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.

AI/ML Overview

The provided text describes a 510(k) summary for the "Mongoose Angiographic Catheter," which is a diagnostic intravascular catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study proving device performance are not applicable based on the provided text. The document details non-clinical (bench) testing to establish substantial equivalence.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner as would be typical for a clinical performance study. Instead, the "acceptance criteria" for this 510(k) submission are that the device demonstrates substantial equivalence to existing predicate devices by having the same intended use and similar technological characteristics, and importantly, not raising new questions of safety and effectiveness.

The "reported device performance" is a summary of non-clinical testing confirming that the Mongoose Angiographic Catheter meets established standards and internal requirements, thereby demonstrating it is as safe and effective as its predicates.

Parameter	Acceptance Criteria (Implied by 510(k) Submission)	Reported Device Performance (Summary of Non-Clinical Data)
Safety & Effectiveness	No new questions of safety and effectiveness compared to predicate devices.	Demonstrated through performance testing (dimensional, functional, biocompatibility) and validated sterilization.
Intended Use	Same intended use as predicate devices.	"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." (Matches predicates)
Technological Characteristics	Similar technological characteristics to predicate devices, or differences that do not raise new questions of safety/effectiveness.	Detailed comparison table showing similarities in dimensions, physical characteristics (lumen, coating, reinforcement, tip shapes, side holes), sterilization, and shelf life to predicate devices.
Dimensional Requirements	Meet established international standards and in-house requirements.	Dimensional testing conducted.
Functional Requirements	Meet established international standards and in-house requirements (e.g., surface, corrosion, tensile strength, leakage, radiodetectability, catheter fittings).	Functional performance testing conducted.
Biocompatibility	Meet ISO 10993 standards.	Biocompatibility testing conducted in accordance with ISO 10993-1:2009.
Sterilization	Ethylene Oxide sterilization validated according to ISO 11135-1:2007.	Adopted into existing ethylene oxide sterilization cycle, validated per ISO 11135-1:2007.

The study that "proves" the device meets the acceptance criteria is the sum of non-clinical performance testing and the demonstration of substantial equivalence to predicate devices.

Information Not Applicable/Provided for a Clinical Study

Based on the provided text, the following information, typically found in a clinical study report proving device performance, is not applicable or not provided as this submission is for a 510(k) based on substantial equivalence through non-clinical testing.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as no clinical test set is described. The "test set" comprised physical units of the device subjected to bench testing. The provenance of that bench testing (where it was done) is implied to be by the manufacturer or their contracted labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no clinical test set requiring expert ground truthing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an angiographic catheter, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" would be objective measurements and adherence to specified engineering tolerances and international standards. For example, tensile strength measured against a predefined acceptable range, or sterility confirmed by standard microbiological methods.
The sample size for the training set:
- Not applicable. There is no algorithm or AI component requiring a training set mentioned.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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 (512) 327-9997

Fax (512) 327-9998

Contact Caroline Tontini Project Manager project.management@emergogroup.com

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).
1. K060116: Micrus Courier Microcatheters

Indications for Use

Device Description

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	PediaCathMongoose AngiographicCatheter	Merit Medical PerformaPediatric JL/JR and AngiographyPigtail Catheters	Micrus Courier Microcatheters
510(k) Number	To be assigned	K943739	K060116
Indications for Use	The Mongoose AngiographicCatheter is intended for thedelivery of contrast media toselected sites in the vascularsystem of adult and pediatricpatients of all ages inconjunction with routinediagnostic procedures.	Angiographic catheters aredesigned to be used fordelivering radiopaque media toselected sites in the vascularsystem in conjunction withroutine diagnostic procedures.Angiographic catheters withmarker bands may also be usedfor anatomical measurements.	The Micrus Couriermicrocatheters are intended toassist in the delivery ofdiagnostic agents, such ascontrast media, and therapeuticagents such as occlusion coils,into peripheral, coronary, andneuro vasculature.
Regulation Number	870.1200	870.1200	870.1200
FDA Product Code	DQO	DQO	DQO
Prescription/OTC Use	Prescription	Prescription	Prescription
Single-Use/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/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 DistalTip Shape from 0.030" (0.76 mm)to 0.038" (0.97 mm)	Varies by catheter French Sizefrom .021" (0.53 mm) to .038"(0.97 mm)	.014"
Physical Characteristics
Lumen Construction	Single	Single	Single
Coating	Hydrophilic	No	Hydrophilic
Parameter	PediaCathMongoose AngiographicCatheter	Merit Medical PerformaPediatric JL/JR and AngiographyPigtail Catheters	Micrus Courier Microcatheters
Reinforcement Material	Wire braid design	Wire braid design	Wire braid design
Distal Tip Shapes	- Pigtail- JB- JR- JL- MP- Cobra	- JL- JR- Pigtail	- Straight- 45°- 90°- 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

mparison Table Davico C-1 oblo

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The state of the state

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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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).