(183 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of an empty fluid container, with no mention of AI or ML capabilities.
No.
The device acts as a container for administering fluids, but it does not directly treat or prevent a disease or condition itself.
No
The device is described as an "empty container." Its intended use is to "hold an admixture of compatible fluids for administration to the patient." This function is for delivery of substances, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical container made of EVA material, and the performance studies focus on physical properties and integrity, 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 "hold an admixture of compatible fluids for administration to a patient." This describes a container for delivering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description reinforces the intended use as a container for fluids to be administered.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information. The performance studies focus on the physical integrity and sterility of the container, which are relevant to its function as a delivery system, not a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
KPE
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.
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
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 )
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
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)
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 Technologies
200 Butterfield Drive
Ashland, MA 01721 |
|-------------------------------|-------------------------------------------------------------------------------------------------------|
| Primary Contact: | Dawn Norman
Executive Vice President, MRC X, LLC
Phone: 618.604.3064
dawn.norman@mrc-x.com |
| Company/Secondary
Contact: | Adam T. Benson President
Health Care Technologies
Phone: 508.881.6400
adam@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:
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.
4
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 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| 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. | 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. | Identical |
| Materials | Ethylene-vinyl acetate, Polyvinyl
chloride, Polycarbonate,
Polyisoprene | Ethylene-vinyl acetate, Polyvinyl
chloride, 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) | Same
method;
different
packaging. |
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 ) -
In addition, the Device complies with the following standards:
- -ISO 11137-1:2006 - Sterilization of Health Care Products -Radiation - Part 1:
5
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.