The BridgePoint Medical BigBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.

Device Description

The BigBoss™ Catheter is a single use, over-the-wire, disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with Pebax exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The device will be available in two models that are differentiated by the distal shaft stiffness. The distal shaft stiffness is specified by the distal grind dimensions of the coiled shaft component. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The BigBoss Catheter is hydrophilic coated to enhance lubricity. A torque device. coaxially positioned over the proximal portion of the BigBoss Catheter, provides a comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the use remains within the torsional operating strength of the catheter shaft.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BigBoss™ Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details in vitro bench testing and in vivo animal testing that confirm the performance characteristics relative to the predicate device. However, it does not explicitly state specific quantitative acceptance criteria (e.g., "tensile strength greater than X N") for each test, nor does it provide exact numerical measured performance values for the BigBoss™ Catheter. Instead, it concludes that "All test results demonstrated the materials, manufacturing processes, and design of the BigBoss™ Catheters met the established performance criteria and will perform as intended."

Therefore, here's a table based on the types of tests conducted and the general performance outcomes described:

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
In Vitro Bench Testing	Performance characteristics comparable to predicate device K081130 and K091841.	Met established performance criteria; performed as intended.
Tensile	Similar tensile strength to predicate.	Met criteria.
Dimensional	Dimensions within specified ranges and comparable to predicate.	Met criteria.
Guidewire Insert & Withdrawal	Smooth insertion and withdrawal of guidewire, comparable to predicate.	Met criteria.
Device Shaft Tip Deflection & Trackability	Appropriate flexibility and ability to track through vasculature, comparable to predicate.	Met criteria.
Kink Resistance	Resistant to kinking under expected use, comparable to predicate.	Met criteria.
Coating	Hydrophilic coating performs as intended (lubricity).	Met criteria.
Torque	Torsional operating strength within limits, comparable to predicate.	Met criteria.
Surface Defects	Absence of significant surface defects.	Met criteria.
Corrosion Resistance	Resistant to corrosion in physiological environment.	Met criteria.
Luer and Hub Tests	Functionality and secure connection of Luer and Hub.	Met criteria.
Radiopacity	Adequate visibility under fluoroscopy, comparable to predicate.	Met criteria.
Packaging	Packaging maintains sterility and device integrity.	Met criteria.
In Vivo Testing (Porcine)	No reported complications, no angiographic evidence of vessel injury or embolism, no abnormal pathologic findings, all animals survived.	No reported complications, all animals survived, no angiographic evidence of vessel injury or downstream embolism, no abnormal pathologic findings.
Biocompatibility Testing	Materials and processes must be non-toxic and non-sensitizing.	Successfully completed; materials and processes are non-toxic and non-sensitizing.
Cytotoxicity	Non-cytotoxic.	Met criteria.
Sensitization	Non-sensitizing.	Met criteria.
Irritation	Non-irritating.	Met criteria.
Acute Systemic Cytotoxicity	Non-acutely systemically cytotoxic.	Met criteria.
Pyrogen	Non-pyrogenic.	Met criteria.
Hemocompatibility	Hemocompatible (e.g., low hemolysis, low complement activation, low thrombogenicity).	Met criteria.
Thrombogenicity	Non-thrombogenic.	Met criteria.

2. Sample Size Used for the Test Set and Data Provenance

In Vitro Bench Testing: The specific sample sizes for each bench test (e.g., number of catheters tested for tensile strength) are not explicitly provided.
In Vivo Testing:
- Sample Size: 6 animals (porcine model). In each animal, BigBoss™ Catheters were inserted into four arteries, totaling 24 insertions.
- Data Provenance: Prospective animal study (porcine model). The country of origin is not specified but is implicitly within the scope of Good Laboratory Practices (GLP) for nonclinical laboratory studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

In Vitro Bench Testing: Not applicable in the context of expert ground truth as these are mechanical/physical property tests.
In Vivo Testing: The assessment involved:
- Angiographic evaluation.
- Histology and pathology.
- Hematology and serum chemistry.
- Gross necropsy.
- The number and specific qualifications of the experts (e.g., veterinarians, pathologists) conducting these evaluations are not specified in the provided text.

4. Adjudication Method for the Test Set

In Vitro Bench Testing: Not applicable. Results are typically quantitative measurements against defined specifications.
In Vivo Testing: The text does not describe a specific adjudication method like "2+1" or "3+1" for interpreting findings. The assessments (angiography, histology, pathology, etc.) would typically be performed by relevant specialists, but a formal adjudication process involving multiple independent reviewers for discordant findings is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human reader performance (with and without AI assistance) and is not relevant to a medical device like a catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. The BigBoss™ Catheter is a physical medical device, not a software algorithm, so this type of study is not applicable.

7. The Type of Ground Truth Used

In Vitro Bench Testing: Ground truth is established by engineering specifications and comparative data against the predicate device for physical and mechanical properties.
In Vivo Testing: Ground truth was established through a combination of:
- Angiographic evaluation: Visual assessment of vessel status.
- Histology and pathology: Microscopic and macroscopic examination of tissues for injury or abnormalities.
- Hematology and serum chemistry: Lab tests for physiological impacts.
- Gross necropsy: Post-mortem examination for overall health and specific organ assessment.
- This is a form of empirical observation and scientific measurement in an animal model.
Biocompatibility Testing: Ground truth is established by validated laboratory assay results (e.g., ISO and ASTM standards) that demonstrate the biological safety of the materials.

8. The Sample Size for the Training Set

Not applicable. The BigBoss™ Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See point 8).

Summary

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K113589

BridgePoint Medical BigBoss Catheter Special 510(k)

JAN - 4 2012

9. 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:

Applicant Information:

Date Prepared:	December 1, 2011
Name:Address:	BridgePoint Medical13355 10th Ave N, #110Plymouth, MN 55441Phone: 763-225-8500Fax: 763-225-8718

Contact Person: .	Jill Munsinger
Phone Number:	office: 763-225-8510 / cell: 651-270-0572
E-mail:	jmunsinger@bridgepointmedical.com

Device Information:

Classification:	Class II Percutaneous Catheter
Trade Name:	BigBossTM Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter

Predicate Devices:

The BridgePoint Medical BigBoss™ Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device:

K081130 and K091841 - CrossBoss™ Catheter

Device Description:

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comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the use remains within the torsional operating strength of the catheter shaft.

Intended Use:

Comparison to Predicate Device(s):

The BigBoss™ Catheters are substantially equivalent to the CrossBoss™ Catheter. K081130 and K091841 in that they are both designed to access discrete regions of the peripheral vasculature:

The BigBoss™ Catheters are constructed of similar materials as the CrossBoss Catheter. Modifications were made to the coiled shaft dimensions. The CrossBoss™ Catheters and BigBoss™ Catheters are manufactured using similar processes and components and have similar physical attributes (torque fatigue, trackability, tensile, and radiopacity, etc.).

Performance Data:

The BigBoss™ Catheters have been evaluated using the following in vitro bench testing to confirm the performance characteristics as compared to the predicate device:

. Tensile
. Dimensional
Guidewire Insert & Withdrawal .
Device Shaft Tip Deflection & Trackability ●
Kink Resistance .
. Coating
. Torque
. Surface Defects
Corrosion Resistance .
Luer and Hub Tests, .
. Radiopacity, and
. Packaging

In vivo testing was also completed in accordance with 21 CFR Part 58, "Good Laboratory Practices for Nonclinical Laboratory Studies." The functional performance and safety of the BigBoss™ Catheters were evaluated in a porcine animal model. BigBoss™ Catheters were inserted into four arteries in each of six animals used for the evaluation. The vessels were evaluated angiographically followed by histology and pathology. Hematology and serum chemistry along with gross necropsy were also used for evaluations. There were no reported complications during each treatment. All six-

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animals survived the in-life period with no angiographic evidence of vessel injury or downstream embolism and no abnormal pathologic findings.

Biocompatibility testing was successfully completed and demonstrates the materials and processes used in the design and manufacture of the device are non-toxic and nonsensitizing to biological tissues consistent with the intended use. The following Biocompatibility tests were completed:

. Cytotoxicity L929 MEM - ISO
Kligman Sensitization (Maximization) ISO .
Irritation- Intracutaneous Injection ISO .
Acute Systemic Cytotoxicity ISO .
Pyrogen ISO ●
. Hemocompatibility - (Direct and Indirect) Hemolysis - ASTM
. In Vitro Hemocompatibility Assay - ISO
. Complement Activation (Direct) Assay - ISO
. In Vivo Thrombogenicity Assay - ISO, and
Unactivated Partial Thromboplastin Time ISO ●

All test results demonstrated the materials, manufacturing processes, and design of the BigBoss™ Catheters met the established performance criteria and will perform as intended.

Summary:

Based upon the intended use and descriptive information provided in this pre-market notification, the BridgePoint Medical BigBoss™ Catheters have been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

BridgePoint Medical, Inc. c/o Jill Munsinger 13355 10th Ave N. #110 Plymouth, MN 55441

Re: K113589

Trade/Device Name: BigBoss™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 01, 2011 Received: December 05, 2011

Dear Ms. Munsinger:

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.

JAN - 4 2012

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Page 2 - Ms. Jill Munsinger

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 (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. A. Willeben

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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8. INDICATIONS FOR USE STATEMENT

510(k) Number: (TBA)

BridgePoint Medical BigBoss™ Catheter Device Name:

Indications For Use:

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 Device Evaluation (ODE)

WAZilleh

mr. 1811 Cardrovascular Davices

510(k) Number K113584

Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).