(266 days)
No
The summary describes a physical vascular graft made of ePTFE and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is designed to repair or replace peripheral arteries and provide vascular access, which are therapeutic interventions.
No
The device is a vascular graft designed to repair or replace peripheral arteries and provide vascular access. Its intended use focuses on treatment and structural support, not on diagnosing medical conditions.
No
The device description clearly states it is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube and potentially a PTFE spiral support coil, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair or replace peripheral arteries and to provide vascular access." This describes a surgical implant used directly within the body for therapeutic purposes.
- Device Description: The description details a physical graft made of ePTFE, designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implantable medical device used inside the body for treatment.
N/A
Intended Use / Indications for Use
The MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.
Product codes
Not Found
Device Description
The unwrapped version of the MEADOX® EXXCEL" ePTFE Vascular Graft is comprised of an expanded polytetraffuoroethylene (ePTFE) core tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft. The MEADOX® EXXCEL™ ePTFE Vascular Graft is produced by heating, stretching and winding an extruded polytetrafluoroethylene tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries
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
The following tests were performed to evaluate equivalence to predicate devices: Internodal Distance, Water Entry Pressure, Radial Tensile Strength, Longitudinal Tensile Strength, Burst Strength, Suture Retention Strength (longitudinal), Suture Retention Strength (oblique), Suture Hole Elongation, Kink Diameter, Crush Resistance, Burst After Repeated Puncture (12 months), Burst After Repeated Puncture (18 months), Relaxed Internal Diameter, Usable Length, Nominal Wall Thickness. All tests passed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
0
MAR 1 7 1997
SUMMARY OF SAFETY & E
| GENERAL INFO: | Sponsor - | Meadox Medicals, Inc. |
|---|---|---|
| Contact Person - | Susan Eichler-Huston | |
| Submission Date - | June 21, 1996 | |
| DEVICE INFO: | Generic Name - | Expanded PTFE Vascular Graft |
| Trade Name - | MEADOX® EXXCEL™ ePTFE Vascular Graft | |
| Classification Name - | Vascular Graft Prosthesis (less than 6 mm) | |
| Vascular Graft Prosthesis (6 mm and greater) |
PREDICATE DEVICES:
| Preamendment | IMPRA® Vascular Graft | IMPRA, Inc. |
|---|---|---|
| K791810 | IMPRA® Vascular Graft | IMPRA, Inc. |
| K955460 | EXXCEL™ ePTFE Graft (6 - 10mm) | Meadox Medicals, Inc. |
| K960766 | EXXCEL™ ePTFE Graft (3 - 5mm) | Meadox Medicals, Inc. |
DEVICE DESCRIPTION: The unwrapped version of the MEADOX® EXXCEL" ePTFE Vascular Graft is comprised of an expanded polytetraffuoroethylene (ePTFE) core tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.
Biocompatibility testing on MEADOX® EXXCEL™ ePTFE Vascular Grafts was BIOCOMPATIBILITY: performed on single-cycle steam sterilized grafts in accordance with the ISO-10993 standard for biological evaluation of medical devices. Carcinogenicity testing was
not performed on MEADOX® EXXCEL" ePTFE Vascular Grafts destress
established nontoxic prop for their intended use.
| Summary of Biocompatibility Testing | |||
|---|---|---|---|
| Test Description | ISO | ||
| 10993 | MEADOX* | ||
| EXXCEL | Pass or | ||
| Fail | |||
| Cytotoxicity | ✓ | ✓ | pass |
| Sensitization | ✓ | ✓ | pass |
| Irritation or Intracutaneous reactivity | ✓ | ✓ | pass |
| Systemic Toxicity (acute) | ✓ | ✓ | pass |
| Sub-chronic toxicity (sub-acute) | ✓ | ✓ | pass |
| Genotoxicity / Mutagenicity | ✓ | ✓ | pass |
| Implantation | ✓ | ✓ | pass |
| Hemocompatibility (Hemolysis) | ✓ | ✓ | pass |
| Chronic Toxicity | ✓ | pass | |
| Carcinogenicity | ✓ | N/A |
8 IMPRA is a registered trademark of IMPRA, Inc.
· MEADOX is a registered trademark of MEADOX MEDICALS, INC. a Division of the Boston Scientific Corporation
** EXXCEL is a trademark of MEADOX MEDICALS, INC. a Division of the Boston Scientific Corporation
1
The MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace INDICATIONS: peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired. Design materials of the MEADOX® EXXCEL™ ePTFE Vascular Grafts are DESIGN MATERIALS: substantially equivalent to the predicate devices identified above.
The MEADOX® EXXCEL™ ePTFE Vascular Graft is produced by heating, stretching MANUFACTURING: and winding an extruded polytetrafluoroethylene tube.
SPECIFICATIONS:
Performance specifications of the MEADOX® EXXCEL™ ePTFE Vascular Grafts are substantially equivalent to the range of performance specifications found in the
previously identified predicate devices. The following tests were performed to evaluate equivalence to predicate devices:
| Test Description | | AAMI Standard Equivalence
(reference) | pass/fail |
|-------------------------------------------|---|------------------------------------------|-----------|
| Internodal Distance | ✓ | (8.2.1.3) | pass |
| Water Entry Pressure | ✓ | (8.2.4) | pass |
| Radial Tensile Strength | ✓ | (8.3.1) | pass |
| Longitudinal Tensile Strength | ✓ | (8.3.2) | pass |
| Burst Strength | ✓ | (8.3.3.3) | pass |
| Suture Retention Strength (longitudinal) | ✓ | (8.8.4.1) | pass |
| Suture Retention Strength (oblique) | ✓ | (8.8.4.2) | pass |
| Suture Hole Elongation | | N/A | pass |
| Kink Diameter | ✓ | (8.9) | pass |
| Crush Resistance | | N/A | pass |
| Burst After Repeated Puncture (12 months) | ✓ | (8.3.4) | pass |
| Burst After Repeated Puncture (18 months) | ✓ | (8.3.4) | pass |
| Relaxed Internal Diameter | ✓ | (8.5) | pass |
| Usable Length | ✓ | (8.4) | pass |
| Nominal Wall Thickness | ✓ | (8.7) | pass |
CONCLUSION:
The MEADOX® EXXCEL™ ePTFE Vascular Graft has a level of safety and effectiveness comparable to currently marketed ePTFE Vascular Grafts.
8 IMPRA is a registered trademark of IMPRA, Inc.
@ MEADOX is a registered trademark of MEADOX MEDICALS, INC. a Division of the Boston Scientific Corporation
™ EXXCEL is a trademark of MEADOX MEDICALS, INC. a Division of the Boston Scientific Corporation