SYRINGE WITH HANDI-FIL

K082212 · Mallinckrodt Inc., Liebel-Flarsheim Business · DXT · Jan 22, 2009 · Cardiovascular

Device Facts

• Record ID: K082212
• Device Name: SYRINGE WITH HANDI-FIL
• Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
• Product Code: DXT · Cardiovascular
• Decision Date: Jan 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Syringe with Handi-Fil is part of the contrast delivery system which is designed to mject radiopaque contrast media and/or saline into the vascular system for Angrographic or CT procedures as prescribed by qualified healthcare professionals

Device Story

Disposable, single-use syringe with Handi-Fil attachment; used to deliver radiopaque contrast media and/or saline into patient vascular system for enhanced diagnostic imaging. Device functions as component of contrast delivery system; operated by healthcare professionals in clinical settings (Angiographic or CT suites). Syringe connects to delivery system via ISO 594-2 standard luer thread. Provides controlled delivery of contrast/saline to facilitate diagnostic imaging procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Disposable, single-use syringe. Materials: polycarbonate, synthetic rubber, polyethylene, polypropylene. Connectors: ISO 594-2 standard luer thread. Pressure ratings: 150ml (1200 psi dynamic/1300 psi static), 200ml (300 psi dynamic/400 psi static). Sterilization: Sterile (SAL 10^-6).

Indications for Use

Indicated for use in patients undergoing Angiographic or CT procedures requiring the injection of radiopaque contrast media and/or saline into the vascular system. For use by qualified healthcare professionals.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Angiomat Illumena (K963071)

Submission Summary (Full Text)

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# Special 510(k) Summary

# 1. Company Identification

Mallinckrodt Inc , Liebel-Flarsheim Business 2111 East Galbraith Road Cıncınnatı, OH 45237

Establishment Registration 1518293

JAN 2 2 2009

# 2. Contact Person

Dale Moore Quality Manager Phone [phone] Fax [phone] Email dale moore@covidien com

# 3. 510(k) Preparation Date

04/29/2008

#### 4. Device Name

Trade Name Syringe with Handi-Fil Common Name Syringe

### 5. Device Classification

Class II

# 6. Indications for Use

The Syringe with Handi-Fil is part of the contrast delivery system which is designed to mject radiopaque contrast media and/or saline into the vascular system for Angrographic or CT procedures as prescribed by qualified healthcare professionals

# 7. Description of Device

The proposed device is a disposable, single-use syringe, used to deliver radiographic contrast media and/or salme into a patient's vascular system for the purpose of obtaming enhanced diagnostic images The Syringe with Handi-Fil is plastic and consists of the same components as the predicate device The configuration is equivalent to other syringes already marketed by Mallinckrodt The synnge is provided to the customer packaged and sterilized

This submission covers the following devices

150 ml syringe with Handı-Fil 200 ml syringe with Handı-Fil

# 8. Substantial Equivalence

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, 21 CFR & 807, Subpart E A determination of substantial equivalency under this submission is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters No

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statements related to, or in support of, substantial equivalence in this submission shall be construed as an admission against interest under the US Patent Laws or their application by the courts

The predicate device to the Syringe with Handi-Fil is the syringe described in the premarket notification for Angiomat Illumena (K963071)

The Syringe with Handi-Fil maintains the same intended use as the predicate device It is intended to be used for the specific purpose of injecting radiopaque contrast media and/or salme mto a patient's vascular system for Anglographic or CT procedures

| Feature | Syringe with Handi-Fil (New Device) | Angiomat Illumena (Predicate Device (K963071)) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Syringe with Handi-Fil is part of the contrast delivery system which is designed to inject radiopaque contrast media and/or saline into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals | The Angiomat Illumena is designed to inject radiopaque contrast media into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals |
| Syringe Sizes | 150 ml syringe with Handi-Fil<br>200 ml syringe with Handi-Fil | 150 ml syringe with Handi-Fil<br>200 ml syringe with Handi-Fil |
| Sterility | Sterile, Single Use<br>SAL - 10-6 | Sterile, Single Use<br>SAL - 10-6 |
| Pressure Rating | 150 ml syringe 1200 psi - dynamic 1300 psi - static 200 ml syringe 300 psi - dynamic 400 psi - static | 150 ml syringe 1200 psi - dynamic 1300 psi - static 200 ml syringe 300 psi - dynamic 400 psi - static |
| Materials of<br>Constructions | 150 ml Syringe polycarbonate synthetic rubber polyethylene Polypropylene 200 ml syringe polycarbonate polypropylene synthetic rubber polyethylene Handi-Fil Polyethylene | 150 ml Syringe polycarbonate synthetic rubber polyethylene Copolyester 200 ml syringe polycarbonate polypropylene synthetic rubber polyethylene Handi-Fil Polyethylene |
| Connectors | ISO 594-2 standard luer thread | ISO 594-2 standard luer thread |

Below is a table that compares the predicate device to the proposed Device

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that converge at the bottom, and it is positioned slightly off-center within the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mallınckrodt, Inc , Liebel-Flarsheim Business c/o Mr Dale Moore Site Quality Manager 2111 East Galbraith Rd Cıncınnatı, OH 45237

JAN 22 2009

K082212 Re Trade/Device Name Syringe with Handı-Fıl Regulation Number 21 CFR 870 1650 Regulation Name Angiographic Injector and Syringe Regulatory Class Class II Product Code DXT Dated December 19, 2008 Received December 22, 2008

Dear Mr Moore

We have reviewed your Section 510(k) premarket notification of intent to market the device we have revelopment your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10. use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the ensordance 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 1 ou may, mercerore, manel afte a ct include requrements 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 If your device is classified (soc above) this Existing major regulations affecting your device can
may be subject to such additional controls Existing major regulations may be subject to such additional connects - 1 Title 21, Parts 800 to 898 In addition, FDA may be found in the OOD acements concerning your device in the Federal Register

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled or our device complies with other requirements of the Act that IDA has made a decemmation administered by other Federal agencies You must of ally reactal statutes and regulations ancluding, but not limited to registration and listing (21 Comply with an the 110 - 110 - 11 CFR Part 801), good manufacturing practice requirements as set

दिशा दे 10 शिक्षा को 10 शादी कर 10 रही को 2016 में 10 रही को 2016 में 12 रहा कि 2016 में 12 में 12 कि 2016 में 12 मिसी 2019 में 12 मिसी 2019 में 12 मिसी 2019 में 12 मिसी 20

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Brometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 vours.

er R lulumes

Bram D Zuckerman, M D Director Division of Cardiovascular 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 Syringe with Handı-Fil

Indications For Use

The Syringe with Handi-Fil is part of the contrast delivery system which is designed to mject radiopaque contrast media and/or salıne into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals

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

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

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

Concurrence of CDRH, Office of in Vitro Diagnostic Devices (OIVD)

Donna R. Wimer

(Division Sign-Off) sion of Cardiovascular 1 1 avice

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'भारतीय प्रभावित की संस्थान के बाद हो रहा है कि कह कर रहा है कि कह कह कि को कहा कि को किस्तान करने को किसी को मिली को मिली को मिली को मिली को मिली को मिली को मिली को मिली क

510(k) Number_ E6 82Z12_______________________________________________________________________________________________________________________________________________________

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