K Number
K122105
Device Name
SMI CARDIOVASCULAR PATCH
Date Cleared
2012-12-07

(143 days)

Product Code
Regulation Number
870.3470
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.
Device Description
The SMI Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester) fabric covered silicone sheet and with a thin nickel-titanium (nitinol) alloy mesh. It is provided in various sizes and as flat and curved shapes. The SMI Cardiovascular Patch in the flat configuration is 2 cm x 7.5 cm and the following curved sizes: 6, 7, 8, 9, and 10 mm diameters, 4.5 cm length, and 360° arc angle. A manufacturing change was also made to bond the polyester fabric to the silicone.
More Information

No
The device description and performance studies focus on the material properties and mechanical performance of a physical patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is a cardiovascular patch used for anatomical repair, which is a structural device, not a device that provides therapy.

No
Explanation: The device is described as a "Cardiovascular Patch" used for "cardiovascular patching," which is a therapeutic intervention, not a diagnostic one. The performance studies detailed are mechanical tests of the patch itself, not diagnostic performance metrics.

No

The device description clearly states it is comprised of physical components: knitted fabric, silicone sheet, and a nitinol alloy mesh. It is a physical implantable device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "cardiovascular patching." This describes a surgical implant used to repair or reinforce cardiovascular tissue.
  • Device Description: The description details a physical patch made of fabric, silicone, and metal mesh. This is a physical implant, not a device used to examine samples from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SMI Cardiovascular Patch is a therapeutic device used in surgery.

N/A

Intended Use / Indications for Use

The SMI Cardiovascular Patch is intended for cardiovascular patching.
The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.

Product codes

DXZ

Device Description

The SMI Cardiovascular Patch is designed for cardiovascular patching. The SMI Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester) fabric covered silicone sheet and with a thin nickel-titanium (nitinol) alloy mesh. It is provided in various sizes and as flat and curved shapes. The SMI Cardiovascular Patch in the flat configuration is 2 cm x 7.5 cm and the following curved sizes: 6, 7, 8, 9, and 10 mm diameters, 4.5 cm length, and 360° arc angle. A manufacturing change was also made to bond the polyester fabric to the silicone.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The non-clinical test data provided in this submission demonstrated that the SMI Cardiovascular Patch meets the performance specifications. The submission includes bench mechanical testing, including: Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability Tests. These tests demonstrate the SMI Cardiovascular Patch has results that are substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112683

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

Appendix 4: 510(k) Summary per (21CFR807.92)

:

DEC 7 2012

510(k) NumberK122105
Submitter Name and Address
Name:Solinas Medical, Inc.
Contact:Michael Kolber
Consultant, Regulatory Affairs
Address:443 Costa Mesa Terrace, Unit A
Sunnyvale, CA 94085
Telephone:650-793-5015
Fax:408-720-9466
Date Prepared:November 7, 2012
General Device Information
Product Name:SMI Cardiovascular Patch
Common Name:Cardiovascular patch
Classification:21CFR870.3470
Classification NameIntracardiac patch or pledget made of polypropylene,
polyethylene terephthalate, or
polytetrafluoroethylene
Device Class:Class II
Product Code:DXZ
Predicate Device
ManufacturerDevice Name510(k) Number
Solinas Medical Inc.SMI Cardiovascular PatchK112683
Description
The SMI Cardiovascular Patch is designed for cardiovascular patching. The SMI
Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester)
fabric covered silicone sheet and with a thin nickel-titanium (nitinol) alloy mesh. It is
provided in various sizes and as flat and curved shapes. The SMI Cardiovascular Patch in
the flat configuration is 2 cm x 7.5 cm and the following curved sizes: 6, 7, 8, 9, and 10
mm diameters, 4.5 cm length, and 360° arc angle. A manufacturing change was also
made to bond the polyester fabric to the silicone.
Intended Use (Indications)
The SMI Cardiovascular Patch is intended for cardiovascular patching.
Comparison to the Predicate Device
The predicate SMI Cardiovascular Patch includes a curved configuration of 6mm
diameter, 3, 7.5, and 15 cm lengths, and 120° arc angle and flat configuration of 1 and 2
cm width by 3, 7.5, and 15 cm lengths. This submission increases the number sizes
available and implements a manufacturing change to securely bond the polyester fabric

1

Image /page/1/Picture/0 description: The image shows a stylized symbol that resembles two curved arrows facing opposite directions. The arrows are arranged vertically, with the top arrow curving to the right and the bottom arrow curving to the left. The arrows are thick and black, and there are small dots on either side of the symbol.

K122105 for the SMI Cardiovascular November 7.

rather than stitching the fabric to the silicone.

The SMI Cardiovascular Patch has the same intended use and fundamental scientific technology as the predicate device. The technological characteristics of the SM1 Cardiovascular Patch are substantially equivalent to the predicate device including biocompatibility, sterilization, packaging, and labeling. Through bench performance testing it was demonstrated that the additional sizes, dimension changes and manufacturing change does not adversely affect safety and effectiveness.

Summary of Non-clinical Testing

The non-clinical test data provided in this submission demonstrated that the SMI Cardiovascular Patch meets the performance specifications. The submission includes bench mechanical testing, including: Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability Tests. These tests demonstrate the SMI Cardiovascular Patch has results that are substantially equivalent to the predicate device.

Statement of Equivalence

The SMI Cardiovascular Patch has the same indications for use and the same technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device and the predicate device have been shown to be substantially equivalent.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The logo is printed in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 7 2012

Solinas Medical, Inc. C/O James Hong 443 Costa Mesa Terrace Sunnyvale, CA 94089

Re: K122105

Trade/Device Name: SMI Cardiovascular Patch 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: DXZ Dated: November 07, 2012 Received: November 08, 2012

Dear Mr. Hong:

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. 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.

3

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

for

Sincerely vours.

Kenneth J. Cavanaugh

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510(k) for the Solinas Medical, Inc. SMI Cardiovascular Patch July 16, 2012

Indications for Use

510(k) Number (if known): _

Device Name: Solinas Medical, Inc. SMI Cardiovascular Patch

Indications for Use: The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) NumberK122105

Page 26