Who is the manufacturer of BOSS 8F Balloon Guide Catheter?

Marblehead Medical, LLC filed the 510(k) submission for BOSS 8F Balloon Guide Catheter (K203840).

What is the FDA product code for BOSS 8F Balloon Guide Catheter?

QJP. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BOSS 8F Balloon Guide Catheter?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like BOSS 8F Balloon Guide Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BOSS 8F Balloon Guide Catheter

Q: What are the predicate devices for BOSS 8F Balloon Guide Catheter?

BOSS Balloon Guide Catheter (K200910).

K203840 · Marblehead Medical, LLC · QJP · Jan 28, 2021 · Cardiovascular

Device Facts

Record ID	K203840
Device Name	BOSS 8F Balloon Guide Catheter
Applicant	Marblehead Medical, LLC
Product Code	QJP · Cardiovascular
Decision Date	Jan 28, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.

Device Story

Sterile, single-use 8F balloon guide catheter; 85/95 cm length; variable stiffness shaft with stainless steel coil and braid reinforcement; bifurcated dual-port luer hub; distal radiopaque marker band; hydrophilic coating. Used by physicians in clinical settings for peripheral and neurovascular procedures. Device inserted over guidewire via introducer sheath or direct access; central lumen facilitates interventional device delivery; annular inflation lumen allows balloon inflation/deflation via syringe for temporary vascular occlusion. Provides conduit for retrieval devices. Output is physical guidance and vascular access; enables targeted treatment delivery; benefits patient by facilitating complex neurovascular/peripheral interventions.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical bench testing, including visual/dimensional inspection, torque, tensile strength, kink resistance, lubricity, particulate/coating integrity, radiopacity, simulated use, leak testing, tip stiffness, corrosion resistance, burst pressure, and balloon fatigue/inflation performance. Biocompatibility testing per ISO 10993-1 confirmed safety.

Technological Characteristics

Materials: medical-grade plastics, stainless steel. Construction: coaxial lumen, stainless steel coil/braid reinforced shaft, compliant polyurethane balloon. Dimensions: 8F (0.111" OD), 85/95 cm length. Connectivity: none. Sterilization: 100% Ethylene Oxide (EtO) to SAL 10^-6. Standards: ISO 10555-1, ISO 10555-4, ISO 80369-7, ISO 10993 series, ASTM F756.

Indications for Use

Indicated for patients requiring intravascular catheter insertion and guidance in peripheral and neurovascular systems, temporary vascular occlusion, or as a conduit for retrieval devices.

Regulatory Classification

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.

Predicate Devices

BOSS Balloon Guide Catheter (K200910)

Related Devices

K200910 — BOSS Balloon Guide Catheter · Marblehead Medical · May 2, 2020
K190749 — 087 Balloon Guide Catheter System · Q'Apel · Jul 15, 2019
K192525 — 087 Balloon Guide Catheter System · Q'Apel Medical, LLC · Oct 31, 2019
K153729 — 8F FlowGate2 Balloon Guide Catheter · Concentric Medical · Jan 27, 2016
K231629 — 091 Balloon Guide Catheter · Eosolutions, Corp. · Oct 31, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 28, 2021 Marblehead Medical, LLC Kristin Mortenson Director of Quality and Regulatory 753 Fox Chase Road SW Rochester, Minnesota 55902-8749 Re: K203840 Trade/Device Name: BOSS 8F Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: December 29, 2020 Received: December 31, 2020 # Dear Kristin Mortenson: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203840 Device Name BOSS 8F Balloon Guide Catheter #### Indications for Use (Describe) The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices. Type of Use (Select one or both, as applicable) | <div> <svg height="16" width="16"> <path d="M14.75 3.5L5.5 12.75L1.25 8.5L2.75 7L5.5 9.75L13.25 2L14.75 3.5Z" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {3}------------------------------------------------ ### BOSS™ 8F Balloon Guide Catheter 510(k) Summary #### SUBMITTER [807.92(a)(1)] | Submitter's Name: | Marblehead Medical, LLC | |---------------------------|----------------------------------------------| | Address: | 753 Fox Chase Rd SW, Rochester MN 55902-8749 | | Contact Person: | Kristin Mortenson | | Telephone: | (612) 202-1142 | | email | Mortenson.Kristin@MarbleheadMedical.com | | Date Prepared: | Jan 25, 2021 | | DEVICE [807.92(a)(2)] | | | Device Trade Name: | BOSS™ 8F Balloon Guide Catheter | | Common Name: | Balloon Guide Catheter | | Classification Name: | Percutaneous Catheter | | Product Code: | QJP, DQY | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 870.1250 | | PREDICATE [807.92(a)(3)] | | | Primary Predicate Device: | BOSS Balloon Guide Catheter, K200910 | #### DEVICE DESCRIPTION [807.92(a)(4)] The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS 8F Balloon Guide Catheter is an 85 and 95 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS 8F Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 8F Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath. #### INDICATION FOR USE [807.92(a)(5)] The BOSS 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices. #### PREDICATE DEVICE COMPARISON [807.92(a)(6)] The following table provides a comparison of the key characteristics of the BOSS 8F Balloon Guide Catheter System to the predicate devices. {4}------------------------------------------------ | Feature | Predicate Device BOSS Balloon Guide Catheter System | Subject Device BOSS 8F Balloon Guide Catheter System | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Classification | Same | Same | | Product Code(s) | QJP, DQY | Same | | Regulation Number | Same | Same | | Regulation Name | Percutaneous Catheter | Same | | Indications for Use | The BOSSTM Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices. | Same | | Anatomical Locations | Peripheral and neurovasculature | Same | | Principle of Operation | The Balloon Guide Catheter is used to facilitate the selective placement of interventional devices. After needle access and insertion of up to a 0.038" guidewire into the femoral artery, the device is inserted into the artery through an introducer sheath over the guidewire. The lumen of device is used for insertion and guidance of an intravascular catheter and / or retrieval devices into a selected blood vessel for treatment. Operation includes the direct access use option without an introducer sheath | Same | | Material | Commonly used medical grade plastics and stainless steel | Same | | Reinforced Catheter Shaft Reinforcement | Stainless Steel coil and braid reinforced | Same | | Marker Band / Location | Radiopaque marker 0.08-in (2 mm) wide, 0.02-in (0.5mm) from the distal tip edge distal to the balloon. | Marker band 1.3 mm, 2 mm from distal tip edge distal to the balloon. Similar, difference does not raise new questions regarding safety and efficacy, all devices utilize radiopaque marker bands | | Compliant Balloon | Yes, polyurethane | Same | | Labeled Shaft Outer Diameter | 0.123-in (max) (3.1mm) 9.4Fr | 0.111" (2.8 mm) 8F Similar differences do not raise | | | Predicate Device | Subject Device | | Feature | BOSS Balloon Guide Catheter System | BOSS 8F Balloon Guide Catheter System | | Labeled Shaft Inner Dimension | 0.088-in (2.24 mm) 6.7F | 0.0870" (2.2 mm) Similar, differences do not raise new questions of safety and efficacy. | | Effective length | 90 cm | 85 and 95 cm Similar, differences do not raise new questions of safety and efficacy. | | Tip Shape | Straight | Same | | Maximum Balloon Volume | 0.6 mL | Same | | Radiopaque | Distal Tip has radiopaque marker bands, stainless steel reinforcement in the catheter shaft renders the shaft visible on fluoroscopy | Same | | Coating | Coating is on the distal portion proximal to the balloon | Same | | Internal Construction | Coaxial Lumen | Same | | Supplied items / accessories | Dilator is provided | Same | | How Supplied | Sterile, single use | Same | | Sterilization Method | EtO | Same | | Sterility Assurance Level | 10-6 | Same | {5}------------------------------------------------ The differences between the subject device and predicates described in the comparison table above are not critical to the intended therapeutic or surgical use of the device, do not raise questions of safety and effectiveness, and as shown through testing and analysis, do not affect the safety and effectiveness of the device when used as labeled. # NONCLINICAL PERFORMANCE TESTING SUMMARY [807.92(b)] Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data. The BOSS 8F Balloon Guide Catheter System has successfully completed the following relevant performance testing to demonstrate substantial equivalence. Testing was performed to evaluate physical integrity, functionality, and performance of the BOSS 8F Guide Catheter. A summary of the tests performed is provided in the table below: {6}------------------------------------------------ | Performance Bench Testing Summary | | | | |----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Study Name | Description | Reference Standard | Results | | Visual Inspection and Dimensional Verification | To demonstrate that the product meets the dimensional specifications | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | Surface Inspection | To demonstrate the product satisfies the visual surface requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | Torque Testing | To demonstrate that the product is capable of 360 degrees of rotation about the central lumen axis without failure. | FDA guidance PTCA Catheters:2010 §VIII.A.10 | Pass All samples met the pre-determined acceptance criteria | | Tensile | To demonstrate the product satisfies the tensile strength requirements for bonds and tip pull test | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements, FDA guidance PTCA Catheters:2010 §VIII.A.7, 8 | Pass All samples met the pre-determined acceptance criteria | | Kink Resistance | To demonstrate that the product has acceptable kink resistance | FDA Guidance PTCA:2010 §VIII.A.9 Kink Test | Pass All samples met the pre-determined acceptance criteria | | Catheter Lubricity | Pad friction test to compare coated to uncoated samples | Characterization only | Results show a 97% reduction in friction compared to uncoated samples | | Particulates, Coating Integrity | This study was conducted to determine the quantity and size of particles generated during simulated use | AAMI TIR42:10 Evaluation of particulates associated with vascular medical devices, USP <788> Particulate Matter in Injections | Pass All samples met the pre-determined acceptance criteria | | Radiopacity | To determine the radiopaque characteristics of the device. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | Performance Bench Testing Summary | | | | | Study Name | Description | Reference Standard | Results | | Push/Track, Simulated Use, Device Compatibility | To demonstrate that the device is deliverable through tortuous path model without kinking or buckling, is able inflate, deflate balloon at target, is compatible with treatment devices and removed without damage. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | System Leak - Liquid Leak | To demonstrate that the product meets the liquid leakage under pressure requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | System Leak - Aspiration | To demonstrate that the product meets the hub aspiration air leakage requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | Tip Stiffness | To demonstrate that the stiffness of the distal end of the product is similar to other marketed devices. | N/A | Pass All samples met the pre-determined acceptance criteria | | Corrosion Resistance | To demonstrate the product satisfies the corrosion resistance requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | Catheter Burst Pressure Under Static Conditions | To demonstrate the catheter does not leak or rupture up to rated internal pressure. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre-determined acceptance criteria | | Balloon Inflation / Deflation | To demonstrate balloon meets the inflation and deflation time specifications | ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Pass All samples met the pre-determined acceptance criteria | | Balloon Fatigue | To demonstrate that there is no degradation of the balloon after 10 inflation cycles. | ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Pass All samples met the pre-determined acceptance criteria | {7}------------------------------------------------ {8}------------------------------------------------ | Performance Bench Testing Summary | | | | | | |--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--|--| | Study Name | Description | Reference Standard | Results | | | | Balloon Diameter / Volume | To demonstrate that the product meets the inflation volume vs balloon diameter specifications | ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Pass All samples met the pre-determined acceptance criteria | | | | Balloon Rated Burst Volume | To demonstrate that the balloon is capable of withstanding an injection volume to the rated burst volume | ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Pass All samples met the pre-determined acceptance criteria | | | | Small Bore Connector Compliance with Standard | To demonstrate that the product meets the requirements for small bore connectors | ISO 80369-7: 2016 Small- bore connectors for liquids and gases in healthcare applications - Part 7, Connectors for intravascular or hypodermic applications. | Pass All samples met the pre-determined acceptance criteria | | | | Usability Study / Simulated Use | Evaluation of device performance to meet the user needs under simulated use conditions with accessories and treatment devices | FDA Guidance Human Factors and Usability Engineering 2016, IEC 62366:2015 | Pass All samples met the pre-determined acceptance criteria | | | | Conditioning, Distribution, and Shelf-life Aging | To demonstrate the device met all specifications at both baseline (T=0) and following accelerated aging to a 6-month shelf life equivalent (T=6) | Evaluation of device following accelerated aging to a 6-month shelf life equivalent | Pass All samples met the pre-determined acceptance criteria | | | | Package Testing | | | | | | | Conditioning, Distribution, and Shelf-Life Aging | Evaluation of packaging strength and integrity at both baseline (T=0) and following accelerated aging to a 6-month shelf life equivalent (T=6) | ISTA procedure 3A (2018), ASTM D4169-16, ASTM F1980-16, ASTM F88-15, ASTM F2096- 11, ASTM 1929-15 | Pass All samples met the pre-determined acceptance criteria | | | | Visual Inspection Packaging and Labeling | To demonstrate that the product meets the packaging and labeling visual and adherence requirements | N/A | Pass All samples met the pre-determined acceptance criteria | | | The results of these tests provide reasonable assurance that the BOSS 8F Balloon Guide Catheter has been designed and tested to assure conformance to the requirements for its intended use and {9}------------------------------------------------ indications for use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate devices. # Biocompatibility Testing Summary The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (≤ 24 hours), per ISO 10993-1, the following testing was conducted: | Test Name | Test Method | Results | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity | Tested in accordance with ISO 10993-5:2009, Biological Evaluation of Medical Devices – Part 5: Tests for in vitro toxicity, Neutral Red Uptake Method | Pass Noncytotoxic according to the predetermined acceptance criteria | | Intracutaneous Irritation | Tested in accordance with ISO 10993- 10:2010, Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization | Pass Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria | | Sensitization | Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices – Part 10 Tests for Irritation and Skin Sensitization, Kligman Maximization Test | Pass Did not elicit a sensitization response according to the predetermined acceptance criteria | | Systemic Toxicity | Tested in accordance with ISO 10993- 11:2017, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity | Pass Test requirements for systemic toxicity were met according to the predetermined acceptance criteria | | Material Mediated Pyrogenicity | Tested in accordance with ISO 10993-11:2017, Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity and USP 40 <151> Pyrogen Test | Pass Nonpyrogenic, met the predetermined acceptance criteria | | Hemolysis | Tested in accordance with ASTM F756-17, Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4, Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood, Tests for Hemolytic Properties, Direct and Indirect Methods | Pass Non-hemolytic, met the predetermined acceptance criteria | | Complement Activation | Tested in accordance with ISO 10993-4, Biological Evaluation of Medical Devices – Part 4:2017: Selection of Tests for Interactions with Blood, SC5b-9 Complement Activation | Pass Demonstrates similar complement activation characteristics as the control device, met the predetermined acceptance criteria | | Test Name | Test Method | Results | | In vivo Thromboresistance | Tested in accordance with ISO 10993-4:2017, Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood | Pass Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria | {10}------------------------------------------------ # Sterilization and Shelf Life The BOSS 8F Balloon Guide Catheter sterilization process using 100% Ethylene Oxide (EO) has been validated in accordance with ISO 11135-1:2014 to achieve a SAL of 10°. EO and ECH residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels (BET) were below the level of 2.15 EU/device in accordance with ANSI AAMI ST72:2011/(R)2016. Both baseline and accelerated shelflife testing were conducted (T = 0 and T = 6-month AA (accelerated aging)) demonstrating the device will perform as intended to support the proposed 6-month shelf-life. ### Animal Testing No animal studies were required to demonstrate substantial equivalence. ### Clinical Testing No clinical studies were required to demonstrate substantial equivalence. ### Conclusion Marblehead Medical LLC concludes through a review of the benchtop assessments, the comparison of the device classification, intended use, operating principle, technological characteristics, sterility, and biocompatibility that the BOSS 8F Balloon Guide Catheter System is substantially equivalent to the predicate device.