(319 days)
No
The device description and performance studies focus on the material properties and biological response of a collagen matrix, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended for "pericardial reconstruction and repair and for epicardial support and repair," indicating it is used to treat or manage a disease or condition.
No
Explanation: The device description states it is a "porous acellular matrix designed to provide soft tissue reinforcement, repair, and reconstruction," which indicates a therapeutic or restorative function, not a diagnostic one. Its intended use is for "pericardial reconstruction and repair and for epicardial support and repair."
No
The device description clearly states it is a "porous acellular matrix derived from fetal bovine dermis," which is a physical material, 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 for "pericardial reconstruction and repair and for epicardial support and repair." This describes a surgical implant used directly on the patient's tissues.
- Device Description: The description details a "porous acellular matrix derived from fetal bovine dermis" designed for "soft tissue reinforcement, repair, and reconstruction." This is a material intended to be implanted in the body.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples from the body. This device is used inside the body to repair and reconstruct tissue.
N/A
Intended Use / Indications for Use
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.
Product codes
PSO
Device Description
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a porous acellular matrix derived from fetal bovine dermis designed to provide soft tissue reinforcement, repair, and reconstruction. The single-layer (1 ply) device is not chemically crosslinked and consists of a naturally woven network of collagen fibers.
The single use device is supplied terminally sterilized via ethylene oxide and is available in a variety of sizes to be trimmed by the physician to meet individual patient needs. The following sizes are provided:
- 4 x 7 cm (thickness 0.40 0.75 mm)
- 5 x 6 cm (thickness 0.75 1.54 mm)
- 6 x 12 cm (thickness 0.75 = 1.54 mm) .
- 8 x 12 cm (thickness 0.40-0.75 mm)
- 8 x 16 cm (thickness 0.75-1.54 mm)
- 10 x 15 cm (thickness 0.75 1.54 mm)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardial, epicardial
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)
The following performance data were provided in support of the substantial equivalence determination:
- Sterilization validation/re-qualification
- EO/ECH residuals per ISO 10993-7
- Packaging validation and shelf-life per ISO 11607-1 and ISO 11607-2
- Device Characterization Testing
- Dimensional verification
- Tensile Strength
- Tensile Stiffness/Elastic Modulus
- Burst Strength
- Suture Pullout Strength
- Cellular Infiltration
- Porosity
- Collagen Denaturation
- Design Validations
- Usability Validation
- GLP Study in an Ovine Model
- The performance and safety of CardiaMend™ Pericardial and Epicardial Reconstruction Matrix was evaluated in an ovine model compared to the predicate device, CorMatrix Pericardial Patch (K051405; marketed as ProxiCor for Pericardial Closure).
- All study objectives were met. The sheep did not exhibit any test article-related abnormalities throughout the study. At the completion of the study, all animals survived and were evaluated as being in excellent health. There were no adverse events in any of the animals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 21, 2021
Helios Cardio Inc. % Roshana Ahmed, President Quaras. LLC 2101 Camino Rey Fullerton, California 92833
Re: K210331
Trade/Device Name: CardiaMend™ Pericardial and Epicardial Reconstruction Matrix Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene Regulatory Class: Class II Product Code: PSO Dated: November 23, 2021 Received: November 24, 2021
Dear Roshana Ahmed:
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.
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/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,
for Rachel Neubrander 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
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Indications for Use
510(k) Number (if known) K210331
Device Name
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix
Indications for Use (Describe)
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.
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
I. Submitter
Helios Cardio Inc. 11 Dellbrook Road Weston MA 02493 Phone: (617) 818-4008 Fax: N/A
Contact Person: Yiannis Monovoukas, President & CEO Date Prepared: December 17, 2021
II. Device
| Device Proprietary Name: | CardiaMend™ Pericardial and Epicardial Reconstruction Matrix |
|---|---|
| Common or Usual Name: | Intracardiac Patch |
| Classification Name: | Intracardiac Patch Or Pledget Made Of Polypropylene, |
| Polyethylene Terephthalate, Or Polytetrafluoroethylene | |
| Regulation Number: | 21 CFR 870.3470 |
| Product Code: | PSQ |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- CorMatrix® Cor Patch, K181038, CorMatrix Cardiovascular, Inc. ●
- CorMatrix Pericardial Patch (currently marketed as ProxiCor for Pericardial Closure by Aziyo Biologics, Inc.), K051405, CorMatrix Cardiovascular, Inc.
The following devices are cited as reference devices within the submission:
- SurgiMend™ Collagen Matrix for Soft Tissue Reconstruction, K071807, TEI Biosciences Inc.
- Durepair Dura Regeneration Matrix, K041000, Medtronic Neurosurgery ●
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Device Description IV.
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a porous acellular matrix derived from fetal bovine dermis designed to provide soft tissue reinforcement, repair, and reconstruction. The single-layer (1 ply) device is not chemically crosslinked and consists of a naturally woven network of collagen fibers.
The single use device is supplied terminally sterilized via ethylene oxide and is available in a variety of sizes to be trimmed by the physician to meet individual patient needs. The following sizes are provided:
- 4 x 7 cm (thickness 0.40 0.75 mm) ●
- 5 x 6 cm (thickness 0.75 1.54 mm) ●
- 6 x 12 cm (thickness 0.75 = 1.54 mm) .
- 8 x 12 cm (thickness 0.40-0.75 mm) ●
- 8 x 16 cm (thickness 0.75-1.54 mm) ●
- 10 x 15 cm (thickness 0.75 1.54 mm) ●
V. Indications for Use
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.
VI. Technological Characteristics
The technological characteristics of CardiaMend™ Pericardial and Epicardial Reconstruction Matrix are substantially equivalent to the cleared CorMatrix® Pericardial Patch (K051405) and CorMatrix Cor Patch (K181038). A comparison of the devices is provided in the table below.
| | CardiaMend™
Pericardial and
Epicardial
Reconstruction
Matrix | CorMatrix® Cor
Patch
(K181038) | CorMatrix
Pericardial Patch
(K051405;
marketed as
ProxiCor for
Pericardial
Closure) | Analysis |
|---------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------|
| Indications for
Use | Pericardial
reconstruction and
repair, and
epicardial support
and repair. | The CorMatrix Cor
Patch is intended for
epicardial tissue
support and repair. | The CorMatrix
Pericardial Patch is
intended for the
reconstruction and
repair of the
pericardium. | Same |
| | CardiaMend™
Pericardial and
Epicardial
Reconstruction
Matrix | CorMatrix® Cor
Patch
(K181038) | CorMatrix
Pericardial Patch
(K051405;
marketed as
ProxiCor for
Pericardial
Closure) | Analysis |
| Reusable or
single use | Rx Only, Single-Use | Rx Only, Single-Use | Rx Only, Single-Use | Same |
| Material Type | Collagen,
Extracellular Matrix | Collagen,
Extracellular Matrix | Collagen, Extracellular
Matrix | Same |
| Animal Tissue
Source | Fetal bovine dermis | Porcine small
intestinal submucosa
(SIS) | Porcine small intestinal
submucosa (SIS) | Different |
| Chemical
Crosslinking | No | No | No | Same |
| Acellular | Yes | Yes | Yes | Same |
| Resorbable | Yes | Yes | Yes | Same |
| Shape | Rectangular sheet | Rectangular sheet | Rectangular sheet | Same |
| Size(s) | ● 4 x 7 cm
● 5 x 6 cm
● 6 x 12 cm
● 8 x 12 cm
● 8 x 16 cm
● 10 x 15 cm | ● 4 x 7 cm
● 7 x 10 cm | ● 7 x 10 cm
● 7 x 15 cm | Different |
| Number of
Layers | Single-ply | Multi-ply | Multi-ply | Different |
| Thickness | 0.4 - 0.75 mm and
0.75 - 1.54 mm | ~0.4 mm | ~0.4 mm * | Different |
| Rehydration | Room temperature
sterile saline | Room temperature
sterile saline | Room temperature
sterile saline | Same |
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | Same |
| Storage | Store dry, at room
temperature | Store dry, at room
temperature | Store dry, at room
temperature | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | Same |
5
*as reported in the literature.
6
As seen in the table above, the primary differences between the subject and predicate device are the animal tissue source, the available product sizes, number of layers, and thickness. These differences do not raise different questions of safety and effectiveness, and substantial equivalence to the predicate devices is demonstrated through verification and validation studies.
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination:
- Sterilization validation/re-qualification ●
- · EO/ECH residuals per ISO 10993-7
- Packaging validation and shelf-life per ISO 11607-1 and ISO 11607-2 ●
- Device Characterization Testing
- o Dimensional verification
- Tensile Strength O
- Tensile Stiffness/Elastic Modulus O
- Burst Strength O
- Suture Pullout Strength O
- Cellular Infiltration O
- O Porosity
- o Collagen Denaturation
- Design Validations ●
- o Usability Validation
- GLP Study in an Ovine Model
- The performance and safety of CardiaMend™ Pericardial and Epicardial O Reconstruction Matrix was evaluated in an ovine model compared to the predicate device, CorMatrix Pericardial Patch (K051405; marketed as ProxiCor for Pericardial Closure).
- All study objectives were met. The sheep did not exhibit any test article-related o abnormalities throughout the study. At the completion of the study, all animals survived and were evaluated as being in excellent health. There were no adverse events in any of the animals.
In addition, existing viral inactivation, sterilization, and biocompatibility data were leveraged from the reference SurgiMend™ Collagen Matrix for Soft Tissue Reconstruction (K071807) device, as the subject and reference devices are identical in material source, thickness, manufacturing, sterilization processes, and packaging.
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VIII. Conclusion
The subject device design was evaluated through biocompatibility, animal studies, and other performance testing to provide evidence of safe and effective use of CardiaMend™ Pericardial and Epicardial Reconstruction Matrix. CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is substantially equivalent to the specified predicate devices based on comparisons of device functionality, technological characteristics, and indications for use.