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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, which is a submission to the FDA for review of a new device to determine if it is "substantially equivalent" to an already legally marketed device (predicate device). It is not a study report that directly provides acceptance criteria and performance data in the format requested.

Therefore, the requested information elements (1-9) cannot be fully extracted and formatted as a direct study report from the provided text. The document primarily focuses on establishing substantial equivalence based on indications for use, technological characteristics, and a summary of non-clinical tests to demonstrate safety and performance without providing specific acceptance criteria and detailed study results for each.

However, I can extract the relevant information regarding the tests performed to support the substantial equivalence claim.

Here's an interpretation of the available information in the context of your request:

Device: TrueCare Biomedix Tamper Evident Cap

Predicate Device: International Medical Industries Prep-Lock Tamper Evident Cap (K193192)

Indication for Use: Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.

Summary of Device Performance and Testing (Not a Direct Acceptance Criteria Table):

The document states that the subject device (TrueCare Biomedix Tamper Evident Cap) was tested and demonstrated to be in conformance with certain standards and internal methods. It does not provide specific numerical acceptance criteria alongside performance reports for each test, but rather mentions the standards or types of tests performed to deem the device safe and effective and substantially equivalent to the predicate.

Here's a breakdown of the testing mentioned:

1. Performance Testing:

Standard Conformance: ISO 80369-7:2016 (Small-bore connectors for liquids and gases in healthcare applications - Part 7 Connectors for intravascular or hypodermic application).
Specific Functional Tests (Internal Methods):
- Pull-off force testing
- Tamper evidence functional testing ("to demonstrate that if the housing feature has been removed or tampered with, that it is obvious to the user.")

2. Biocompatibility Testing (In accordance with ISO 10993-1):

Classification: Limited duration, externally communicating device, Blood Path Indirect (<24hours).
Tests Conducted:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity
- Hemocompatibility

3. Sterility Testing:

Validation Standard: ISO 11135 (Sterilization of healthcare products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices).
Sterilization Method: Ethylene Oxide (EO)
Sterility Assurance Level (SAL): 10^-6 (achieved using the half-cycle overkill method).
EO and ECH Residual Testing: Per ISO 10993-7 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals).
- Limits Met: < 4mg/device (for EO) and < 9mg/device (for ECH).
Bacterial Endotoxins (Pyrogenicity) Testing:
- Method: Limulus Amebocyte Lysate (LAL) test.
- Limits Met: < 20 EU/device.
- Additional: Material-mediated pyrogen testing was also conducted as part of biocompatibility.

4. Shelf Life Testing:

Claimed Shelf Life: 3-year.
Testing Basis: Shelf life verification testing.
Packaging System Integrity Testing (Standards):
- ISO 11607-1 (Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems)
- ISO 11607-2 (Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes)
- ASTM F1886 (Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection)
- ASTM F1929 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)
- ASTM F88/F88M (Standard Test Method for Seal Strength of Flexible Barrier Materials)
- ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems)
- ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)
- ISTA 2A (Packaged-products weighing 150 lbs. (68kg) or less)

Addressing Specific Information Requests (based on available text):

1. A table of acceptance criteria and the reported device performance:

Test Type	Acceptance Criteria (Implied/Standard)	Reported Device Performance
Performance Testing	Conformance to ISO 80369-7:2016	Demonstrated conformance to ISO 80369-7:2016
Pull-off Force	(Internal method, "obvious to the user")	Tested (demonstrated "obvious" tamper evidence)
Tamper Evidence Function	(Internal method, "obvious to the user")	Tested (demonstrated "obvious" tamper evidence)
Biocompatibility	Conformance to ISO 10993-1 for indicated tests	All listed tests conducted successfully
Sterilization (SAL)	SAL of 10^-6	Achieved SAL of 10^-6
EO Residuals	EO < 4mg/device, ECH < 9mg/device (per ISO 10993-7)	Met limits for EO (< 4mg/device) and ECH (< 9mg/device)
Bacterial Endotoxins	< 20 EU/device (per LAL test)	Met limits (< 20 EU/device)
Shelf Life	Maintain integrity and performance for 3 years	3-year shelf life verified
Packaging Integrity	Conformance to listed ISO/ASTM/ISTA standards	Demonstrated conformance to listed standards

2. Sample size used for the test set and the data provenance:
* Sample Size: Not specified in the provided text for any of the tests.
* Data Provenance: Not specified in the provided text. The tests were performed to support this 510(k) submission, implying they are part of the device manufacturer's internal validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not specified in the context of device performance testing. Ground truth in this context would typically refer to gold standard for diagnostic accuracy, which is not relevant for this type of device (tamper evident cap).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not specified. This relates to expert review for diagnostic AI, not simple device performance testing.

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:
* Not applicable. This is a medical device (cap), not an AI diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device (cap), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable in the AI/diagnostic sense. For the device, "ground truth" for performance is established by objective measurements based on engineering standards (e.g., ISO, ASTM) and functional criteria (e.g., visual evidence of tampering).

8. The sample size for the training set:
* Not applicable. This is a medical device (cap), not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
* Not applicable. This is a medical device (cap), not an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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.

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

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}------------------------------------------------

K210818. 510K SUMMARY

TrueCare Biomedix Tamper Evident Cap

Preparation Date	September 15, 2021
I.	Company:	US Infusion Inc. D/B/A Truecare Biomedix-USA6356 Manor Lane, Suite 101South Miami, FL 33143Telephone: (866) 593-8444
II.	Contact:	Abbey KramarzDirector of Quality and Complianceakramarz@tcbiomedix.com
III.	Proprietary Trade Name:	TrueCare Biomedix Tamper Evident Cap
IV.	Regulation Name:Regulation Number:Product Code:Device Class:	Piston Syringe21 CFR 880.5860FMFClass II
	Predicate Device:	K193192 – International Medical IndustriesPrep-Lock Tamper Evident Cap

Product Description V.

{4}------------------------------------------------

VI. Indications for Use

Characteristic	Predicate DeviceInternational Medical IndustriesPrep-Lock Tamper Evident CapK193192	Subject DeviceTrueCare BiomedixTamper Evident CapK210818
Indication for Use	Tamper Evident Caps are indicated foruse as a sterile tamper evident cap for IVsyringes.	Tamper Evident Caps are indicated foruse as a sterile tamper evident cap for IVsyringes.
Prescription Only orOver 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:

TechnologicalCharacteristic	Predicate DeviceInternational MedicalIndustriesPrep-Lock TamperEvident CapK193192	Subject DeviceTrueCare BiomedixTamper Evident CapK210818	Comments
Fundamental ScientificTechnology	Female luer lock cap withclear tamper evident outershell/housing	Female luer lock cap withclear tamper evident outershell/housing	Same
Intended Use	Cap for attachment to maleluer ports on syringes	Cap for attachment to maleluer ports on syringes	Same
Connection	Female luer lock	Female luer lock	Same
Tamper Evidence Feature	Clear outer shell/housing thatseparates from the cap uponopening	Clear outer shell/housing thatseparates from the cap uponopening	Same
Biocompatibility Contact/ Duration	Indirect blood contact, limitedduration	Indirect blood contact, limitedduration	Same
Materials	Indirect patient contacting:Polypropylene with redcolor additiveNon-patient contacting:Polystyrene	Indirect patient contacting:PP 1024 polypropylene withred color additiveNon-patient contacting:Acrylonitrile ButadieneStyrene	Substantiallyequivalent
Sterilization	Supplied sterile via ethyleneoxide (SAL of 10-6)	Supplied sterile via ethyleneoxide (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 (<24hours). The following testing was conducted:

Cytoxicity .
Sensitization .
Intracutaneous Reactivity
Material Mediated Pyrogenicity
. Acute Systemic Toxicity
Hemocompatibility .

Sterility

A sterilization validation was conducted to ensure a Sterility Assurance Level (SAL) of 10° using the half-cycle overkill method in compliance with ISO 11135 Sterilization of healthcare products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

EO and ECH residual testing was completed for the subject device per ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals and the devices met the limits of < 4mg/device and < 9mg/device, respectively.

The sterile subject devices were evaluated for the potential to produce a pyrogenic response. The Limulus Amebocyte Lysate (LAL) test was used to test for Bacterial Endotoxins as part of process validations, and the devices met the limits of < 20 EU/device. Additionally, material-mediated pyrogen testing conducted as part of the biocompatibility testing conducted in support of this submission.

{7}------------------------------------------------

The subject device is currently labeled with a 3-year shelf life based on shelf life verification testing. Packaging system characteristics and integrity testing was conducted in accordance with the following standards:

ISO 11607-1 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
. ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
. ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
. ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials
. ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for . Medical Devices
ISTA 2A Packaged-products weighing 150 lbs. (68kg) or less

IX. Conclusions

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The TrueCare BioMedix Tamper Evident Cap is substantially equivalent to the International Medical Industries Prep-Lock Tamper Evident Cap with respect to the indications for use, target populations, treatment method, and technological characteristics.

Regulation Number and Section

§ 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).