(181 days)
Not Found
No
The device is a physical tamper-evident cap and the description focuses on its mechanical properties and sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a tamper-evident cap for IV syringes, designed to reduce contamination and leakage, not to treat or diagnose a disease or condition.
No
Explanation: The device is a tamper-evident cap for IV syringes, designed to reduce contamination and leakage. Its function is to provide an obvious indication if tampering has occurred, not to diagnose a medical condition.
No
The device description clearly describes a physical, sterile tamper evident cap for IV syringes, not a software application. The performance studies also focus on physical characteristics like pull-off force, biocompatibility, and sterility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a sterile tamper evident cap for IV syringes." This describes a device used to maintain the sterility and integrity of a syringe and its contents, not to perform a diagnostic test on a sample from the human body.
- Device Description: The description focuses on the physical characteristics of the cap, its function in preventing contamination and leakage, and its tamper-evident feature. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: 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 specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies focus on physical properties (conformance to standards, pull-off force, tamper evidence), biocompatibility, sterility, and shelf life – all relevant to a medical device used for containing and protecting substances, but not for in vitro diagnostics.
In summary, the device is a sterile accessory for syringes designed to prevent tampering and maintain sterility, not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The subject device is a tamper evident female luer lock cap intended for use with male luer ports on syringes. Covering luer fittings on syringes helps reduce the risk of touch contamination and medication leakage. The user group consists of those involved in pharmacy compounding as well as health care professionals.
The subject device's clear outer shell/housing provides tamper evidence if the cap or the contents of the container is tampered with prior to clinical administration. Once removed, the shell/housing cannot be replaced back onto the luer cap, thus making it obvious if someone has previously attempted to remove the cap and/or attempted to tamper with the contents of the syringe.
The subject TrueCare Biomedix Tamper Evident Cap is packaged in a bulk pharmacy tray with 25 caps per tray and is provided sterile via ethylene oxide sterilization.
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
The user group consists of those involved in pharmacy compounding as well as health care professionals.
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:
The single use, sterile TrueCare BioMedix Tamper Evident Cap described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standard:
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare . applications - Part 7 Connectors for intravascular or hypodermic application
Additionally, the subject device has undergone pull-off force testing and tamper evidence functional testing per TrueCare's internal test methods to demonstrate that if the housing feature has been removed or tampered with, that it is obvious to the user.
Biocompatibility:
In accordance with ISO 10993-1, the device is classified as Limited duration, externally communicating device, Blood Path Indirect (
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
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September 15, 2021
US Infusion Inc. D/B/A Truecare Biomedix-USA Abbey Kramarz Director of Quality and Compliance 6356 Manor Ln Ste 101 South Miami, Florida 33143
Re: K210818
Trade/Device Name: TrueCare Biomedix Tamper Evident Cap Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 17, 2021 Received: August 19, 2021
Dear Abbey Kramarz:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 medical devices and radiation-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.
For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210818
Device Name
TrueCare Biomedix Tamper Evident Cap
Indications for Use (Describe)
Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
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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K210818. 510K SUMMARY
TrueCare Biomedix Tamper Evident Cap
| Preparation Date | September 15, 2021 | |
|---|---|---|
| I. | Company: | US Infusion Inc. D/B/A Truecare Biomedix-USA |
| 6356 Manor Lane, Suite 101 | ||
| South Miami, FL 33143 | ||
| Telephone: (866) 593-8444 | ||
| II. | Contact: | Abbey Kramarz |
| Director of Quality and Compliance | ||
| akramarz@tcbiomedix.com | ||
| III. | Proprietary Trade Name: | TrueCare Biomedix Tamper Evident Cap |
| IV. | Regulation Name: | |
| Regulation Number: | ||
| Product Code: | ||
| Device Class: | Piston Syringe | |
| 21 CFR 880.5860 | ||
| FMF | ||
| Class II | ||
| Predicate Device: | K193192 – International Medical Industries | |
| Prep-Lock Tamper Evident Cap |
Product Description V.
The subject device is a tamper evident female luer lock cap intended for use with male luer ports on syringes. Covering luer fittings on syringes helps reduce the risk of touch contamination and medication leakage. The user group consists of those involved in pharmacy compounding as well as health care professionals.
4
VI. Indications for Use
| Characteristic | Predicate Device
International Medical Industries
Prep-Lock Tamper Evident Cap
K193192 | Subject Device
TrueCare Biomedix
Tamper Evident Cap
K210818 |
|------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Indication for Use | Tamper Evident Caps are indicated for
use as a sterile tamper evident cap for IV
syringes. | Tamper Evident Caps are indicated for
use as a sterile tamper evident cap for IV
syringes. |
| Prescription Only or
Over the Counter | Prescription Only | Prescription Only |
Discussion of differences in Indications for Use statement:
The indication for use statement for the subject device is identical to the predicate.
VII. Summary of Technological Characteristics
Luer fittings are commonly used on syringes to provide universal compatibility. Luer lock fittings are securely joined by means of a tabbed hub on the female fitting which screws into threads in a sleeve on the male fitting. The subject device has been designed to be used with standard male luer connections on syringes.
The subject device's clear outer shell/housing provides tamper evidence if the cap or the contents of the container is tampered with prior to clinical administration. Once removed, the shell/housing cannot be replaced back onto the luer cap, thus making it obvious if someone has previously attempted to remove the cap and/or attempted to tamper with the contents of the syringe.
The subject TrueCare Biomedix Tamper Evident Cap is packaged in a bulk pharmacy tray with 25 caps per tray and is provided sterile via ethylene oxide sterilization.
5
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
| Technological
Characteristic | Predicate Device
International Medical
Industries
Prep-Lock Tamper
Evident Cap
K193192 | Subject Device
TrueCare Biomedix
Tamper Evident Cap
K210818 | Comments |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Fundamental Scientific
Technology | Female luer lock cap with
clear tamper evident outer
shell/housing | Female luer lock cap with
clear tamper evident outer
shell/housing | Same |
| Intended Use | Cap for attachment to male
luer ports on syringes | Cap for attachment to male
luer ports on syringes | Same |
| Connection | Female luer lock | Female luer lock | Same |
| Tamper Evidence Feature | Clear outer shell/housing that
separates from the cap upon
opening | Clear outer shell/housing that
separates from the cap upon
opening | Same |
| Biocompatibility Contact
/ Duration | Indirect blood contact, limited
duration | Indirect blood contact, limited
duration | Same |
| Materials | Indirect patient contacting:
Polypropylene with red
color additive
Non-patient contacting:
Polystyrene | Indirect patient contacting:
PP 1024 polypropylene with
red color additive
Non-patient contacting:
Acrylonitrile Butadiene
Styrene | Substantially
equivalent |
| Sterilization | Supplied sterile via ethylene
oxide (SAL of 10-6) | Supplied sterile via ethylene
oxide (SAL of 10-6) | Same |
Discussion of differences in technological characteristics:
Although the subject device's materials of construction are not the same as the predicate device, they are substantially equivalent based on the on biocompatibility assessment/ testing completed in support of the submission.
Brief Discussion of the Non-Clinical Tests Submitted VIII.
Performance testing
The single use, sterile TrueCare BioMedix Tamper Evident Cap described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standard:
6
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare . applications - Part 7 Connectors for intravascular or hypodermic application
Additionally, the subject device has undergone pull-off force testing and tamper evidence functional testing per TrueCare's internal test methods to demonstrate that if the housing feature has been removed or tampered with, that it is obvious to the user.
Biocompatibility
In accordance with ISO 10993-1, the device is classified as Limited duration, externally communicating device, Blood Path Indirect (