(156 days)
No
The description focuses on mechanical components and their functions, with no mention of AI or ML capabilities.
No.
The device is an access system for cardiovascular catheters, not a device that directly treats a medical condition.
No
The device is intended to puncture the interatrial septum and introduce catheters, which are interventional and procedural tasks, not diagnostic ones. While it mentions fluoroscopy for visual aid, its primary function is not to collect or analyze data for diagnosis.
No
The device description clearly outlines multiple physical components including a steerable introducer sheath, dilator, and transseptal needle with stylet, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to puncture the interatrial septum and introduce catheters into the heart. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The description details a system of physical tools (sheath, dilator, needle) used for accessing and navigating within the heart. These are instruments used in vivo (within a living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing on samples.
The device is clearly designed for a medical procedure performed on the patient, not for analyzing samples from the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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 stainless-steel stylet. The needle is used to puncture the interatrial septum during the catheterization procedure and houses a central lumen that accommodates the stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum, left heart chambers
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)
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.
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.
St. Jude ACross™ Transseptal Access System (K070417)
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.
St. Jude Agilis™ NxT Steerable Introducer (K081645)
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).
0
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
1
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
2
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)
Device Name
TSP CrosserTM Transseptal Access System
Indications for Use (Describe)
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.
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)
3
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 4060 | |
| Netanya, 4250708 | |
| Israel | |
| 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 870.1340 |
| Division of Cardiovascular Devices |
Predicate Device 6.3
| Primary Predicate Name
| and 510(k) Number: | St. Jude ACross™ Transseptal Access System (K070417) |
|---|---|
| Reference Device: | St. Jude Agilis™ NxT Steerable Introducer (K081645) |
Device Description 6.4
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:
4
- . 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
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.
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
| Technical
Characteristic | Proposed Device
TSP Crosser System
(Pending) | Predicate Device
ACross System
(K070417) | Predicate Device
Agilis NxT System
(K081645) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Integrated System | | | |
| Indications for Use | The TSP Crosser
Transseptal Access System
is intended to both to
puncture the interatrial | The St. Jude Medical
ACross Transseptal
Access System is
used both to puncture | The Agilis NxT Steerable
Introducer is indicated for
introducing various
cardiovascular catheters |
| Technical | Proposed Device
TSP Crosser System | Predicate Device
ACross System | Predicate Device
Agilis NxT System |
| Characteristic | (Pending) | (K070417) | (K081645) |
| | septum during a transseptal
catheterization procedure
and to introduce various
cardiovascular catheters into
the left side of the heart. | the interatrial septum
during a transseptal
catheterization
procedure and to
introduce various
cardiovascular
catheters into the left
side of the heart. | into the heart, including the
left side of the heart
through the interatrial
space. |
| 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 Catheter
Introducer | Transseptal Catheter
Introducer | Transseptal Catheter
Introducer |
| | Introducer / Sheath | | |
| Sheath Characteristics | TSP Crosser Steerable
Introducer | ACross
Swartz™ Guiding
Introducer | Agilis Steerable
Introducer |
| Shaft Deflection | Pull Wire | Stable braided (fixed
curve) | Pull Wire |
| Deflection Mechanism | Rotating knob on handle | Not steerable | Rotating knob on handle |
| Labeled Internal
Diameter | 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° Clockwise
180° Counter Clockwise
Bi-directional |
| Radiopaque Tip | YES | YES | YES |
| Hemostasis | Internal valve | Internal valve | Internal valve |
| Shaft Construction | Laminated, SS braided
shaft, inner PTFE liner,
deflectable sheath | Braided Sheath | Laminated, SS braided
shaft, inner PTFE liner,
deflectable sheath |
| Sheath Primary
Materials | Stainless steel and PTFE
inner liner, outer Pebax
jacket | 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 the
sheath and ensure smooth
advancement into the vessel | To provide support to
the sheath and ensure
smooth advancement
into the vessel | To provide support to the
sheath and ensure smooth
advancement into the
vessel |
| 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 | | | |
| Technical
Characteristic | Proposed Device
TSP Crosser System
(Pending) | Predicate Device
ACross System
(K070417) | Predicate Device
Agilis NxT System
(K081645) |
| Transseptal
Needle/Stylet
Characteristics | TSP Crosser Needle | TSP Crosser Stylet | ACross BRK Transseptal
Needle |
| 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 using
sheath deflection) | Straight | BRK: Standard curve, 19°
angle between curved
segment and need shaft
BRK-1: Accentuated
curve, 53° angle |
| Material | 304 Stainless Steel | 304 Stainless Steel | Stainless Steel |
| System Performance | | | |
| Bench Testing
Demonstrate
Equivalence | YES | YES | YES |
| Biocompatible | YES | YES | YES |
| Sterilization | EO | EO | EO |
Table 6-1: Substantial Equivalence
5
6
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.
7
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.