(123 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep learning or neural networks. The description focuses on standard image viewing, measurement, and storage functionalities.
No
The device is a software for planning orthopedic surgeries and measuring spinopelvic parameters, not for directly treating or diagnosing a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The app is for planning use only and is not intended for primary diagnostic use."
Yes
The device description explicitly states it is a "standalone software" for viewing, measuring, and storing x-ray images and performing measurements from images taken with the "device's camera". While it uses images from a camera, the device itself is described as software.
Based on the provided information, the ATEC Alignment App is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ATEC Alignment App's Function: The ATEC Alignment App works with x-ray images, which are external imaging data, not specimens taken from the body. Its purpose is to assist healthcare professionals in viewing, measuring, and planning orthopedic surgeries based on these images.
- Intended Use Statement: The "Intended Use / Indications for Use" explicitly states that the app is for "planning use only and is not intended for primary diagnostic use." While it provides measurements that can inform clinical decisions, it doesn't perform a diagnostic test on a biological sample.
Therefore, the ATEC Alignment App falls under the category of a medical device software used for image processing and surgical planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATEC Alignment App assists healthcare professionals in viewing, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.
Product codes
LLZ
Device Description
The ATEC Alignment App is intended for use by trained healthcare professionals as a standalone software for viewing, measuring, and storing of x-ray images. The app is a medical device software used to measure spinopelvic parameters from patient x-rays images taken with the device's camera. These measured parameters provide a quantifiable way to assess a patient's spinal deformity and correction correlated to health-related quality of life (HRQOL) scores based on published literature. Clinical judgment and experience are required to properly use the software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray images
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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
Performance testing confirmed that the app accurately measures angles from x-ray images, and that resultant values are displayed properly with correct color-coded range. Angle measurements were verified within ± 2° accuracy. Validation testing was performed to confirm that the graphical user interface (GUI) and that data system features function as intended. A direct comparison test between the ATEC Alignment App and the Surgimap device using the same clinically representative images was conducted which concluded that the performance between the two devices was similar.
Key Metrics
Angle measurements were verified within ± 2° accuracy.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 29, 2021
Alphatec Spine, Inc. David Gramse Sr. Director, Regulatory Affairs 1950 Camino Vida Roble CARLSBAD CA 92008
Re: K211987
Trade/Device Name: ATEC Alignment App Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 30, 2021 Received: October 1, 2021
Dear David Gramse:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 mediation-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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K211987
Device Name ATEC Alignment App
Indications for Use (Describe)
The ATEC Alignment App assists healthcare professionals in viewing, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.
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 of Safety and Effectiveness
(21 CFR 807.92)
| I. | SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|----|-----------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | David Gramse
Sr. Director, Regulatory Affairs
Contact Phone: (760) 494-6711 |
Date Summary Prepared: June 25, 2021
II. DEVICE
Name of Device: | ATEC Alignment App |
---|---|
510(k) Number: | K211987 |
Common or Usual Name: | Medical Image Management and Processing System |
Classification Name: | Medical Image Management and Processing System |
(21 CFR 892.2050) | |
Regulatory Class: | Class II |
Product Code: | LLZ |
LEGALLY MARKETED PREDICATE DEVICES III.
510(k) | Product Code | Trade Name | Manufacturer |
---|---|---|---|
Primary Predicate Device | |||
K141669 | LLZ | Surgimap 2.0 | Nemaris, Inc. |
Additional Predicate Device | |||
K162647 | LLZ | NuVasive NuvaLine Mobile App | NuVasive, Inc. |
IV. DEVICE DESCRIPTION
The ATEC Alignment App is intended for use by trained healthcare professionals as a standalone software for viewing, measuring, and storing of x-ray images. The app is a medical device software used to measure spinopelvic parameters from patient x-rays images taken with the device's camera. These measured parameters provide a quantifiable way to assess a patient's spinal deformity and correction correlated to health-related quality of life (HRQOL) scores based on published literature. Clinical judgment and experience are required to properly use the software.
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V. INDICATIONS FOR USE
The ATEC Alignment App assists healthcare professionals in viewing, measuring, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject ATEC Alignment App were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
Predicate Devices | Subject Device | |||
---|---|---|---|---|
Characteristic | Nemaris Surgimap | NuVasive NuvaLine | ATEC | |
2.0 (K141669) | Mobile App | |||
(K162647) | Alignment | |||
App (K211987) | Discussion | |||
Indications for | ||||
Use | The Surgimap software | |||
assists healthcare | ||||
professionals in | ||||
viewing, storing, and | ||||
measuring images as | ||||
well as planning | ||||
orthopedic surgeries. | ||||
The device allows | ||||
service providers to | ||||
perform generic as well | ||||
as specialty | ||||
measurements of the | ||||
images, and to plan | ||||
surgical procedures. | ||||
The device also | ||||
includes tools for | ||||
measuring anatomical | ||||
components for | ||||
placement of surgical | ||||
implants, and offer | ||||
online synchronization | ||||
of the database with the | ||||
possibility to share data | ||||
among Surgimap users. | ||||
Clinical judgment and | ||||
experience are required | ||||
to properly use the | ||||
software. | The NuVasive | |||
NuvaLine Mobile App | ||||
is a medical device | ||||
software mobile | ||||
application intended to | ||||
assist healthcare | ||||
professionals in | ||||
capturing, measuring, | ||||
and storing spinal | ||||
alignment assessment | ||||
images at various time | ||||
points in patient care. | ||||
The device allows the | ||||
healthcare professional | ||||
to conveniently perform | ||||
and review spinal | ||||
alignment assessments | ||||
of images by featuring | ||||
measurement tools on | ||||
their mobile device. | The ATEC | |||
Alignment App | ||||
assists healthcare | ||||
professionals in | ||||
viewing, | ||||
measuring, and | ||||
storing images as | ||||
well as planning | ||||
orthopedic | ||||
surgeries. The | ||||
device allows the | ||||
healthcare | ||||
professional to | ||||
perform generic | ||||
and specialty | ||||
measurements of | ||||
the images, and | ||||
to plan surgical | ||||
procedures. The | ||||
device offers the | ||||
possibility to | ||||
share data | ||||
among ATEC | ||||
Alignment App | ||||
users. | Similar to Surgimap | |||
— the only difference | ||||
is that the subject | ||||
device does not | ||||
include tools for | ||||
measuring | ||||
anatomical | ||||
components for | ||||
implant selection. | ||||
This difference does | ||||
not affect substantial | ||||
equivalence to the | ||||
predicate. | ||||
Same as NuvaLine | ||||
Regulatory | ||||
Class/Code | Class II | |||
LLZ | ||||
(21 CFR 892.2050) | Class II | |||
LLZ | ||||
(21 CFR 892.2050) | Class II | |||
LLZ | ||||
(21 CFR | ||||
892.2050) | Same | |||
Device | ||||
Classification | ||||
Name | Medical Image | |||
Management and | ||||
Processing System | Medical Image | |||
Management and | ||||
Processing System | Medical Image | |||
Management and | ||||
Processing | ||||
System | Same | |||
Operating | ||||
System | PC: Windows + MAC | |||
Mobile: Android + iOS | Mobile: Android + iOS | Mobile: Android |
- iOS | Similar to Surgimap
— the subject device
is limited to use on
mobile phones (iOS
and Android). This
difference does not
affect substantial
equivalence to the
predicate. |
| Software
Functionalities /
Modalities | Spinal alignment
assessments of images | Spinal alignment
assessments of images | Spinal alignment
assessments of
images | Same as NuvaLine
Similar |
| Provides
Normative Values
for Measurement
Comparison | Yes | Yes | Yes | Same |
| Includes user-
defined circles for
anatomical
location of
femoral head for
sagittal
measurements | Yes | Yes | Yes | Same |
| Includes user-
defined lines for
identification of
endplates for
sagittal and
coronal
measurements | Yes | Yes | Yes | Same |
| Provides color-
coded
measurement
results to display
variance from the
defined norm | Yes | Yes | Yes | Same |
| Algorithms | Patient parameters and
calculations based on
published literature | Lumbar Algorithm (PT,
PI-LL, SVA)
Cervical Algorithm
(TPA,
TS-CL, CSVA) | Patient
parameters and
calculations
based on
published
literature | Same |
| User Interface | PC or mobile device | Mobile device | Mobile device | Similar to Surgimap
- the subject device
is limited to use on |
| | | | | mobile phones (iOS
and Android). This
difference does not
affect substantial
equivalence to the
predicate. |
| | | | | Same as NuvaLine |
| Obtaining an
image | Transferred from other
devices, or mobile
device camera | Mobile Device Camera | Transferred from
other devices, or
mobile device
camera | Same |
| Sharing an
image | Email | None | Email/QR Code | Same |
| Human
Intervention for
interpretation
and
manipulation of
images | Required | Required | Required | Same |
| Control of life-
saving devices | None | None | None | Same |
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VII. PERFORMANCE DATA
The ATEC Alignment App was subjected to verification and validation testing in accordance with the functional requirements. Performance testing confirmed that the app accurately measures angles from x-ray images, and that resultant values are displayed properly with correct color-coded range. Angle measurements were verified within ± 2° accuracy. Validation testing was performed to confirm that the graphical user interface (GUI) and that data system features function as intended. A direct comparison test between the ATEC Alignment App and the Surgimap device using the same clinically representative images was conducted which concluded that the performance between the two devices was similar.
The results demonstrate that the subject ATEC Alignment App is substantially equivalent to Surgimap 2.0 (K141669) and the NuvaLine Mobile App (K162647) and verifies that the subject device meets design specifications and performance characteristics based upon its intended use.
Clinical Information
Not applicable: determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission. it has been determined that the subject device is substantially equivalent to the legally marketed primary predicate
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device (Surgimap 2.0, K141669) based on intended use, design, functionality, performance testing and other key technological characteristics.