STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

• K Number: K132276
• Device Name: STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
• Manufacturer: HOSPIRA, INC.
• Date Cleared: 2013-11-12 ( 113 days)
• Product Code: KPE
• Regulation Number: 880.5025

Intended Use

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

Device Description

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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define a simple, sterile glass container for medication admixing, with no mention of any computational or analytical capabilities that would involve AI/ML.

Therapeutic

No
Explanation: The device is an empty glass container for admixing medications, not for therapeutic use itself.

Diagnostic

No
Explanation: The device is described as a "Sterile Empty Glass Container" for "admixing of compatible medications." There is no mention of it being used to identify, monitor, or diagnose a disease or condition. It serves as a container for medication preparation, not for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glass container with a stopper and overseal, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "for admixing of compatible medications." This describes a container used to prepare medications for administration to a patient, not for testing a sample taken from the human body to diagnose a condition.
• Device Description: The description details a sterile container for holding and mixing substances. It doesn't mention any components or functions related to analyzing biological samples.
• Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring specific analytes
  • Providing information for diagnosis, monitoring, or screening

This device is a container used in the preparation of medications, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hospira Sterile Empty Glass Container is intended to be used for admixing compatible medications.

Product codes

KPE

Device Description

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.

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

Performance testing was conducted to ensure the device performs as intended. All testing is acceptable. The product Sterility Assurance Level is 10-6.

Key Metrics

Not Found

Predicate Device(s)

Empty Evacuated Container

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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.

| Submitter

Information
Name	Hospira, Incorporated
Address	D-393, Bldg. H2
275 North Field Drive
Lake Forest, IL. 60046
Phone number	[phone]
Fax number	[phone]
Establishment
Registration
Number	3005579246 (Owner/Operator No. 9063339)
Name of contact
person	Abigail Ferguson
Date prepared	July 15, 2013
Name of device	NOV 12 2013
Trade or
proprietary
name	Sterile Empty Glass Container
Common or
usual name	I.V. Container
Classification
panel	Class II
Regulation	21 CFR 880.5025
Product Code(s)	KPE
Legally marketed
device(s) to
which
equivalence is
claimed	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 has
been moved from Hospira to the stopper vendor, Datwyler.
Additionally, Datwyler has instituted a revised procedure. A
comparison of the wash procedures is provided in Section
11 Device Description.
Device
Description	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.
Intended Use of
the Device	The Hospira Sterile Empty Glass Container is intended to be used
for 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 the

predicate device
Characteristic	Preamendment	Proposed
Indications for
Use	For use in admixing compatible
medications and collection of
blood.	The Hospira Sterile Empty Glass
Container is indicated for
admixing compatible
medications.
Materials of
Construction	Type II Glass Container
28 mm EPDM Rubber Stopper
Aluminum Overseal
Unit Label with integrated Hanger	Same
Summary of non-
clinical tests for
determination of
substantial
equivalence	All materials of construction for
the Sterile Empty Glass
Container meet the applicable
material test requirements of ISO

10993.                      | Same                                                                                                 |
       

| Summary of
Performance
Testing | Performance testing was
conducted to ensure the device
performs as intended. All testing
is acceptable.
The product Sterility Assurance
Level 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 [phone] or [phone] 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'