MONGOOSE ANGIOGRAPHIC CATHETER

K113819 · Pediacath, Inc. · DQO · Jul 11, 2012 · Cardiovascular

Device Facts

• Record ID: K113819
• Device Name: MONGOOSE ANGIOGRAPHIC CATHETER
• Applicant: Pediacath, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jul 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Mongoose Angiographic Catheter is intended for the delivery of contrast media to selected sites in the vascular system of adult and pediatric patients of all ages in conjunction with routine diagnostic procedures.

Device Story

Single-use, sterile, non-pyrogenic intravascular catheter; used in angiographic procedures to deliver contrast media to vascular sites. Available in 3.3F, 4.0F, and 5F sizes; lengths 35-135 cm; various distal tip shapes (pigtail, JB, JR, JL, MP, Cobra). Features hydrophilic coating, wire-braided reinforcement, and radiopaque barium sulfate for fluoroscopic visualization; optional side holes for contrast dispersion. Includes optional inserter accessory for pigtail configurations. Operated by physicians in clinical settings. Device facilitates diagnostic imaging; aids in visualization of vascular anatomy; supports clinical decision-making through improved contrast delivery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including dimensional and functional performance testing (surface requirements, corrosion resistance, tensile strength, leakage, radiodetectability, and catheter fittings) and biocompatibility testing per ISO 10993.

Technological Characteristics

Single-lumen intravascular catheter; wire-braided reinforcement; hydrophilic coating; radiopaque barium sulfate for visualization. Sizes: 3.3F, 4.0F, 5F. Lengths: 35-135 cm. Sterilization: Ethylene oxide (ISO 11135-1:2007). Single-use, disposable.

Indications for Use

Indicated for delivery of contrast media to vascular sites in adult and pediatric patients of all ages during routine diagnostic procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Softouch Diagnostic Intravascular Catheter (K943739)
• Micrus Courier Microcatheters (K060116)

Submission Summary (Full Text)

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# Section 5. 510(k) Summary

Submission Correspondent Emergo Group, Inc. www.emergogroup.com

# Address

611 West Fifth Street Third Floor Austin, TX 78701

Phone [phone]

Fax [phone]

Contact Caroline Tontini Project Manager [e-mail]

## Submission Sponsor

PediaCath Inc 10000 Cedar Avenue #16 Cleveland, OH 44106 USA 888-691-6161 (Telephone)

Date Prepared 15 December 2011

Trade Name Mongoose Angiographic Catheter

Classification Name Diagnostic Intravascular Catheter

Regulation Number 870.1200

Product Code DQO

JUL 1 1 2012

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Classification Panel Cardiovascular

### Device Class

Class II

#### Predicate Devices

- 1. K943739: Softouch Diagnostic Intravascular Catheter (Merit Medical is currently responsible for marketing the device originally submitted under this premarket notification).
- 2. K060116: Micrus Courier Microcatheters

### Indications for Use

The Mongoose Angiographic Catheter is intended for the delivery of contrast media to selected sites in the vascular system of adult and pediatric patients of all ages in conjunction with routine diagnostic procedures. .

#### Device Description

The Mongoose Angiographic Catheter is a single-use, sterile, non-pyrogenic disposable intravascular catheter for use in angiographic procedures. The Mongoose Angiographic Catheter is intended for adult and pediatric patients of all ages.

The Mongoose Angiographic Catheter is available in 3.3 F, 4.0 F and 5 F sizes. These catheters are available in effective lengths ranging from 35-135 cm and a variety of distal end shapes. The distal tip, soft tube and shaft of Mongoose Angiographic Catheters are manufactured with radiopaque barium sulfate to aid in device visualization under fluoroscopy. Catheters have a hydrophilic coating and are reinforced with wire braiding. Side holes are available to disperse the contrast medium.

An inserter is made available as an accessory to the Mongoose Angiographic Catheters with a pigtail distal configuration. The inserter facilitates insertion of the angiographic catheter into an introducer.

### Technological Characteristics and Substantial Equivalence

The following table compares the Mongoose Angiographic Catheter to the predicate devices with respect to intended use and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.

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| Parameter | PediaCath<br>Mongoose Angiographic<br>Catheter | Merit Medical Performa<br>Pediatric JL/JR and Angiography<br>Pigtail Catheters | Micrus Courier Microcatheters |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To be assigned | K943739 | K060116 |
| Indications for Use | The Mongoose Angiographic<br>Catheter is intended for the<br>delivery of contrast media to<br>selected sites in the vascular<br>system of adult and pediatric<br>patients of all ages in<br>conjunction with routine<br>diagnostic procedures. | Angiographic catheters are<br>designed to be used for<br>delivering radiopaque media to<br>selected sites in the vascular<br>system in conjunction with<br>routine diagnostic procedures.<br>Angiographic catheters with<br>marker bands may also be used<br>for anatomical measurements. | The Micrus Courier<br>microcatheters are intended to<br>assist in the delivery of<br>diagnostic agents, such as<br>contrast media, and therapeutic<br>agents such as occlusion coils,<br>into peripheral, coronary, and<br>neuro vasculature. |
| Regulation Number | 870.1200 | 870.1200 | 870.1200 |
| FDA Product Code | DQO | DQO | DQO |
| Prescription/<br>OTC Use | Prescription | Prescription | Prescription |
| Single-Use/<br>Reusable | Single-Use | Single-Use | Single-Use |
| Dimensions | | | |
| French Sizes (available) | 3.3 F, 4 F, 5 F | 3 F, 4 F, 5 F, 6 F, 7 F | 2.3-2.4 F Proximal OD/<br>1.8-1.9 F Low Profile Distal OD |
| Total Length (cm) | 42 cm – 142 cm | 40 cm – 100 cm | 156 cm |
| Recommended Guide Wire | Varies by French Size and Distal<br>Tip Shape from 0.030" (0.76 mm)<br>to 0.038" (0.97 mm) | Varies by catheter French Size<br>from .021" (0.53 mm) to .038"<br>(0.97 mm) | .014" |
| Physical Characteristics | | | |
| Lumen Construction | Single | Single | Single |
| Coating | Hydrophilic | No | Hydrophilic |
| Parameter | PediaCath<br>Mongoose Angiographic<br>Catheter | Merit Medical Performa<br>Pediatric JL/JR and Angiography<br>Pigtail Catheters | Micrus Courier Microcatheters |
| Reinforcement Material | Wire braid design | Wire braid design | Wire braid design |
| Distal Tip Shapes | - Pigtail<br>- JB<br>- JR<br>- JL<br>- MP<br>- Cobra | - JL<br>- JR<br>- Pigtail | - Straight<br>- 45°<br>- 90°<br>- Custom tip shape accomplished using steam-shaping mandrel supplied with catheter |
| Side Holes | Yes | Yes | No |
| Sterilization and Shelf Life | | | |
| Sterilization Method | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| Non-Pyrogenic | Yes | Yes | Yes |
| Sterile Package | Pouch | Pouch | Pouch |
| Shelf Life (Use By Date) | Three (3) years | Three (3) years (at minimum) | One (1) year |

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#### Summary of Non-Clinical Data Submitted

Performance testing was conducted on the Mongoose Angiographic Catheter to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements, and included dimensional and functional testing. Functional performance testing included surface requirements, corrosion resistance, tensile strength, leakage tests, radiodetectability and tests specific to catheter fittings. The Angiographic Catheter was subjected to biocompatibility testing in accordance with ISO 10993-Additionally the Mongoose Angiographic Catheter was adopted into the existing 1:2009. ethylene oxide sterilization cycle which was validated in accordance with !SO 11135-1:2007.

#### Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the Mongoose Angiographic Catheter and predicate devices do not raise any questions regarding its safety and effectiveness. The Mongoose Angiographic Catheter, as designed and manufactured, therefore is determined to be substantially equivalent to the referenced predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

Pediacath Inc. c/o Ms. Caroline Tontini Emergo Group, Inc. 611 West 5th Street Third Floor Austin, TX 78701

Re: K113819

Trade/Device Name: Mongoose Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: June 21, 2012 Received: June 22, 2012

Dear Mr. Mr. Moran:

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.

JUL 1 1 2012

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Page 2 - Ms. Timothy Moran

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 or any I vith 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 de riot 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 11 you desire speethe ad ready Jor Jor J 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,

M. G. Hilleben

C مر 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): | K113819 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Mongoose Angiographic Catheter

Indications for Use:

The Mongoose Angiographic Catheter is intended for the delivery of contrast media to selected sites in the vascular system of adult and pediatric patients of all ages in conjunction with routine diagnostic procedures.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cmsf. Ytllahan

Division Sian-Off) Division of Cardiovascular Devices Page 1 of 1

510(k) Number