(88 days)
Not Found
No
The summary mentions "proprietary 3D Shape generation software" used by CAD designers, but there is no mention of AI or ML being used within this software or any other part of the system. The focus is on the physical devices and the design process being driven by human designers using software.
Yes.
The device is indicated for the "orthodontic treatment of malocclusion," specifically for "rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla." This description clearly points to the device being used for the treatment of a medical condition, which is the definition of a therapeutic device.
No
The device is an orthodontic treatment system designed for rapid expansion and subsequent holding of the maxilla, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical components (Invisalign Palatal Expanders, Invisalign Palatal Holders, Attachment Template) in addition to the software. The software is used for design and fabrication, but the final medical device includes hardware.
Based on the provided information, the Invisalign Palatal Expander System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the orthodontic treatment of malocclusion, specifically rapid expansion and holding of the maxilla. This is a therapeutic use, not a diagnostic one.
- Device Description: The device consists of physical expanders, holders, a template, and software for designing these physical devices. These are all components used for physical manipulation and treatment of the anatomical structure.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Invisalign Palatal Expander System does not involve the analysis of any biological samples. Its input is a digital scan of the patient's anatomy.
Therefore, the Invisalign Palatal Expander System falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and tooth, palate) with primary, mixed, or permanent dention during orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The subject device, Invisalign Palatal Expander (IPE) System (hereafter referred to as the IPE System) is a modification to the legally marketed multiple predicate devices. Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secondary.
The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template and the proprietary 3D Shape generation software.
Invisalign Palatal Expanders are a staged series of removable orthodontic devices designed to expand the patient's skeletal and/or dental narrow maxilla (upper jaw, dental arch, teeth and palate) in small increments to an optimal position determined by the doctor. Once the desired clinical outcome of the expansion phase has been achieved, patients progress to the holding phase.
The Invisalign Palatal Holder is a copy of the last stage of the expansion phase designed to hold the maxilla post active expansion, to allow the maxilla to stabilize before the patient progresses to the next phase of treatment (retention, phase 2 or other treatment).
The proprietary Align internal personnel-facing 3D software enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device. Using this software, CAD designers create digital files for the incremental stages of the doctorprescribed expansion amount and the design and quantity of holders per the prescribed holding duration. Each device in the series is fabricated via additive manufacturing (3D printing).
The Attachment Template (also a component of the primary predicate device, the Invisalign System) enables correct placement and bonding of attachments made of dental composite (material provided by doctor) to the tooth surface for IPE engagement and retention.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla (upper jaw, dental arch and tooth, palate)
Indicated Patient Age Range
children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The IPE System underwent a complete set of functional and performance testing, including, durability, expander fatigue/insertion & removal, bioburden, and packaging validation testing. Clinical performance of the IPE System was also evaluated in an early feasibility study and realworld data post-market study. Based on the performance testing outcomes, the subject device, the IPE System is substantially equivalent to its predicates and there are no new risks from the differences between the subject device and the predicate devices.
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.
Invisalign System (K220287), Dentaurum Expansion Screws (K935154)
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
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
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 & 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.
December 15, 2023
Align Technology, Inc. Sindhura Gaddamanugu Sr. Regulatory Affairs Specialist II 2820 Orchard Parkway San Jose, California 95134
Re: K232887
Trade/Device Name: Invisalign Palatal Expander System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 18, 2023 Received: September 18, 2023
Dear Sindhura Gaddamanugu:
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.
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 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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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) K232887
Device Name Invisalign Palatal Expander System
Indications for Use (Describe)
The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and tooth, palate) with primary, mixed, or permanent dention during orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.
| 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
Section 7: 510(K) Summary - K232887
Align Technology's Invisalign System Palatal Expander (IPE) System
General Information
| 510(k) Sponsor | Align Technology, Inc. |
|---|---|
| Address | 2820 Orchard Parkway |
| San Jose, CA 95134 | |
| FDA Registration Number | 2953749 |
| Contact Person | Sindhura Gaddamanugu |
| Sr. Regulatory Affairs Specialist II, Regulatory Affairs | |
| Align Technology, Inc. | |
| cc: Shweta Daga | |
| Director, Regulatory Affairs | |
| Align Technology Inc. | |
| Contact Information | Email: sgaddamanugu@aligntech.com |
| Phone: +1 408-470-1000 | |
| Fax: +1408-470-1010 | |
| Date Prepared | September 18, 2023 |
Name of Modified Device and Name/Address of Sponsor
| Name of Device | Invisalign Palatal Expander (IPE) System |
|---|---|
| Name/Address of Sponsor | Align Technology, Inc. |
| 2820 Orchard Parkway, San Jose, CA 95134 | |
| Trade/Proprietary Name | Invisalign Palatal Expander (IPE) System |
| Common Name | Palatal Expander, Sequential |
| Classification Name | Orthodontic Plastic Bracket |
| Regulation Number | 21 CFR 872.5470 |
| Product Code | NXC |
| Regulatory Class | II |
Primary Predicate Device
| Name of Device | Invisalign System |
|---|---|
| Name/Address of Sponsor | Align Technology, Inc. |
| 2820 Orchard Parkway, San Jose, CA 95134 | |
| Trade/Proprietary Name | Invisalign System |
| Common Name | Aligner, Sequential |
| Classification Name | Orthodontic Plastic Bracket |
| Regulation Number | 21 CFR 872.5470 |
| Product Code | NXC |
| Regulatory Class | II |
ALIGN CONFIDENTIAL
5
| Name of Device | Dentaurum Expansion Screws |
|---|---|
| Name/Address of Sponsor | Dentauraum, Inc. |
| Trade/Proprietary Name | Dentaurum Expansion Screws |
| Common Name | Retainer, Screw Expansion, Orthodontic |
| Classification Name | Orthodontic appliance and accessories |
| Regulation Number | 21 CFR 872.5410 |
| Product Code | DYJ |
| Regulatory Class | I |
Secondary Predicate Device
Purpose of the Traditional 510(k) Notice
The purpose of this Traditional 510(k) notice is to request clearance for the Subject device. the Invisalign Palatal Expander (IPE) System. Additionally, this Traditional 510(k) introduces the proprietary, 3D Shape generation software, and labeling documentation associated with the Invisalign Palatal Expander System.
Intended Use/Indications For Use
The intended use of the Subiect device is as follows:
The Invisalign Palatal Expander System is intended for use in the treatment of dental and/or skeletal malocclusion in primary, mixed or permanent dentition.
The Indications for Use of the subject device is as follows:
The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.
The general purpose of the subject device and the primary predicate, i.e. Invisalign System and the secondary predicate device (Dentaurum Expansion Screws) is the treatment of malocclusion and the subject device's intended use falls within the intended use of the predicate devices. The subject device and the primary predicate device are indicated for the treatment of malocclusion. Additionally, the subject device and the secondary predicate device are used for rapid expansion of narrow maxilla. While the Indication for Use is similar, both the subject and primary predicate device have the same intended use that is used in the treatment of dental or skeletal malocclusion in primary, mixed or permanent dentition.
6
Device Description
The subject device, Invisalign Palatal Expander (IPE) System (hereafter referred to as the IPE System) is a modification to the legally marketed multiple predicate devices. Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secondary.
The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template and the proprietary 3D Shape generation software.
Invisalign Palatal Expanders are a staged series of removable orthodontic devices designed to expand the patient's skeletal and/or dental narrow maxilla (upper jaw, dental arch, teeth and palate) in small increments to an optimal position determined by the doctor. Once the desired clinical outcome of the expansion phase has been achieved, patients progress to the holding phase.
The Invisalign Palatal Holder is a copy of the last stage of the expansion phase designed to hold the maxilla post active expansion, to allow the maxilla to stabilize before the patient progresses to the next phase of treatment (retention, phase 2 or other treatment).
The proprietary Align internal personnel-facing 3D software enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device. Using this software, CAD designers create digital files for the incremental stages of the doctorprescribed expansion amount and the design and quantity of holders per the prescribed holding duration. Each device in the series is fabricated via additive manufacturing (3D printing).
The Attachment Template (also a component of the primary predicate device, the Invisalign System) enables correct placement and bonding of attachments made of dental composite (material provided by doctor) to the tooth surface for IPE engagement and retention.
Comparison with Predicate Devices
In accordance with 21 CFR 807.92(a)(6) a summary of the technological characteristics' comparison of the proposed subject device to the predicate devices is provided below.
Technological Characteristics Comparison with the Predicate Devices
The IPE System provides an additional method for palate expansion during malocclusion treatment as achieved with the primary and secondary predicate devices. The technological differences are limited to the material, additive manufacturing, and the 3D Software used to deliver a patient-matched device to meet its proposed intended use.
7
| | Subject Device
Invisalign Palatal
Expander System | Primary
Predicate Device
Invisalign System
(K220287) | Secondary
Predicate Device
Dentaurum
Expansion
Screws
(K935154) | Substantial
Equivalency |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use, User Population | | | | |
| Intended
Use | The Invisalign Palatal
Expander System is
intended for use in the
treatment of dental
and/or skeletal
malocclusion in
primary, mixed or
permanent dentition. | The Invisalign
System is intended
for use in the
treatment of dental
or skeletal
malocclusion in
primary, mixed
and permanent
dentition. | The Expansion
Screw is intended
for use in the
treatment for
palatal expansion
in all dentition
types. | Same as primary
predicate device
Similar to
secondary
predicate device
The subject
device's intended
use falls within the
intended use of
the secondary
predicate device. |
| Indications
for Use | The Invisalign Palatal
Expander System is
indicated for the
orthodontic treatment
of malocclusion. The
system is used for
rapid expansion and
subsequent holding of
skeletal and/or dental
narrow maxilla (upper
jaw, palate, dental
arch and teeth) with
primary, mixed, or
permanent dentition
during orthodontic or
orthopedic treatment
in children or
adolescents. In adults,
to be used in
conjunction with
surgery or other
interventions when
necessary. | The Invisalign
System is
indicated for the
orthodontic
treatment of
malocclusion. | The device is
indicated for case
of transverse
under-development
of the upper jaw. | Similar to primary
predicate device
Same as the
secondary
predicate device
The subject
device and the
primary predicate
device have
similar Indication
for Use and both
are indicated for
the treatment of
malocclusion.
Both the subject
device and the
secondary
predicate device
have the same
indication for use
to expand the
narrow
maxilla/upper jaw. |
| Patient
Population | Children, Adolescents
and Adults | Children,
Adolescents and
Adults | All patients for
whom a fixed
appliance with an
expansion screw
can be placed as
part of orthodontic
treatment. | Same as primary
predicate device
Similar to
secondary
predicate device
The subject
device patient |
| | Subject Device
Invisalign Palatal
Expander System | Primary
Predicate Device
Invisalign System
(K220287) | Secondary
Predicate Device
Dentaurum
Expansion
Screws
(K935154) | Substantial
Equivalency |
| | | | | population is the
same as the
primary predicate
device and the
population is a
subset of
secondary
predicate device
patient population. |
| Use
Location | Dental intraoral
devices. | Dental intraoral
devices. | Dental intraoral
devices. | Same as primary
and secondary
predicate devices |
| OTC or
Prescription
(Rx) Device | Rx only | Rx only | Rx only | Same as primary
and secondary
predicate devices |
| Principle of
Operation | Expanders:
Sequential expanders
apply continuous
outward
pressure/force to the
maxilla. | Aligners:
Sequential
aligners apply
continuous gentle
force to the teeth
and/or position
mandible forward. | Hyrax has an
expansion screw
suspended above
the palatal
vault/gingiva. A key
is used to turn the
expansion screws
(quarter turn - 90
degrees rotation)
on a specified
schedule per the
doctor's discretion,
and this keeps the
pressure on both
halves of the
jawbone causing
them to widen and
move apart. The
number of quarter
turns per day is
instructed by the
doctor to the
patient and/or
parent/supervising
adult per the
treatment plan for
rapid or slow
expansion. | Similar to primary
and secondary
predicate devices.
Subject device
operates same as
primary predicate
device in the
context of
removability,
exerting
continuous force,
and sequential
devices.
Subject device
and secondary
predicate operate
similarly regarding
separating the
mid-palatal suture
and movement of
maxillary halves.
Subject device
and secondary
predicate device
operate similarly
by exerting
continuous force. |
| | Subject Device
Invisalign Palatal
Expander System | Primary
Predicate Device
Invisalign System
(K220287) | Secondary
Predicate Device
Dentaurum
Expansion
Screws
(K935154) | Substantial
Equivalency |
| | Holders: The palatal
holder is a copy of last
stage of the
expansion phase. | Retainers: The
retainers are a
copy of the last
stage of the
aligners.
Note: Invisalign
Retainers are not
part of the primary
predicate device
Invisalign System
(K220287) as they
are classified as a
Class I under
21CFR872.5525. | The expansion
screw-based
device should
remain in the
mouth after active
expansion without
turning the screw
for approximately 2
- 3 months for
stabilization
purposes and to
avoid relapse. | Similar to the
primary and
secondary
predicate devices
Subject device
has the same
principle of
operation of
maintaining and
preventing
movement using
passive devices
as both predicate
devices. |
| | Technological Characterization | | | |
| Software | Produces 3D-model
file of the IPE devices
based on the digital
scan and
doctor/dental
practitioner's
prescription.
3D Software of the
subject device is an
internal Align facing
only shape generation
software which
includes software
algorithms that are
used to determine the
shape and calculate
the quantity of devices
required per the
doctor prescribed
expansion distance
and holding duration. | Produces 3D-
model file of the
PVS impression or
the digital scan.
Identifies the
individual teeth
that requires
treatment (i.e.,
repositioning).
Creates a
treatment plan
(i.e., 3-D models
that represent the
treatment plan)
which is reviewed
by the treating
dental practitioner
using ClinCheck's
doctor facing
function to reject
or request
modifications to
the set-up prior to
approval. | Not Applicable | Similar to the
primary predicate.
The 3D software
used in the
subject and
predicate devices
are both used for
treatment planning
and designing the
shape of the
device. The
subject device
utilized a
simplified version
of 3D software
based on the
purpose and
design of the
device. |
| Materials | Thermoplastic
polyamide | Thermoplastic
polymer | The screws are
made of stainless
steel (DIN 1.4301) | Similar to the
primary predicate
device. |
| | Subject Device
Invisalign Palatal
Expander System | Primary
Predicate Device
Invisalign System
(K220287) | Secondary
Predicate Device
Dentaurum
Expansion
Screws
(K935154) | Substantial
Equivalency |
| Durability | Durability was tested
to verify the
performance of the
IPE device. All IPE
devices maintained
the engagement on
attachments, without
deformation, cracks,
chips or breaks. | Performance Testing
No new durability
testing was
required with the
primary predicate
device pre-market
notification
(K220287).
Durability testing
was performed on
previously cleared
Invisalign System
and testing results
met all acceptance
criteria. | Unknown | Same as primary
predicate device |
| Stiffness/
Force
system | The subject device
was tested to verify
that the device is
structurally stiff and
can deliver the
required force in the
lateral direction on the
posterior teeth. The
test results met the
acceptance criteria
and performed as
intended. | No new force
system testing was
required with the
primary predicate
device pre-market
notification
(K220287).
Force mechanical
verification testing
demonstrated with
previously cleared
Invisalign System
provides adequate
force systems on
the dentition for its
intended use. | The mechanical
behavior
(stiffness/force) of
Hyrax was used as
one of the
acceptance criteria
for the subject
device bench
testing. | Similar to Primary
Predicate device
Same as secondary
predicate device |
| Packaging | The subject device
was tested to validate
that the packaging
can protect the
System from
exposure to all
relevant shipping and
handling scenarios.
The testing confirmed
that the product
integrity was
maintained during | No new packaging
validation testing
was required with
the primary
predicate device
pre-market
notification
(K220287).
The Packaging
validation testing
on previously | Unknown | Similar to Primary
Predicate device
Both the subject
and primary
predicate devices
use the same
primary
packaging, and
packaging testing
on the subject
device confirmed |
| Subject Device
Invisalign Palatal
Expander System | Primary
Predicate Device
Invisalign System
(K220287) | Secondary
Predicate Device
Dentaurum
Expansion
Screws
(K935154) | Substantial
Equivalency | |
| shipping and handling
scenarios. | cleared Invisalign
System
demonstrated that
the device integrity
was maintained
during the various
shipping and
handling
scenarios. | | that device
integrity is
maintained during
all relevant
shipping and
handling
scenarios | |
| Retention | The subject device
was tested to verify
that the device can
retain engagement
with attachments on
posterior teeth while
the device is under
compression during
an active expansion
and holding period.
The test results met
the acceptance
criteria and performed
as intended. | No new testing
was required with
the primary
predicate device
pre-market
notification
(K220287).
Retention testing
performed on
previously cleared
Invisalign System
demonstrated that
the device
performed as
intended. | Unknown | Similar to_Primary
Predicate device |
| Insertion
and
Removal
Force | The Insertion and
Removal Force test
was conducted to
verify that the forces
required to insert and
remove device are
significantly less than
the bond force of the
attachment on the
tooth. | No force system
testing was
required with the
primary predicate
device pre-market
notification
(K220287).
The testing
performed on
previously cleared
Invisalign System
demonstrated that
the device
performed as
intended. | Unknown | Similar to_Primary
Predicate device |
| Human
Factors &
Usability | Human factors &
Usability testing was
conducted on the
subject device to
validate that it is | No human factors
& usability
validation testing
was required for
the primary | Unknown | Similar to_Primary
Predicate device
Based on
available data |
| | Subject Device
Invisalign Palatal
Expander System | Primary
Predicate Device
Invisalign System
(K220287) | Secondary
Predicate Device
Dentaurum
Expansion
Screws
(K935154) | Substantial
Equivalency |
| | adequately designed
for its intended users,
uses and use
environments | predicate device
pre-market
notification
(K220287).
Human Factors &
Usability validation
on previously
cleared Invisalign
System has been
found to be
adequately
designed for the
intended users,
uses, and use
environments. | | both the subject
device and
primary predicate
device perform as
intended and
additional device
modifications to
the user interface
are not needed
and would not
further reduce
risk. |
| Clinical
Testing | Not Applicable.
An early feasibility
study was conducted
which concluded that
desired active
expansion of the
upper jaw width was
observed in all the
subjects. There were
no unanticipated or
serious adverse
events reported from
this study.
Additionally, real-
world data was also
analyzed from
commercially
available product. | Not Applicable | Not Applicable | Similar to primary
predicate and
secondary
predicate devices.
The subject
device is a Class
II medical device
and clinical testing
was not warranted
to support
substantial
equivalency with
the primary and
secondary
predicate devices. |
Table 7-1: Substantial Equivalency Overview
ALIGN CONFIDENTIAL
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ALIGN CONFIDENTIAL
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Performance Data
The IPE System underwent a complete set of functional and performance testing, including, durability, expander fatigue/insertion & removal, bioburden, and packaging validation testing. Clinical performance of the IPE System was also evaluated in an early feasibility study and realworld data post-market study. Based on the performance testing outcomes, the subject device,
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the IPE System is substantially equivalent to its predicates and there are no new risks from the differences between the subject device and the predicate devices.
Biocompatibility
Biocompatibility testing for the proposed IPE System was completed and assessed in accordance with ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process, and ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. The results demonstrate that the IPE System does not pose any significant biologicals risks and is considered safe for its intended use in the intra-oral cavity.
Software Testing
In accordance with IEC 62304. Medical device software - Software life cycle processes; successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the orthodontic software component of the subject device.
Substantial Equivalence
The subject device is similar to its predicate devices in that it has:
- intended use, same as primary predicate device and similar to secondary predicate o device;
- . indications for use, similar to primary predicate device and same as secondary predicate device:
- principles of operation, similar to both predicate devices; and
- technological characteristics, similar to primary predicate device ●
The differences in the indications for use, principles of operation and technological characteristics between the subject device and its predicate devices do not raise different questions of safety or efficacy. Therefore, the subject device is found to be substantially equivalent to the legally marketed primary predicate device, Invisalign System (K220287) and secondary predicate device, Dentaurum Expansion Screws.
Conclusion
Align Technology's Invisalign Palatal Expander (IPE) System has the same intended use and similar indications for use as the previously cleared primary predicate, Invisalign System (K220287). The IPE System has similar intended use and same indications for use as the secondary predicate device Dentaurum Expansion Screws. The difference in principles of operation and technological characteristics between the subject device and the predicate devices were evaluated using standard test methods and do not raise new issues of safety or effectiveness. Performance data (bench and clinical) and biocompatibility testing demonstrate that the subject device is as safe and effective as both predicate devices. Thus, the
Invisalign Palatal Expander (IPE) System is substantially equivalent to both predicate devices.