(168 days)
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No
The device description and performance studies focus on physical properties and volume measurement, with no mention of AI/ML terms or data processing.
No.
The device is a sizer used to determine the appropriate volume and symmetry of mammary implants prior to implantation, not for treating a disease or condition.
No
Explanation: The device is used to determine the appropriate volume and symmetry of mammary implants prior to implantation, which is a pre-surgical sizing aid, not a diagnostic tool for identifying a disease or condition.
No
The device description explicitly states the device is constructed of physical materials (polyurethane) and includes physical components (balloon, tubing, luer lock). It is a physical medical device, not software-only.
Based on the provided information, the GSI, Inc. Mammary Sizer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Mammary Sizer Function: The Mammary Sizer is a physical device used during surgery to help determine the appropriate size of a mammary implant in vivo (within the living body). It is not used to analyze a sample taken from the patient.
- Intended Use: The intended use clearly states it's to "assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation," which is a surgical procedure.
Therefore, the GSI Mammary Sizer falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The GSI Mammary Sizer is designed to be used during plastic and reconstructive surgery when it is desirable to determine the correct volume and/or symmetry of mammary implants prior to implantation. The device is constructed of smooth semi-elastomeric polyurethane. The device consists of a balloon and balloon tubing used for filling the sizer. There is an attachment to prevent fluid leakage and a female luer lock at the proximal end of the filler tube.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
sub-glandular of sub-muscular tissue plane
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing performed to support the appropriateness of the Mammary Sizer for its intended use include biocompatibility, material strength, and volume rating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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N/A
0
General Surgical Innovations, Inc. 3172A Porter Dr. Palo Alto, CA. 94304
SMDA Summary Attachment B
)
510(K) SUMMARY
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA
Summary of Safety and Effectiveness
Contact Person
Theresa M. Nazaroff General Surgical Innovations, Inc. 3172A Porter Dr. Palo Alto, CA 94304
Device Name
Mammary Sizer
Substantial Equivalence and Conclusions
The Mammary Sizer which is proposed for use in the sub-glandular of sub-muscular tissue plane is substantially equivalent to Mentor's Volume Sizer for Mammary Implants that are marketed for use in the area of plastic and reconstructive surgery.
Intended Use
The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.
1
Device Description
The GSI Mammary Sizer is designed to be used during plastic and reconstructive surgery when it is desirable to determine the correct volume and/or symmetry of mammary implants prior to implantation. The device is constructed of smooth semi-elastomeric polyurethane. The device consists of a balloon and balloon tubing used for filling the sizer. There is an attachment to prevent fluid leakage and a female luer lock at the proximal end of the filler tube.
Testing Results and Conclusions
Testing performed to support the appropriateness of the Mammary Sizer for its intended use include biocompatibility, material strength, and volume rating.
Nazareff
Theresa M Nazaroff
General Surgical Innovations, Inc.
March 30, 1996