An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

Device Description

The subject device is an empty two-port style EVA container available in sizes ranging from 50 mL to 4000 mL. The devices are provided sterile and packaged in multi-pack kits. The intended use is to hold an admixture of compatible fluids for administration to the patient. Medication transfer is done using aseptic technique.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification from the FDA regarding the "HCT Empty EVA Container Pack." This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a novel AI/Ml medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not present in this regulatory document. These types of details are typically found in validation studies for AI/ML devices, not premarket notifications for substantially equivalent medical containers.

The document does include details about performance testing, which serves a similar purpose of demonstrating the device meets certain specifications or thresholds. Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing that was conducted to ensure the device's safety and effectiveness, particularly addressing the differences in packaging from the predicate device. While explicit "acceptance criteria" values are not listed in a quantifiable table, the tests implicitly aim to demonstrate performance meeting internal specifications and relevant ISO/ASTM standards. The "Reported Device Performance" is stated by the declaration that the tests were conducted "to confirm that the differences in packaging do not affect the safety or effectiveness of the device."

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Hanger Hold Performance Tests	Meets internal specification	Confirmed to not affect safety or effectiveness
Bag Volume Capacity	Meets internal specification	Confirmed to not affect safety or effectiveness
Resistance to Dropping (per ISO 15747 Section 4.1.3 & A. 4)	Complies with ISO 15747	Confirmed to not affect safety or effectiveness
Administration Port Leak Tests	Meets internal specification	Confirmed to not affect safety or effectiveness
Performance of Injection Site (per ISO 15747 Section 4.1.10 & A. 10)	Complies with ISO 15747	Confirmed to not affect safety or effectiveness
Integrity (Strength of Joints) Testing	Meets internal specification	Confirmed to not affect safety or effectiveness
Particulate Testing (per USP <788>)	Complies with USP <788>	Confirmed to not affect safety or effectiveness
Sterilization (ISO 11137-1:2006, ISO 11137-2:2013)	Meets ISO 11137 standards for radiation sterilization	Complies with relevant standards
Shipping Containers (ASTM D4169)	Complies with ASTM D4169	Complies with relevant standards
Bacterial Endotoxins (ANSI/AAMI ST72:2011)	Complies with ANSI/AAMI ST72	Complies with relevant standards
Gross Leaks in Packaging (ASTM F2096-11)	Complies with ASTM F2096-11	Complies with relevant standards
Integrity of Seals (ASTM F1886/F1886M-16)	Complies with ASTM F1886/F1886M-16	Complies with relevant standards

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only lists the types of tests performed.
Data Provenance: Not specified, but generally implies in-house testing by the manufacturer (Health Care Technologies) or contracted labs. The tests are non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not an AI/ML device requiring clinical expert adjudication for "ground truth." The tests are physical and chemical property evaluations.

4. Adjudication method for the test set:

Not applicable. This is not a clinical study requiring adjudication. Test results are based on objective measurements against specified standards or internal criteria.

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 an empty container, not an AI/ML algorithm.

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

Not applicable. This device is an empty container, not an AI/ML algorithm.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For this device, "ground truth" refers to the objective physical and chemical properties and performance characteristics measured against established industry standards (ISO, ASTM, USP) and the manufacturer's internal specifications.

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth for its establishment.

Summary for the provided document:

The regulatory submission for the HCT Empty EVA Container Pack is a substantial equivalence determination (510(k)) for a medical device container. The document details non-clinical performance testing to demonstrate that the device, despite minor packaging differences, maintains the same safety and effectiveness as its predicate device. This involves physical and chemical tests against industry standards and internal specifications, not clinical or AI/ML-specific validation studies. Therefore, many of the questions asked, which are highly relevant to AI/ML device evaluation, are not applicable to this type of medical device and regulatory submission.

Summary

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August 15, 2019

Health Care Technologies % Dawn Norman Executive Vice President MRC|X, LLC 6075 Poplar Avenue Suite 500 Memphis, Tennessee 38112

Re: K190328

Trade/Device Name: HCT Empty EVA Container Pack Regulation Number: 21 CFR 880.5025 Regulation Name: IV Container Regulatory Class: Class II Product Code: KPE Dated: July 17, 2019 Received: July 18, 2019

Dear Dawn Norman:

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 Alan M. 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)

K190328

Device Name HCT Empty EVA Container Pack

Indications for Use (Describe)

An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

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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510(k) Summary (K190328)

HCT Empty EVA Container Pack July 17, 2019

Company:	Health Care Technologies200 Butterfield DriveAshland, MA 01721
Primary Contact:	Dawn NormanExecutive Vice President, MRC X, LLCPhone: 618.604.3064dawn.norman@mrc-x.com
Company/SecondaryContact:	Adam T. Benson PresidentHealth Care TechnologiesPhone: 508.881.6400adam@healthcaretech.us
Trade Name:	HCT Empty EVA Container Pack
Common Name:	I.V. Container
Classification:	Class II
Regulation Number:	21 CFR 880.5025
Regulation Name:	I.V. Container
Panel:	General Hospital
Product Code:	KPE
Predicate Device:	EVA Empty Solution Container (K030888)

Device Description:

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Indications for Use:

An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

Substantial Equivalence:

	HCT Empty EVA Container Pack	EVA Empty Solution Container(Predicate)	Comments
Indicationsfor Use	An empty container with sterilefluid path used to hold anadmixture of compatible fluids foradministration to a patient.Medication transfer is done usingaseptic technique.	An empty container with sterilefluid path used to hold anadmixture of compatible fluids foradministration to a patient.Medication transfer is done usingaseptic technique.	Identical
Materials	Ethylene-vinyl acetate, Polyvinylchloride, Polycarbonate,Polyisoprene	Ethylene-vinyl acetate, Polyvinylchloride, Polycarbonate,Polyisoprene	Identical
Sizes	50 mL, 100 mL, 250 mL, 1000 mL,2000 mL, 3000 mL, and 4000 mL	50 mL, 100 mL, 250 mL, 1000 mL,2000 mL, 3000 mL, and 4000 mL	Identical
Sterilization	Radiation (Gamma)	Radiation (Gamma)	Samemethod;differentpackaging.

Performance Testing:

There are no differences in manufacturing, sterilization method (gamma), or maximum radiation dose between the HCT Empty EVA Container Pack and the predicate device. The only difference is that the subject packs are packaged and sterilized in different quantities. The following non-clinical tests have been conducted to confirm that the differences in packaging do not affect the safety or effectiveness of the device:

-Hanger Hold Performance Tests (per internal specification)
-Bag Volume Capacity (per internal specification)
Resistance to Dropping (per ISO 15747 Section 4.1.3 & A. 4) -
-Administration Port Leak Tests (per internal specification)
-Performance of Injection Site (per ISO 15747 Section 4.1.10 & A. 10)
-Integrity (Strength of Joints) Testing (per internal specification)
Particulate Testing (per USP <788>) -

In addition, the Device complies with the following standards:

-ISO 11137-1:2006 - Sterilization of Health Care Products -Radiation - Part 1:

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Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-2:2013- Sterilization of Health Care Products –Radiation Part 2: -Establishing the Sterilization Dose
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
ANSI/AAMI ST72:2011, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing
ASTM F2096-11 – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F1886/F1886M-16 – Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

Conclusion:

The subject HCT Empty EVA Container Pack were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the predicate device.

Regulation Number and Section

§ 880.5025 I.V. container.

(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).