cover the intended dental instruments and equipment. The Minitube Dentasleeve Protective Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment of those parts of the devices used during dental procedures. Minitube Dentasleeve Protective Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean- up. | 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 de- vices, allowing for the attachment of those parts of the devices used during dental procedures. Disposable Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean- up. | | | Delivery forms/dosage | There are several sleeves for dental instruments and equipment. | There are several sleeves for dental instruments and equipment. | SE Minitube Dentasleeve Protective Barrier Sleeves are supposed to be 3 articles, which differ in size of the | | | | | sleeve. These will fit perfectly over a 1ml, 5ml and 50ml syringe, respectively. | | Shelf life | 5 years | 5 years | SE | | Principles of operation | The disposable barrier sleeves and covers fit over and cover the intended dental instruments and equipment. | The disposable barrier sleeves and covers fit over and cover the intended dental instruments and equipment. | SE | | Material | Polyethylene film | Polyethylene film | SE | | Material composition | Low density polyethylene film | Low density polyethylene film | SE The material in the Predicate device and the new device are identical. | | Summary of Material Composition | No difference. The same supplier (Minitube AB, Sweden) manufactures the predicate and the subject devices. Both the devices made of the identical material. | | | | Dimensions | Size 1: 29 * 148 mm Size 2: 43 * 195 mm Size 3: 63 * 126 mm | Size 1: 29 * 148 mm Size 2: 36 * 279 mm | SE | | Film Thickness | 0.03 mm | 0.03 mm | SE | | | | | The material in the Predicate device and the new device are identical. | | Shape | Custom design to fit the intended dental instruments and equipment they cover | Custom design to fit the intended dental instruments and equipment they cover | SE | | Dimensions | Determined by the size and shape of the dental instruments and equipment they cover | Determined by the size and shape of the dental instruments and equipment they cover | 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 product is non-sterile | | Synthetic Blood Penetration test (ASTM F1670) | Pass | Pass | SE | | Synthetic Blood Penetration at seams and non-continuou components ASTM F1670/F1670M | Pass | Pass | SE | | Viral Penetration test (ASTM F1671) | Pass | Pass | SE | | Viral penetration at seams and non- continuous components ASTM F1671/F1671M | Pass | Pass | SE | | Performance Testing Summary | No difference. The same supplier (Minitube AB, Sweden) manufactures the predicate and the subject devices. Both the devices made of the identical material. The results of Performance testing are included in this submission. | | | | Biocompatibility: Cytotoxicity - ISO10993-5 Sensitization - ISO10993- 10 | Non-cytototoxic Non-sensitizing, non-irritating | Non-cytototoxic Non-sensitizing, non-irritating | SE SE The material in the Predicate device and the new device are identical. | | Summary of Biocompatibility | No difference. The same supplier (Minitube AB, Sweden) manufactures the predicate and the subjec devices. Both the devices made of the identical material. The results of Biocompatibility testing are included in this submission. | | | | Tensile strength ASTM D882 | 0.03 mm - acceptable | 0.03 mm - acceptable | SE | | Puncture Resistance ASTM F1342/F1342M | 0.03 mm - acceptable | 0.03 mm - acceptable | SE | | Tear Resistance ASTM D1004 | 0.03 mm - acceptable | 0.03 mm - acceptable | SE | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ # 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 {11}------------------------------------------------ | Mechanical Property | Standard | Proposed Subject Device | Predicate Device Barrier Sleeves K191448 | |------------------------|----------------------|-------------------------------------------|------------------------------------------------| | Tensile strengt | ASTM D882 | 0.03mm – Identical to Predicate Device | FDA 510(k) cleared with 0.03mm result. | | Puncture Resistance | ASTM F1342/F1342M | 0.03mm – Identical to Predicate Device | FDA 510(k) cleared with 0.03mm result. | | Tear Resistance | ASTM D1004 | 0.03mm – Identical to Predicate Device | FDA 510(k) cleared with 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.

Minitube Dentasleeve Protective Barrier Sleeves

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Minitube Dentasleeve Protective Barrier Sleeves

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!