(267 days)
Not Found
Yes
The device description explicitly states that a logistic regression model was used to calculate the risk stratification, and this model was developed using a database of patient data. Logistic regression is a common machine learning algorithm.
No
The device is an assessment tool designed to provide deformity measurements and risk stratification for scoliosis, not to treat or cure a condition.
Yes
The device is intended as an "adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations" and "calculates the risk of having clinically significant scoliosis." This directly aligns with the definition of a diagnostic device, which is used to identify a condition or aid in the diagnosis of a disease.
Yes
The device description explicitly states it "leverages 3D scanning on a mobile device" and "generates a 3D scan of the individual using a mobile device camera." While it uses a mobile device as a platform, the core medical device functionality (generating the 3D scan, analyzing asymmetry, calculating the Asymmetry Index, and performing risk stratification) is described as software running on that device. The predicate device also appears to be a system that includes hardware for surface topography, but the description of the proposed device focuses on the software's function using a standard mobile device camera.
Based on the provided information, this device 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.
- Device Function: The NSite Scoliosis Assessment App uses a 3D scan of the surface of the patient's back to assess asymmetry and predict the likelihood of clinically significant scoliosis. It does not analyze any biological samples taken from the body.
- Input Modality: The input modality is "Surface Topography - structured light projection," which is a non-invasive imaging technique applied to the external surface of the body.
Therefore, since the device operates on external body surface data rather than biological samples, it falls outside the definition of an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The relevant section is marked "Not Found".
Intended Use / Indications for Use
The NSite Scoliosis Assessment App is intended as an adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations based on a calculated Asymmetry Index for patients with or at risk for idiopathic scoliosis, which will yield an output of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees.
Product codes (comma separated list FDA assigned to the subject device)
LDK
Device Description
NSite Medical leverages 3D scanning on a mobile device for scoliosis screening and monitoring. NSite's proprietary algorithm calculates the risk of having clinically significant scoliosis that may require treatment by a specialist.
The NSite Scoliosis Assessment App generates a 3D scan of the individual using a mobile device camera. Using the 3D scan, the application analyzes the asymmetry of the individual's back surface and calculates an Asymmetry Index (AI). The Asymmetry Index is a quantitative measure of the back asymmetry. The Asymmetry Index is then used to calculate a high/low risk stratification that a patient will have clinically significant scoliosis (defined as Cobb angle > 20 degrees) using a logistic regression model. This risk stratification, when considered in combination with the stated NSite Scoliosis Assessment App performance, is intended to provide health care providers with information that can be used for management recommendations. The model was developed using a database of patient Asymmetry Indexes with known Cobb angles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface Topography - structured light projection
Anatomical Site
Back surface
Indicated Patient Age Range
The clinical study was performed using adolescent patients spanning the age range where Adolescent Idiopathic Scoliosis (AIS) commonly presents and remains treatable.
Child / Adolescent age 10-18
Intended User / Care Setting
Intended_Users: Health care medical professionals, such as primary care providers, pediatricians, orthopaedic surgeons, physical therapists, orthotists, school nurses, and chiropractors.
Environment: Health care facilities
Description of the training set, sample size, data source, and annotation protocol
The model was developed using a database of patient Asymmetry Indexes with known Cobb angles.
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)
A clinical study of the NSite Scoliosis Assessment App was conducted to assess the reproducibility and reliability of the scanning functionality and validate the accuracy of the predicated probability of major Cobb angle as compared to a Cobb angle obtained via radiograph. The clinical study was performed using adolescent patients spanning the age range where Adolescent Idiopathic Scoliosis (AIS) commonly presents and remains treatable. The clinical study was performed using adolescents of gender and race at ratios where AIS is commonly observed. The clinical study demonstrated that the NSite Scoliosis Assessment App is safe and effective for its intended use, substantially equivalent to the currently cleared predicate device (K923792), and raises no new questions of safety and effectiveness.
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.
K923792 - Quantec Image Processing Ltd. Quantec Spinal Measurement System
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 is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2023
NSite, Inc. Michael Gardner, MD Co-Founder & CEO 821 Stanford Ave. Menlo Park, California 94025
Re: K230463
Trade/Device Name: NSite Scoliosis Assessment App Regulatory Class: Unclassified Product Code: LDK Dated: October 16, 2023 Received: October 17, 2023
Dear Dr. Gardner:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230463
Device Name NSite Scoliosis Assessment App
Indications for Use (Describe)
The NSite Scoliosis Assessment App is intended as an adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations based on a calculated Asymmetry Index for patients with or at risk for idiopathic scoliosis, which will yield an output of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees.
| 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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4
Image /page/4/Picture/0 description: The image shows a logo for NSITE. The logo features a stylized icon of three interconnected shapes stacked vertically, resembling a molecule or network. The icon is enclosed within a square frame with a gradient color scheme, transitioning from teal at the top to blue at the bottom. Below the icon, the word "NSITE" is written in a bold, sans-serif font, also with a gradient color scheme.
510(k) Summary
| Date Prepared: | November 14, 2023 |
|---|---|
| Submitter: | NSite, Inc. |
| 821 Stanford Ave. | |
| Menlo Park, CA 94025 | |
| Contact: | Michael J. Gardner, MD |
| Co-Founder & CEO | |
| NSite, Inc. | |
| 917-584-6909 | |
| mike@nsitemedical.com | |
| Proprietary Name: | NSite Scoliosis Assessment App |
| Common Name: | Optical Contour Sensing Device |
| Classification: | Unclassified, Pre-Amendment |
| Product Code: LDK | |
| Review Panel: | Physical Medicine |
| Substantially | |
| Equivalent Device: | K923792 - Quantec Image Processing Ltd. Quantec Spinal |
| Measurement System |
Device Description:
NSite Medical leverages 3D scanning on a mobile device for scoliosis screening and monitoring. NSite's proprietary algorithm calculates the risk of having clinically significant scoliosis that may require treatment by a specialist.
The NSite Scoliosis Assessment App generates a 3D scan of the individual using a mobile device camera. Using the 3D scan, the application analyzes the asymmetry of the individual's back surface and calculates an Asymmetry Index (AI). The Asymmetry Index is a quantitative measure of the back asymmetry. The Asymmetry Index is then used to calculate a high/low risk stratification that a patient will have clinically significant
5
Image /page/5/Picture/0 description: The image is a logo for NSITE. The logo features a square frame with rounded corners, inside of which is a stack of three interconnected shapes resembling molecules or stylized links. The frame and the stacked shapes are rendered in a gradient that transitions from teal at the top to a deep blue-purple at the bottom. Below the frame is the word "NSITE" in a sans-serif font, also rendered in the same teal-to-purple gradient.
scoliosis (defined as Cobb angle > 20 degrees) using a logistic regression model. This risk stratification, when considered in combination with the stated NSite Scoliosis Assessment App performance, is intended to provide health care providers with information that can be used for management recommendations. The model was developed using a database of patient Asymmetry Indexes with known Cobb angles.
Indications for Use:
The NSite Scoliosis Assessment App is intended as an adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations based on a calculated Asymmetry Index for patients with or at risk for idiopathic scoliosis, which will yield an output of low or high risk of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees.
Comparison of Technological Characteristics:
The proposed NSite Scoliosis Assessment App and its predicate device, Quantec Spinal Measurement System (K923792), are similar with regards to their intended use, clinical indications, principle of operation and fundamental technology. In conclusion, NSite, Inc. believes that the NSite Scoliosis Assessment App does not introduce any new potential safety and/or effectiveness issues and is comparable to the identified predicate device, Quantec Spinal Measurement System (K923792).
| Characteristic | Proposed Device
NSite, Inc.
NSite Scoliosis
Assessment App
(K230463) | Predicate Device
Quantec Image Processing
Ltd.
Quantec Spinal
Measurement System
(K923792) | Similarities
and
Differences |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Unclassified | Unclassified | Identical |
| Regulation | Unclassified | Unclassified | Identical |
| Product Code | LDK | LDK | Identical |
| Prescription | Yes | No | Difference –
Both devices
are intended to |
| Characteristic | Proposed Device
NSite, Inc.
NSite Scoliosis
Assessment App
(K230463) | Predicate Device
Quantec Image Processing
Ltd.
Quantec Spinal
Measurement System
(K923792) | Similarities
and
Differences |
| | | | be used by
health care
professionals.
The restriction
to use the
proposed NSite
Scoliosis
Assessment
App by
prescription
only does not
raise new
questions of
safety and
effectiveness. |
| Indications
for Use | The NSite Scoliosis
Assessment App is
intended as an adjunct tool
for qualified healthcare
professionals to provide
deformity measurements
and guide management
recommendations based on
a calculated Asymmetry
Index for patients with or at
risk for idiopathic scoliosis,
which will yield an output of
low or high risk of clinically
significant scoliosis, which
is defined as a Cobb Angle
greater than 20 degrees. | Quantec Spinal
Measurement System is
indicated as an optical
contour sensing device to
provide topographical
images for the 3D
assessment of back
asymmetries. | Similar
Both devices
are intended to
be used by
health care
professionals.
Both devices
are optical
sensing devices
intended to
generate 3D
surface images
of a patient's
back and trunk
and quantify
surface
alignment and
deformity
parameters. |
| Patient
Population | Child / Adolescent age 10-
18 | Adult or pediatric
populations | Similar - Both
devices include
pediatric
patients in their
intended use. |
| Characteristic | Proposed Device
NSite, Inc.
NSite Scoliosis
Assessment App
(K230463) | Predicate Device
Quantec Image Processing
Ltd.
Quantec Spinal
Measurement System
(K923792) | Similarities
and
Differences |
| Intended
Users | Health care medical
professionals, such as
primary care providers,
pediatricians, orthopaedic
surgeons, physical
therapists, orthotists,
school nurses, and
chiropractors. | Health specialists such as
podiatrists, pedorthists,
orthopedist,
physiotherapists,
chiropractors, osteopaths,
and kinesiotherapists. | Similar - Both
devices are
intended to be
used by health
care
professionals. |
| Environment | Health care facilities | Health care facilities | Identical |
| Technique | Surface Topography -
structured light projection | Surface Topography -
structured light projection | Identical |
| Method | Non-Tactile | Non-Tactile | Identical |
| Measurement | Static | Static | Identical |
| Principle of
Operation | Based upon TrueDepth
vertical-cavity surface-
emitting laser (VCSEL)
technology scanning
technology, the image is
obtained with iOS mobile
device camera. | Based upon digital
photogrammetry | Similar - Both
devices utilize
digital cameras
to obtain patient
images |
| Hardware
Component | None - The NSite Scoliosis
Assessment App is a
software only device.
The minimum mobile
device hardware
requirements are defined in
the IFU. | Digital Camera;
Quartz halogen light
Booth | Similar - Both
devices operate
on compatible
hardware, the
NSite Scoliosis
Assessment
App is installed
on user
supplied
hardware. |
| Software | Software provides user
interface to acquire images,
identify regions of interest,
perform asymmetry
calculations, report
asymmetry results and
patient scan images. | Software to control the
camera, measure the 3D
trunk images and to record
and quantify deformities
(3D assessment) | Similar - Both
devices utilize
software to
analyze images
and report
deformity
values. |
| Characteristic | Proposed Device
NSite, Inc.
NSite Scoliosis
Assessment App
(K230463) | Predicate Device
Quantec Image Processing
Ltd.
Quantec Spinal
Measurement System
(K923792) | Similarities
and
Differences |
| Use of Body
Markers | No | Yes | Difference -
The proposed
device is
manually
segmented.
Once the 3D
mesh is
annotated, the
scan points are
automatically
measured and
the Asymmetry
Index and heat
map is
calculated and
reported.
The predicate
device features
body markers
the user places
in specified
locations to
help identify
and reference
anatomical
landmarks in
the
photographs.
The annotation
method and
proposed
device results
have been
demonstrated
to perform
substantially
equivalent to
the predicate
device method. |
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Image /page/6/Picture/0 description: The image shows a logo for NSITE. The logo features a square frame with rounded corners, colored in a gradient from teal to purple. Inside the frame is a stylized graphic of three vertically stacked, interconnected shapes resembling molecules or interconnected nodes. The word "NSITE" is written in a bold, sans-serif font below the frame, also colored in the same teal-to-purple gradient.
7
Image /page/7/Picture/1 description: The image is a logo for NSITE. The logo features a square frame with rounded corners, and the frame is colored with a gradient that transitions from teal at the top to purple at the bottom. Inside the frame is a symbol that looks like three interconnected molecules or beads stacked vertically. The symbol is also colored with a gradient that transitions from teal at the top to purple at the bottom. Below the frame, the word "NSITE" is written in a bold, sans-serif font, and the word is also colored with a gradient that transitions from teal at the top to purple at the bottom.
8
Image /page/8/Picture/0 description: The image shows a logo for NSITE. The logo features a stylized image of three vertically stacked, rounded shapes, each connected by a small dot in the center. The shapes are enclosed within a square frame. Below the frame, the word "NSITE" is written in a bold, sans-serif font. The logo uses a gradient color scheme, transitioning from a lighter blue at the top to a darker blue at the bottom.
9
Image /page/9/Picture/0 description: The image is a logo for NSITE. The logo features a square border with rounded corners, inside of which is a stylized image of three vertically stacked, connected shapes that resemble molecules or interconnected nodes. The word "NSITE" is written in capital letters below the square border. The color scheme of the logo transitions from a teal color at the top to a blue color at the bottom.
The general intended use and technology are equivalent between the predicate and the NSite Scoliosis Assessment App. The predicate device is not limited to use by prescription, whereby the proposed NSite Scoliosis Assessment App in intended to be used by prescription only. Further, the NSite Scoliosis Assessment App is intended to be used by healthcare professionals. The restriction to the use of the proposed NSite Scoliosis Assessment App does not raise new questions of safety and effectiveness. The difference in technology is that the predicate quantifies related alignment and deformity parameters that corresponds to given anatomical markers placed by the user, whereas the NSite Scoliosis Assessment App quantifies surface alignment and deformity parameters that correspond to manually segmented regions of interest (ROIs). The method was found to be appropriate and reproducible for its intended use per a clinical study.
Non-Clinical Testing Summary:
The following design control, risk management and quality assurance methodologies were utilized to develop the NSite Scoliosis Assessment App:
- . Risk Analysis
- Requirements Review .
- . Design Reviews
- Testing on Unit Level (Verification) .
- . Integration Testing (System Verification)
- Performance Testing (V&V) .
- Safety Testing (V&V) .
- . Simulated Use Testing (Validation)
Software documentation for Moderate Level of Concern software per the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005, was established and maintained for the NSite Scoliosis Assessment App. The NSite Scoliosis Assessment App was tested in accordance with NSite's verification and validation procedures.
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Image /page/10/Picture/0 description: The image shows a logo for NSITE. The logo features a stylized icon of three vertically stacked, rounded shapes resembling connected molecules or links. The icon is enclosed within a square frame, and the word "NSITE" is written in a bold font below the icon. The color scheme transitions from a teal at the top to a purple at the bottom.
All predefined acceptance criteria for the performance testing were met. The results from the performance testing executed on the NSite Scoliosis Assessment App produced results consistently according to its intended use.
Clinical Testing Summary:
A clinical study of the NSite Scoliosis Assessment App was conducted to assess the reproducibility and reliability of the scanning functionality and validate the accuracy of the predicated probability of major Cobb angle as compared to a Cobb angle obtained via radiograph. The clinical study was performed using adolescent patients spanning the age range where Adolescent Idiopathic Scoliosis (AIS) commonly presents and remains treatable. The clinical study was performed using adolescents of gender and race at ratios where AIS is commonly observed. The clinical study demonstrated that the NSite Scoliosis Assessment App is safe and effective for its intended use, substantially equivalent to the currently cleared predicate device (K923792), and raises no new questions of safety and effectiveness.
Conclusions Drawn from Non-Clinical and Clinical Tests:
The subject device and the predicate devices are substantially equivalent, with respect to intended use, design features, technological characteristics, performance, and safety and effectiveness. The subject device is substantially equivalent to the predicate device, K923792.
Conclusion:
The non-clinical and clinical software testing performed on the NSite Scoliosis Assessment App demonstrates that the NSite Scoliosis Assessment App performs according to its intended use. NSite, Inc. considers the NSite Scoliosis Assessment App (subject device) to be similar to the legally marketed predicate device, K923792, and is as safe and effective as the predicate device without raising any new safety and/or effectiveness concerns.