(116 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterility, and packaging of a simple mechanical cap, with no mention of AI or ML.
No.
The device is described as a cap for Luer ports on medical devices, intended to cover these ports and provide evidence of access, rather than to treat or provide therapy to a patient.
No
The device is described as a tamper-evident cap used to cover female Luer ports on medical devices, providing evidence of access. Its intended use is as a physical barrier, not to identify or measure a medical condition, disease, or risk factor.
No
The device description clearly states it is a physical cap made of polystyrene and polypropylene resin, intended to cover female Luer ports. The performance studies focus on physical and material properties, sterilization, and packaging, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cap female Luer ports on medical devices like manifolds, stopcocks, or sets. This is a mechanical function related to fluid delivery systems, not the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on the physical characteristics and function of a cap for Luer ports. It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies listed are related to the physical and biological safety of the device (ISO standards for connectors, sterilization, packaging, biocompatibility), not the analytical or clinical performance of an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
Therefore, the Tamper Evident Cap with Male Luer Lock is a medical device, but it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tamper Evident Cap with Male Luer Lock is indicated for use as a cap for female Luer ports on medical devices such as manifolds, stopcocks or set.
Product codes
FPA
Device Description
The Tamper Evident Cap with Male Luer Lock (MTEC) is a sterile, single use device which will be used to cover female Luer ports on medical devices and provide evidence of access. MTEC is provided in two packaging configurations; a 10-up tray and single unit blisters. Both configurations are offered in multiple colors and all the components used in the manufacture of MTEC are comprised of polystyrene and polypropylene resin.
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
Bench testing was performed to demonstrate that the proposed MTEC device is substantially equivalent to both the primary predicate and secondary predicate devices.
Test Name:
- ISO 80369-7:2016
- Shelf Life Evaluation
- Sterilization Product Adoption (AAMI TIR 28:2009/(R)2013)
- Packaging (ISO 11607-1:2006)
- Sterility (ISO 11135:2014)
- Residuals (ISO 10993-7:2008)
- Biocompatibility (ISO 10993-1)
Key Results:
- The MTEC device meets the bench testing requirements of ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications.
- Compliance with ISO 80369-7:2016 demonstrates that The MTEC device meets the Bench performance testing requirements for: Separation Force, Unscrewing torque, Ease of assembly, Stress cracking, Liquid leakage test, and Resistance to overriding.
- The MTEC device's tamper evident design feature was tested and successfully passed all internal specifications. All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use.
- Biocompatibility testing was conducted in accordance with the cited guidance and standards as required for an External Communicating Device, Blood Path, Indirect Contact, Limited Duration.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows 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.
January 11, 2019
International Medical Industries, Inc. Kathleen Lavender Director, Quality and Compliance 2981 Gateway Drive Pompano Beach, Florida 33069
Re: K182545
Trade/Device Name: Tamper Evident Cap with Male Luer Lock Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: December 10, 2018 Received: December 12, 2018
Dear Kathleen Lavender:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting 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) K182545
Device Name
Tamper Evident Cap with Male Luer Lock
Indications for Use (Describe)
The Tamper Evident Cap with Male Luer Lock is indicated for use as a cap for female Luer ports on medical devices such as manifolds, stopcocks or set.
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)
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3
510(K) Summary: K182545
| Manufacturer: | International Medical Industries, Inc. |
|---|---|
| Address: | 2981 Gateway Drive |
| Pompano Beach, Florida 33069 | |
| Corresponding official: | Kathleen Lavender |
| Director of Quality and Compliance | |
| Telephone Number: | 954.917.9570 x 283 |
| Email: | klavender@imiweb.com |
| Summary Date: | January 10, 2019 |
| Trade Name: | Tamper Evident Cap with Male Luer Lock |
| Common or Usual Name: | I.V. Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular Administration Set |
| Product Code: | FPA |
| Class: | II |
| Panel: | General Hospital |
| Primary Predicate Device: | Dual Luer Lock Cap (K101385) |
| Secondary Predicate Device: | Tamper Evident Cap with Luer Lock (K861276) |
Device Description:
The Tamper Evident Cap with Male Luer Lock (MTEC) is a sterile, single use device which will be used to cover female Luer ports on medical devices and provide evidence of access. MTEC is provided in two packaging configurations; a 10-up tray and single unit blisters. Both configurations are offered in multiple colors and all the components used in the manufacture of MTEC are comprised of polystyrene and polypropylene resin.
4
| Feature of the device: | Device:
K182545
Tamper Evident Cap
with male Luer Lock | Primary Predicate:
K101385
Baxter Dual Luer
Lock Cap | Secondary Predicate:
K861276
Tamper Evident Cap
with Luer Lock | Discussion/Comment |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FPA | FPA | FPA | No Change |
| Classification | Class II | Class II | Class II | No Change |
| Number of uses | Single use Rx only | Single use Rx only | Single use Rx only | No Change |
| Materials | Device is an injection
molded polypropylene
component. | Device is an injection
molded polypropylene
component. | Device is an injection
molded polypropylene
component. | Same: No Change |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same: No Change |
| Biocompatibility | Biocompatibility
assessment of the Dual
Luer Lock Cap has
been conducted based
on ISO 10993-1 -
Biological Evaluation
of Medical Devices. | Biocompatibility
assessment of the Dual
Luer Lock Cap has
been conducted based
on ISO 10993-1 -
Biological Evaluation
of Medical Devices. | Biocompatibility
assessment of the Dual
Luer Lock Cap has been
conducted based on ISO
10993-1 - Biological
Evaluation of Medical
Devices. | Same: No Change |
| Indication for Use: | The Tamper Evident
Cap with Male Luer
Lock is indicated for
use as a cap for female
Luer ports on medical
devices such as
manifolds, stopcocks
or sets. | The Dual Luer Lock
Cap is indicated for
use as a cap for male
or female Luer ports
on medical devices
such as manifolds,
stopcocks or sets. | The Tamper Evident
Cap with Female Luer
Lock is indicated for use
as a cap for male Luer
ports on medical devices | Device is pending
premarket notification.
Predicate is
commercially available
as Baxter Dual Luer
Lock Cap
Not subject to recall
The primary difference
is that the primary
predicate device has
both male and female
Luer connection points
whereas the proposed
device only has a male
Luer lock connection
point.
The primary difference
between the secondary
predicate device and the
proposed device is that
the secondary predicate
only has a female Luer
lock connection point. |
| Design Feature:
Tamper
Evidence | Device is designed to
cover an open Luer
port after the Luer port
has been accessed and
will provide evidence
of tampering if
removed after | Device is designed to
cover an open Luer
port after the Luer port
has been accessed. | Device is designed to
cover an open Luer port
after the Luer port has
been accessed and will
provide evidence of
tampering if removed
after installation. | The proposed product is
designed with a primary
function of a standard
male Luer lock cap with
a secondary function as
a tamper evident
(evidence of access) |
5
Technological Characteristics:
The MTEC device is an assembly of injection molded components with a polypropylene Luer lock tip cap. The intended use and function of the proposed device is identical to the primary predicate device with respect to functionality. Both the proposed device (tip cap) and the primary predicate device are comprised of polypropylene resin. There are two design differences between the proposed device and the primary predicate device. The primary difference is that the primary predicate device has both male and female Luer connection points whereas the proposed device only has a male Luer lock connection point. The second difference is that the proposed device has a tamper evident design feature. This design feature is identical to the secondary predicate device.
Performance Data:
Bench testing was performed to demonstrate that the proposed MTEC device is substantially equivalent to both the primary predicate and secondary predicate devices.
| Test Name | Test Description |
|---|---|
| ISO 80369-7:2016 | Design verification to ISO 80369-7:2016 Small-bore connectors for |
| liquids and gases in healthcare applications -- Part 7: Connectors for | |
| intravascular or hypodermic applications | |
| Shelf Life Evaluation | Design verification of the shelf life. |
| Sterilization Product | |
| Adoption | AAMI TIR 28:2009/(R)2013 Product adoption and process |
| equivalence for ethylene oxide sterilization | |
| Packaging | ISO 11607-1:2006 Packaging for terminally sterilized medical |
| devices -- Part 1: Requirements for materials, sterile barrier systems | |
| and packaging systems | |
| Sterility | ISO 11135:2014 Sterilization of health-care products -- Ethylene |
| oxide -- Requirements for the development, validation and routine | |
| control of a sterilization process for medical devices | |
| Residuals | ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: |
| Ethylene oxide sterilization residuals | |
| Biocompatibility | ISO 10993-1, “Biological evaluation of medical devices – Part 1: |
| Evaluation and testing within a risk management process”; Guidance | |
| for Industry and Food and Drug Administration Staff, Jun 16, 2016 | |
| and "Guidance for Industry and FDA Staff – Intravascular | |
| Administration Sets Premarket Notification Submissions [510(k)],” | |
| July 11, 2008, as recognized by the FDA. |
6
Discussion of Non-Clinical Testing:
International Medical Industries conducts risk analyses and design verification tests that are based on the result of these analyses. All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use.
The MTEC device meets the bench testing requirements of ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications. The primary predicate device was tested to ISO 594-2:1998 which has since been replaced by ISO 80369-7:2016.
Compliance with ISO 80369-7:2016 demonstrates that The MTEC device meets the Bench performance testing requirements as follows:
-
- Separation Force
-
- Unscrewing torque
-
- Ease of assembly * Stress cracking
-
- Liquid leakage test
-
- Resistance to overriding
Proposed device vs. primary predicate device
The MTEC device meets the bench testing requirements of ISO 80369-7:2016 Small-bore connectors for liguids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications. The primary predicate device was tested to ISO 594-2:1998 which has since been replaced by ISO 80369-7:2016. Compliance with ISO 80369-7:2016 demonstrates that the proposed device is substantially equivalent to the primary predicate device K101385.
Proposed device vs. secondary predicate device
The MTEC device's tamper evident design feature was tested and successfully passed all internal specifications. It is substantially equivalent to the secondary predicate device K861276.
7
Biocompatibility Testing
Biocompatibility testing of the Tamper Evident Cap with Male Luer Lock was conducted per Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff, Jun 16, 2016 and "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]," July 11, 2008, as recognized by the FDA. Biocompatibility testing was conducted in accordance with the cited guidance and standards as required for an External Communicating Device, Blood Path, Indirect Contact, Limited Duration.
Conclusion:
Review of the in-vitro performance test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the subject device, Tamper Evident Cap with Male Luer Lock (MTEC) is substantially equivalent to the primary predicate device, the Baxter Dual Luer Lock Cap (K101385). Any technological differences between the subject and the predicate devices do not raise any issues of safety and effectiveness.