(387 days)
Not Found
No
The description focuses on electronic detection and display, with no mention of AI/ML terms, data sets, or complex algorithms typically associated with AI/ML.
No.
The device is strictly for locating the ports of a tissue expander and does not directly treat a medical condition or restore function.
No.
The device is described as a port detection device that externally locates subcutaneous ports of an implanted tissue expander to enable filling or draining, not to diagnose a medical condition or disease.
No
The device description explicitly states it is a "battery-operated standalone port detection device" and an "electronic handheld injection port detector device," indicating it is a physical hardware device with embedded software, not a software-only device.
Based on the provided information, the Sientra Portfinder is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Portfinder's Function: The Portfinder is an external device that locates subcutaneous ports of an implanted medical device (tissue expander). It does not interact with or analyze any biological specimens from the patient. Its function is purely to aid in the physical location of a component of an implanted device.
- Intended Use: The intended use clearly states it's for locating ports to enable fill or use of a drain system, not for diagnostic purposes based on biological samples.
Therefore, the Sientra Portfinder falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Portfinder is intended to be used by clinicians in medical settings such as hospitals and medical clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Mentor Corp. Mentor injection Port Detector (K963066)
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.
Not Found
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).
Not Found
N/A
0
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
1
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 650 | |
| Irvine, California 92612 | |
| Contact: | Denise Dajles |
| SVP R&D, Regulatory and Quality | |
| Sientra, Inc. | |
| 949-739-9255 | |
| denise.dajles@sientra.com | |
| Proprietary Name: | Portfinder |
| Common Name: | Injection Port Detector |
| Classifications: | Unclassified (pre-amendment) |
| Product Code: LCJ | |
| Classification Panel: | General & Plastic Surgery |
| Substantially | |
| Equivalent 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.
4
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
5
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 | Proposed
Sientra, Inc.
Portfinder
(K221127) | Predicate
Mentor 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 a
battery-operated standalone
port detection device that is
intended for use with the
Sientra AlloX2 Pro and
Dermaspan Tissue
Expanders.
The Portfinder will locate the
port(s) subcutaneously,
enabling fill of the tissue
expander or use of the drain
system.
The enclosed device is
nonsterile and for
postoperative use only. | The Mentor H/S Injection Port
detector is used to detect
Mentor Tissue Expander
remote and integral injection
ports.
The device is nonsterile and
for postoperative use only. |
| Intended Use | The Portfinder can be used to
detect and locate Sientra
AlloX2 Pro and Dermaspan
Tissue Expander
subcutaneous fill and drain
ports. | The detector can be used to
detect Mentor tissue expander
standard remote and integral
injection ports. |
| Sterility | Supplied nonsterile / not
sterilizable | Supplied nonsterile / not
sterilizable |
| Reuse | Multi-patient use, cleaned and
disinfection prior to use using
a 70% IPA wipe. | Multi-patient use, cleaned and
disinfection prior to use with
IPA swab or antibacterial
soap and water. The device
cannot be immersed in liquid
or allow liquid to enter the
device. |
| Contraindications | Dermaspan or AlloX2 Pro
subcutaneous ports implanted | Mentor integral injection ports
implanted more than 2" and |
| Characteristic | Proposed
Sientra, Inc.
Portfinder
(K221127) | Predicate
Mentor 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 | Proposed
Sientra, Inc.
Portfinder
(K221127) | Predicate
Mentor Corp.
Injection Port Detector
(K963066) |
| | detect the center of the
magnetic field.
The sensors operate as
analog transducers, directly
returning a voltage. Using
groups of sensors, the relative
position of the magnet is
displayed on the screen and
the screen displays when the
center of the port has been
located. | the injection port, inducing a
current in the coils. LED
display indicated when center
of 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 Sientra
AlloX2 Pro and Dermaspan
Tissue Expander integral
injection ports | Detector locates Mentor
tissue expander integral
injection ports and standard
remote injection ports |
| Location Modes | Fill
Drain (AlloX2 Pro only) | Fill |
| User Interface | Display screen on handheld
device
Image: FILL AlloX2 Pro screen 1
Image: FILL AlloX2 Pro screen 2 | Directional arrows that
illuminate
Image: Injection Port Detector arrows 1
Image: Injection Port Detector arrows 2 |
| Detection Indicator | Position cursor (indicator) will
be concentric with the target
at the screen center. The
position cursor and center
target will turn green to
indicate successful alignment
with the desired tissue
expander port. | Directional arrows rotating
when detection in progress.
When complete, all direction
arrows stop and turn green. |
| Marking of Port
Location | Portfinder features two
methods for marking the port
location.
Option 1: Skin Marking
Feature | Detector features a Skin
Marking Plunger for marking
the port location. Using the
button on the top of the
device, the plunger is |
| Characteristic | Proposed
Sientra, Inc.
Portfinder
(K221127) | Predicate
Mentor Corp.
Injection Port Detector
(K963066) |
| | The feature is depressed into
the tissue and removed; the
center of the cross is then
marked with a skin marking
pen.
Image: Portfinder | depressed into the skin and
leaves a circular mark which
can be marked with skin
marker or immediately
injected through.
Image: Injection Port Detector |
| | Option 2: Perimeter Marking
Notches
The skin is marked at the
apex of each of the three
perimeter notches on the
Portfinder. Perpendicular lines
are drawn with a skin marker
to mark the port center
location.
Image: Perimeter Marking Notches | |
| Patient Contacting
Materials | Device outer case, button and
charging base case injection
molded from Avient Mevopur-
White NC0M820283
(Avient blend of Makrolon
2458 and Eggshell colorant) | Unknown plastic |
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Image /page/6/Picture/0 description: The image shows the word "sientra." in a gray, sans-serif font. There is a small orange dot above the "i" in "sientra.". The word is slightly blurred, suggesting it may be a logo or brand name. The background is plain white.
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Image /page/7/Picture/0 description: The image shows the word "sientra." in a sans-serif font. The word is gray, except for a small orange dot above the "i". The dot is slightly offset to the right.
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Image /page/8/Picture/0 description: The image shows the word "sientra." in a sans-serif font. The letters are gray, and there is an orange dot above the "i" in "sientra."
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
9
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.