(98 days)
EarliPoint System K230337
Not Found
Yes
The device description explicitly states that "Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD."
No.
The device is indicated as a diagnostic tool for Autism Spectrum Disorder and provides developmental delay indices; it does not provide any form of therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD)". Additionally, the "Device Description" states that the system "outputs a diagnosis of the patient's ASD status".
No
The device description explicitly states that the system includes an "Eye-tracking module and a separate Operator Module" which are hardware components used to capture patient data. While software is used for analysis, the system is not solely software.
Based on the provided information, the EarliPoint System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The EarliPoint System analyzes the patient's behavior (eye-tracking data) while they are viewing videos. It does not analyze blood, urine, tissue, or any other biological sample.
- The device description focuses on eye-tracking and behavioral analysis. The input is eye-tracking data, and the analysis is based on how the patient visually responds to stimuli.
- The intended use is to aid in the diagnosis of ASD based on behavioral responses. This is a behavioral assessment tool, not a test that analyzes biological markers.
While the device provides a diagnosis and uses software analysis, the fundamental nature of the input data (eye-tracking of visual behavior) places it outside the definition of an In Vitro Diagnostic.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP)' section explicitly states 'Not Found'.
Intended Use / Indications for Use
The EarliPoint System device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months, who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.
Product codes (comma separated list FDA assigned to the subject device)
QPF
Device Description
The EarliPoint system uses an eye tracker to capture the patient's looking behavior while viewing a series of videos. The system then remotely analyzes the looking behavior data using software and outputs a diagnosis of the patient's ASD status and associated developmental delay indicies.
The EarliPoint System device consists of the following:
• Eye-tracking module and a separate Operator Module that can control the Eye-tracking module remotely. The patient sits on a chair and the Eye-tracking module is adjusted by the operator such that the patient's eyes are within the specification of the eye tracking window.
• Eye-tracking module captures the patient visual response to social information provided in the form of a series of age-appropriate videos.
• Operator's module is used to initiate and monitors the session remotely
• WebPortal securely stores all patient information, analyzes the eye tracking data, and outputs the results. Users can retrieve the results directly from the web-portal.
• Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 developmental delay indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments Social Disability Index correlates and proxies ADOS-2 Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD.
Input Imaging Modality
Not Found
Anatomical Site
Eyes (eye-tracking)
Indicated Patient Age Range
16 months through 30 months
Intended User / Care Setting
Qualified clinicians.
The EarliPoint System in the predicate device was indicated for use in specialized developmental disabilities centers. While this is not explicitly stated for the subject device, the subject device is stated to be substantially equivalent to the predicate.
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
The pivotal study was a prospective, double-blind, multi-center, within-subject comparison where 500 patients from six sites in the United States were enrolled, of which 475 were evaluable for primary and secondary endpoint analysis and 25 patients had missing data of the device or the control diagnosis (standard of care).
All patients were evaluated for ASD by both the EarliPoint system and by expert clinician diagnosis (current best practice for diagnosis of ASD) to evaluate the sensitivity and specificity of the EarliPoint System diagnosis relative to the expert clinical diagnosis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Studies: The safety and effectiveness of the EarliPoint System in collecting eye tracking data and analyzing the data for the diagnosing the presence of ASD was evaluated in a pivotal study where patients were diagnosed by the device as well and expert clinicians (reference standard). The pivotal study was a prospective, double-blind, multi-center, within-subject comparison where 500 patients from six sites in the United States were enrolled, of which 475 were evaluable for primary and secondary endpoint analysis and 25 patients had missing data of the device or the control diagnosis (standard of care). All patients were evaluated for ASD by both the EarliPoint system and by expert clinician diagnosis (current best practice for diagnosis of ASD) to evaluate the sensitivity and specificity of the EarliPoint System diagnosis relative to the expert clinical diagnosis. The study also correlated the three EarliPoint Severity.
Mechanical/Electrical Safety and Electromagnetic Compatibility (EMC): Mechanical/electrical safety and EMC testing were conducted on the EarliPoint device. The EarliPoint device is classified as Class I for protection against electric shock with Type B applied part and is intended for continuous mode of operation. Compliance testing shows that the EarliPoint device complies with all the applicable tests of IEC 60601-1 standard for mechanical/electrical safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation: Software verification and validation testing were successfully completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
EarliPoint (mITD) N=475: Sensitivity 71% (157/221), 95% CI 64.6% - 76.9%; Specificity 80.7% (205/254), 95% CI 75.3% - 85.4%
EarliPoint CertainDx (Clinicians are Certain of Diagnosis only) N=335: Sensitivity 78.0% (117/150), 95% CI 70.5%, 84.3%; Specificity 85.4% (158/185), 95% CI 79.5% - 90.2%
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.
EarliPoint System K230337
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
§ 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.
(a)
Identification. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis and assessment of patient behavioral symptomology.
(2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a detailed, technical description of the algorithm(s) used to generate device output(s), and a cybersecurity assessment of the impact of threats and vulnerabilities on device functionality and user(s).
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Labeling must include:
(i) Instructions for use, including a detailed description of the device, compatibility information, and information to facilitate clinical interpretation of all device outputs; and
(ii) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of patient behavioral symptomology associated with Autism Spectrum Disorder. The summary must include the following:
(A) A description of each device output and clinical interpretation;
(B) Any performance measures, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV);
(C) A description of how the cutoff values used for categorical classification of diagnoses were determined; and
(D) Any expected or observed adverse events and complications.
(iii) A statement that the device is not intended for use as a stand-alone diagnostic.
0
March 26, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem of the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The emblem features a stylized depiction of an eagle or other bird-like figure. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.
EarliTec Diagnostics, Inc. % Amy Wolbeck Regulatory Consultant ROM+ 2790 Mosside Blvd. Monroeville, Pennsylvania 15146
Re: K243891
Trade/Device Name: EarliPoint System Regulation Number: 21 CFR 882.1491 Regulation Name: Pediatric Autism Spectrum Disorder Diagnosis Aid Regulatory Class: Class II Product Code: OPF Dated: February 21, 2025 Received: February 24, 2025
Dear Amy Wolbeck:
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.
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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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
Device Name
EarliPoint
Indications for Use (Describe)
The EarliPoint System device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months, who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.
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
| 510(k) Information | |
|---|---|
| 510(k) Number | |
| 510(k) Type | Special 510(k) |
| Date Prepared | 18 December 2024 |
| Submitter Information | |
| 510(k) Submitter: | Ryan Bormann, Director of Quality and Operations |
| EarliTec Diagnostics, Inc. | |
| 13895 Industrial Park Blvd, Suite 140 | |
| Tel:+1-833-504-9937 | |
| Email: rbormann@earlitecdx.com | |
| Primary Correspondent: | Amy Wolbeck |
| Regulatory Consultant | |
| RQM+ | |
| 2790 Mosside Blvd. | |
| Monroeville, PA 15146 | |
| Tel:+1-707-291-3457 | |
| Email: awolbeck@rqmplus.com | |
| EarliPoint System Device Information | |
| Trader Name (Common Name): | EarliPoint System Device |
| Device Classification Name | Pediatric Autism Spectrum Disorder Diagnostic Aid |
| Classification Regulation: | 21 CFR 882.1491 |
| Class: | II |
| Panel: | Neurology Devices Panel |
| Product Code: | QPF |
| Predicate Device | EarliPoint System K230337 |
| Device Description | The EarliPoint system uses an eye tracker to capture the patient's |
| looking behavior while viewing a series of videos. The system then | |
| remotely analyzes the looking behavior data using software and | |
| outputs a diagnosis of the patient's ASD status and associated | |
| developmental delay indicies. | |
| The EarliPoint System device consists of the following: | |
| • Eye-tracking module and a separate Operator Module that can | |
| control the Eye-tracking module remotely. The patient sits on a | |
| chair and the Eye-tracking module is adjusted by the operator | |
| such that the patient's eyes are within the specification of the | |
| eye tracking window. | |
| • Eye-tracking module captures the patient visual response to | |
| social information provided in the form of a series of age- | |
| appropriate videos. | |
| • Operator's module is used to initiate and monitors the session | |
| remotely | |
| • WebPortal securely stores all patient information, analyzes the | |
| eye tracking data, and outputs the results. Users can retrieve | |
| the results directly from the web-portal. | |
| • Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 | |
| developmental delay indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments Social Disability Index correlates and proxies ADOS-2 Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score | |
| Intended Use | The EarliPoint System is intended for use by healthcare providers to objectively diagnose and assess children for ASD using software algorithm to analyze a child's response to an external stimulus in the form of videos. |
| Indications for Use | The EarliPoint System device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months, who are at risk based on concerns identified by a parent, caregiver, or healthcare provider. |
| EarliPoint System Nonclinical and Clinical Data (unchanged from predicate device) | |
| Performance Testing | EarliPoint was verified to meet the electrical safety standards and the software were designed and tested per IEC 62304. |
| Mechanical/Electrical Safety and | |
| Electromagnetic Compatibility | |
| (EMC) | Mechanical/electrical safety and EMC testing were conducted on the EarliPoint device. The EarliPoint device is classified as Class I for protection against electric shock with Type B applied part and is intended for continuous mode of operation. Compliance testing shows that the EarliPoint device complies with all the applicable tests of IEC 60601-1 standard for mechanical/electrical safety and the IEC 60601-1-2 standard for EMC. |
| Software Verification and | |
| Validation | Software verification and validation testing were successfully completed. |
| Clinical Studies | The safety and effectiveness of the EarliPoint System in collecting eye tracking data and analyzing the data for the diagnosing the presence of ASD was evaluated in a pivotal study where patients were diagnosed by the device as well and expert clinicians (reference standard). |
The pivotal study was a prospective, double-blind, multi-center, within-subject comparison where 500 patients from six sites in the United States were enrolled, of which 475 were evaluable for primary and secondary endpoint analysis and 25 patients had missing data of the device or the control diagnosis (standard of care).
All patients were evaluated for ASD by both the EarliPoint system and by expert clinician diagnosis (current best practice for diagnosis of ASD) to evaluate the sensitivity and specificity of the EarliPoint System diagnosis relative to the expert clinical diagnosis. The study also correlated the three EarliPoint Severity |
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6
| Population | Sensitivity
Mean (n/N)
95% CI | Specificity
Mean (n/N)
95% CI |
|-----------------------------------------------------------------------------------|-------------------------------------|-------------------------------------|
| EarliPoint (mITD)
N=475 | 71% (157/221)
64.6% - 76.9% | 80.7% (205/254)
75.3% - 85.4% |
| EarliPoint CertainDx
(Clinicians are
Certain of Diagnosis
only)
N=335 | 78.0% (117/150)
70.5%, 84.3% | 85.4% (158/185)
79.5% - 90.2% |
SUBSTANTIAL EQUIVALENT COMPARISON
| Device
Characteristic | Predicate Device K230337
EarliPoint System | Subject Device
EarliPoint System |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The EarliPoint System is intended for use
by healthcare providers to objectively
diagnose and assess children for ASD
using software algorithm to analyze a
child's response to an external stimulus in
the form of videos. | Same as predicate |
| Indications for
Use | The EarliPoint System is indicated for
use in specialized developmental
disabilities centers as a tool to aid
clinicians in the diagnosis and assessment
of ASD patients ages 16 months through
30 months. | The EarliPoint System device is indicated
as a tool to aid qualified clinicians in the
diagnosis and assessment of Autism
Spectrum Disorder (ASD) in children
ages 16 months through 30 months, who
are at risk based on concerns identified
by a parent, caregiver, or healthcare
provider. |
| Prescription Use | Yes | Same as predicate |
| Product Code and | QPF | Same as predicate |
| Regulation
Number | 882.1491 | Same as predicate |
| Device
Components | • Eye-tracking module captures the
patient visual response to social
information provided in the form of a
series of age-appropriate videos.
• Operator's module is used to initiate
and monitor the session remotely | Same as predicate |
7
| Device
Characteristic | Predicate Device K230337
EarliPoint System | Subject Device
EarliPoint System | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------|
| | WebPortal securely stores all patient information, analyzes the eye tracking data, and outputs the results. Users can retrieve the results directly from the web-portal. Software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 developmental delay indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments | | | |
| | ASD Diagnosis | | Use software algorithm to analyze the eye tracking data for ASD diagnosis ad assessment | Same as predicate |
| | Electrical Safety
Testing | | Meets electrical safety standards per: IEC 60601-1:2005/AMD1:2012/AMD2:2020 IEC 60601-1-2:2014/AMD1:2020 | Same as predicate |
| | Software | | Compliant to ISO 62304 | Same as predicate |
| | Clinical data | | Pivotal trials provide safety and effectiveness data. | Same as predicate |
| | Risk level of the
device | | Low risk device, non-invasive | Same as predicate |
CONCLUSION
Both devices have the same intended use and technological characteristics. The clarifications made to the indications for use statement do not impact the safety and effectiveness of the device. The conclusions drawn from the nonclinical studies have not been impacted by this clarification in the indications for use statement. Hence, the subject device is substantially equivalent to the predicate device.