The Sterile Empty Glass Container consists of a Type II glass container in 250 mL, 500 mL and 1000 mL sizes, a 28 mm EPDM rubber stopper, an aluminum overseal that secures the stopper to the glass container, and a unit label with an integrated hangar. The device is sterile and non-pyrogenic.

AI/ML Overview

The provided text describes a traditional 510(k) submission for a Sterile Empty Glass Container. This device is a container for admixing compatible medications and is not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone performance, training set details, ground truth establishment for training data, and expert qualifications for ground truth) are not applicable to this submission.

The acceptance criteria and the study proving the device meets them are focused on the physical and functional aspects of the container, as well as its sterility and material compatibility.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use	For admixing compatible medications.	The device's intended use is "admixing compatible medications". The previous indication for "collection of blood" has been removed.
Materials of Construction	Must meet applicable material test requirements of ISO 10993.	All materials of construction for the Sterile Empty Glass Container meet the applicable material test requirements of ISO 10993.
Functionality	The device must perform as intended.	Performance testing was conducted and found acceptable, ensuring the device performs as intended.
Sterility Assurance Level (SAL)	The product SAL must be acceptable for a sterile device.	The product Sterility Assurance Level is 10-6.
Non-pyrogenic	The device must be non-pyrogenic.	The device is non-pyrogenic.
Manufacture/Washing Procedure	Changes to the washing procedure for the EPDM rubber stopper (moved to vendor, revised procedure) must not negatively impact performance.	A comparison of the wash procedures was provided in Section 11 Device Description, implying the new procedure is acceptable and does not compromise the device. (Specific performance impact of this change is not detailed in the summary, but implied acceptable by overall conclusion).

Study Details (as inferable for a non-AI/ML device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated in the provided summary. For a physical device, this would typically involve a certain number of units subjected to various physical, chemical, and biological tests.
- Data Provenance: Not specified, but generally, testing for such medical devices occurs under controlled laboratory conditions, often in the manufacturing country or specialized testing facilities. The tests are prospective, involving new device units.
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)
- Not Applicable. This is a hardware medical device (empty glass container) and does not involve AI/ML or expert interpretation of diagnostic output. Ground truth is established through standardized physical, chemical, and biological testing protocols (e.g., meeting ISO 10993 for biocompatibility, sterility testing, pyrogenicity testing, package integrity).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI/ML ground truth establishment involving human interpretation. For this device, "adjudication" would refer to expert review and approval of test results against predefined specifications, a standard Quality Assurance/Regulatory Affairs process rather than an adjudication method for ground truth.
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
- No. This is a hardware medical device, not an AI-powered device. Therefore, no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware medical device, not an algorithm. Therefore, no "standalone" algorithm performance study was conducted.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Defined Standards and Specifications: The "ground truth" for this device's performance is established by adherence to recognized international standards (e.g., ISO 10993 for biocompatibility) and internal specifications for physical properties, sterility (SAL of 10-6), and non-pyrogenicity. It's objective, measurable data rather than human interpretation or pathology.
The sample size for the training set
- Not Applicable. This is a hardware medical device, not an AI/ML system requiring a training set.
How the ground truth for the training set was established
- Not Applicable. This device does not have an AI/ML component; therefore, there is no training set or ground truth associated with one.

Summary

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

K132276

Sterile Empty Glass Container Traditional 510(k) Date: July 15, 2013

ﻧ

CONFIDENTIAL

510(k) Summary Section 5

The following is a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 for the Sterile Empty Glass Container.

SubmitterInformation
Name	Hospira, Incorporated
Address	D-393, Bldg. H2275 North Field DriveLake Forest, IL. 60046
Phone number	(224) 212-6162
Fax number	(224) 212-5401
EstablishmentRegistrationNumber	3005579246 (Owner/Operator No. 9063339)
Name of contactperson	Abigail Ferguson
Date prepared	July 15, 2013
Name of device	NOV 12 2013
Trade orproprietaryname	Sterile Empty Glass Container
Common orusual name	I.V. Container
Classificationpanel	Class II
Regulation	21 CFR 880.5025
Product Code(s)	KPE
Legally marketeddevice(s) towhichequivalence isclaimed	Empty Evacuated Container (Pre-amendment Device)
	The changes addressed in this submission include:
	The name of the product will be changed from "Empty Evacuated Container" to "Sterile Empty Glass Container". The current Empty Evacuated Container label indicates the product is to be used in admixing compatible medications as well as the use for the collection of blood. The proposed Sterile Empty Glass Container will only be indicated for admixing of compatible medications. The product's use for the collection of blood will be removed from the label. A new Instructions for Use document has been created and will be included as an enclosure with the product.
	• The washing procedure for the EPDM rubber stopper hasbeen moved from Hospira to the stopper vendor, Datwyler.Additionally, Datwyler has instituted a revised procedure. Acomparison of the wash procedures is provided in Section11 Device Description.
DeviceDescription	The Sterile Empty Glass Container consists of a Type II glasscontainer in 250 mL, 500 mL and 1000 mL sizes, a 28 mm EPDMrubber stopper, an aluminum overseal that secures the stopper tothe glass container, and a unit label with an integrated hangar. Thedevice is sterile and non-pyrogenic.
Intended Use ofthe Device	The Hospira Sterile Empty Glass Container is intended to be usedfor admixing compatible medications

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

Sterile Empty Glass Container Traditional 510(k) Date: July 15, 2013

Summary of the technological characteristics of the device compared to thepredicate device
Characteristic	Preamendment	Proposed
Indications forUse	For use in admixing compatiblemedications and collection ofblood.	The Hospira Sterile Empty GlassContainer is indicated foradmixing compatiblemedications.
Materials ofConstruction	Type II Glass Container28 mm EPDM Rubber StopperAluminum OversealUnit Label with integrated Hanger	Same
Summary of non-clinical tests fordetermination ofsubstantialequivalence	All materials of construction forthe Sterile Empty GlassContainer meet the applicablematerial test requirements of ISO10993.	Same
Summary ofPerformanceTesting	Performance testing wasconducted to ensure the deviceperforms as intended. All testingis acceptable.The product Sterility AssuranceLevel is 10-6.	Same

Conclusion

The Sterile Empty Glass Container meets the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the Empty Evacuated Container, which is a preamendment device.

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 12, 2013

Hospira, Incorporated C/O Ms. Abigail Ferguson Associate, Regulatory Affairs 275 Field Drive LAKE FOREST ILLINOIS 60045

Re: K132276

Trade/Device Name: Sterile Empty Glass Container Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: October 11, 2013 Received: October 16, 2013

Dear Ms. Ferguson:

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. 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.

{3}------------------------------------------------

Page 2 - Ms. Ferguson

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary FDAnner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, Genera! Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number: K132276

Device Name: Sterile Empty Glass Container

Indications for Use: The Hospira Sterile Empty Glass Container is indicated for admixing of compatible medications.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

.. . .

Digitally signed by Richard C. Chapman Date: 2013.11.20 17:30:14 -05'00'

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).