(119 days)
No
The device is a simple physical barrier made of polyethylene film and the description focuses on its material properties and physical dimensions. There is no mention of any computational or analytical functions.
No.
The device is a disposable barrier for dental instruments and equipment, augmenting existing infection control techniques. It does not treat or diagnose any medical condition.
No
The device is described as a disposable barrier for dental instruments and equipment, functioning as a physical barrier to augment infection control techniques and facilitate cleanup. It does not perform any diagnostic function.
No
The device description clearly states it is a physical barrier made of polyethylene film, intended to cover dental instruments. It is a hardware device, not software.
Based on the provided information, the Minitube Dentasleeve Protective Barrier Sleeves are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to serve as a disposable barrier for dental instruments and equipment. This is a physical barrier function, not a diagnostic one.
- Device Description: The description focuses on the material (polyethylene film), how it's used (slips over instruments), and its function (physical barrier, facilitates cleanup). There is no mention of analyzing samples from the human body or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for infection control and hygiene in a dental setting by providing a physical barrier. This falls under the category of general medical devices, not IVDs.
N/A
Intended Use / 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.
Product codes
PEM
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 following biocompatibility testing have been conducted on the subject device:
- ISO 10993-5: Invitro Cytotoxicity: Cytotoxicity Study Using the ISO Elution Method: Non-cytototoxic
- ISO 10993-10: Irritation and Skin Sensitization: ISO Guinea Pig ● Maximization Sensitization Test - Extract: Non-sensitizing, non-irritating
- 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: Pass
- 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: Pass
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: 0.03 mm - acceptable; Identical to Predicate Device
- ASTM F1342/ F1342M Standard Test Method for Protective Clothing ● Material Resistance to Puncture: 0.03 mm - acceptable; Identical to Predicate Device
- ASTM D1004 Standard Test Method for Tear Resistance (Graves Tear) of . Plastic Film and Sheeting: 0.03 mm - acceptable; Identical to Predicate Device
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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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 |
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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
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.