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 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.

AI/ML Overview

The provided text is a 510(k) summary for the STARband 3D cranial orthosis, which is a medical device for treating infants with abnormal head shapes. This document does not include information about a study that proves the device meets acceptance criteria related to AI/algorithm performance or human reader improvement, as it is not an AI-powered device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing conducted for the STARband 3D. The device is a physical cranial orthosis, and its evaluation revolves around its physical characteristics, manufacturing process, and safety, not AI diagnostic performance.

Therefore, many of the requested points regarding AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for AI, and sample sizes for training sets of AI models are not applicable to this device and the provided document.

However, I can extract information related to the physical device's performance testing and "acceptance criteria" from the document.

Here's the relevant information from the provided text, adapted to the closest interpretations of your questions for a non-AI device:

Acceptance Criteria and Device Performance (for a physical medical device)

The device is a cranial orthosis (a helmet) designed to improve cranial symmetry and/or shape in infants. The "acceptance criteria" for a physical device like this are met through demonstrating that its design, manufacturing process, and materials are safe and perform as intended, comparable to a predicate device.

Here's a table summarizing the non-clinical performance and acceptance criteria for the STARband 3D, as reported in the 510(k) summary:

Test Type	Test Name	Acceptance Criteria (Implicit from Test Results)	Reported Device Performance
Dimensional Analysis	Dimensional Analysis	Acceptable part consistency and reproducibility across build cycles for both controlled and random sample populations. The dimensional differences between 3D printed parts and computer design files must be within acceptable limits (implied by "acceptable part consistency and reproducibility").	"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	Proper fit, form, and function when 3/16" pads are installed and the device is fit to an unmodified patient-matched mold. All helmets must align and secure properly, and total contact (appropriate hold) must be achieved at the prominent or bossed areas of the unmodified patient model.	"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	Pressure distribution for the Starband 3D design, when fit on patient (or model), must be 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 must successfully exceed the established don & doff cycles without fatigue or failure impacting function during normal utilization. The design must maintain operational criteria of latching and successfully securing the anterior and posterior shells on the patient model throughout the duration of the cyclic fatigue testing.	"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."
Mechanical Analysis	Latch Closure Destructive Testing	The maximum force required to fail the latch must exceed a maximum average pull strength of 9.18 lbf for an adult using defined pinch grips (Razza et al., 2022). This demonstrates it can withstand and surpass the pull forces of Don & Doff throughout the entire treatment.	"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	All biocompatibility testing must successfully meet the acceptance criteria of ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization, Irritation).	"Biocompatibility test reports demonstrate that all biocompatibility testing successfully met the acceptance criteria."

Here are the answers to your specific questions, indicating where the information is not applicable (N/A) for this type of device submission:

A table of acceptance criteria and the reported device performance
- See the table above.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document refers to "test samples" for Dimensional Analysis, Fit Assessment, and Mechanical Testing, and "test samples" or "finished, fully assembled additively manufactured device" for Biocompatibility. However, specific numerical sample sizes for these tests are not provided in this 510(k) summary.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (bench/lab) tests for a physical device, the concepts of retrospective/prospective clinical data are not directly applicable. These appear to be laboratory-based validation studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- N/A. This device does not involve "ground truth" derived from expert interpretation of medical images or patient data in the typical sense of AI/diagnostic device evaluation. The "ground truth" for these tests comes from engineering specifications, known dimensions, mechanical properties of materials, and successful operation based on design intent. For example, the "unmodified patient matched mold" serves as a reference for the fit assessment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically relevant for clinical studies or studies where multiple human readers interpret data to establish a consensus "ground truth." This is a non-clinical, bench testing report for a physical device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is not an AI-powered diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical cranial orthosis, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A in the typical AI sense. For this physical device, "ground truth" is established by:
  - Engineering Specifications/Design Files: For Dimensional Analysis (comparison of 3D printed part to original design file).
  - Physical Models/Molds: For Fit Assessment (fitting to an "unmodified patient matched mold").
  - Predicate Device Performance: For Pressure Test (comparing pressure force to the predicate device).
  - Defined Mechanical Criteria: For Latch Closure tests (e.g., specific cycle counts, exceeding a defined pull strength threshold).
  - International Standards: For Biocompatibility (conformance to ISO 10993-5 and ISO 10993-10).
The sample size for the training set
- N/A. This device does not involve machine learning or a "training set."
How the ground truth for the training set was established
- N/A. This device does not involve machine learning or a "training set."

Summary

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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

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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 (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

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Indications for Use

510(k) Number (if known) K223238

Device Name STARband 3D

Indications for Use (Describe)

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 TrailOrlando, 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 TrailOrlando, 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 TrailOrlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419
FDA Establishment Registration Number:	1058152

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Description of Device/Modification IV.

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:

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.

DeviceCharacteristic	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 overareas of bossing or protrusionand creates voids over areasof depression or flattening toredirect cranial growthtoward greater symmetry.	Maintains total contactover areas of bossing orprotrusion and createsvoids over areas ofdepression or flattening toredirect cranial growthtoward greater symmetry.	Redirects head growth bymaintaining contact overcranialareas which protrude and bycreating voidsover areas of depression orflattening in order to improvesymmetry.
Contraindications	Not for use on infants withsynostosis orhydrocephalus	Not for use on infants withsynostosis orhydrocephalus	Not for use on infants withpre-surgical craniosynostosisor hydrocephalus
Prescriptionrequired?	Prescription Use Only	Prescription Use Only	Prescription Use Only
Size Options	Patient-matched sizing byscanning an image ofpatient's head shape	Patient-matched sizing byscanning an image ofpatient's head shape	Patient-matched sizing byscanning an image of patient'shead 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 makepositive mold of headshape
Software Used forShape	CAD software is used tomodify the shape of thescanned image to improvesymmetry and shape of thehelmet to bemanufactured	Customized and/or CADsoftware may be used tomodify the shape of thescanned image to improvesymmetry and shape ofthe helmet to bemanufactured	CAD software is used tomodify the shape of thescanned image to improvesymmetry and shape of thehelmet to bemanufactured
DesignComponents	Polymer helmet with bi-lateral side-opening, closures,and zone padded lining	Polymer helmet with sideopening closure andpadded lining	Polymer helmet with sideopening closure and paddedlining
ApproximateDeviceWeight	4 — 6.5 oz	6 — 10 oz	4 — 6.5 oz
ManufacturingProcess	Additively manufacturedorthosis basedupon measurements of theinfant's head captured by apreviously cleared 3-dimensional imaging device	- Form orthosis from apositive mold of infant'shead- Positive mold is formedbased uponmeasurements of theinfant's head taken by anapproved 3-dimensionalimaging device from whicha 3-dimensional image ismade or from a traditionalplaster cast- The 3-dimensional imageis used to produce apositive mold using a 5-axis routing machine	Additively manufacture theorthosis based uponmeasurements of the infant'shead taken by a compatible 3-dimensional imaging device
Approved 3-DimensionalImaging Devices	STARscanner ISTARscanner II	Spectra 3D ScannerM4DScan/BodyScanSystemOmega Scanner3dMDhead System3dMDcranial System3dMDflex SystemscanGogh-IISTARscanner lSTARscanner IISmartSoc System forAndroid and iOS devices	Creaform HCPCreaform Peel1Creaform Peel 3DRodin4D M4D ScanTechMed3D BodyScanOMEGA Scanner 3DArtec EvaArtec Eva LiteiFab EasyScan
DeviceCharacteristic	Proposed Device	Predicate Device K211376	Reference Device K201426
Testing	Test samples wereadditively manufactured from3Dimages of representativecranial shapesusing previous clearedscanning device(s).Process Validation includedDimensional Analysis, FitAssessment and MechanicalTesting of test samples toevaluate the additivemanufacturing processperformance, which wascompared to the process usedfor the predicate device.	Cranial Shape CaptureAccuracy Study utilized arepresentative cranialshape that possesses apredefined shape withknown dimensions, whichcompared proposed deviceto cast and predicatedevice. Associatedparameters analyzedincluded coordinate planes(A-P; M-L; P-D) and variousradius parameters,squareness, and flatness.	Scanner Evaluation utilized aworst-case challengereference object of knowndimensions to assess 3Dimaging devices for adequateaccuracy, repeatability, andreproducibility. Scanners werecompared to those previouslycleared for use for thepredicate device as well asinternal acceptance criteria.Software Validationdemonstrated softwareperformance,interoperability, and abilityto meet internal devicespecifications. In addition toIQ, OQ, and PQ studies, a FitAssessment was performedusing test samples whichwere additively manufacturedfrom 3Dimages of representativesimulated cranial shapesusing a compatible scanner.Process Validation includeddimensional analysis andmechanical testing of testsamples to evaluate theadditive manufacturingprocess performance, whichwas compared to the processused for thepredicate device.
Biocompatibility	Material BiocompatibilityTesting● Cytotoxicity● Sensitization● Irritation	Material BiocompatibilityTesting● Cytotoxicity● Sensitization● Irritation	Material BiocompatibilityTesting● Cytotoxicity● Sensitization● Irritation

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Test Type	Test Name	Test Method Summary	Test Results
DimensionalAnalysis	DimensionalAnalysis	Dimensional analysis was performed bymanually overlaying the 3D-printed partscan file on the original design file usingAutodesk Netfabb Premium Software.Dimensional differences were recorded atassigned locations to analyze thedimensional variability between 3D printedparts and computer design files.	Dimensional analysis ofthe additivelymanufactured Starband®3D orthoses resulted inacceptable partconsistency andreproducibility acrossbuild cycles for bothcontrolled and randomsample population.
Fit Analysis	Fit Assessment	The fit assessment was performed using3/16" pads that were installed in theadditively manufactured samples whichwere fit to the unmodified patient matchedmold and visually assessed for proper fit,form and function	The fit assessment of theadditively manufacturedStarband® 3D orthoseswas successful for allparts evaluated. Allhelmets aligned andsecured properly andtotal contact(appropriate hold) wasachieved at theprominent or bossedareas of the unmodifiedpatient model.
Pressure Test	Pressure Test	The pressure test was performed by placingforce sensors at the holding areas(dependent on diagnosis and padconfiguration) at the patient-helmetinterface and then pressure force wasrecorded. Results of this test are aimed toprove that pressure distribution for theStarband 3D design, when fit on patient, isequivalent to or better than the predicatedevice.	The Starband® 3Dorthoses designsuccessfully showed thatthe pressure force iscomparable to thepredicate device.
MechanicalAnalysis	Latch Closure CyclicTest	The latch closure cyclic test consisted ofintroducing localized fatigue at the latchclosure by applying repeated stress for aspecific amount of cycles. Pull forces todisengage (open) the latch closure whereobtained before starting the cycle testingand then every predetermined amount ofcycles.	The latch closure designsuccessfully exceededthe established don &doff cycles withoutfatigue or failureimpacting functionduring normal utilization.The design maintainedoperational criteria oflatching and successfullysecuring the anterior andposterior shells on thepatient modelthroughout the durationof the cyclic fatigue.
			testing.
	Latch ClosureDestructive Testing	Latch closure samples were affixed to thetesting machine and a linear pull-force(perpendicular to the helmet's exteriorsurface) was applied to the latch untilfailure occurred. The maximum forcerequired to fail the latch must exceed amaximum average pull strength of 9.18 lbffor and adult using defined pinch grips(Razza et al., 2022)	Destructive testingsuccessfully proved thatthe STARband 3D latchclosure design exceedsthe average pull strengthof an adult when usingvarious pinch grips inapplication. It wasconcluded that the latchclosure mechanism canwithstand and surpassthe pull forces of Don &Doff throughout theentire treatment.
BiocompatibilityAnalysis	MaterialBiocompatibilityTest	Biological evaluation tests were performedto verify conformance of the materials usedin the STARband 3D device in accordancewith the ISO 10993-5 and ISO 10993-10standards. Biocompatibility testing involvedirritation, cytotoxicity and sensitizationtesting on the finished, fully assembledadditively manufactured device.	Biocompatibility testreports demonstratethat all biocompatibilitytesting successfully metthe 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.

Regulation Number and Section

§ 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)).