(182 days)
No
The summary describes the use of 3D imaging and CAD software for modifying the device design, but there is no mention of AI or ML being used in the process. The modifications are described as being performed by a practitioner.
Yes
The device is intended to treat non-synostotic positional plagiocephaly, brachycephaly, and scaphocephaly by applying pressure to improve cranial symmetry and/or shape, which qualifies as a therapeutic purpose.
No
The device is a cranial orthosis (helmet) used to apply pressure to an infant's head to improve symmetry and shape. While its creation involves 3D imaging to capture the existing head shape, this imaging is part of the manufacturing process of the treatment device itself, not for diagnosing a condition. The "Indications for Use" section states it's for use "on infants... with moderate to severe non-synostotic positional plagiocephaly," implying that the diagnosis is already made before the device is used.
No
The device description clearly indicates that the STARband 3D is a physical cranial orthosis (a helmet) that is additively manufactured based on 3D images. While software is used in the process (for image modification and manufacturing), the device itself is a physical product applied to the infant's head.
Based on the provided information, the STARband 3D is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- STARband 3D Function: The STARband 3D is a cranial orthosis (a helmet-like device) that is worn externally on an infant's head. Its purpose is to physically reshape the skull by applying pressure.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the infant. While it uses a 3D image of the head, this is for measurement and design purposes, not for analyzing biological markers or substances.
The STARband 3D falls under the category of a medical device, specifically a Class II medical device (as indicated by the 510(k) submission process and the predicate device information). It is a therapeutic device used to treat a physical condition (positional plagiocephaly).
N/A
Intended Use / Indications for Use
The STARband 3D is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, infants with plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape.
Product codes
MVA, OAN
Device Description
The STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARband® 3D™ cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K211376. The difference with this proposed device is a structural change with a bilateral side opening design and two latch closure mechanisms at each opening. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain the same.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3-dimensional imaging
Anatomical Site
Cranium/Head
Indicated Patient Age Range
three to 18 months of age
Intended User / Care Setting
Practitioner / Not specified, but implied to be a clinical setting for fitting and modifications.
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
Test samples were additively manufactured from 3D images of representative cranial shapes using previously cleared scanning device(s).
Summary of Performance Studies
Dimensional Analysis
- Test Name: Dimensional Analysis
- Test Method Summary: Dimensional analysis was performed by manually overlaying the 3D-printed part scan file on the original design file using Autodesk Netfabb Premium Software. Dimensional differences were recorded at assigned locations to analyze the dimensional variability between 3D printed parts and computer design files.
- Test Results: Dimensional analysis of the additively manufactured Starband® 3D orthoses resulted in acceptable part consistency and reproducibility across build cycles for both controlled and random sample population.
Fit Analysis
- Test Name: Fit Assessment
- Test Method Summary: The fit assessment was performed using 3/16" pads that were installed in the additively manufactured samples which were fit to the unmodified patient matched mold and visually assessed for proper fit, form and function.
- Test Results: The fit assessment of the additively manufactured Starband® 3D orthoses was successful for all parts evaluated. All helmets aligned and secured properly and total contact (appropriate hold) was achieved at the prominent or bossed areas of the unmodified patient model.
Pressure Test
- Test Name: Pressure Test
- Test Method Summary: The pressure test was performed by placing force sensors at the holding areas (dependent on diagnosis and pad configuration) at the patient-helmet interface and then pressure force was recorded. Results of this test are aimed to prove that pressure distribution for the Starband 3D design, when fit on patient, is equivalent to or better than the predicate device.
- Test Results: The Starband® 3D orthoses design successfully showed that the pressure force is comparable to the predicate device.
Mechanical Analysis
-
Test Name: Latch Closure Cyclic Test
-
Test Method Summary: The latch closure cyclic test consisted of introducing localized fatigue at the latch closure by applying repeated stress for a specific amount of cycles. Pull forces to disengage (open) the latch closure where obtained before starting the cycle testing and then every predetermined amount of cycles.
-
Test Results: The latch closure design successfully exceeded the established don & doff cycles without fatigue or failure impacting function during normal utilization. The design maintained operational criteria of latching and successfully securing the anterior and posterior shells on the patient model throughout the duration of the cyclic fatigue testing.
-
Test Name: Latch Closure Destructive Testing
-
Test Method Summary: Latch closure samples were affixed to the testing machine and a linear pull-force (perpendicular to the helmet's exterior surface) was applied to the latch until failure occurred. The maximum force required to fail the latch must exceed a maximum average pull strength of 9.18 lbf for and adult using defined pinch grips (Razza et al., 2022)
-
Test Results: Destructive testing successfully proved that the STARband 3D latch closure design exceeds the average pull strength of an adult when using various pinch grips in application. It was concluded that the latch closure mechanism can withstand and surpass the pull forces of Don & Doff throughout the entire treatment.
Biocompatibility Analysis
- Test Name: Material Biocompatibility Test
- Test Method Summary: Biological evaluation tests were performed to verify conformance of the materials used in the STARband 3D device in accordance with the ISO 10993-5 and ISO 10993-10 standards. Biocompatibility testing involved irritation, cytotoxicity and sensitization testing on the finished, fully assembled additively manufactured device.
- Test Results: Biocompatibility test reports demonstrate that all biocompatibility testing successfully met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 20, 2023
Orthomerica Products Inc. Najiba Katir Regulatory Compliance Manager 6333 North Orange Blossom Trail Orlando, Florida 32810
Re: K223238
Trade/Device Name: STARband 3D Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: March 20, 2023 Received: March 21, 2023
Dear Najiba Katir:
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 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 803) for
1
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 (QS) 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.
Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Adam D. Pierce -S" and "Date: 2023.04.20 14:31:57 -04'00'". This indicates that the document was digitally signed by Adam D. Pierce on April 20, 2023 at 2:31 PM.
Adam D. Pierce, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K223238
Device Name STARband 3D
Indications for Use (Describe)
The STARband 3D is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, infants with plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape.
| 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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K223238 510(k) Summary
I. Applicant Information
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
FDA Establishment Registration Number
1058152
Contact Information
| Contact Person: | Najiba Katir, Regulatory Compliance Manager |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| Email: | nkatir@orthomerica.com |
| Date Prepared: | March 20th, 2023 |
II. Submission Information
| Submission Number: | K223238 |
|---|---|
| Type: | Traditional 510(k) Submission |
| Proprietary Name: | STARband 3D |
| Classification: | Class II (special controls); OAN; MVA; 21 CFR 882.5970 |
| Classification Name: | Cranial Orthosis |
| Predicate Device: | K211376 |
III. Manufacturing Site Information
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| FDA Establishment Registration Number: | 1058152 |
4
Description of Device/Modification IV.
The STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The following designs are identical to the predicate and have underdone no changes since the predicate clearance:
The STARband® Side Opening design and STARband® Bi-Valve design are made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene).
The STARband® Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1½" for STARband® Side Opening) across the side opening. The STARband® Bi-Valve design consists of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop. The STARband® Plus device consists of a dual side opening low profile design with a one-piece living hinge at the top and multiple liner options.
The following design is the Subject Device:
The STARband® 3D™ cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K211376. The difference with this proposed device is a structural change with a bilateral side opening design and two latch closure mechanisms at each opening. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain the same.
Indications and Intended Use V.
Indications:
The STARband 3D is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic- shaped
5
heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape.
Intended Use:
The STARband® is designed to treat infants with abnormal head shapes from age 3 to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the STARband® for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The same principles of cranial remolding apply to positional deformities.
VI. Predicate Device and Reference Device
Summary of Technological Characteristics VII.
The STARband® 3D™ cranial orthosis device proposed in this submission has the same indications for use, intended use, underlying principles of operations and basic design as the predicate device as illustrated in Table 1 below.
| Device
| Characteristic | Proposed Device | Predicate Device K211376 | Reference Device K201426 |
|---|---|---|---|
| Manufacturer | Orthomerica Products, Inc. | Orthomerica Products, Inc. | Otto Bock HealthCare LP |
| Product Code | OAN, MVA | OAN, MVA | OAN, MVA |
| Intended Use | Maintains total contact over | ||
| areas of bossing or protrusion | |||
| and creates voids over areas | |||
| of depression or flattening to | |||
| redirect cranial growth | |||
| toward greater symmetry. | Maintains total contact | ||
| over areas of bossing or | |||
| protrusion and creates | |||
| voids over areas of | |||
| depression or flattening to | |||
| redirect cranial growth | |||
| toward greater symmetry. | Redirects head growth by | ||
| maintaining contact over | |||
| cranial | |||
| areas which protrude and by | |||
| creating voids | |||
| over areas of depression or | |||
| flattening in order to improve | |||
| symmetry. | |||
| Contraindications | Not for use on infants with | ||
| synostosis or | |||
| hydrocephalus | Not for use on infants with | ||
| synostosis or | |||
| hydrocephalus | Not for use on infants with | ||
| pre-surgical craniosynostosis | |||
| or hydrocephalus | |||
| Prescription | |||
| required? | Prescription Use Only | Prescription Use Only | Prescription Use Only |
| Size Options | Patient-matched sizing by | ||
| scanning an image of | |||
| patient's head shape | Patient-matched sizing by | ||
| scanning an image of | |||
| patient's head shape | Patient-matched sizing by | ||
| scanning an image of patient's | |||
| head shape |
| Table 1 - Comparison of Proposed Device, Predicate Device, and Reference Device |
|---|
| --------------------------------------------------------------------------------- |
6
| Device | Proposed Device | Predicate Device K211376 | Reference Device K201426 |
|---|---|---|---|
| Characteristic | |||
| plaster mold to make | |||
| positive mold of head | |||
| shape | |||
| Software Used for | |||
| Shape | CAD software is used to | ||
| modify the shape of the | |||
| scanned image to improve | |||
| symmetry and shape of the | |||
| helmet to be | |||
| manufactured | Customized and/or CAD | ||
| software may be used to | |||
| modify the shape of the | |||
| scanned image to improve | |||
| symmetry and shape of | |||
| the helmet to be | |||
| manufactured | CAD software is used to | ||
| modify the shape of the | |||
| scanned image to improve | |||
| symmetry and shape of the | |||
| helmet to be | |||
| manufactured | |||
| Design | |||
| Components | Polymer helmet with bi- | ||
| lateral side-opening, closures, | |||
| and zone padded lining | Polymer helmet with side | ||
| opening closure and | |||
| padded lining | Polymer helmet with side | ||
| opening closure and padded | |||
| lining | |||
| Approximate | |||
| Device | |||
| Weight | 4 — 6.5 oz | 6 — 10 oz | 4 — 6.5 oz |
| Manufacturing | |||
| Process | Additively manufactured | ||
| orthosis based | |||
| upon measurements of the | |||
| infant's head captured by a | |||
| previously cleared 3- | |||
| dimensional imaging device | - Form orthosis from a | ||
| positive mold of infant's | |||
| head |
- Positive mold is formed
based upon
measurements of the
infant's head taken by an
approved 3-dimensional
imaging device from which
a 3-dimensional image is
made or from a traditional
plaster cast - The 3-dimensional image
is used to produce a
positive mold using a 5-
axis routing machine | Additively manufacture the
orthosis based upon
measurements of the infant's
head taken by a compatible 3-
dimensional imaging device |
| Approved 3-
Dimensional
Imaging Devices | STARscanner I
STARscanner II | Spectra 3D Scanner
M4DScan/BodyScan
System
Omega Scanner
3dMDhead System
3dMDcranial System
3dMDflex System
scanGogh-II
STARscanner l
STARscanner II
SmartSoc System for
Android and iOS devices | Creaform HCP
Creaform Peel1
Creaform Peel 3D
Rodin4D M4D Scan
TechMed3D BodyScan
OMEGA Scanner 3D
Artec Eva
Artec Eva Lite
iFab EasyScan |
| Device
Characteristic | Proposed Device | Predicate Device K211376 | Reference Device K201426 |
| Testing | Test samples were
additively manufactured from
3D
images of representative
cranial shapes
using previous cleared
scanning device(s).
Process Validation included
Dimensional Analysis, Fit
Assessment and Mechanical
Testing of test samples to
evaluate the additive
manufacturing process
performance, which was
compared to the process used
for the predicate device. | Cranial Shape Capture
Accuracy Study utilized a
representative cranial
shape that possesses a
predefined shape with
known dimensions, which
compared proposed device
to cast and predicate
device. Associated
parameters analyzed
included coordinate planes
(A-P; M-L; P-D) and various
radius parameters,
squareness, and flatness. | Scanner Evaluation utilized a
worst-case challenge
reference object of known
dimensions to assess 3D
imaging devices for adequate
accuracy, repeatability, and
reproducibility. Scanners were
compared to those previously
cleared for use for the
predicate device as well as
internal acceptance criteria.
Software Validation
demonstrated software
performance,
interoperability, and ability
to meet internal device
specifications. In addition to
IQ, OQ, and PQ studies, a Fit
Assessment was performed
using test samples which
were additively manufactured
from 3D
images of representative
simulated cranial shapes
using a compatible scanner.
Process Validation included
dimensional analysis and
mechanical testing of test
samples to evaluate the
additive manufacturing
process performance, which
was compared to the process
used for the
predicate device. |
| Biocompatibility | Material Biocompatibility
Testing
● Cytotoxicity
● Sensitization
● Irritation | Material Biocompatibility
Testing
● Cytotoxicity
● Sensitization
● Irritation | Material Biocompatibility
Testing
● Cytotoxicity
● Sensitization
● Irritation |
7
8
| Test Type | Test Name | Test Method Summary | Test Results |
|---|---|---|---|
| Dimensional | |||
| Analysis | Dimensional | ||
| Analysis | Dimensional analysis was performed by | ||
| manually overlaying the 3D-printed part | |||
| scan file on the original design file using | |||
| Autodesk Netfabb Premium Software. | |||
| Dimensional differences were recorded at | |||
| assigned locations to analyze the | |||
| dimensional variability between 3D printed | |||
| parts and computer design files. | Dimensional analysis of | ||
| the additively | |||
| manufactured Starband® | |||
| 3D orthoses resulted in | |||
| acceptable part | |||
| consistency and | |||
| reproducibility across | |||
| build cycles for both | |||
| controlled and random | |||
| sample population. | |||
| Fit Analysis | Fit Assessment | The fit assessment was performed using | |
| 3/16" pads that were installed in the | |||
| additively manufactured samples which | |||
| were fit to the unmodified patient matched | |||
| mold and visually assessed for proper fit, | |||
| form and function | The fit assessment of the | ||
| additively manufactured | |||
| Starband® 3D orthoses | |||
| was successful for all | |||
| parts evaluated. All | |||
| helmets aligned and | |||
| secured properly and | |||
| total contact | |||
| (appropriate hold) was | |||
| achieved at the | |||
| prominent or bossed | |||
| areas of the unmodified | |||
| patient model. | |||
| Pressure Test | Pressure Test | The pressure test was performed by placing | |
| force sensors at the holding areas | |||
| (dependent on diagnosis and pad | |||
| configuration) at the patient-helmet | |||
| interface and then pressure force was | |||
| recorded. Results of this test are aimed to | |||
| prove that pressure distribution for the | |||
| Starband 3D design, when fit on patient, is | |||
| equivalent to or better than the predicate | |||
| device. | The Starband® 3D | ||
| orthoses design | |||
| successfully showed that | |||
| the pressure force is | |||
| comparable to the | |||
| predicate device. | |||
| Mechanical | |||
| Analysis | Latch Closure Cyclic | ||
| Test | The latch closure cyclic test consisted of | ||
| introducing localized fatigue at the latch | |||
| closure by applying repeated stress for a | |||
| specific amount of cycles. Pull forces to | |||
| disengage (open) the latch closure where | |||
| obtained before starting the cycle testing | |||
| and then every predetermined amount of | |||
| cycles. | The latch closure design | ||
| successfully exceeded | |||
| the established don & | |||
| doff cycles without | |||
| fatigue or failure | |||
| impacting function | |||
| during normal utilization. | |||
| The design maintained | |||
| operational criteria of | |||
| latching and successfully | |||
| securing the anterior and | |||
| posterior shells on the | |||
| patient model | |||
| throughout the duration | |||
| of the cyclic fatigue. | |||
| testing. | |||
| Latch Closure | |||
| Destructive Testing | Latch closure samples were affixed to the | ||
| testing machine and a linear pull-force | |||
| (perpendicular to the helmet's exterior | |||
| surface) was applied to the latch until | |||
| failure occurred. The maximum force | |||
| required to fail the latch must exceed a | |||
| maximum average pull strength of 9.18 lbf | |||
| for and adult using defined pinch grips | |||
| (Razza et al., 2022) | Destructive testing | ||
| successfully proved that | |||
| the STARband 3D latch | |||
| closure design exceeds | |||
| the average pull strength | |||
| of an adult when using | |||
| various pinch grips in | |||
| application. It was | |||
| concluded that the latch | |||
| closure mechanism can | |||
| withstand and surpass | |||
| the pull forces of Don & | |||
| Doff throughout the | |||
| entire treatment. | |||
| Biocompatibility | |||
| Analysis | Material | ||
| Biocompatibility | |||
| Test | Biological evaluation tests were performed | ||
| to verify conformance of the materials used | |||
| in the STARband 3D device in accordance | |||
| with the ISO 10993-5 and ISO 10993-10 | |||
| standards. Biocompatibility testing involved | |||
| irritation, cytotoxicity and sensitization | |||
| testing on the finished, fully assembled | |||
| additively manufactured device. | Biocompatibility test | ||
| reports demonstrate | |||
| that all biocompatibility | |||
| testing successfully met | |||
| the acceptance criteria. |
VIII. Summary and Conclusion of Non-Clinical Performance Data
9
The above Non-Clinical Performance test results demonstrate that the proposed device performs and is as safe and effective as the predicate device and support the determination of substantial equivalence between the proposed device and the predicate device.
Conclusion on Substantial Equivalence IX.
The STARband® 3D™ cranial orthosis device proposed in this submission is substantially equivalent to the predicate device in K211376, given that it has the same indications for use, intended use, and underlying principles of operation and that nonclinical performance test results support that determination.