The SafeCross Transseptal Puncture Device and Introducer (TSP/I) System is used to introduce various cardiovascular catheters to the heart, including the left side of the heart. The system enables left heart access through a puncture of the atrial septum during a transseptal catheterization procedure. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

Device Description

The SafeCross Transseptal Puncture and Introducer (TSP/I) System is used to access the heart left atrium through a puncture of the atrial septum. The System includes three (3) components: the Steerable Introducer Sheath, the RF Puncture Member, and an Access Dilator. The Steerable Introducer Sheath has a compliant balloon at the tip for protection of the septum, and the RF Puncture member is compatible with five (5) of the most common electrosurgical generators.

AI/ML Overview

The provided text describes a medical device, the SafeCross Transseptal Puncture and Introducer (TSP/I) System, and its substantial equivalence to predicate devices, as reviewed by the FDA. However, the document does not contain the specific acceptance criteria or the study data that would allow for a detailed table of acceptance criteria versus reported device performance, nor does it provide information on sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance, as these are typically part of a comprehensive V&V report rather than a 510(k) summary.

The document does list various performance tests conducted and mentions that "All testing passed the acceptance criteria." It also lists biocompatibility testing, sterilization validation, and packaging/shelf-life validation.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of what information is available from the text provided:

1. A table of acceptance criteria and the reported device performance

The document states: "A series of bench tests was performed to demonstrate that the TSP/I System meets its performance specifications using final finished, sterilized and preconditioned product. Comprehensive verification and validation activities were successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria."

Specific acceptance criteria and reported numerical performance values are not provided in the document. The general categories of tests performed are listed under "PERFORMANCE TESTING."

Acceptance Criteria Category	Reported Device Performance
Performance and Physical Requirements of the TSP/I System	All tests passed acceptance criteria. (No specific numerical values or criteria provided in this document)
Validation testing to demonstrate compatibility with accessory devices and radiopacity	Passed
Dimensional verification	Passed
Deliverability and retraction	Passed
Structural integrity (leakage, joint strength, flexibility, torque strength)	Passed
Particulate testing	Passed
Usability validation testing	Passed
Performance and Physical Requirements of the TSP/I Steerable Introducer Sheath	All tests passed acceptance criteria.
Balloon dimensional and performance characteristics, deployment and retraction	Passed
Flow and pressure testing	Passed
Performance and Physical Requirements of the TSP/I RF Puncture Member	All tests passed acceptance criteria.
Electrical verification and compatibility according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2	Passed
Arc integrity verification	Passed
Coring test	Passed
Biological Safety Testing (ISO 10993-1)	All tests passed acceptance criteria.
Cytotoxicity	Passed
Sensitization	Passed
Intracutaneous Reactivity	Passed
Acute Systemic Toxicity	Passed
Hemocompatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time, Thromboresistance)	Passed
Material Mediated Pyrogenicity	Passed
Sterilization	All tests passed acceptance criteria.
SAL of 10^-6	Achieved
Packaging Validation and Shelf Life	All tests passed acceptance criteria.
Visual Inspection, Bubble Leak and Seal Strength	Passed

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided document. The document refers to "a series of bench tests" and "comprehensive verification and validation activities," but no sample sizes are given for any of these tests.
Data Provenance: Not specified in the provided document. The tests were conducted as part of the 510(k) submission, likely by or for East End Medical I LLC (based in Sunrise, FL, USA), but the geographical origin of the data or whether it was retrospective/prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The testing described is primarily bench and biocompatibility testing, not clinical studies requiring expert ground truth for interpretation of medical images or diagnoses. Usability validation testing is mentioned, which may involve experts, but details are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As mentioned above, the disclosed testing is largely bench-based, where "adjudication" in the clinical sense is not typically applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a transseptal puncture and introducer system, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.
Effect Size of AI improvement: Not applicable, as it is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Study: No, a standalone algorithm-only performance study was not done. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the performance testing mentioned (e.g., dimensional verification, structural integrity, electrical verification), the "ground truth" would be the engineering specifications, design requirements, and established industry standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). These are objective criteria rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable.

Summary

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July 6, 2021

East End Medical I LLC % Diane Horwitz Owner Mandell Horwitz Consultants LLC 5 Lake Como Ct. Greenville, South Carolina 29609

Re: K203459

Trade/Device Name: SafeCross Transseptal Puncture and Introducer (TSP/I) System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB, DXF Dated: June 7, 2021 Received: June 8, 2021

Dear Diane Horwitz:

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.

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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 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 medical devices and radiation-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.

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K203459

Device Name

SafeCross Transseptal Puncture and Introducer (TSP/I) 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)

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510(k) SUMMARY

GENERAL INFORMATION 1.

K203459

1.1 Submitter and 510(k) Owner

East End Medical I LLC 1157 Sawgrass Corporate Parkway Sunrise, FL 33323

1.2 Official Correspondent

Diane Horwitz, Ph.D. 5 Lake Como Ct. Greenville, SC 29609

1.3 Date of Preparation

July 1, 2021

2. NAME OF THE DEVICE

2.1.1 Trade/Proprietary Name

SafeCross Transseptal Puncture and Introducer (TSP/I) System

2.1.2 Common/Usual Name

Introducer Catheter Septostomy Catheter

Classification Information 2.1.3

Classification Name:	Introducer Catheter
Classification Regulation:	21 CFR §870.1340
Class:	2
Product Code:	DYB, Introducer, Catheter
Panel:	Cardiovascular
Classification Name:	Septostomy Catheter
Classification Regulation:	21 CFR §870.5175
Class:	2
Product Code:	DXF, Catheter, Septostomy
Panel:	Cardiovascular

PREDICATE DEVICES 3.

Primary Predicate Device: Agilis NXT Steerable Introducer, K081645, St. Jude Medical

Secondary Predicate Device: NRG Transseptal Needle, K073326, Baylis Medical Company, Inc.

Reference Device: AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX, K193509, Acutus Medical

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4. DESCRIPTION OF THE DEVICE

న. INTENDED USE

6. INTENDED USE COMPARED TO THE PREDICATES

The TSP/I System has an intended use statement that is comprised of a combination of the intended uses from both Predicates. The statement is similar with the exception of several word changes specific to the subject devices also share the same target patient population, the same users and conditions of use (Table 1).

	Subject DeviceSafeCrossTSP/I SystemEast End Medical I Inc.	Primary PredicateAgilis NXT SteerableIntroducerSt. Jude MedicalK081645	Secondary PredicateNRG Transseptal NeedleBaylis Medical Company,Inc.K073326
Intended UseStatement	The SafeCross TransseptalPuncture Device andIntroducer (TSP/I) System isused to introduce variouscardiovascular catheters tothe heart, including the leftside of the heart. The systemenables left heart accessthrough a puncture of theatrial septum during atransseptal catheterizationprocedure. In addition, thedevice can be used formonitoring intracardiacpressures, sampling blood,and infusing solutions.	The Agilis ™ NXT SteerableIntroducer is indicated forintroducing variouscardiovascular catheters into theheart, including the left side ofthe heart through the interatrialseptum.	Creation of an atrial septaldefect in the heart. Secondaryapplications include transseptalheart access, monitoringintracardiac pressures,sampling blood, and infusingsolutions.

Table 1. Intended Use / Indications for Use Comparison

7. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATES

A comparison of the technological features between the TSP/I System and the Predicates is shown in Table 2 below for the Steerable Introducer Catheter and in Table 3 for the RF Puncture Member.

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	Subject Device - SteerableIntroducer SheathSafeCross TSP/I SystemEast End Medical I Inc.	Primary PredicateAgilis NXT SteerableIntroducerSt. Jude MedicalK081645 (L Curve)	Same or Different
Deflectable DistalSegment Length	S: 5.5 mmM: 6.6 mmL: 9.5 mm	K081645L: 8.4 mm	Same
Materials	Biocompatible materials	Biocompatible materials	Same
Radiopacity	Shaft is radiopaquePositioning balloon is inflatedwith 1 cc of 20% contrast - 80%saline through the PositioningBalloon Inflation Port	"The sheath is filled withradiopaque material forvisualization under fluoroscopy"	Similar. Visibility underfluoroscopy was confirmedwith bench and usabilitytesting
Proximal end	Hemostasis valve and 2 sideports with 3-way stopcock forPositioning Balloon InflationPort and Flushing Line Port(injection /aspiration of fluids)	Hemostasis valve and a side portwith 3-way stopcock forinjection or aspiration of fluids	Same
Distal end/tip	Inflatable positioning balloon atthe distal tip to facilitatepositioning at the fossa ovalisand stabilize the introducersystem for precise use of the RFPuncture Member	No balloon	Different. Use of anatraumatic compliant balloonis common in cardiovascularprocedures.Bench testing and usevalidation study confirmrequirements andspecifications were met.This change does not raisenew issues of safety oreffectiveness
OD	0.160"	0.161"	Similar
ID	8.5F compatible	8.5F compatible	Same
Sheath effective length	75 cm	71 cm	Similar
Compatible guidewire	0.035"	0.032"	Similar
Distal curve(s)	> 90° bidirectional	> 90° bidirectional	Same
Access Dilator	103 cm TSP/I AD provided withkit; compatible with 0.035"guidewire	94 cm AD provided with kit;compatible with 0.032"guidewire	Same

Table 2. TSP/I Steerable Introducer Sheath and Access Dilator Technology Comparison to Predicates

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	Subject Device - RFPuncture MemberSafeCross TSP/I SystemEast End Medical I Inc.	Secondary PredicateNRG TRANSSEPTAL NEEDLEBaylis Medical Company, Inc.K073326	Same or Different
Working length	103 cm	98 cm	Similar
Outer shaft diameter	0.110" (8.5F)	0.053" and requires 8.5F dilator for use	Same
Visibility under fluoroscopy	Visible due to metal material	Visible due to metal material	Same
Compatible guidewire	0.035"	0.032"	Similar
Compatible Generator	Third-party FDA-cleared electrosurgical generators:• Bovie OR/PRO 300• CONMED System 5000• ERBE VIO 300D• Ethicon / Megadyne Mega Power• Medtronic/ Covidien/ Valleylab Force FX/FX-C	The companion generator is cleared by the Baylis Medical Company, Inc., Models RFP-100 and RFP-100A	Different. The Predicate device is used with one generator from the same manufacturer, while the Subject device may be used with several qualified generators.All generators are set to 50 W Power; Subject device details the generator settings in IFU and in training.A Reference Device was selected, AcQGuide Flex (Acutus Medical, Inc., K193509) as it is similarly cleared for use with an electrosurgical generator from a Third Party manufacturer (which is the same as the Subject device compatible generator).
Mode	Monopolar mode, CUT modality, 50 W	Up to 50W (RFP-100A Generator)	Each compatible generator has been tested with the Subject device and been characterized to have equivalent electrical performance with the Predicate device.
Connector	Bovie D-shape 4mm connector	Proprietary connector	Similar

Table 3. TSP/I RF Puncture Member Technology Comparison to Predicate

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7.1 Similarities and Differences in Technology Comparison

The SafeCross TSP/I System is equivalent to the combination of the Agilis NXT Steerable Introducer (K081645) and the NRG Transseptal Needle (K073326) in terms of components and operational use.

The technology of the Subject Steerable Introducer Sheath is identical to the Predicate Introducer Sheaths with the exception that the Subject device includes a Positioning Balloon on its distal end. Both the SafeCross Steerable Introducer Sheath and the Predicate are co-packaged with an access dilator.

The technology of the SafeCross RF Puncture Member is almost identical to the Predicate Puncture Member. Both devices use RF energy technology to cross the septal wall, using an electrosurgical generator. Both devices are radiopaque for visualization during the procedure using fluoroscopy. Both devices utilize similar output powers from similar electrosurgical generators. The SafeCross RF Puncture Member has the advantage of being compatible with the most common electrosurgical generators. Electrical safety and compatibility have been demonstrated.

8. PERFORMANCE TESTING

A series of bench tests was performed to demonstrate that the TSP/I System meets its performance specifications using final finished, sterilized and preconditioned product. Comprehensive verification and validation activities were successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria.

Performance testing was conducted against known standards and product specifications and evaluated the following:

Performance and Physical Requirements of the TSP/I System

Validation testing to demonstrate compatibility with accessory devices and radiopacity ●
. Dimensional verification
Deliverability and retraction ●
. Structural integrity (leakage, joint strength, flexibility, torque strength)
Particulate testing ●
Usability validation testing

Performance and Physical Requirements of the TSP/I Steerable Introducer Sheath

Balloon dimensional and performance characteristics, deployment and retraction ●
. Flow and pressure testing

Performance and Physical Requirements of the TSP/I RF Puncture Member

Electrical verification and compatibility according to IEC 60601-1, IEC 60601-1-2, IEC ● 60601-2-2
Arc integrity verification ●
Coring test ●

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Biological Safety Testing

The TSP/I System was subjected to a series of biocompatibility tests in accordance with FDA guidance, using International Standard ISO 10993-1.

. Cytotoxicity
. Sensitization
Intracutaneous Reactivity ●
. Acute Systemic Toxicity
Hemocompatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time, . Thromboresistance)
Material Mediated Pyrogenicity ●

Sterilization

Sterilization and sterilization were performed to ensure a SAL of 10°, according to international sterilization standards.

Packaging Validation and Shelf Life

Visual Inspection, Bubble Leak and Seal Strength testing was used to evaluate integrity of the packaging configuration. Testing was conducted after sterilization, environmental conditioning including aging, and simulated shipping and distribution.

The results of the performance testing conclude the SafeCross TSP/I System is safe and is substantially equivalent to the predicate devices.

9. CONCLUSIONS

The information presented in this 510(k) submission demonstrates that the East End Medical I LLC SafeCross TSP/I System is substantially equivalent to the 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).