(90 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 designed for cardiovascular patching. The SMI Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester) fabric covered silicone sheet reinforced with a thin sheet of polyester embedded in the silicone and optionally with a thin nickel-titanium (nitinol) alloy mesh. It is provided in various sizes and as flat and curved sheets.
The Solinas Medical, Inc. SMI Cardiovascular Patch is a physical device intended for cardiovascular patching, not a software device or AI algorithm. Therefore, the questions related to AI/algorithm performance metrics, sample sizes for training/test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing absolute performance acceptance criteria for a novel device. The "acceptance criteria" here are implicitly tied to demonstrating mechanical properties comparable to existing, legally marketed devices.
| Acceptance Criteria (Implicit - based on predicate device performance) | Reported Device Performance |
|---|---|
| Mechanical properties (Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability) substantially equivalent to predicate devices (W.L. Gore & Associates, Inc. ACUSEAL Cardiovascular Patch, Meadox Medicals, Inc. Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch, C.R. Bard DeBakey Elastic Knit Fabric, Teleflex, Inc. Cottony Silky II Polydeck Tevdek) | "Mechanical testing, including: Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability Tests, demonstrates the applicant device has strength values that are substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the mechanical tests. The data provenance is not explicitly mentioned, but it would have been generated from laboratory testing of the SMI Cardiovascular Patch.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable (N/A). The "ground truth" for the mechanical properties of a physical device is established through standardized laboratory testing, not by expert consensus or interpretation in the way it applies to AI/image analysis.
4. Adjudication Method for the Test Set
N/A. This concept is not applicable to the mechanical testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. MRMC studies are typically used for evaluating diagnostic imaging systems or AI software where human interpretation is involved. This is a physical cardiovascular patch.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating the device's performance was based on the objective measurements of its mechanical properties (Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability) against the established performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
N/A. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
N/A. This is a physical medical device, not an AI model.
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DEC 1 4 2011
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510(k) for the Solinas Medical, Inc SMI Cardiovascular Patch
510(k) Summary (per 21CFR807.92)
| General Company Information | ||
|---|---|---|
| Name: | Solinas Medical, Inc. | |
| Contact: | James Hong | |
| President and CEO | ||
| Address: | 443 Costa Mesa Terrace, Unit A | |
| Sunnyvale, CA 94085 | ||
| Telephone: | 650-793-5015 | |
| Fax: | 408-720-9466 | |
| Date Prepared: | September 13, 2011 | |
| General Device Information | ||
| Product Name: | SMI Cardiovascular Patch | |
| Common Name: | Cardiovascular patch | |
| Classification: | 21CFR870.3470 | |
| Device Class: | The SMI Cardiovascular Patch has not yet been | |
| classified. Based on FDA's classification of this | ||
| type of device, the SMI Cardiovascular Patch | ||
| should be classified as a class II device. | ||
| Product Code: | DXZ | |
| Predicate Devices | ||
| Manufacturer | Device Name | 510(k) Number |
| W.L. Gore & Associates, Inc. | ACUSEAL | K984526 |
| Cardiovascular Patch | ||
| Meadox Medicals, Inc. | Hemashield Finesse | K962342 |
| Ultra-thin Knitted | ||
| Cardiovascular Patch | ||
| C.R. Bard | DeBakey Elastic Knit | Pre-amendment |
| Fabric | device | |
| Teleflex, Inc. | Cottony Silky II PolydeckTevdek | K021019 |
| 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 reinforced with a thin sheet of polyester | ||
| embedded in the silicone and optionally with a thin nickel-titanium (nitinol) alloy | ||
| mesh. It is provided in various sizes and as flat and curved sheets. | ||
| Intended Use (Indications) | ||
| The SMI Cardiovascular Patch is intended for cardiovascular patching. | ||
| Substantial Equivalence | ||
| The SMI Cardiovascular Patch is substantially equivalent to currently marketed | ||
| cardiovascular patch devices. Mechanical testing, including: Tensile Strength, | ||
| Burst Strength, Suture Pullout, and Water Permeability Tests, demonstrates the |
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applicant device has strength values that are substantially equivalent to the predicate devices.
Conclusions & Conclusions
Solinas Medical, Inc. believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate devices and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to predicate devices the SMI Cardiovascular Patch has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 4 2011
Solinas Medical, Inc. c/o Michael Kolbe 443 Costa Mesa Terrace Sunnyvale, CA 94085
Re: K112683
Trade/Device Name: SMI Cardiovascular Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polvethylene terephthalate, or polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: September 13, 2011 Received: September 15, 2011
Dear Mr. Kolbe:
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.
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Page 2 – Mr. Michael Kolbe
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 Pat 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 tollifilife (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. G. Hillemann
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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_k 112683
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§ 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).