(387 days)
The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders.
The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system.
The enclosed device is nonsterile and for postoperative use only.
The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander. The Portfinder is intended to locate the fill and drain ports of the Sientra AlloX2 Pro Breast Tissue Expanders (AlloX2 Pro) and fill port of the Sientra OPUS Dermaspan Breast Tissue Expanders (Dermaspan); enabling the user to mark the location of the ports for subsequent fill and drain of the respective tissue expander.
The Portfinder contains an LCD screen that displays the location of the intended port (drain or fill port). A single button of the Portfinder is used to power on/off and change modes.
The Portfinder housing has features to temporarily indent the port location on the surface of the skin or use a skin marker to mark the port location.
The Portfinder is intended to be used by clinicians in medical settings such as hospitals and medical clinics. It can be disinfected between uses for multi-patient reuse.
The provided document does not contain detailed information about the acceptance criteria or a specific study proving the device meets those acceptance criteria. However, it does mention "Design verification tests were performed on the Portfinder as a result of the risk analysis and product requirements" and "Software Verification and Validation testing was performed on Portfinder".
Without the full details of these verification and validation tests, it's not possible to populate all the requested fields comprehensively. The document explicitly states that clinical testing was not necessary to demonstrate substantial equivalence, which means the study described would likely be bench testing.
Based on the available information, here is a summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Locates subcutaneous ports of implanted tissue expanders for Sientra AlloX2 Pro and Dermaspan | Device externally locates subcutaneous ports of implanted tissue expanders (AlloX2 Pro and Dermaspan) |
| LCD screen displays port location | LCD screen displays the location of the intended port (drain or fill port) |
| Single button for power on/off and mode change | Single button used to power on/off and change modes |
| Ability to temporarily indent or mark port location | Housing features to temporarily indent or mark port location |
| Software Safety & Effectiveness: | |
| Meets safety and effectiveness for a "moderate level of concern" software (avoiding minor injury due to erroneous diagnosis or delayed care) | Software Verified and Validated in accordance with IEC 62304:2006/A1:2016 for safety and effectiveness |
| Disinfection & Reuse: | |
| Multi-patient use with disinfection capability | Can be disinfected between uses for multi-patient reuse (using 70% IPA wipe) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "Design verification tests" and "Software Verification and Validation testing."
- Data provenance: Not specified. These would be laboratory-based verification and validation data, likely from internal testing at Sientra, Inc.
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. Since clinical testing was not performed, "experts" in the context of establishing clinical ground truth (e.g., radiologists) would not be applicable here. Ground truth would likely be based on engineering specifications and direct measurement/observation in a lab setting.
4. Adjudication method for the test set
- Not specified. Given the nature of bench and software testing, a formal adjudication process like 2+1 or 3+1 would not typically be used. Testing would likely involve comparing device output against known inputs or expected behaviors.
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
- No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of Portfinder to the predicate device." The device is a port detector, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a form of standalone performance was assessed. The "Software Verification and Validation testing" and "Design verification tests" would evaluate the device's performance independently, without human interaction in a clinical setting, to ensure it met its operational requirements. The device itself is described as a "standalone port detection device."
7. The type of ground truth used
- Engineering specifications and known physical properties/measurements. For functional testing, ground truth would be established by the known location of the tissue expander ports in test setups. For software testing, the ground truth would be defined by the expected behavior and outputs based on software requirements.
8. The sample size for the training set
- Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The software mentioned is likely embedded control software, not a learning algorithm.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 10, 2023
Sientra, Inc. Denise Dajles SVP R&D, Regulatory and Quality 420 South Fairview Avenue Suite 200 Santa Barbara, California 93117
Re: K221127
Trade/Device Name: Sientra, inc. Portfinder Regulatory Class: Unclassified Product Code: LCJ Dated: April 17, 2023 Received: April 20, 2023
Dear Denise Dajles:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Deborah A. Fellhauer -S
Deborah Fellhauer RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221127
Device Name Portfinder
Indications for Use (Describe)
The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders.
The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system.
The enclosed device is nonsterile and for postoperative use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared: | May 10, 2023 |
|---|---|
| Submitter: | Sientra, Inc.3333 Michelson Dr. Suite 650Irvine, California 92612 |
| Contact: | Denise DajlesSVP R&D, Regulatory and QualitySientra, Inc.949-739-9255denise.dajles@sientra.com |
| Proprietary Name: | Portfinder |
| Common Name: | Injection Port Detector |
| Classifications: | Unclassified (pre-amendment)Product Code: LCJ |
| Classification Panel: | General & Plastic Surgery |
| SubstantiallyEquivalent Device: | Mentor Corp. Mentor injection Port Detector (K963066) |
Intended Use / Indications:
The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders.
The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system.
The enclosed device is nonsterile and for postoperative use only.
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sientra.
Device Description:
The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander. The Portfinder is intended to locate the fill and drain ports of the Sientra AlloX2 Pro Breast Tissue Expanders (AlloX2 Pro) and fill port of the Sientra OPUS Dermaspan Breast Tissue Expanders (Dermaspan); enabling the user to mark the location of the ports for subsequent fill and drain of the respective tissue expander.
The Portfinder contains an LCD screen that displays the location of the intended port (drain or fill port). A single button of the Portfinder is used to power on/off and change modes.
The Portfinder housing has features to temporarily indent the port location on the surface of the skin or use a skin marker to mark the port location.
The Portfinder is intended to be used by clinicians in medical settings such as hospitals and medical clinics. It can be disinfected between uses for multi-patient reuse.
Image /page/4/Picture/7 description: The image shows a medical device with several labeled features. The device has a white plastic body with a rounded head and a long handle. The head of the device has 3X perimeter marking notches, a skin marking feature, and an LCD display. The handle has an on/off/select button and a micro USB charging input.
Substantial Equivalence Discussion:
The proposed Portfinder and its predicate device, Mentor Corp. Mentor Injection Port Detector (K963066), are similar in regards to their intended use, clinical indications, principle of operation and fundamental technology. Sientra concludes that the
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sientra.
Portfinder does not introduce any new potential safety and/or effectiveness issues and is substantially equivalent to the identified predicate device, Mentor Injection Port Detector (K963066).
| Characteristic | ProposedSientra, Inc.Portfinder(K221127) | PredicateMentor Corp.Injection Port Detector(K963066) |
|---|---|---|
| Regulatory | ||
| Regulation Number | N/A | N/A |
| Regulation Name | N/A | N/A |
| Regulatory Class | Unclassified (pre-amendment) | Unclassified (pre-amendment) |
| Product Code | LCJ | LCJ |
| Common Name | Expander, Skin, Inflatable | Expander, Skin, Inflatable |
| Indications for Use | The Sientra Portfinder is abattery-operated standaloneport detection device that isintended for use with theSientra AlloX2 Pro andDermaspan TissueExpanders.The Portfinder will locate theport(s) subcutaneously,enabling fill of the tissueexpander or use of the drainsystem.The enclosed device isnonsterile and forpostoperative use only. | The Mentor H/S Injection Portdetector is used to detectMentor Tissue Expanderremote and integral injectionports.The device is nonsterile andfor postoperative use only. |
| Intended Use | The Portfinder can be used todetect and locate SientraAlloX2 Pro and DermaspanTissue Expandersubcutaneous fill and drainports. | The detector can be used todetect Mentor tissue expanderstandard remote and integralinjection ports. |
| Sterility | Supplied nonsterile / notsterilizable | Supplied nonsterile / notsterilizable |
| Reuse | Multi-patient use, cleaned anddisinfection prior to use usinga 70% IPA wipe. | Multi-patient use, cleaned anddisinfection prior to use withIPA swab or antibacterialsoap and water. The devicecannot be immersed in liquidor allow liquid to enter thedevice. |
| Contraindications | Dermaspan or AlloX2 Prosubcutaneous ports implanted | Mentor integral injection portsimplanted more than 2" and |
| Characteristic | ProposedSientra, Inc.Portfinder(K221127) | PredicateMentor Corp.Injection Port Detector(K963066) |
| more than 40mm or less than 5mm below the surface of the skin cannot be located accurately with this device.The use of the Portfinder in these situations is contraindicated. | standard remote injection ports implanted more than 1.4" below the surface of the skin cannot be located accurately with this device.The use of the detector in these situations is contraindicated. | |
| The use of the Portfinder near a magnetic field may interfere with the device. It may be necessary to move the interfering equipment farther away or move the patient to another room in order to properly use the device. | The use of the detector near an electromagnetic field may interfere with device tuning. It may be necessary to move the interfering equipment farther away or move the patient to another room in order to properly use the device. | |
| The use of the Portfinder is not recommended in patients with metallic or magnetic devices located internally or externally near the subcutaneous port. | The use of the detector is not recommended in patients with metallic or magnetic devices located internally or externally near the injection port. | |
| Configuration and Accessories | ||
| Accessory to tissue expander | Portfinder is an accessory to Sientra AlloX2 Pro and Dermaspan Tissue Expanders | The detector is an accessory to Mentor tissue expanders |
| Included components to detector | Charging base and cord is included | No accessories included |
| Technological Characteristics | ||
| Hand-held | Yes | Yes |
| Battery Powered | Yes | Yes |
| Rechargeable | Yes - charging base or via charging port on handheld device | No - replaceable 9V battery |
| Software Controlled | Yes | Yes |
| Operating Principle | Array of magnetometers used as hall effect sensors to | Electromechanical coils detect changes in magnetic field. |
| Characteristic | ProposedSientra, Inc.Portfinder(K221127) | PredicateMentor Corp.Injection Port Detector(K963066) |
| detect the center of themagnetic field.The sensors operate asanalog transducers, directlyreturning a voltage. Usinggroups of sensors, the relativeposition of the magnet isdisplayed on the screen andthe screen displays when thecenter of the port has beenlocated. | the injection port, inducing acurrent in the coils. LEDdisplay indicated when centerof port has been located. | |
| Self-calibrating | Yes - when powered on,mode screen will appear | Yes - when powered on,indicator turns green |
| Compatible Ports | Portfinder will locate SientraAlloX2 Pro and DermaspanTissue Expander integralinjection ports | Detector locates Mentortissue expander integralinjection ports and standardremote injection ports |
| Location Modes | FillDrain (AlloX2 Pro only) | Fill |
| User Interface | Display screen on handhelddeviceImage: FILL AlloX2 Pro screen 1Image: FILL AlloX2 Pro screen 2 | Directional arrows thatilluminateImage: Injection Port Detector arrows 1Image: Injection Port Detector arrows 2 |
| Detection Indicator | Position cursor (indicator) willbe concentric with the targetat the screen center. Theposition cursor and centertarget will turn green toindicate successful alignmentwith the desired tissueexpander port. | Directional arrows rotatingwhen detection in progress.When complete, all directionarrows stop and turn green. |
| Marking of PortLocation | Portfinder features twomethods for marking the portlocation.Option 1: Skin MarkingFeature | Detector features a SkinMarking Plunger for markingthe port location. Using thebutton on the top of thedevice, the plunger is |
| Characteristic | ProposedSientra, Inc.Portfinder(K221127) | PredicateMentor Corp.Injection Port Detector(K963066) |
| The feature is depressed intothe tissue and removed; thecenter of the cross is thenmarked with a skin markingpen.Image: Portfinder | depressed into the skin andleaves a circular mark whichcan be marked with skinmarker or immediatelyinjected through.Image: Injection Port Detector | |
| Option 2: Perimeter MarkingNotchesThe skin is marked at theapex of each of the threeperimeter notches on thePortfinder. Perpendicular linesare drawn with a skin markerto mark the port centerlocation.Image: Perimeter Marking Notches | ||
| Patient ContactingMaterials | Device outer case, button andcharging base case injectionmolded from Avient Mevopur-White NC0M820283(Avient blend of Makrolon2458 and Eggshell colorant) | Unknown plastic |
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Bench Testing:
Design verification tests were performed on the Portfinder as a result of the risk analysis and product requirements. Sientra has determined that the modifications have no impact on the safety and effectiveness of the device.
Software Verification and Validation testing was performed on Portfinder, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software is considered as a "moderate level of concern" since a
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sientra
failure or latent design flaw could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. The Verification and Validation testing was performed in accordance with IEC 62304:2006/A1:2016 to assess the safety and effectiveness of the device, via system level testing.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of Portfinder to the predicate device.
Overall Conclusion:
Based on the information presented in this submission, Sientra concludes that Portfinder is substantially equivalent to the predicate devices in regard to indications, principles of operation, and technological characteristics. Additionally, verification and validation tests demonstrate the safety and efficacy of the device to meet its intended use and specifications. Sientra believes that the proposed device, Portfinder, is substantially equivalent to the identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.
N/A