(224 days)
No
The summary describes a mechanical and RF-based device for transseptal puncture and does not mention any AI or ML components or capabilities.
No
The device is described as an access system used to introduce catheters and perform procedures (puncture, monitoring, sampling, infusing), not to treat a condition.
No
The device is described as an introducer system for various cardiovascular catheters, used to access the left side of the heart through a puncture of the atrial septum. While it can be used for "monitoring intracardiac pressures, sampling blood, and infusing solutions," its primary function is access and delivery, not diagnosis. These secondary uses (monitoring and sampling) are a means to an end, often for diagnosis, but the device itself does not perform the diagnostic interpretation or analysis.
No
The device description clearly outlines physical components (Steerable Introducer Sheath, RF Puncture Member, Access Dilator) and mentions hardware compatibility (electrosurgical generators), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the SafeCross Transseptal Puncture Device and Introducer (TSP/I) System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for a surgical procedure (transseptal puncture) to access the heart. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system of physical components (sheath, puncture member, dilator) designed for insertion into the body.
- Anatomical Site: The device is used on the heart, an internal organ.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or providing diagnostic information based on laboratory tests.
The device is a surgical tool used for a medical procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DYB, DXF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, left side of the heart, atrial septum
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, sample size, AUC, MRMC, standalone performance, key results)
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 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
1
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)
Device Name
SafeCross Transseptal Puncture and Introducer (TSP/I) System
Indications for Use (Describe)
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.
| 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.
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
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.
న. INTENDED USE
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.
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 Device
SafeCross
TSP/I System
East End Medical I Inc. | Primary Predicate
Agilis NXT Steerable
Introducer
St. Jude Medical
K081645 | Secondary Predicate
NRG Transseptal Needle
Baylis Medical Company,
Inc.
K073326 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | 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. | The Agilis ™ NXT Steerable
Introducer is indicated for
introducing various
cardiovascular catheters into the
heart, including the left side of
the heart through the interatrial
septum. | Creation of an atrial septal
defect in the heart. Secondary
applications include transseptal
heart access, monitoring
intracardiac pressures,
sampling blood, and infusing
solutions. |
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 - Steerable
Introducer Sheath
SafeCross TSP/I System
East End Medical I Inc. | Primary Predicate
Agilis NXT Steerable
Introducer
St. Jude Medical
K081645 (L Curve) | Same or Different |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Deflectable Distal
Segment Length | S: 5.5 mm
M: 6.6 mm
L: 9.5 mm | K081645
L: 8.4 mm | Same |
| Materials | Biocompatible materials | Biocompatible materials | Same |
| Radiopacity | Shaft is radiopaque
Positioning balloon is inflated
with 1 cc of 20% contrast - 80%
saline through the Positioning
Balloon Inflation Port | "The sheath is filled with
radiopaque material for
visualization under fluoroscopy" | Similar. Visibility under
fluoroscopy was confirmed
with bench and usability
testing |
| Proximal end | Hemostasis valve and 2 side
ports with 3-way stopcock for
Positioning Balloon Inflation
Port and Flushing Line Port
(injection /aspiration of fluids) | Hemostasis valve and a side port
with 3-way stopcock for
injection or aspiration of fluids | Same |
| Distal end/tip | Inflatable positioning balloon at
the distal tip to facilitate
positioning at the fossa ovalis
and stabilize the introducer
system for precise use of the RF
Puncture Member | No balloon | Different. Use of an
atraumatic compliant balloon
is common in cardiovascular
procedures.
Bench testing and use
validation study confirm
requirements and
specifications were met.
This change does not raise
new issues of safety or
effectiveness |
| 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 with
kit; 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 - RF
Puncture Member
SafeCross TSP/I System
East End Medical I Inc. | Secondary Predicate
NRG TRANSSEPTAL NEEDLE
Baylis 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.