The TSP Crosser Transseptal Access System is intended to both puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

Device Description

The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. The main components of the TSP Crosser System are:

. Steerable introducer sheath with handle and radiopaque wire loop that is compatible with catheters up to 8F
. Dilator that is compatible with guidewires up to a maximum diameter of 0.035"
Transseptal needle with Stylet ●
The System is provided sterile (EO) and is intended for single use only. The device is designed to provide controlled transseptal access in the cardiac left atrial anatomy. The TSP catheter introducer sheath is an elongated shaft with a central lumen capable of incorporating the needle and stylet assembly, the dilator, as well as allow passage and orientation of operational catheters up to 8F. The introducer incorporates a steerable tip that can be deflected bidirectionally up to 180° with a curvature radius of 22mm. The steerable introducer handle includes a rotating knob that maintains the rotational and longitudinal positioning of the sheath and deflects the sheath's tip 180° on each side. There is a nitinol loop wire positioned at the distal end of the introducer that is visible under fluoroscopy and provides a visual aid to the user when positioning the needle on the fossa ovalis. The introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring.
The dilator has an outer diameter of 8F and inner diameter of 0.035" and includes a central lumen that facilitates the transseptal needle/stylet in a similar fashion to conventional dilators. The transseptal needle assembly consists of a luminal stainless-steel needle and solid stainlesssteel stylet. The needle is used to puncture the interatrial septum during the catheterization procedure and houses a central lumen that accommodates the stylet.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TSP Crosser™ Transseptal Access System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness from scratch through extensive clinical trials for new medical devices.

Therefore, the document does not provide the kind of detailed information about acceptance criteria, study design (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truths for AI models) that would be present for a novel AI/ML-based device. This device is a physical medical instrument, not an AI model.

The "performance data" section (6.7) refers to bench testing, biocompatibility testing, and in vivo animal studies to assure reliable design and performance, and support substantial equivalence. It also mentions "clinical data collected outside the United States" but doesn't elaborate on its specifics or how it supports the claims for the device.

Given the nature of this document (a 510(k) for a physical medical device and not an AI/ML product), I cannot provide the requested information regarding acceptance criteria for an AI model's performance, sample sizes for AI test/training sets, details on expert ground truth establishment, adjudication methods, or MRMC studies.

The document discusses performance testing in the context of a physical device:

1. Acceptance Criteria and Reported Device Performance (Summary based on the provided text)

Performance Characteristic	Acceptance Criteria (Implied by testing for substantial equivalence)	Reported Device Performance (as demonstrated by testing)
Functional Equivalence	Comparable to predicate devices in terms of:	Supported by design, material, and dimensional comparison.
	- Transseptal septal puncture capability	Bench and biocompatibility tests performed.
	- Introduction of cardiovascular catheters into left heart	In vivo animal studies performed.
	- Single-use, sterile (EO)	Clinical data (OUS) supports safety and performance.
Mechanical Performance	Device maintains integrity and function under simulated use.	In vitro bench testing performed: Visual & Dimensional Verification, Steerability, Air Leakage, Liquid Leakage, Pushability, Torqueability, Simulated Use, Tensile Strength, Corrosion.
Biocompatibility	Biocompatible with human tissue.	Biocompatibility testing performed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, ASTM Hemolysis (Direct and Indirect), SC5b-9 Complement Activation, and In Vivo Thrombogenicity.
Safety in vivo	Safe and performs as intended in a live system.	In vivo animal studies confirmed safety and performance, and ability to introduce commercial percutaneous catheters.

Missing Information (Not applicable or not provided in the context of this 510(k) for a physical device):

The following points are pertinent to AI/ML device evaluations and are not found in this 510(k) submission for a physical medical device. Therefore, I cannot answer them from the provided text.

1. Sample sizes used for the test set and the data provenance.
1. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
1. Adjudication method for the test set.
1. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or what the effect size of human readers improving with AI vs without AI assistance was.
1. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
1. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
1. The sample size for the training set.
1. How the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows 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 the FDA logo, which 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.

September 28, 2018

Transseptal Solutions Ltd. % Mary LeGraw Consultant to Transseptal Solutions Boston Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, Massachusetts 01752

Re: K181088

Trade/Device Name: TSP Crosser Transseptal Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: August 23, 2018 Received: August 24, 2018

Dear Mary LeGraw:

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/cfpmp/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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Rachel E. Neubrander -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 STATEMENT 5

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

orm Approved: OMB No. 0910-0120 xpiration Date: 06/30/2020 ee PRA Statement below.

510(k) Number (if known)

K181088

Device Name

TSP CrosserTM Transseptal Access System

Indications for Use (Describe)

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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-674)

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6 510(K) SUMMARY

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date is April 4, 2018 [21 CFR 807.92(a)(1)].

Submitter 6.1

Name:	Transseptal Solutions Ltd.
Address:	10 HaGavish St.P.O. Box 4060Netanya, 4250708Israel
Phone:	+972 9 8914217

Contact Person:	Mary P. LeGraw
	Boston Biomedical Associates
	100 Crowley Drive, Suite 216
	Marlborough, MA 01752
	mlegraw@bbacro.com
	Phone: (508) 691-7038
	Fax: (508) 351-8637

6.2 Device

Name of Device:	TSP Crosser™ Transseptal Access System (Model Number TSUS001)
Common Name:	Introducer Catheter
Classification Name:	Catheter, Introducer
Regulatory Class:	Class II
Product Code:Device Panel:	DYB, 21 CFR 870.1340Division of Cardiovascular Devices

Predicate Device 6.3

Primary Predicate Nameand 510(k) Number:	St. Jude ACross™ Transseptal Access System (K070417)
Reference Device:	St. Jude Agilis™ NxT Steerable Introducer (K081645)

Device Description 6.4

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. Steerable introducer sheath with handle and radiopaque wire loop that is compatible with catheters up to 8F
. Dilator that is compatible with guidewires up to a maximum diameter of 0.035"
Transseptal needle with Stylet ●

The System is provided sterile (EO) and is intended for single use only. The device is designed to provide controlled transseptal access in the cardiac left atrial anatomy. The TSP catheter introducer sheath is an elongated shaft with a central lumen capable of incorporating the needle and stylet assembly, the dilator, as well as allow passage and orientation of operational catheters up to 8F. The introducer incorporates a steerable tip that can be deflected bidirectionally up to 180° with a curvature radius of 22mm. The steerable introducer handle includes a rotating knob that maintains the rotational and longitudinal positioning of the sheath and deflects the sheath's tip 180° on each side. There is a nitinol loop wire positioned at the distal end of the introducer that is visible under fluoroscopy and provides a visual aid to the user when positioning the needle on the fossa ovalis. The introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring.

The dilator has an outer diameter of 8F and inner diameter of 0.035" and includes a central lumen that facilitates the transseptal needle/stylet in a similar fashion to conventional dilators. The transseptal needle assembly consists of a luminal stainless-steel needle and solid stainlesssteel stylet. The needle is used to puncture the interatrial septum during the catheterization procedure and houses a central lumen that accommodates the stylet.

Indications for Use 6.5

Comparison of Technological Characteristics with the Predicate Device 6.6

The proposed device is substantially equivalent to the design and materials in the predicate device. The table below summarizes the comparisons between the predicate device and the TSP Crosser System

TechnicalCharacteristic	Proposed DeviceTSP Crosser System(Pending)	Predicate DeviceACross System(K070417)	Predicate DeviceAgilis NxT System(K081645)
Integrated System
Indications for Use	The TSP CrosserTransseptal Access Systemis intended to both topuncture the interatrial	The St. Jude MedicalACross TransseptalAccess System isused both to puncture	The Agilis NxT SteerableIntroducer is indicated forintroducing variouscardiovascular catheters
Technical	Proposed DeviceTSP Crosser System	Predicate DeviceACross System	Predicate DeviceAgilis NxT System
Characteristic	(Pending)	(K070417)	(K081645)
	septum during a transseptalcatheterization procedureand to introduce variouscardiovascular catheters intothe left side of the heart.	the interatrial septumduring a transseptalcatheterizationprocedure and tointroduce variouscardiovascularcatheters into the leftside of the heart.	into the heart, including theleft side of the heartthrough the interatrialspace.
Regulatory Class	Class II	Class II	Class II
Product Code	DYB	DYB	DYB
Regulation Name	Catheter Introducer	Catheter Introducer	Catheter Introducer
Regulation Number	21 CFR 870.1340	21 CFR 870.1340	21 CFR 870.1340
Common Name	Transseptal CatheterIntroducer	Transseptal CatheterIntroducer	Transseptal CatheterIntroducer
	Introducer / Sheath
Sheath Characteristics	TSP Crosser SteerableIntroducer	ACrossSwartz™ GuidingIntroducer	Agilis SteerableIntroducer
Shaft Deflection	Pull Wire	Stable braided (fixedcurve)	Pull Wire
Deflection Mechanism	Rotating knob on handle	Not steerable	Rotating knob on handle
Labeled InternalDiameter	8.7F	8F	8.5F
Labeled Outer Diameter	14 F	Unavailable	11.5F
Catheter Compatibility	8F OD or less	8F OD or less	8F OD or less
Shaft Usable Length	68.5cm	63cm and 81cm	61cm, 71cm, 82cm
Maximum Deflection	180°Bi-directional	45°, 60°, 90°, 135°,180°(Fixed Curves)	90° Clockwise180° Counter ClockwiseBi-directional
Radiopaque Tip	YES	YES	YES
Hemostasis	Internal valve	Internal valve	Internal valve
Shaft Construction	Laminated, SS braidedshaft, inner PTFE liner,deflectable sheath	Braided Sheath	Laminated, SS braidedshaft, inner PTFE liner,deflectable sheath
Sheath PrimaryMaterials	Stainless steel and PTFEinner liner, outer Pebaxjacket	Unavailable	PE, polycarbonate, ABS,PVC and silicone rubber(IFU)
	System Dilator
Dilator Characteristics	TSP Crosser Dilator	ACross Dilator	Agilis Dilator
Purpose	To provide support to thesheath and ensure smoothadvancement into the vessel	To provide support tothe sheath and ensuresmooth advancementinto the vessel	To provide support to thesheath and ensure smoothadvancement into thevessel
Outer Diameter	8.5F	8F, 8.5F	8.5F
Guidewire Compatibility	0.035"	0.032"	0.032"
Effective Length	94.9cm	71cm, 89cm	98cm
Tip Length	10.5mm	Unavailable	9mm
Material	High Density Polyethylene(HDPE)	Unavailable	Unavailable
Transseptal Needle / Stylet
TechnicalCharacteristic	Proposed DeviceTSP Crosser System(Pending)	Predicate DeviceACross System(K070417)	Predicate DeviceAgilis NxT System(K081645)
TransseptalNeedle/StyletCharacteristics	TSP Crosser Needle	TSP Crosser Stylet	ACross BRK TransseptalNeedle
Overall Length	105.5 cm	107.8 cm	71cm, 89cm, 98cm
Working Length	100 cm	120.5 cm	Unknown
Internal Diameter	0.6 mm	N/A	Unknown
Outer Diameter	0.9 mm	0.45 mm	1.02 mm
Curve Angle	Straight with flexible tip(passive steering usingsheath deflection)	Straight	BRK: Standard curve, 19°angle between curvedsegment and need shaftBRK-1: Accentuatedcurve, 53° angle
Material	304 Stainless Steel	304 Stainless Steel	Stainless Steel
System Performance
Bench TestingDemonstrateEquivalence	YES	YES	YES
Biocompatible	YES	YES	YES
Sterilization	EO	EO	EO

Table 6-1: Substantial Equivalence

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6.7 Performance Data and Substantial Equivalence

The technical characteristics between the subject device and the predicate devices have been evaluated through design, material and dimensional comparison, bench and biocompatibility tests to provide evidence of substantial equivalence. The TSP Crosser Transseptal Access System is substantially equivalent to the predicate devices based on comparison of the devices functionality, compatibility, technological characteristics and indications for use.

In vitro bench testing was performed on the TSP Crosser System to assure reliable design and performance. The non-clinical tests performed include Visual and Dimensional Verification, Steerability, Air Leakage, Liquid Leakage, Pushability, Torqueability, Simulated Use, Tensile Strength, and Corrosion.

Biocompatibility testing consisted of Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, ASTM Hemolysis (Direct and Indirect), SC5b-9 Complement Activation and In Vivo Thrombogenicity.

In vivo animal studies were performed to confirm the safety and performance of the TSP Crosser System in a left heart catheterization and to demonstrate the ability of the System to successfully introduce commercial percutaneous catheters into the left chambers of the heart.

Clinical data was also collected outside the United States that supports the safety and performance of the TSP Crosser System for its labeled indications for use.

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6.8 Conclusions

Transseptal Solutions believes the proposed TSP Crosser System is substantially equivalent to the legally marketed predicate devices. The indications for use, methods of operation, design and materials used are either identical or substantially equivalent to existing legally marketed predicate products. In addition, performance testing, in addition to in vivo animal studies and clinical data supports substantial equivalence of the proposed and predicate devices.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).