(30 days)
The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastection of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer identical to the predicate device (K241918). Again, identical to the predicate device, the subject device contains superior and anterior reinforcement which allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with self-sealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet. This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.
This FDA 510(k) premarket notification is for the Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander, which is a medical device for breast reconstruction. The submission is specifically to expand the lower limit fill volume of the device from 930cc to 850cc, aligning it with a predicate device (K152496).
Based on the provided text, here's a description of the acceptance criteria and the study that demonstrates the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test | Acceptance Criteria | Reported Device Performance | Study Proving Performance |
|---|---|---|---|---|
| Biocompatibility | All materials used in the device | Materials identical to predicate device (K241918) which has established biocompatibility. | All patient contact materials are identical to the predicate device with fill volumes from 930cc-1445cc. No new biocompatibility testing was warranted. | Not explicitly described as a new study for this submission; relies on previous testing of the predicate device. |
| Mechanical Performance | Overexpansion and Bladder Leakage | Meet pre-determined acceptance criteria based on ASTM F1441-03 at a label fill volume of 1445cc. | Previous testing on the predicate CPX™4 PLUS Enhance expander (K241918) with fill volumes 930cc to 1445cc demonstrated ability to meet pre-determined mechanical performance testing requirements at a volume up to and including 1445cc. | Relies on previous mechanical testing performed on the predicate device (K241918) which was at the worst-case highest fill volume. No new mechanical testing was conducted for this submission. |
| Puncture Integrity | Self-sealing technology (BUFFERZONE™) | Minimize and/or prevent leakage in the event of an accidental needle puncture. | The device incorporates a BUFFERZONE™ area with self-sealing technology to minimize and/or prevent leakage. Filling is achieved via an integral injection dome with needle guard. | Not explicitly described as a new study for this submission; is a design feature identical to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
No new test set was used for this 510(k) submission. The submission relies on the established performance of the predicate device (K241918) and the equivalence of the materials and design. The change is solely to expand the lower limit of the fill volume range.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no new clinical or performance test set was described for this specific submission. The submission leverages the prior clearance of predicate devices, which would have undergone their own testing and validation processes.
4. Adjudication Method for the Test Set:
Not applicable, as no new test set requiring expert adjudication was described for this specific submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not a diagnostic imaging AI algorithm that would typically be evaluated with MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable, as this is a physical medical device (breast tissue expander), not an algorithm or AI software.
7. The Type of Ground Truth Used:
For the original predicate device clearances on which this submission relies, the ground truth for mechanical performance would have been established through objective measurement of physical properties and performance benchmarks (e.g., pressure testing, leak testing) according to ASTM standards. Biocompatibility ground truth would be established through established biological evaluation tests based on ISO 10993.
8. The Sample Size for the Training Set:
Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.
Summary of the Study Proving the Device Meets Acceptance Criteria for this specific 510(k):
The submission for the Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander with fill volumes from 850cc to 1445cc does not describe new studies or new acceptance criteria. Instead, it presents a special 510(k) where the core argument for meeting acceptance criteria is that:
- Identical Technology and Materials: The proposed device has the same scientific technology, principles of operation, intended use, indications for use, and all patient contact materials as the cleared predicate device (K241918).
- Worst-Case Mechanical Testing Already Performed: Previous mechanical testing on the predicate device (K241918) was conducted at the maximum labeled fill volume of 1445cc. This volume represents the "worst case" for overexpansion and bladder leak testing, as it results in the most internal pressure.
- No Impact of Lower Fill Volume: Reducing the lower limit fill volume from 930cc to 850cc does not adversely affect the mechanical performance (overexpansion and bladder leak) already demonstrated at the worst-case 1445cc. Therefore, no new mechanical testing was deemed necessary.
- Established Biocompatibility: Since all patient contact materials are identical to the predicate device, which has already established biocompatibility, no new biocompatibility testing was required for this submission.
In essence, the "study" proving the device meets acceptance criteria for this particular submission is the analysis of device equivalence and the justification that prior testing on the predicate device at its most challenging parameters (highest fill volume) sufficiently covers the slightly expanded range offered by the subject device (lower fill volume).
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