(98 days)
None
Not Found
No
The description focuses on converting a user's prism prescription into fixed digital image adjustment parameters based on standardized tolerances (ISO 8980-1:2017). There is no mention of learning, adaptation, or algorithms that change based on data, which are characteristic of AI/ML.
No
The device is solely intended to provide digital image adjustments to fulfill the prism part of an eyeglass prescription, aiming for a high-quality visual experience, not to treat, diagnose, cure, or prevent any disease or condition.
No
The DPCF is described as software that provides digital image adjustments in accordance with a user's existing prism prescription, fulfilling the prism part of an eyeglass prescription. It does not diagnose a condition or derive a new prescription.
Yes
The device is explicitly described as "software that is intended to provide digital image adjustments" and the validation testing focuses on the software's ability to meet prism tolerance requirements, not on the hardware of the Apple Vision Pro itself. While it operates within the Apple Vision Pro, the device being regulated is the software feature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The Digital Prism Correction Feature (DPCF) is software that adjusts digital images within a spatial computing device (Apple Vision Pro) to correct for a user's prism prescription. It directly affects the visual experience of the user based on their known prescription, not by analyzing biological samples.
- Intended Use: The intended use is to provide digital image adjustments for users with prism prescriptions to improve their visual experience within the device. This is a form of visual correction, not a diagnostic test.
- Device Description: The description clearly states it's software that converts a prescription into digital image adjustments. There is no mention of analyzing biological samples or diagnosing any condition.
The DPCF is a feature designed to improve the user's visual comfort and clarity within the Apple Vision Pro based on a pre-existing medical prescription. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription.
DPCF is available for users with prism in their eyeglass prescription. When a prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro.
DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e., base-up, base-down, base-in, base-out), per eye.
Product codes
SCW
Device Description
The Digital Prism Correction Feature (DPCF) is intended to provide a high quality visual experience in Apple Vision Pro spatial computing applications for users with a prism prescription. Specifically, the DPCF is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription, in the horizontal and/or vertical dimensions. DPCF fulfills the prism part of an eyeglass prescription. When an eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), DPCF fulfills the prism part of the prescription, while prescription optical inserts fulfill the other parts of the prescription.
The DPCF achieves its intended use by converting a user's prism prescription into digital image adjustment parameters that are utilized by the spatial computing image system to automatically provide digital image adjustments in horizontal and/or vertical dimensions in accordance with a user's prism prescription. At this time, DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e. base-down, base-in, base-out), per eye.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Users in need of prism correction.
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
Non-clinical testing was conducted, including software verification and validation and bench validation testing. Software verification and validation followed Apple's quality system and FDA's "Content of Premarket Submissions for Device Software Functions" guidance, with DPCF determined to be a Basic Documentation Level. Bench validation testing demonstrated that DPCF provides prismatic adjustments that meet ISO 8980-1:2017 prism tolerance requirements for both virtual and digital passthrough content, and performs as intended with and without optical inserts. The general purpose spatial computing platform (Apple Vision Pro) was assessed, and its impact on DPCF was determined to be acceptable. No clinical testing data was submitted.
Key Metrics
Not Found
Predicate Device(s)
21 CFR 886.1655
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1655 Ophthalmic Fresnel prism.
(a)
Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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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 & Human Services logo. To the right of that is the FDA logo, which 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.
October 21, 2024
Ian Marcus Regulatory Affairs Apple Inc. One Apple Park Way Cupertino, CA 95014
Re: K242058
Trade/Device Name: Digital Prism Correction Feature (DPCF) Regulation Number: 21 CFR 886.1655 Regulation Name: Ophthalmic Fresnel Prism Regulatory Class: Class I Product Code: SCW Dated: July 12, 2024 Received: September 10, 2024
Dear Ian Marcus:
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.
1
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.
2
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,
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242058
Device Name Digital Prism Correction Feature (DPCF)
Indications for Use (Describe)
The Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription.
DPCF is available for users with prism in their eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro.
DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e., baseup, base-down, base-in, base-out), per eye.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
1. Submitter
| Applicant | Apple Inc.
One Apple Park Way
Cupertino, CA 95014 |
|-----------------------------|--------------------------------------------------------------------------------------------------|
| Submission
Correspondent | lan Marcus
Regulatory Affairs
Phone: 408-761-2934
Email: lan_Marcus@apple.com |
| Secondary
Correspondent | Sam Surette
US Regulatory Affairs Manager
Phone: 628-629-4161
Email: ssurette@apple.com |
| Date Prepared | July 12, 2024 |
| Premarket Submission | Traditional 510(k), K242058 |
2. Device Names and Classifications
Subject Device:
| Name of Device | Digital Prism Correction Feature (DPCF) |
|---|---|
| Classification | Ophthalmic Fresnel prism, 21 CFR 886.1655 |
| Regulatory Class | Class I |
| Product Code | SCW (Digital prismatic correction) |
| 510(k) Review Panel | Ophthalmic |
3. Predicate Device
Ophthalmic Fresnel prism, 21 CFR 886.1655.
4. Device Description
The Digital Prism Correction Feature (DPCF) is intended to provide a high quality visual experience in Apple Vision Pro spatial computing applications for users with a prism prescription. Specifically, the DPCF is software that is intended to provide digital image adjustments in Apple
5
Vision Pro in accordance with a user's prism prescription, in the horizontal and/or vertical dimensions. DPCF fulfills the prism part of an eyeglass prescription. When an eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), DPCF fulfills the prism part of the prescription, while prescription optical inserts fulfill the other parts of the prescription.
The DPCF achieves its intended use by converting a user's prism prescription into digital image adiustment parameters that are utilized by the spatial computing image system to automatically provide digital image adjustments in horizontal and/or vertical dimensions in accordance with a user's prism prescription. At this time, DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e. base-down, base-in, base-out), per eye.
5. Indications for Use
The Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription.
DPCF is available for users with prism in their eyeglass prescription. When a prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro.
DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e., base-up, base-down, base-out), per eve.
6. Comparison with the Predicate Device
The subject and predicate device, as described by the identification (21 CFR 886.1655), are both intended to provide a prismatic effect. The subject device provides a prismatic effect by providing perceived digital image shift in horizontal and/or vertical dimensions in accordance with a user's prescription; the predicate device also provides perceived prismatic effects. Furthermore, the DPCF can be used in conjunction with ophthalmic lenses, consistent with the intended use of the predicate device, for which the classification's identification describes a device that can be applied to lenses. Since both the subject and predicate device (per 21 CFR 886.1655) are intended to provide prismatic effects in accordance with a prism prescription, and can be used in coniunction with spectacle lenses, thev have the same intended use.
While DPCF prismatically adjusts a digital image using software, and the predicate provides a prismatic effect through a plastic sheet adhered to lenses, these technological differences do not raise different questions of safety or effectiveness, given that devices that provide prismatic effects are well characterized and have a known history of very low risk. Furthermore, the differences in technological characteristics are addressed through acceptable scientific methods, from which the data demonstrate substantial equivalence.
The subject device has been appropriately verified and validated through non-clinical testing to ensure that the device is substantially equivalent to the predicate. A complete comparison of the subject and predicate device can be found in Table 1 below.
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| ltem | Subject Device
Digital Prism Correction Feature
(DPCF) | Predicate Device
21 CFR 886.1655 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Device Name | Digital Prism Correction Feature | N/A |
| Manufacturer | Apple, Inc. | N/A |
| Regulation Number | 21 CFR 886.1655 | 21 CFR 886.1655 |
| Product Code | SCW | HKT |
| Regulation Name | Ophthalmic Fresnel prism | Ophthalmic Fresnel prism |
| Device Classification | Class I | Class I |
| OTC/Prescription | Rx Only | N/A |
| Intended Use | Provide prismatic effect, and can be
used in conjunction with lenses | Provide prismatic effect, and are used
in conjunction with lenses |
| Indications for Use | The Digital Prism Correction Feature
(DPCF) is software that is intended to
provide digital image adjustments in
Apple Vision Pro in accordance with a
user's prism prescription.
DPCF is available for users with prism
in their eyeglass prescription. When a
prescription also includes other parts
(e.g., sphere, cylinder, ADD), which can
be fulfilled by optical inserts, the DPCF
fulfills the prism part of the prescription
while using Apple Vision Pro.
DPCF supports prism prescriptions up
to 7.75 Prism Diopters (PD) in the
horizontal and/or vertical dimension
(i.e., base-up, base-down, base-in,
base-out), per eye. | N/A |
| Principle of Operation | Digital image adjustment in
accordance with a prism prescription,
to provide a prismatic effect. | Optical refraction in accordance with a
prism prescription, to provide a
prismatic effect. |
| Use Scenario(s) | Used with Apple Vision Pro, which can
also include use in conjunction with
optical inserts. | Used in conjunction with spectacle
lenses |
| Intended Users | Users in need of prism correction. | Users in need of prism correction. |
| Performance | Meets standardized prism tolerance
requirements | Meets standardized prism tolerance
requirements |
Table 1: DPCF Comparison with the Predicate
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The subject device shares the same intended use and represents the same generic device type as the predicate device, as established by 21 CFR 886.1655. While there are differences of technological characteristics, these differences do not raise different questions of safety and effectiveness. Data from acceptable methods have been provided in this 510(k) submission. including results from bench validation testing, to substantiate the intended use of the subject device and demonstrate the subject device is substantially equivalent to the predicate device. The differences between the subject and predicate device do not present any new issues of safety or effectiveness as they do not increase the risk of the device, and can be appropriately verified and validated through existing methods. Thus, the DPCF is substantially equivalent to the predicate device, ophthalmic Fresnel prism (21 CFR 886,1655).
7. Summary of Non-Clinical Testing
Non-clinical Testing Summary
Apple conducted non-clinical testing on DPCF with passing results, supporting a determination of substantial equivalence. Non-clinical testing conducted included the following:
Software Verification and Validation
Software verification and validation was conducted in accordance with Apple's robust quality system and documented to address the recommendations in FDA's "Content of Premarket Submissions for Device Software Functions" quidance document. DPCF was determined to be a Basic Documentation Level. Apple's good software engineering practices, as demonstrated by the 510(k) submission's documentation, supports a conclusion that DPCF was appropriately designed, verified, and validated.
Bench Validation Testing
The bench validation testing demonstrated that the DPCF provides prismatic adjustments in accordance with a prism prescription. Specifically, the results validate that the digital image adiustments provided by DPCF meet the prism tolerance requirements specified in ISO 8980-1:2017, and demonstrates that the DPCF provides reliable and acceptable prism adjustments for the available prism adjustment range, including for both virtual and digital passthrough content. Furthermore, the results demonstrate that the DPCF performs as intended with and without optical inserts, and that the general purpose spatial computing platform (i.e., Apple Vision Pro) and it's "other functions" do not adversely affect the DPCF's ability to meet standardized prism tolerances.
General Purpose Spatial Computing Platform Assessment
DPCF is a software-only device, available on compatible general purpose spatial computing platforms (i.e., Apple Vision Pro); therefore, medical device hardware testing is not applicable. However, as a multiple function device product, the impact of the general purpose spatial computing platform on DPCF was assessed as part of the feature's risk management, verification, and validation activities, and determined to be acceptable.
8. Summary of Clinical Testing
No clinical testing data has been submitted.
8
9. Conclusion
The Digital Prism Correction Feature is substantially equivalent to the predicate device as they share the same intended use and where there are differences in technological characteristics, these differences do not raise different questions of safety and effectiveness. Furthermore, the scientific methods used for evaluating the different technological characteristics of the subject device are acceptable and the results of that testing supports a decision of substantial equivalence.