The Tamper Evident Cap (TEC) is a sterile, single use device which will be used to cover male luer ports on medical devices and provide evidence of access. TEC is offered in multiple colors and all the components used in the device are comprised of polystyrene and polypropylene resin. The TEC device is marketed as a stand-alone device and packaged in bulk.

AI/ML Overview

This document is a 510(k) summary for the Prep-Lock™ Tamper Evident Cap for IV Syringes (K193192). It focuses on demonstrating substantial equivalence to a predicate device (K861276), primarily due to a change in packaging configuration.

Here's an analysis of the provided text in relation to your request:

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

The document lists various non-clinical bench tests performed to assess the new packaging configuration of the Tamper Evident Cap. It states that "All pre-determined acceptance criteria were met." However, it does not explicitly define the specific acceptance criteria for each test in a quantitative manner, nor does it provide detailed numerical results for the reported device performance. It only states that the device "conforms to the same functional and sterility specifications as the predicate device."

Test Name	Acceptance Criteria (Implied)	Reported Device Performance
Sterility Assurance 10-6 SAL	Sterilization per ANSI/AAMI/ISO 11737-2:2009/(R)2014 achieved 10-6 SAL.	Meets established sterility assurance level.
Sterilization Product Adoption	Conformance to AAMI TIR 28 for ethylene oxide sterilization.	Conforms to AAMI TIR 28.
Shelf Life	Conformance to ASTM F1980-16 for accelerated aging.	Maintains 3-year shelf life.
EO/ECH Residuals	Conformance to ISO 10993-1 and relevant guidance for residuals.	Meets requirements for EO/ECH residuals.
Device Function (HE75, ISO 80369-7, IMI Internal Tests)	Design per AAMI ANSI HE75, connectors per ISO 80369-7, and satisfactory internal tests for tamper evident break force, simulated use, and weld strength.	Meets functional specifications.
Packaging Integrity (ASTM F 1886, ASTM F 88)	Integrity of seals per ASTM F 1886, minimum peel strength per ASTM F 88.	Packaging maintains integrity.
Transportation (ISTA 3B, ASTM F1886, F1929)	Packaging withstands ISTA 3B test, visual seal inspection per ASTM F1886, and dye penetration per F1929.	Withstands transportation challenges.
Product Validation (Human factors)	Usability assessment of packaging use.	Packaging deemed usable.
Biocompatibility Testing	Conformance to ISO 10993-1 and FDA guidance for indirect blood contact, limited duration.	Device is biocompatible.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the described non-clinical bench tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of bench testing for a device modification (packaging), these would typically be conducted prospectively by the manufacturer (International Medical Industries, Inc., Pompano Beach, Florida, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the provided document. The study described is a non-clinical bench testing for a physical medical device (tamper evident cap) and its packaging, not an AI/diagnostic device that would require expert-driven ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is non-clinical bench testing. Human adjudication methods like 2+1 are typically used for clinical studies involving interpretation of medical images or patient outcomes.

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 device is not an AI-powered diagnostic tool, and therefore, no MRMC comparative effectiveness study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench tests, the "ground truth" is implied by the standards and internal specifications that the device and its packaging must meet (e.g., ANSI/AAMI/ISO 11737-2 for sterility, ASTM F1980-16 for shelf life, ISO 10993-1 for biocompatibility). The tests directly measure whether the physical properties and performance characteristics of the device and its packaging conform to these established benchmarks.

8. The sample size for the training set

Not applicable. This document describes the testing of a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

January 31, 2020

International Medical Industries Inc. David Meily Director of Quality & Regulatory Affairs 2981 Gateway Drive Pompano Beach, Florida 33069

Re: K193192

Trade/Device Name: Tamper Evident Cap Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 7, 2019 Received: January 8, 2019

Dear David Meily:

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/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,

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) K193192

Device Name

Prep-LockTM Tamper Evident Cap for IV Syringes

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)

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

K193192 510(k) Summary

Date Summary Prepared:	November 15, 2019
Manufacturing Company:	International Medical Industries, Inc.
Manufacturing Address:	2981 Gateway Drive, Pompano Beach, Florida 33069
Corresponding Official:	David Meily
	Director of Quality and Regulatory Affairs
Telephone Number:	954.917.9570 x 283
Fax Number:	954.917.9244
Email Address:	dmeily@imiweb.com
Trade Name:	Prep-Lock™ Tamper Evident Cap
	for IV Syringes
Device 510(k):	K193192
Device Common Name:	Tamper Evident Cap
Regulation Number:	21 CFR 880.5860
Regulation Name:	Piston syringe
Product Class:	II
Product Panel:	General Hospital
Product Code:	FMF
Predicate Device Name:	Prep-Lock™ Tamper Evident Cap
	for IV Syringes
	(Originally cleared as Tamper Proof Cap)
Predicate Device 510(k):	K861276 cleared May 5, 1986
Device Common Name:	Tamper Evident Cap
Regulation Number:	21 CFR 880.5860
Regulation Name:	Piston syringe
Product Class:	II
Product Panel:	General Hospital
Product Code:	FMF

1. Device Description

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

2. Indications for Use

Subject Device IFU:	Predicate Device IFU
TEC in Bulk BagsTamper Evident Caps are indicated for useas a sterile tamper evident cap for IVsyringes.	TEC in Individual Trays and Blister PacksTamper Evident Caps are indicated for useas a sterile tamper evident cap for IVsyringes.

Discussion of differences in indications for use

The Indications For Use remains the same.

3. Comparison of Technological Characteristics and Basis for Substantial Equivalence

Parameter	Subject Device	Predicate Device	Comparison
ProprietaryDevice Name	Prep-Lock™ Tamper Evident Capfor IV Syringes	Prep-Lock™ TamperEvident Cap for IV Syringes	Same
PackagingConfiguration	Pouches that contain 100 TECunits.	Individual blister packs and10-up trays.	The packagingconfiguration has beentested and conforms tothe same functional andsterility specifications asthe predicate device. Thecap itself is unchanged.
Labeling	Instructions on how to open 100cap packaging	Instructions on how toopen 10 cap packaging	Labeling has been slightlymodified on how to openthe new packaging
Sterility	Sterile EO (10^-6)	Sterile EO (10^-6)	Same
Number ofUses	Single Use, Rx only	Single Use, Rx only	Same
Cap Material	Polypropylene / Polystyrene	Polypropylene /Polystyrene	Same
Shelf Life	3 years	3 years	Same

Table 5.3.1 - Comparison Between Subject and Predicate Devices

{5}------------------------------------------------

TamperEvidenceDesign Feature	Cap separation upon opening	Cap separation uponopening	Same
Biocompatibility Contact /Duration	Indirect blood contact, limitedduration.	Indirect blood contact,limited duration.	Same

Discussion of Technological differences

The device is a tamper evident cap used to cover male luer ports on medical devices and provide evidence of access. The device is marketed as a stand-alone device and packaged in bulk. Both the subject device and the predicate device are comprised of the same resin and are manufactured by the same injection molding / assembly process. There are no changes in the cap from the currently marketed predicate device and the subject device. The update is in the packaging configuration in which the caps are provided. The subject device is provided in a new packaging configuration; a carton containing 10 pouches where each pouch contains 100 TEC units. The predicate device was offered in 10-up trays and single unit blisters. The instructions for use have been updated to provide slight modifications to the instructions on how to open the new packaging.

The safety and effectiveness of the proposed TEC device is adequately supported by the material information, comparison of design characteristics with the predicate device, testing rationale and data summarized within this premarket notification. This testing supports the equivalence of the TEC in bulk packaging to the predicate TEC device and shows that no new questions of safety and effectiveness have been introduced with the packaging modification.

4. Non-Clinical Bench Testing

The new packaging configuration was assessed and the following performance testing was conducted. Packaging design verification and validation were performed to ensure that the subject TEC device in bulk packaging meets the existing functional specifications and demonstrates equivalence to the predicate device packaging. A summary of the testing conducted is presented below. All pre-determined acceptance criteria were met. The data demonstrates that the subject device is substantially equivalent to the predicate device.

Test Name	Test Description
Sterility Assurance 10-6 SAL	Sterilization product adoption for Tamper evident capin Tyvek Pouch (Bulk Bag) conducted per ANSI/AAMI/ISO 11737-2: 2009/(R)2014 Sterilization of medicaldevices – Microbiological methods – Part 2: Tests ofsterility performed in the definition, validation andmaintenance of a sterilization process
Sterilization Product Adoption	AAMI TIR 28 Product adoptionand process equivalencefor ethylene oxide sterilization

Table 5.4.1 – Summary of Performance Testing Conducted on Subject Device

{6}------------------------------------------------

Shelf Life	ASTM F1980-16 Standard Guide forAccelerated Aging of Sterile Barrier Systems for MedicalDevices1
EO/ECH Residuals	ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk managementprocess
Device Function	AAMI ANSI HE75 Human factors engineering—Design ofmedical devicesISO 80369-7 Small-bore connectors for liquids andgases in healthcare applications – Connectors forintravascular or hypodermic applicationsTamper Evident Break Force Test Method (IMI Internal)Simulated Use Test Method (IMI Internal)Weld Strength (IMI Internal)
Packaging Integrity	Standard Test Method for Determining Integrity ofSeals for Flexible Packaging by Visual Inspection (ASTMF 1886)
Transportation	Minimum Peel Strength (ASTM F 88)
Transportation	ISTA 3B TEST Over 150 lbs. Pallet Test,Visual on Seal per ASTM F1886, Dye Penetration perF1929,
Product Validation	Human factors and Usability, limited to assessment ofpackaging use.

Biocompatibility Testinq

The packaging material for the subject and predicate devices have no patient contact. Biocompatibility testing of the TEC device 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.

5. Clinical Bench Testing

Not applicable for this change.

6. Conclusion

Review of the performance test summaries 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 in the bulk bag configuration is substantially equivalent to the predicate Tamper Evident Cap in single and 10up packaging configurations. The difference between the subject and the predicate devices do not raise any new questions of safety or effectiveness.

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).