ISECURE SYRINGE CARTRIDGE HOLDER

K063180 · Hospira, Inc. · IQG · Dec 11, 2006 · Physical Medicine

Device Facts

• Record ID: K063180
• Device Name: ISECURE SYRINGE CARTRIDGE HOLDER
• Applicant: Hospira, Inc.
• Product Code: IQG · Physical Medicine
• Decision Date: Dec 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5050
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

Device Story

The iSecure Syringe Cartridge Holder is a preassembled unit combining a syringe cartridge and holder; eliminates need for separate holder. Device operates by attaching a plunger rod to the end of a syringe cartridge to actuate an injection. Used in clinical settings for the withdrawal and administration of sterile materials under aseptic conditions. Operated by physicians. Benefits include simplified assembly and use compared to traditional separate holder/cartridge systems.

Clinical Evidence

Bench testing only.

Technological Characteristics

Preassembled syringe cartridge and holder unit. Plunger rod mechanism for injection actuation. Compatible with empty and prefilled Carpuject cartridges. Mechanical device; no software or energy source.

Indications for Use

Indicated for the withdrawal and administration of sterile materials under aseptic conditions by a physician.

Regulatory Classification

Identification

A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.

Predicate Devices

• Empty Sterile Carpuject® Cartridge Syringe holder Accessory (K820164)

Submission Summary (Full Text)

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KO63180

## 510(k) SUMMARY

| 1. | Submitted by: | Hospira, Inc.<br>D-389, Bldg. H2<br>275 N. Field Drive<br>Lake Forest, IL 60045<br>Attn: Diane Rennpferd | Phone: | [phone]<br>Fax: [phone] | |
|----|--------------------------------------|----------------------------------------------------------------------------------------------------------------|--------|---------------------------------------|--------------|
| | | | | | DEC 1 1 2006 |
| 2. | Date Prepared: | October 18, 2006 | | | |
| 3. | Name/Classification<br>of Device: | Adaptor, holder, syringe<br>Class I, IQG, 21 CFR 890.5050<br>Syringe, Piston<br>Class II, FMF, 21 CFR 880.5860 | | | |
| | 4. Trade Name of<br>Proposed Device: | iSecure Syringe Cartridge Holder | | | |

#### Predicate Devices: 5.

| Device Name | 510(k) Number |
|------------------------------------|---------------|
| Empty Sterile Carpuject® Cartridge | K820164 |
| Syringe holder Accessory | |

### Proposed Device Description: 6.

The proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit thereby eliminating the need for a separate holder. The operating principle remains the same. The modified syringe holder accessory can still be used with both empty and prefilled (not the subject of this 510(k) application) Carpuject® Syringe Cartridges. The proposed name for this modification is the iSecure Syringe Cartridge Holder.

### 7. Statement of Intended Use:

The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

### Summary of Technological Characteristics of New Device Compared to Predicate 8. Devices

The iSecure Syringe Cartridge Holder as described in this submission is substantially equivalent to the predicate Empty Sterile Carpuject Syringe Holder Accessory with respect to the following characteristics:

- . Both devices are intended to be used with either empty or prefilled (not the subject of this submission) Carpuject cartridges
- The technology and operating principles are the same for both devices .

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- The plunger rod for both devices is attached to the end of the syringe cartridge to . actuate an injection.
The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping, curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Ms. Diane Rennpferd Senior Associate, Global Regulatory Affairs Devices Hospira, Incorporated 275 North Field Drive Dept. 389, Bldg. H2 Lake forest, Illinois 60045

DEC 1 1 2006

Re: K063180

Trade/Device Name: iSecure Syringe Cartridge Holder Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, IQG Dated: November 20, 2006 Received: November 21, 2006

Dear Ms. Rennpferd:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Rennpferd

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Sudra y Michael MD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name: iSecure Syringe Cartridge Holder

Indications for Use:

The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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