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

K132276 · Hospira, Inc. · KPE · Nov 12, 2013 · General Hospital

Device Facts

• Record ID: K132276
• Device Name: STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
• Applicant: Hospira, Inc.
• Product Code: KPE · General Hospital
• Decision Date: Nov 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2

Indications for Use

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

Device Story

Sterile, non-pyrogenic glass container used for admixing compatible medications; available in 250 mL, 500 mL, and 1000 mL sizes. Components include Type II glass container, 28 mm EPDM rubber stopper, aluminum overseal, and unit label with integrated hanger. Device serves as a sterile vessel for medication preparation; operated by healthcare professionals in clinical settings. Replaces previous version that included blood collection indications; updated to focus solely on medication admixing.

Clinical Evidence

Bench testing only. Performance testing conducted to ensure device functionality; all testing results were acceptable. Sterility Assurance Level (SAL) of 10^-6 confirmed. Materials of construction meet ISO 10993 requirements.

Technological Characteristics

Type II glass container; 28 mm EPDM rubber stopper; aluminum overseal; unit label with integrated hanger. Sizes: 250 mL, 500 mL, 1000 mL. Materials meet ISO 10993 standards. Sterilization: 10^-6 SAL.

Indications for Use

Indicated for admixing compatible medications.

Regulatory Classification

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.

Predicate Devices

• Empty Evacuated Container (Pre-amendment Device)

Submission Summary (Full Text)

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K132276

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

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# 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<br>Information | |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H2<br>275 North Field Drive<br>Lake Forest, IL. 60046 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration<br>Number | 3005579246 (Owner/Operator No. 9063339) |
| Name of contact<br>person | Abigail Ferguson |
| Date prepared | July 15, 2013 |
| Name of device | NOV 12 2013 |
| Trade or<br>proprietary<br>name | Sterile Empty Glass Container |
| Common or<br>usual name | I.V. Container |
| Classification<br>panel | Class II |
| Regulation | 21 CFR 880.5025 |
| Product Code(s) | KPE |
| Legally marketed<br>device(s) to<br>which<br>equivalence is<br>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<br>been moved from Hospira to the stopper vendor, Datwyler.<br>Additionally, Datwyler has instituted a revised procedure. A<br>comparison of the wash procedures is provided in Section<br>11 Device Description. |
| Device<br>Description | The Sterile Empty Glass Container consists of a Type II glass<br>container in 250 mL, 500 mL and 1000 mL sizes, a 28 mm EPDM<br>rubber stopper, an aluminum overseal that secures the stopper to<br>the glass container, and a unit label with an integrated hangar. The<br>device is sterile and non-pyrogenic. |
| Intended Use of<br>the Device | The Hospira Sterile Empty Glass Container is intended to be used<br>for admixing compatible medications |

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

| Summary of the technological characteristics of the device compared to the<br>predicate device | | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Characteristic | Preamendment | Proposed |
| Indications for<br>Use | For use in admixing compatible<br>medications and collection of<br>blood. | The Hospira Sterile Empty Glass<br>Container is indicated for<br>admixing compatible<br>medications. |
| Materials of<br>Construction | Type II Glass Container<br>28 mm EPDM Rubber Stopper<br>Aluminum Overseal<br>Unit Label with integrated Hanger | Same |
| Summary of non-<br>clinical tests for<br>determination of<br>substantial<br>equivalence | All materials of construction for<br>the Sterile Empty Glass<br>Container meet the applicable<br>material test requirements of ISO<br>10993. | Same |
| Summary of<br>Performance<br>Testing | Performance testing was<br>conducted to ensure the device<br>performs as intended. All testing<br>is acceptable.<br>The product Sterility Assurance<br>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.

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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.

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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

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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)

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