STARband 3D

K223238 · Orthomerica Products, Inc. · MVA · Apr 20, 2023 · Neurology

Device Facts

• Record ID: K223238
• Device Name: STARband 3D
• Applicant: Orthomerica Products, Inc.
• Product Code: MVA · Neurology
• Decision Date: Apr 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

STARband 3D is a cranial orthosis for infants (3-18 months) with non-synostotic positional plagiocephaly. Practitioner captures 3D image of infant's head; CAD software modifies image to create a positive model with improved symmetry. Device is additively manufactured to provide total contact over prominent/bossed areas and voids over depressed areas, redirecting growth toward symmetry. Device features bilateral side-opening design with two latch closure mechanisms. Used in clinical settings by practitioners; worn by infants ~23 hours/day. Output is a custom-fitted polymer helmet. Healthcare providers use the device to guide cranial growth, potentially improving head shape and symmetry. Benefits include non-invasive correction of cranial deformities.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensional analysis (comparing 3D-printed parts to design files), fit assessment on patient-matched molds, pressure distribution testing, and mechanical cyclic/destructive testing of the latch closure mechanism. Biocompatibility testing (cytotoxicity, sensitization, irritation) was performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Polymer cranial orthosis; additively manufactured. Features bilateral side-opening design with dual latch closures and zone-padded lining. Dimensions are patient-matched via 3D scanning. Biocompatibility per ISO 10993-5 and ISO 10993-10. Software-driven CAD design process.

Indications for Use

Indicated for infants 3-18 months old with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic head shapes. Contraindicated for infants with synostosis or hydrocephalus.

Regulatory Classification

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.

Special Controls

*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)).

In addition to the general controls of the act, the Dynamic Orthotic Cranioplasty - DOC™ Band is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) The labeling must include (a) contraindications for the use of the device on infants with synostosis or with hydrocephalus; (b) warnings indicating the need: (i) to evaluate head circumference measurements and neurological status at intervals appropriate to the infant’s age and rate of head growth, and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development; (ii) to evaluate the skin at frequent intervals, e.g., every three to four hours, and to describe steps that should be taken if skin irritation or breakdown occurs; (c) precautions indicating the need: (i) to additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) to evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, possible impairment of brain growth and development and skin irritation and/or breakdown; (iii) to evaluate the structural integrity of the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of this device; (e) clinician’s instructions for casting the infant, for fitting the device, and for care and use of the device; and (f) parents’ instructions for care and use of the device. (3) The materials must be assessed for biocompatibility with testing appropriate for long term direct skin contact.

Predicate Devices

• STARband Cranial Orthosis (K211376)

Reference Devices

• MyCRO Band (K201426)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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<br>Orlando, FL 32810 |
| Telephone: | [phone] |
| Facsimile: | [phone] |

### FDA Establishment Registration Number

### 1058152

### Contact Information

| Contact Person: | Najiba Katir, Regulatory Compliance Manager |
|-----------------|------------------------------------------------------|
| Address: | 6333 North Orange Blossom Trail<br>Orlando, FL 32810 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Email: | [e-mail] |
| 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<br>Orlando, FL 32810 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| FDA Establishment Registration Number: | 1058152 |

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#### 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

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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

- Predicate Device: STARband® Cranial Orthosis K211376 트
- 트 Reference Device: MyCRO Band - K201426

#### 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<br>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<br>areas of bossing or protrusion<br>and creates voids over areas<br>of depression or flattening to<br>redirect cranial growth<br>toward greater symmetry. | Maintains total contact<br>over areas of bossing or<br>protrusion and creates<br>voids over areas of<br>depression or flattening to<br>redirect cranial growth<br>toward greater symmetry. | Redirects head growth by<br>maintaining contact over<br>cranial<br>areas which protrude and by<br>creating voids<br>over areas of depression or<br>flattening in order to improve<br>symmetry. |
| Contraindications | Not for use on infants with<br>synostosis or<br>hydrocephalus | Not for use on infants with<br>synostosis or<br>hydrocephalus | Not for use on infants with<br>pre-surgical craniosynostosis<br>or hydrocephalus |
| Prescription<br>required? | Prescription Use Only | Prescription Use Only | Prescription Use Only |
| Size Options | Patient-matched sizing by<br>scanning an image of<br>patient's head shape | Patient-matched sizing by<br>scanning an image of<br>patient's head shape | Patient-matched sizing by<br>scanning an image of patient's<br>head shape |

| Table 1 - Comparison of Proposed Device, Predicate Device, and Reference Device |
|---------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------|

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| Device | Proposed Device | Predicate Device K211376 | Reference Device K201426 |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | | |
| | | plaster mold to make<br>positive mold of head<br>shape | |
| Software Used for<br>Shape | CAD software is used to<br>modify the shape of the<br>scanned image to improve<br>symmetry and shape of the<br>helmet to be<br>manufactured | Customized and/or CAD<br>software may be used to<br>modify the shape of the<br>scanned image to improve<br>symmetry and shape of<br>the helmet to be<br>manufactured | CAD software is used to<br>modify the shape of the<br>scanned image to improve<br>symmetry and shape of the<br>helmet to be<br>manufactured |
| Design<br>Components | Polymer helmet with bi-<br>lateral side-opening, closures,<br>and zone padded lining | Polymer helmet with side<br>opening closure and<br>padded lining | Polymer helmet with side<br>opening closure and padded<br>lining |
| Approximate<br>Device<br>Weight | 4 — 6.5 oz | 6 — 10 oz | 4 — 6.5 oz |
| Manufacturing<br>Process | Additively manufactured<br>orthosis based<br>upon measurements of the<br>infant's head captured by a<br>previously cleared 3-<br>dimensional imaging device | - Form orthosis from a<br>positive mold of infant's<br>head<br>- Positive mold is formed<br>based upon<br>measurements of the<br>infant's head taken by an<br>approved 3-dimensional<br>imaging device from which<br>a 3-dimensional image is<br>made or from a traditional<br>plaster cast<br>- The 3-dimensional image<br>is used to produce a<br>positive mold using a 5-<br>axis routing machine | Additively manufacture the<br>orthosis based upon<br>measurements of the infant's<br>head taken by a compatible 3-<br>dimensional imaging device |
| Approved 3-<br>Dimensional<br>Imaging Devices | STARscanner I<br>STARscanner II | Spectra 3D Scanner<br>M4DScan/BodyScan<br>System<br>Omega Scanner<br>3dMDhead System<br>3dMDcranial System<br>3dMDflex System<br>scanGogh-II<br>STARscanner l<br>STARscanner II<br>SmartSoc System for<br>Android and iOS devices | Creaform HCP<br>Creaform Peel1<br>Creaform Peel 3D<br>Rodin4D M4D Scan<br>TechMed3D BodyScan<br>OMEGA Scanner 3D<br>Artec Eva<br>Artec Eva Lite<br>iFab EasyScan |
| Device<br>Characteristic | Proposed Device | Predicate Device K211376 | Reference Device K201426 |
| Testing | Test samples were<br>additively manufactured from<br>3D<br>images of representative<br>cranial shapes<br>using previous cleared<br>scanning device(s).<br>Process Validation included<br>Dimensional Analysis, Fit<br>Assessment and Mechanical<br>Testing of test samples to<br>evaluate the additive<br>manufacturing process<br>performance, which was<br>compared to the process used<br>for the predicate device. | Cranial Shape Capture<br>Accuracy Study utilized a<br>representative cranial<br>shape that possesses a<br>predefined shape with<br>known dimensions, which<br>compared proposed device<br>to cast and predicate<br>device. Associated<br>parameters analyzed<br>included coordinate planes<br>(A-P; M-L; P-D) and various<br>radius parameters,<br>squareness, and flatness. | Scanner Evaluation utilized a<br>worst-case challenge<br>reference object of known<br>dimensions to assess 3D<br>imaging devices for adequate<br>accuracy, repeatability, and<br>reproducibility. Scanners were<br>compared to those previously<br>cleared for use for the<br>predicate device as well as<br>internal acceptance criteria.<br>Software Validation<br>demonstrated software<br>performance,<br>interoperability, and ability<br>to meet internal device<br>specifications. In addition to<br>IQ, OQ, and PQ studies, a Fit<br>Assessment was performed<br>using test samples which<br>were additively manufactured<br>from 3D<br>images of representative<br>simulated cranial shapes<br>using a compatible scanner.<br>Process Validation included<br>dimensional analysis and<br>mechanical testing of test<br>samples to evaluate the<br>additive manufacturing<br>process performance, which<br>was compared to the process<br>used for the<br>predicate device. |
| Biocompatibility | Material Biocompatibility<br>Testing<br>● Cytotoxicity<br>● Sensitization<br>● Irritation | Material Biocompatibility<br>Testing<br>● Cytotoxicity<br>● Sensitization<br>● Irritation | Material Biocompatibility<br>Testing<br>● Cytotoxicity<br>● Sensitization<br>● Irritation |

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| Test Type | Test Name | Test Method Summary | Test Results |
|------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensional<br>Analysis | Dimensional<br>Analysis | Dimensional analysis was performed by<br>manually overlaying the 3D-printed part<br>scan file on the original design file using<br>Autodesk Netfabb Premium Software.<br>Dimensional differences were recorded at<br>assigned locations to analyze the<br>dimensional variability between 3D printed<br>parts and computer design files. | Dimensional analysis of<br>the additively<br>manufactured Starband®<br>3D orthoses resulted in<br>acceptable part<br>consistency and<br>reproducibility across<br>build cycles for both<br>controlled and random<br>sample population. |
| Fit Analysis | Fit Assessment | The fit assessment was performed using<br>3/16" pads that were installed in the<br>additively manufactured samples which<br>were fit to the unmodified patient matched<br>mold and visually assessed for proper fit,<br>form and function | The fit assessment of the<br>additively manufactured<br>Starband® 3D orthoses<br>was successful for all<br>parts evaluated. All<br>helmets aligned and<br>secured properly and<br>total contact<br>(appropriate hold) was<br>achieved at the<br>prominent or bossed<br>areas of the unmodified<br>patient model. |
| Pressure Test | Pressure Test | The pressure test was performed by placing<br>force sensors at the holding areas<br>(dependent on diagnosis and pad<br>configuration) at the patient-helmet<br>interface and then pressure force was<br>recorded. Results of this test are aimed to<br>prove that pressure distribution for the<br>Starband 3D design, when fit on patient, is<br>equivalent to or better than the predicate<br>device. | The Starband® 3D<br>orthoses design<br>successfully showed that<br>the pressure force is<br>comparable to the<br>predicate device. |
| Mechanical<br>Analysis | Latch Closure Cyclic<br>Test | The latch closure cyclic test consisted of<br>introducing localized fatigue at the latch<br>closure by applying repeated stress for a<br>specific amount of cycles. Pull forces to<br>disengage (open) the latch closure where<br>obtained before starting the cycle testing<br>and then every predetermined amount of<br>cycles. | The latch closure design<br>successfully exceeded<br>the established don &<br>doff cycles without<br>fatigue or failure<br>impacting function<br>during normal utilization.<br>The design maintained<br>operational criteria of<br>latching and successfully<br>securing the anterior and<br>posterior shells on the<br>patient model<br>throughout the duration<br>of the cyclic fatigue. |
| | | | testing. |
| | Latch Closure<br>Destructive Testing | Latch closure samples were affixed to the<br>testing machine and a linear pull-force<br>(perpendicular to the helmet's exterior<br>surface) was applied to the latch until<br>failure occurred. The maximum force<br>required to fail the latch must exceed a<br>maximum average pull strength of 9.18 lbf<br>for and adult using defined pinch grips<br>(Razza et al., 2022) | Destructive testing<br>successfully proved that<br>the STARband 3D latch<br>closure design exceeds<br>the average pull strength<br>of an adult when using<br>various pinch grips in<br>application. It was<br>concluded that the latch<br>closure mechanism can<br>withstand and surpass<br>the pull forces of Don &<br>Doff throughout the<br>entire treatment. |
| Biocompatibility<br>Analysis | Material<br>Biocompatibility<br>Test | Biological evaluation tests were performed<br>to verify conformance of the materials used<br>in the STARband 3D device in accordance<br>with the ISO 10993-5 and ISO 10993-10<br>standards. Biocompatibility testing involved<br>irritation, cytotoxicity and sensitization<br>testing on the finished, fully assembled<br>additively manufactured device. | Biocompatibility test<br>reports demonstrate<br>that all biocompatibility<br>testing successfully met<br>the acceptance criteria. |

## VIII. Summary and Conclusion of Non-Clinical Performance Data

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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.