(186 days)
No
The summary describes a mechanical steerable introducer system with dilators and a positioning balloon. There is no mention of any computational or algorithmic components, let alone AI or ML. The performance studies focus on mechanical properties, biocompatibility, and deflection angles.
No
The device is described as an introducer system for various cardiovascular catheters, for monitoring pressures, sampling blood, and infusing solutions, not for treating a disease or condition itself.
No
The device is primarily an introducer system for various cardiovascular catheters and can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions, none of which are diagnostic functions.
No
The device description explicitly details physical components (Steerable Introducer Sheath, Long Access Dilator, Short Access Dilator) and mentions biocompatibility testing on a new material, indicating it is a hardware device.
Based on the provided text, the SafeCross Vascular System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is used for "introducing various cardiovascular catheters into the vasculature including the heart," "monitoring intracardiac pressures," "sampling blood," and "infusing solutions." These are all procedures performed in vivo (within the living body).
- Device Description: The description details a physical system with components like a steerable introducer sheath and access dilators, designed for navigating and accessing the vascular system. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, test strips, analyzers, etc., which are not described here.
Therefore, the SafeCross Vascular System is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The SafeCross Vascular System is a Steerable Balloon Introducer System with Access Dilator used for introducing various cardiovascular catheters into the vasculature including the heart. 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
Device Description
The SafeCross Vascular Introducer System is used to introduce various cardiovascular catheters into the vasculature including the heart. Unlike the predicate device, it does not include an RF Puncture Member and is not intended to cross the atrial septum. The subject device system includes three (3) components: the Steerable Introducer Sheath (SIS), a Long Access Dilator (LAD), and a Short Access Dilator (SAD). In the subject device, the SIS and LAD are identical to their respective corresponding components of the predicate device (K203459). The Vascular SIS features a compliant, specially shaped, atraumatic overhanging Positioning Balloon on its distal end to facilitate the accurate positioning and stability of the SIS while navigating the patient's vasculature. The physician is able to bi-directionally deflect the distal segment in a range of 0° to 180°. The subject device includes a new component, the SAD (12 Fr, 20 cm in length).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature including the heart
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)
Design Verification and Validation testing that was conducted on the predicate device was leveraged to support the subject device, due to a risk-based assessment of the similarity or equivalence in geometry and functionality of the device components.
While no new design verification or validation testing was performed on the subject device, in using technical information from the reference device (K151951), a new specification for the SIS deflection angle (149.6°) was retroactively applied to predicate device prior SIS deflection testing to ensure the subject device can be curved to navigate through all potential navigation pathways. Testing was not repeated, as the predicate and subject device have an identical SIS component that met the 149.6° specification.
Additionally, biocompatibility testing was conducted on the newly proposed short access dilator (SAD) for the subject device to provide evidence that the new technological characteristic (i.e., new material of the SAD) does not raise different questions of safety and effectiveness compared to the predicate.
The SAD 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, in vivo thrombogenicity, Heparinized Blood Platelet and Leukocyte Count Assay)
- Material Mediated Pyrogenicity
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.
SafeCross Transseptal Puncture Device and Introducer (TSP/I) System, K203459
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.
Oscor Destino™ Reach Steerable Sheath, K151951
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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September 6, 2024
East End Medical I, LLC Carlos Cruz OA/RA Director 10320 USA Today Way Miramar, Florida 33025
Re: K240600
Trade/Device Name: SafeCross Vascular Introducer System (4001) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 22, 2024 Received: March 4, 2024
Dear Carlos Cruz:
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 (the 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 available 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
2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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, Kalkidan Molla -S
Kalkidan A. Molla, MS Acting Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240600
Device Name
SafeCross Vascular System is a Steerable Balloon Introducer System with Access Dilator
Indications for Use (Describe)
The SafeCross Vascular System is a Steerable Balloon Introducer System with Access Dilator used for introducing various cardiovascular catheters into the vasculature including the heart. 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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K240600
510(k) SUMMARY
1. GENERAL INFORMATION
1.1 Submitter and 510(k) Owner
East End Medical I LLC 10320 USA Today Way Miramar, FL 33025
1.2 Official Correspondent
David Joseph Neugaard 10320 USA Today Way Miramar, FL 33025 +1 (954) 507-7887
1.3 Date of Preparation
September 5, 2024
2. NAME OF THE DEVICE
2.1.1 Trade/Proprietary Name
SafeCross Vascular Introducer System
2.1.2 Common/Usual Name
Introducer Catheter Septostomy Catheter
2.1.3 Classification Information
| Classification Name: | Introducer Catheter |
|---|---|
| Classification Regulation: | 21 CFR§870.1340 |
| Class: | 2 |
| Product Code: | DYB, Introducer, Catheter |
| Panel: | Cardiovascular |
3. PREDICATE DEVICES
Predicates: SafeCross Transseptal Puncture Device and Introducer (TSP/I) System, K203459. The predicate has not been the subject to a design-related recall.
References: Oscor Destino™ Reach Steerable Sheath, K151951
4. DESCRIPTION OF THE DEVICE
The SafeCross Vascular Introducer System is used to introduce various cardiovascular catheters into the vasculature including the heart. Unlike the predicate device, it does not include an RF Puncture Member and is not intended to cross the atrial septum. The subject device system includes three (3) components: the Steerable Introducer Sheath (SIS), a Long Access Dilator (LAD), and a Short Access Dilator (SAD). In the subject device, the SIS and
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LAD are identical to their respective corresponding components of the predicate device (K203459). The Vascular SIS features a compliant, specially shaped, atraumatic overhanging Positioning Balloon on its distal end to facilitate the accurate positioning and stability of the SIS while navigating the patient's vasculature. The physician is able to bi-directionally deflect the distal segment in a range of 0° to 180°. The subject device includes a new component, the SAD (12 Fr, 20 cm in length).
INTENDED USE 5.
The SafeCross™ Vascular System is a Steerable Balloon Introducer System with Access Dilator used for introducing various cardiovascular catheters into the vasculature including the heart. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.
INTENDED USE COMPARED TO THE PREDICATES 6.
The SafeCross Vascular Introducer System has an intended use statement that is a subset of the intended uses from the Predicate. The devices also share the same target patient population, the same users and conditions of use (Table 1).
| | Subject Device
SafeCross Vascular
Introducer System
East End Medical I
Inc. | Predicate
SafeCross Transseptal
Puncture Device and
Introducer (TSP/I)
System, K203459 | Same or Different | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | The SafeCross™ Vascular
System is a Steerable
Balloon Introducer System
with Access Dilator used for
introducing various
cardiovascular catheters into
the vasculature including the
heart. In addition, the device
can be used for monitoring
intracardiac pressures,
sampling blood, and infusing
solutions. It is intended for
use in general vascular
access without requiring
transseptal puncture. | 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 | Different
(Expanded indication for
general vascular access). | |
| Comparison
to Reference
Device | The Subject Device's
intended use aligns with the
Oscor Destino™ Reach
Steerable Sheath (K151951)
Reference Device, which is
used for introducing
diagnostic and therapeutic
devices into the human
vasculature, including
intracardiac, renal, or other
peripheral placements, but
not neural placements. | N/A | Similar
(The use of the Subject Device
in general vascular access
aligns with the intended use of
the Reference Device.) | |
| | Predicate Device - Steerable
Introducer Sheath
SafeCross TSP/I System K203459
East End Medical I Inc. | Reference Device -
Oscor Destino™ Reach
Steerable Sheath
(K151951) | Subject Device - SafeCross
Vascular Introducer System
East End Medical I Inc. | Comparison of Subject
Device to Predicate or
Reference |
| Deflectable
Distal Segment
Length | S: 5.5 mm
M: 6.6 mm
L: 9.5 mm | S: 1.7 cm
M: 2.2 cm
L: 5.0 cm | S: 5.5 mm | Similar, subset |
| Materials | Biocompatible 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 | Radiopaque distal tip | Shaft is radiopaque Positioning
balloon is inflated with 1 cc of 20%
contrast - 80%
saline through the Positioning
Balloon Inflation Port | Same |
| 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 | Hemostasis valve and 2 side ports with
3-way stopcock for Positioning Balloon
Inflation Port and Flushing Line Port
(injection /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 | Inflatable positioning balloon at the
distal tip to facilitate positioning and
stability of the Steerable Introducer
Sheath assembly within the
vasculature. | Similar, appropriate for
indication |
| OD | 0.160" | 0.157", 0.185" or 0.208" | 0.160" | Same |
| ID | 8.5F compatible | 8.5F, 10F or 12F | 8.5F compatible | Same |
| Sheath effective length | 75 cm | 67 to 77 cm | 75 cm | Same |
| Compatible guidewire | 0.035" | 0.035" | 0.035" | Same |
| Distal curve(s) | Min 0° - Max 180° 1 | bi-deflection distal tip | Min 0° - Max 180° 1 | Same |
| | Predicate Device - Steerable
Introducer Sheath
SafeCross TSP/I System K203459
East End Medical I Inc. | Reference Device -
Oscor Destino™ Reach
Steerable Sheath
(K151951) | Subject Device - SafeCross
Vascular Introducer System
East End Medical I Inc. | Comparison of Subject
Device to Predicate or
Reference |
| Access Dilator | 103 cm TSP/I AD provided with kit;
compatible with 0.035" guidewire | 85 cm to 94cm
The dilator has a tapered distal tip | LAD Length: 103cm
SAD Length: 20cm
Both provided with kit; compatible with
0.035" guidewire | Similar, addition of the small
access dilator |
| RF Puncture Member | RF Puncture Member: Working length:
103 cm, provided with kit; compatible
with 0.035" guidewire | Not Included | Not Included | Different: Subject device
does not include RF Puncture
member in the kit, the
Vascular system consists of
three components co-
packaged in a product kit.
- Vascular Device
- Long Access Dilator
(LAD) - Short Access Dilator
(SAD) |
| Endovascular
Navigation Path | Venous: From femoral vein to inferior
vena cava to right atrium (to left atrium). | Venous: From femoral vein to
inferior vena cava to right atrium.
Arterial: From femoral artery to
abdominal aorta bifurcation to
either thoracic aorta or distally to
contralateral femoral/popliteal
artery. | Venous: From femoral vein to inferior
vena cava to right atrium.
Arterial: From femoral artery to
abdominal aorta bifurcation to either
thoracic aorta or distally to contralateral
femoral/popliteal artery. | Same
Similar2 |
Table 1. Intended Use / Indications for Use Comparison
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7. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATES
A comparison of the technological features between the subject device and the Predicate is shown in Table 2 below for the Steerable Introducer Catheter.
Table 2. SafeCross Vascular Introducer System Comparison to Predicate
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¹ Per bench deflection angle testing.
2 Venous vaculature navigation from the groin (femoral vein) up to the 3 devices. Arterial vascular navigation is the same between Reference Device and similar between the Predicate and Subject device in terms of complexity and placement.
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| | (LAD) Access Dilator
(8.5 Fr x 103 cm)
East End Medical I Inc. | (SAD) Access Dilator
(12 Fr x 20 cm)
East End Medical I Inc. | Same or Different |
|----------------|----------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Access Dilator | Shaft, Pebax, barium | Shaft, Polypropylene | Different: The SAD was subjected to a series of
biocompatibility tests in accordance with FDA
guidance, using International Standard ISO 10993-1.
• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity |
| | Hub, Polycarbonate | Hub, High Density Polyethylene | • Acute Systemic Toxicity
• Hemocompatibility (Hemolysis, Complement Activation,
Partial Thromboplastin Time, In Vivo Thrombogenicity,
Heparinized Blood Platelet and Leukocyte Count Assay)
• Material Mediated Pyrogenicity
Results: The test Article (SAD) meet all the test specifications. |
Table 3. Component Materials (AD)
7.1 Similarities and Differences in Technology Comparison
The SafeCross Vascular Introducer System is similar to the SafeCross TSP/I System (K203459) in terms of components and operational use. As outlined in detail in Tables 1-3, technological differences compared to the predicate SafeCross TSP/I System include that the subject SafeCross Vascular Introducer System contains an SAD, does not include an RF puncture member, and incorporates two modifications to the indication for use: (1) removal of transseptal crossing to the left heart and (2) inclusion of peripheral vasculature. While these modifications do not alter the intended use of the device, the subject device's inclusion of general vasculature to the indication necessitated a risk assessment using a reference device (Oscor Destino Reach Steerable Sheath - K151951) to help address safety and effectiveness of the new technological characteristics. A detailed assessment of anatomical navigation paths used for both the reference and subject device led to an SIS deflection angle testing ("distal curve(s)" in Table 2) specification change from 90° to 149.6°. There have been no changes to manufacturing or sterilization of the device. While the packaging materials remain unchanged, the configuration differs between the subject and predicate devices. The subject device, SafeCross Vascular Introducer System, includes both a Long Access Dilator (LAD) and a Short Access Dilator (SAD), whereas the predicate device is co-packaged with a single LAD and an RF puncture member.
The technology of the Subject Steerable Introducer Sheath is identical to the Predicate Introducer Sheaths. Both the SafeCross Steerable Introducer Sheath and the Predicate are copackaged with an access dilator. The technology of the Long Access Dilator (LAD) is identical between the predicate and subject devices.
Performance Testing 8.
Design Verification and Validation testing that was conducted on the predicate device was leveraged to support the subject device, due to a risk-based assessment of the similarity or equivalence in geometry and functionality of the device components.
While no new design verification or validation testing was performed on the subject
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device, in using technical information from the reference device (K151951), a new specification for the SIS deflection angle (149.6°) was retroactively applied to predicate device prior SIS deflection testing to ensure the subject device can be curved to navigate through all potential navigation pathways. Testing was not repeated, as the predicate and subject device have an identical SIS component that met the 149.6° specification.
Additionally, biocompatibility testing was conducted on the newly proposed short access dilator (SAD) for the subject device to provide evidence that the new technological characteristic (i.e., new material of the SAD) does not raise different questions of safety and effectiveness compared to the predicate.
The SAD 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, in vivo thrombogenicity, Heparinized Blood Platelet and Leukocyte Count Assay)
- · Material Mediated Pyrogenicity
9. Conclusions
The SafeCross Vascular Introducer System has the same intended use as the SafeCross TSP/I System predicate device, and similar technological characteristics. The differences in technological characteristics (i.e., new material of the SAD) do not raise new or different questions of safety and effectiveness since all biocompatibility testing conducted meet the specifications. The Oscor Destino™ Reach Device was used as a reference device for some of the performance evaluations. Therefore, the SafeCross Vascular Introducer System is substantially equivalent to the predicate device.