K Number
K211987
Device Name
ATEC Alignment App
Date Cleared
2021-10-29

(123 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

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)

K141669, K162647

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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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 CodeTrade NameManufacturer
Primary Predicate Device
K141669LLZSurgimap 2.0Nemaris, Inc.
Additional Predicate Device
K162647LLZNuVasive NuvaLine Mobile AppNuVasive, 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 DevicesSubject Device
CharacteristicNemaris SurgimapNuVasive NuvaLineATEC
2.0 (K141669)Mobile App
(K162647)Alignment
App (K211987)Discussion
Indications for
UseThe 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/CodeClass II
LLZ
(21 CFR 892.2050)Class II
LLZ
(21 CFR 892.2050)Class II
LLZ
(21 CFR
892.2050)Same
Device
Classification
NameMedical Image
Management and
Processing SystemMedical Image
Management and
Processing SystemMedical Image
Management and
Processing
SystemSame
Operating
SystemPC: Windows + MAC
Mobile: Android + iOSMobile: Android + iOSMobile: 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.