(84 days)
Not Found
No
The summary describes a passive, physical patch made of knitted polyester fabric. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes.
The device is used for cardiac and vascular patch grafting to treat existing conditions, which falls under the definition of a therapeutic device.
No
The device is a knitted cardiovascular patch used for grafting, not for diagnosing conditions. Its description and performance tests relate to its physical properties and intended surgical use, not diagnostic capabilities.
No
The device description clearly states it is a knitted polyester fabric, which is a physical material, not software.
Based on the provided information, the HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cardiac and vascular patch grafting." This describes a device used within the body to repair or replace tissue, not a test performed outside the body on samples like blood or urine.
- Device Description: The description details a "knitted polyester fabric, impregnated with bovine collagen." This is a physical implant, not a reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: The description and intended use do not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
Therefore, the HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Product codes
Not Found
Device Description
The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as a softening agent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 have been performed on the HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch: Burst Strength, Wall Thickness, Suture Retention Strength, Tensile Strength, Water Permeability, Suture Hole Elongation. All results were equivalent to the marketed product.
Key Metrics
Not Found
Predicate Device(s)
HEMASHIELD® Cardiovascular Fabrics (K955349), Gore-Tex® Peripheral Vascular Patch (K821717), Gore-Tex® Cardiovascular Patch (K811841)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Meadox Medicals, Inc.
A Division of Boston Scientific Corporation
112 Bauer Drive
Oakland, New Jersey 07436 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K962342 |
| | SEP 10 1996 |
| Contact Person: | Susan Eichler-Huston
Regulatory Affairs Specialist |
| Submission Date: | June 14, 1996 |
| Device Name: | HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch |
| Predicate Devices: | HEMASHIELD® Cardiovascular Fabrics (K955349)
Gore-Tex® Peripheral Vascular Patch (K821717)
Gore-Tex® Cardiovascular Patch (K811841) |
| Description of Device: | The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch
is a knitted polyester fabric, impregnated with bovine collagen and
contains glycerol as a softening agent. |
| Intended Uses: | The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch
is indicated for cardiac and vascular patch grafting. The fabric is also
recommended for use in patients requiring systemic heparinization prior to,
or during, surgery. |
| Substantial Equivalence: | The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch
is identical to the HEMASHIELD® Knitted Double Velour Cardiovascular
Fabric in materials, manufacturing processes, packaging and sterilization.
The only difference is that the HEMASHIELD FINESSE™ Patch is thinner
than the HEMASHIELD® Knitted Fabric. Testing has been performed that
shows that the HEMASHIELD FINESSE™ Patch is substantially equivalent
to the predicate devices. |
| Product Testing: | The following tests have been performed on the HEMASHIELD FINESSE™
Ultra-Thin, Knitted Cardiovascular Patch: |
| | Burst Strength - equivalent to marketed product
Wall Thickness - equivalent to marketed product
Suture Retention Strength - equivalent to marketed product
Tensile Strength - equivalent to marketed product
Water Permeability - equivalent to marketed product
Suture Hole Elongation - equivalent to marketed product |
| Biocompatibility Testing: | The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch
is identical in materials, processing, packaging and sterilization as the
predicate HEMASHIELD® Cardiovascular Fabrics. As such, it is reasonable
to assume that the device is also identical in biocompatibility to the predicate,
which has been shown through testing performed in accordance with ISO
9000 Standards to be safe for their intended use. |
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