(143 days)
The SMI Cardiovascular Patch is intended for cardiovascular patching.
The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated 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.
The provided text describes a medical device, the SMI Cardiovascular Patch, and its 510(k) submission for regulatory clearance. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. However, it does not contain the detailed information required to answer all parts of your request, particularly regarding clinical studies, AI performance, ground truth establishment for AI, or multi-reader multi-case studies.
Here's an analysis of what information can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not explicitly state quantitative "acceptance criteria" alongside specific numerical "reported device performance." Instead, it broadly states that the device "meets the performance specifications" and has "results that are substantially equivalent to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet performance specifications (unspecified quantitative values) | Demonstrated to meet performance specifications. |
| Substantially equivalent to predicate device for tensile strength | Results are substantially equivalent to the predicate device. |
| Substantially equivalent to predicate device for burst strength | Results are substantially equivalent to the predicate device. |
| Substantially equivalent to predicate device for suture pullout | Results are substantially equivalent to the predicate device. |
| Substantially equivalent to predicate device for water permeability | Results are substantially equivalent to the predicate device. |
| Manufacturing change does not adversely affect safety and effectiveness | Bench performance testing demonstrated the manufacturing change does not adversely affect safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests mentioned are "bench mechanical testing," which implies physical samples of the device, not patient data. Therefore, data provenance, retrospective/prospective nature, and country of origin are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. As this is a 510(k) for a physical medical patch based on bench testing, the concept of "experts establishing ground truth" for test sets of clinical data is not applicable here. The "ground truth" for these tests would be the measurement standards and testing protocols themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for bench mechanical testing. Adjudication methods are typically associated with clinical studies involving interpretation of medical images or patient outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, human readers, or AI in the provided text. This submission pertains to a physical cardiovascular patch, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of any algorithm-only or standalone performance testing, as the device is a physical cardiovascular patch and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical (bench) testing, the "ground truth" would be the established physical and mechanical properties measured according to standardized test methods (e.g., ASTM standards for tensile strength, burst strength, etc.). There is no mention of expert consensus, pathology, or outcomes data, as these are clinical ground truths.
8. The sample size for the training set
There is no mention of a training set, as this submission is for a physical medical device and not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
{0}------------------------------------------------
Appendix 4: 510(k) Summary per (21CFR807.92)
:
DEC 7 2012
| 510(k) Number | K122105 | |
|---|---|---|
| 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 Name | Intracardiac patch or pledget made of polypropylene, | |
| polyethylene terephthalate, or | ||
| polytetrafluoroethylene | ||
| Device Class: | Class II | |
| Product Code: | DXZ | |
| Predicate Device | ||
| Manufacturer | Device Name | 510(k) Number |
| Solinas Medical Inc. | SMI Cardiovascular Patch | K112683 |
| 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) Number | K122105 |
Page 26
§ 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).