Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and mechanical performance of a catheter set, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is intended to aspirate venous air emboli, which is a therapeutic intervention aimed at treating a medical condition.

Diagnostic

No

Explanation: The device description and intended use indicate it is an aspiration set designed to remove venous air emboli, which is a therapeutic rather than a diagnostic function. While it uses fluoroscopy, this is for guidance during the interventional procedure, not for diagnostic imaging.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple physical components (catheter, wire guide, needle, dilator, syringe, stopcock, scalpel) and describes their materials and manufacturing. Performance studies also focus on the physical properties and function of these hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "aspirate venous air emboli." This is a therapeutic procedure performed directly on the patient's body to remove a physical obstruction (air).
Device Description: The device components (catheter, wire guide, needle, etc.) are all designed for physical intervention within the venous system.
Lack of In Vitro Activity: An IVD is designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis on specimens.
Performance Studies: The performance studies focus on the physical properties and functionality of the device within a biological system (animal model testing), not on the accuracy or reliability of diagnostic measurements from specimens.

The Bunegin-Albin Air Aspiration Set is a therapeutic medical device used for a procedure within the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.

Product codes

DXE

Device Description

The Bunegin-Albin Air Aspiration Set is comprised of an air aspiration catheter, wire guide, entry access needle, dilator, syringe, stopcock, and scalpel. The air aspiration catheter is manufactured from radiopaque extruded polyethylene tubing and is designed with a pre-molded winged fitting. The catheter is 5.8 French in size with an endhole diameter of 0.035 inches. The wire guide is manufactured from stainless steel coils, a safety wire, and a mandril wire. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. The set also includes a 12 cc syringe, a low pressure three way stopcock, and a scalpel. The Bunegin-Albin Air Aspiration Set is sterilized by ethylene oxide and intended for one-time use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Study Type: Performance testing and Animal testing.
Performance testing:

Catheter Shaft Tensile (Zero time): Peak load greater than or equal to 15 N in accordance with BS EN ISO 10555-1. Acceptance criterion met.
Catheter Sideport Tensile (Zero time): Peak load greater than or equal to 15 N in accordance with BS EN ISO 10555-1. Acceptance criterion met.
Catheter Hub-to-Shaft Tensile (Zero time): Peak load greater than or equal to 15 N in accordance with BS EN ISO 10555-1. Acceptance criterion met.
Catheter Air Aspiration (Zero time): No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. Acceptance criterion met.
Catheter Liquid Leakage (Zero time): No part of the catheter shall leak liquid when tested in accordance with Annex C of BS EN ISO 10555-1. Acceptance criterion met.
Catheter Kink Length (Zero time): Catheter shall not kink when tested in accordance with Annex B of BS EN 13868. Acceptance criterion met.
Wire Guide Corrosion (Zero time): No evidence of corrosion that could affect functional performance when tested in accordance with Annex B of BS EN ISO 11070. Acceptance criterion met.
Wire Guide Flex (Zero time): No signs of defects or damage, including flaking or material loss when tested in accordance with Annex G of BS EN ISO 11070. Acceptance criterion met.
Wire Guide Fracture (Zero time): Shall not fracture when wound around an approximate former in accordance with Annex F of BS EN ISO 11070. Acceptance criterion met.
Wire Guide Tensile (Zero time): Peak load to failure greater than or equal to 10 N in accordance with Annex H of BS EN ISO 11070. Acceptance criterion met.
Wire Guide Rotations to Failure Testing (Zero time): Number of rotations to failure characterized.
Wire Guide Tip Deflection (Zero time): Tip deflection side loads characterized.
Dilator Shaft Tensile (Zero time): Peak load greater than or equal to 15 N in accordance with BS EN ISO 11070. Acceptance criterion met.
Dilator Hub-to-Shaft Tensile (Zero time): Peak load greater than or equal to 15 N in accordance with BS EN ISO 11070. Acceptance criterion met.
Dimensional, Compatibility, and Surface Analysis (Zero-time): Measurements and dimensional requirements within listed tolerances. Components compatible. External surface free of extraneous matter. Acceptance criterion met.
Particulate Testing (Zero-time): Device met USP 788 thresholds for small volume injections. Acceptance criterion met.
Resistance to Overriding Testing (Zero-time): Conducted in accordance with ISO 594-2. Acceptance criterion met.
Separation Force Testing (Zero-time): Conducted in accordance with ISO 594-2. Acceptance criterion met.
Unscrewing Torque Testing (Zero-time): Conducted in accordance with ISO 594-2. Acceptance criterion met.
Catheter Shaft Tensile (3-year accelerated aging): Peak load greater than or equal to 15 N in accordance with BS EN ISO 1055-1. Acceptance criterion met.
Catheter Sideport Tensile (3-year accelerated aging): Peak load greater than or equal to 15 N in accordance with BS EN ISO 10555-1. Acceptance criterion met.
Catheter Hub-to-Shaft Tensile (3-year accelerated aging): Peak load greater than or equal to 15 N in accordance with BS EN ISO 10555-1. Acceptance criterion met.
Catheter Air Aspiration (3-year accelerated aging): No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. Acceptance criterion met.
Catheter Liquid Leakage (3-year accelerated aging): No part of the catheter shall leak liquid when tested in accordance with Annex C of BS EN ISO 10555-1. Acceptance criterion met.
Catheter Kink Length (3-year accelerated aging): Catheter shall not kink (based on a 20 mm kink radius) when tested in accordance with Annex B of BS EN 13868. Acceptance criterion met.
Dilator Shaft Tensile (3-year accelerated aging): Peak load greater than or equal to 15 N in accordance with BS EN ISO 11070. Acceptance criterion met.
Dilator Hub-to-Shaft Tensile (3-year accelerated aging): Peak load greater than or equal to 15 N in accordance with BS EN ISO 11070. Acceptance criterion met.

Animal Testing:

Acute performance of aspiration catheter in animal model: Catheter received a grading of "adequate" or "good" in each of the performance parameters and was able to remove air from the target sites. Acceptance criterion met.

Biocompatibility:

Testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (hemolysis, complement activation, and in vivo thrombogenicity) were performed per ISO 10993-1 and FDA guidance. Acceptance criterion met.

Key Results: All acceptance criteria were met. The results support the conclusion that the device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K130536

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.

Public Health Service

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

July 27, 2017

Cook Incorporated Johnathan Liu Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404

Re: K163031

Trade/Device Name: Bunegin-Albin Air Aspiration Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 24, 2017 Received: June 27, 2017

Dear Johnathan Liu:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Kenneth J. Cavanaugh -S

for

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Number (if known)

K163031

Device Name Bunegin-Albin Air Aspiration Set

Indications for Use (Describe)

The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The logo is simple and clean, and the red and white color scheme is eye-catching.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX OMINGTON, IN 474

2.0 510(k) SUMMARY

K163031 Bunegin-Albin Air Aspiration Set 21 CFR §870.5150 Date Prepared: July 25, 2017

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated
750 Daniels Way
Bloomington, IN 47404
Contact:	Johnathan Liu
Email:	regsubmissions@cookmedical.com
Contact Phone Number:	(812) 335-3575 x104509
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Bunegin-Albin Air Aspiration Set
Common Name:	Catheter, Embolectomy
Classification Name:	Embolectomy Catheter
Regulation:	21 CFR §870.5150
Product Code:	DXE
Device Class:	II
Classification Panel:	Cardiovascular

Predicate Device:

The Bunegin-Albin Air Aspiration Set is substantially equivalent to the following device: the Export Advance" Aspiration Catheter (K130536, Medtronic Inc.) cleared on July 16, 2013.

Device Description:

The Bunegin-Albin Air Aspiration Set is comprised of an air aspiration catheter, wire guide, entry access needle, dilator, syringe, stopcock, and scalpel. The air aspiration catheter is manufactured from radiopaque extruded polyethylene tubing and is designed

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with a pre-molded winged fitting. The catheter is 5.8 French in size with an endhole diameter of 0.035 inches. The wire guide is manufactured from stainless steel coils, a safety wire, and a mandril wire. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. The set also includes a 12 cc syringe, a low pressure three way stopcock, and a scalpel. The Bunegin-Albin Air Aspiration Set is sterilized by ethylene oxide and intended for onetime use.

Indications for Use:

The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.

Comparison to Predicate Device:

The Bunegin-Albin Air Aspiration Set and the predicate device, the Export Advance™ Aspiration Catheter (K130536), are substantially equivalent in that these devices are similar in intended use and principle of operation. Additionally, the subject device has similar indications for use, materials, and dimensions as the predicate device. The differences between the subject device and the predicate device, including the materials, dimensions, and indications for use do not raise any new issues of safety and effectiveness. The substantial equivalence comparison of the subject device to the predicate is provided in the table below.

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	PREDICATE DEVICE	SUBJECT DEVICE
	Export AdvanceTM Aspiration Catheter	Bunegin-Albin Air Aspiration Set
Manufacturer	Medtronic Incorporated	Cook Incorporated
510(k)	K130536	Subject of this submission
Regulation	21 CFR §870.5150	Identical
Product Code	DXE	Identical
Regulation
Description	Catheter, Embolectomy	Identical
Classification	II	Identical
Indications for
Use	The Export AdvanceTM Aspiration Catheter
is indicated for:

Removal/aspiration of embolic
material (thrombus/debris) from
vessels of the arterial system, and
To sub selectively infuse/deliver
diagnostics or therapeutics agents
with or without vessel occlusion. | To aspirate venous air emboli. |
| Principle of
Operation | Manually aspirate emboli with syringe | Identical |
| Visualization
Guidance | Fluoroscopy | Identical |
| Method of Use | Single use | Identical |
| Catheter
Placement | Percutaneously using Seldinger technique
under fluoroscopy | Identical |
| Catheter
Material | Polytetrafluoroethylene (PTFE) | Radiopaque extruded polyethylene |
| Catheter Outer
Diameter | 6 French | 5.8 French |
| Catheter
Length | 140 cm | 24, 60 cm |
| Catheter Distal
End | Open | Open with 6 side ports |
| Catheter
Lumens | Dual lumen | Single lumen |
| Wire Guide
Compatibility | 0.014 inch, 0.035 inch | 0.035 inch |
| Accessory Set
Components | 2 Syringes
1 Wire Guide
1 Filter Cup | 1 Syringe
1 Wire Guide
1 Needle
1 Dilator
1 Stopcock
1 Scalpel |
| Sterilization
Method | EtO | Identical |
| Sterility
Assurance
Level | 10-6 | Identical |
| Packaging | Tyvek pouch | Tyvek Peel Pouch |

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Technological Characteristics:

The subject Bunegin-Albin Air Aspiration Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:

Performance

Catheter Shaft Tensile (Zero time) The peak load of catheter shaft section shall be . greater than or equal to 15 N in accordance with BS EN ISO 10555-1. The acceptance criterion was met.
. Catheter Sideport Tensile (Zero time) – The peak load of catheter sideport section shall be greater than or equal to 15 N in accordance with BS EN ISO 10555-1. The acceptance criterion was met.
Catheter Hub-to-Shaft Tensile (Zero time) The peak load of catheter hub-to-shaft . section shall be greater than or equal to 15 N in accordance with BS EN ISO 10555-1. The acceptance criterion was met.
Catheter Air Aspiration (Zero time) No air shall enter the hub when tested in . accordance with Annex D of BS EN ISO 10555-1. The acceptance criterion was met.
Catheter Liquid Leakage (Zero time) No part of the catheter shall leak liquid when . tested in accordance with Annex C of BS EN ISO 10555-1. The acceptance criterion was met.
. Catheter Kink Length (Zero time) - Catheter shall not kink when tested in accordance with Annex B of BS EN 13868. The acceptance criterion was met.
. Wire Guide Corrosion (Zero time) – Wire guide shall show no evidence of corrosion that could affect the functional performance when tested in accordance with Annex B of BS EN ISO 11070. The acceptance criterion was met.
. Wire Guide Flex (Zero time) – Wire guide shall show no signs of defects or damage, including flaking or material loss when tested in accordance with Annex G of BS EN ISO 11070. The acceptance criterion was met.
Wire Guide Fracture (Zero time) Wire guide shall not fracture when wound around . an approximate former in accordance with Annex F of BS EN ISO 11070. The acceptance criterion was met.
. Wire Guide Tensile (Zero time) – The peak load to failure shall be greater than or equal to 10 N in accordance with Annex H of BS EN ISO 11070. The acceptance criterion was met.
Wire Guide Rotations to Failure Testing (Zero time) The number of rotations to . failure shall be characterized for the wire guide.

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Wire Guide Tip Deflection (Zero time) The tip deflection side loads will be . characterized for the wire guide.
. Dilator Shaft Tensile (Zero time) – the peak load of dilator shaft section shall be greater than or equal to 15 N in accordance with BS EN ISO 11070. The acceptance criterion was met.
Dilator Hub-to-Shaft Tensile (Zero time) The peak load of dilator hub-to-shaft . section shall be greater than or equal to 15 N in accordance with BS EN ISO 11070. The acceptance criterion was met.
. Dimensional, Compatibility, and Surface Analysis (Zero-time) - All measurements and dimensional requirements shall be within the listed tolerances. The set components shall be compatible for each test specimen. The external surface of the effective length of the catheter, dilator, and wire guide shall appear free of extraneous matter for each test specimen. The acceptance criterion was met.
Particulate Testing (Zero-time) Each device must meet the USP 788 thresholds for . small volume injections. The acceptance criterion was met.
. Resistance to Overriding Testing (Zero-time) – Testing was conducted in accordance with ISO 594-2. The acceptance criterion was met.
. Separation Force Testing (Zero-time) - Testing was conducted in accordance with ISO 594-2. The acceptance criterion was met.
Unscrewing Torque Testing (Zero-time) Testing was conducted in accordance with . ISO 594-2. The acceptance criterion was met.
Catheter Shaft Tensile (3-year accelerated aging) The peak load of catheter shaft . section shall be greater than or equal to 15 N in accordance with BS EN ISO 1055-1. The acceptance criterion was met.
Catheter Sideport Tensile (3-year accelerated aging) The peak load of catheter . sideport section shall be greater than or equal to 15 N in accordance with BS EN ISO 10555-1. The acceptance criterion was met.
. Catheter Hub-to-Shaft Tensile (3-year accelerated aging) - The peak load of catheter hub-to-shaft section shall be greater than or equal to 15 N in accordance with BS EN ISO 10555-1. The acceptance criterion was met.
Catheter Air Aspiration (3-year accelerated aging) No air shall enter the hub when . tested in accordance with Annex D of BS EN ISO 10555-1. The acceptance criterion was met.

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. Catheter Liquid Leakage (3-year accelerated aging) - No part of the catheter shall leak liquid when tested in accordance with Annex C of BS EN ISO 10555-1. The acceptance criterion was met.
. Catheter Kink Length (3-year accelerated aging) - Catheter shall not kink (based on a 20 mm kink radius) when tested in accordance with Annex B of BS EN 13868. The acceptance criterion was met.
Dilator Shaft Tensile (3-year accelerated aging) The peak load of dilator shaft . section shall be greater than or equal to 15 N in accordance with BS EN ISO 11070. The acceptance criterion was met.
Dilator Hub-to-Shaft Tensile (3-year accelerated aging) The peak load of dilator . hub-to-shaft section shall be greater than or equal to 15 N in accordance with BS EN ISO 11070. The acceptance criterion was met.

Animal Testing

Acute performance of aspiration catheter in animal model Catheter shall receive a grading of "adequate" or "good" in each of the performance parameters, and it shall be able to remove air from the target sites. The acceptance criterion was met.

Biocompatibility

Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (hemolysis, complement activation, and in vivo thrombogenicity) were performed to ensure the biocompatibility of the subject device set. The acceptance criterion was met.

Conclusion:

The results of these tests support a conclusion that the Bunegin-Albin Air Aspiration Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device, the Export Advance™ Aspiration Catheter (Medtronic Inc., K130536).