The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads, by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.

Device Description

The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.

The device allows for growth of the flattened areas of the infant's skull into the voids within the shell and foam lining. This combination of total contact and relief allows for significant correction of the asymmetrical head shape; thereby giving the infant's skull a more symmetrical and/or proportioned shape.

The Cranial Remolding Orthosis is fabricated from a 3/16" co-polymer base plastic shell with a ½" foam interface liner. The type of material used on the foam interface liner is Pelite polvethylene foam, Plastazote, or Aliplast foam spacer fills a ½" side opening, opposite the deficit, utilizing the same material as the corresponding foam liner. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above and around the ears. The posterior inferior is trimmed distally to capture the occiput. A hook and loop closure (also referred to as Velcro within the industry) is attached on the side of the deficit, bridging over the side opening, keeping the device securely in place.

AI/ML Overview

The provided text for K111247 primarily focuses on establishing substantial equivalence to a predicate device, the STARband Cranial Remolding Orthosis (K082950/K011350). The FDA 510(k) submission process for this device, a Cranial Remolding Orthosis, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical studies with acceptance criteria in the same way a novel device might.

Here's an analysis of the "acceptance criteria" and "study" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Materials used are safe for skin contact and do not cause irritation or toxic effects.	The device uses 3/16" copolymer plastic and ½" hypoallergenic polyethylene foam (Pelite, Plastazote or Aliplast). These materials are similar to the predicate device and have a "demonstrated history of use in a specified role" without adverse effects. No skin irritation or toxic effects are reported.
Biocompatibility: No adverse biological reactions.	"The safety of the cranial orthosis has been demonstrated through past biocompatibility assessments which revealed that this type of device is not expected to adversely affect children under intended conditions of wear/use." (Referencing ISO 10993-11 guidance). "No testing is needed if the material has a demonstrated history of use."
Mechanical Design/Function Equivalence: The device's design maintains pressure and redirects growth as the predicate.	The device "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," which is identical to the stated function of the STARband. The design and production processes are considered "substantially equivalent."
Manufacturing Process Equivalence: The manufacturing process results in a product comparable to the predicate.	"The materials used and processes of manufacturing the device are handled in an identical manner to the predicate device, incorporating all the safety and standards of practice."
Imaging System Accuracy (for scanning heads): The scanning system used to create the custom mold is accurate, reproducible, and repeatable.	The OMEGA Scanner "provides a 3D digital image of the patient's head that is accurate to .5mm." Its accuracy, reproducibility, and repeatability were "evaluated by scanning three cylindrical shapes five times and downloading the files three times." The OMEGA Scanner "met the predetermined acceptable criteria."
Safety: No improper migration or harmful pressure levels; smooth interior poses no threat during use.	"It is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no threat to the child during application."
Clinical Effectiveness (Implied by Predicate Equivalence): The device effectively improves cranial symmetry and/or shape.	The effectiveness is largely inferred from the equivalence to the predicate device, which has been "effectively used for years without complications."
Special Controls Compliance: Adherence to regulatory special controls for cranial orthoses (21 C.F.R. § 882.5970).	The submission states: "Special controls are required. 21 C.F.R. § 882.5970" and implies compliance through substantial equivalence.
Intended Use Equivalence: The Cranial Remolding Orthosis has the same intended use as the predicate device.	The "Intended Use" statement for the Cranial Remolding Orthosis is nearly identical to the described function of the STARband.

Study Proving Acceptance Criteria:

The "study" or justification for meeting these acceptance criteria is primarily a comparative analysis against the predicate device (STARband) and reference to existing standards and literature.

For material and biocompatibility: The documentation cites ISO 10993-11, indicating that if a material has a "demonstrated history of use in a specified role," no new testing is needed. The materials used are stated to be "identical" or "substantially equivalent" to those in the predicate, which has such a history.
For design and manufacturing: A direct comparison (Table 5.1) is presented, highlighting the similarities in intended use, materials, product design, and production processes between the Cranial Remolding Orthosis and the STARband. The document asserts that "The materials used and processes of manufacturing the device are handled in an identical manner to the predicate device."
For the scanning technology (OMEGA Scanner vs. STARScanner): A specific validation study was performed: "The accuracy, reproducibility, and repeatability of the STARScanner and the OMEGA scanner were evaluated by scanning three cylindrical shapes five times and downloading the files three times to the digital image. Standard measurement system statistical process control procedures were used to evaluate the scan rate of error, standard deviation, repeatability, and reproducibility of multiple scans. Both devices met the predetermined acceptable criteria." This indicates a technical performance study for the measurement component, not the orthosis itself.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- For the orthosis itself: No specific test set sample size for clinical performance is mentioned in the context of this 510(k) submission, as it relies on substantial equivalence to the predicate.
- For the OMEGA Scanner validation: "scanning three cylindrical shapes five times" means 3 shapes * 5 scans = 15 total scans. The files were downloaded "three times" for each scan, suggesting repeated digital processing.
Data Provenance: The document does not specify country of origin for the data in the OMEGA scanner validation study. The study appears to be internal validation by the manufacturer or associated entity. It is a prospective study for the OMEGA scanner's technical performance. For the orthosis, the data provenance is primarily from the known performance and history of the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For the orthosis: No experts are explicitly mentioned for establishing ground truth for a test set of the Cranial Remolding Orthosis itself, as its effectiveness is inferred from the predicate.
For the OMEGA Scanner validation: No experts are mentioned for establishing ground truth in the technical validation of the scanner (i.e., measuring cylindrical shapes). The "ground truth" would be the known dimensions of the cylindrical shapes measured instrumentally.

4. Adjudication Method for the Test Set

No adjudication method is described for the performance of the orthosis, as no clinical test set directly evaluating the orthosis's performance is presented in this 510(k). For the OMEGA scanner, the evaluation was against "predetermined acceptable criteria," implying a comparison to established metric values rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported for the Cranial Remolding Orthosis. This type of study is typically done for diagnostic devices where human interpretation is involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a physical orthosis, not an algorithm. The OMEGA scanner, which is a component of the workflow, had a standalone technical validation for its accuracy, reproducibility, and repeatability in measuring physical objects (cylindrical shapes). This is an "algorithm only" type of test in the sense that the scanner's output (3D digital image) was tested for its fidelity, independent of human interpretation or intervention in the measurement process itself.

7. Type of Ground Truth Used

For the orthosis: The ground truth for effectiveness is implicitly tied to the established clinical outcomes and safety profile of the predicate device (STARband). The clinical literature referenced (Littlefield et al., 1988) speaks to the treatment of craniofacial asymmetry with dynamic orthotic cranioplasty in general, supporting the concept of this type of device.
For the OMEGA Scanner validation: The ground truth was the known dimensions of the "three cylindrical shapes."

8. Sample Size for the Training Set

For the orthosis: There is no mention of a "training set" in the context of this device because it is a physical medical device manufactured based on patient-specific molds, not a machine learning model.
For the OMEGA Scanner: No specific "training set" is mentioned for the scanner's underlying algorithms either. The scanner validation study is a performance evaluation of a pre-existing system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set (in the context of machine learning) is described for this device or its related components.

Summary

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K111247

Orthotic Care Services, LLP

AUG 1 5 2011

510(k) Summary of Effectiveness and Safety

The following summary is provided pursuant to 510(k) summaries specified in 21 CFR 807.92(a) of the Federal Food, Drug, and Cosmetic Act.

1.) Applicant Information:

Submitter and Contact:

Scott Hinshon, CO Orthotic Care Services, LLP 360 Sherman Street, Suite 299 St. Paul, MN 55102 651-291-9000

Summary Date: April 21, 2011

Subject: K11247

2.) Classification and Device Name

Type: Traditional 510(k) Submission

Proprietary Name: Cranial Remolding Orthosis

Common Name: Cranial Orthosis

Classification: Class II, Cranial Orthosis, Code MVA

Classification Name: Cranial Orthosis ( 21 C.F.R. § 882.5970)

3.) Predicate Devices: STARband Cranial Remolding Orthosis (K082950/K011350) 510/k) submitter: Orthomerica Products Inc, 505 31st Street, P.O. Box 2927, Newport Beach, CA 92659, Telephone: (949) 723-4500, Facsimile: (949) 723-4501

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4.) Device Description

The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.

Commonly diagnosed head deformities are positional plagiocephaly, brachycephaly (head is disproportionately wide and flat posteriorly), and scaphocephaly (head is disproportionately long and narrow). In addition, the Cranial Remolding Orthosis can be used following a minimally invasive surgery for infants with craniosynostosis who still need moderate to severe correction of plagiocephaly, brachycephaly and scaphocephaly. They are less common but represent an emerging patient group.

Plagiocephaly, Brachycephaly and Scaphocephaly:

This condition is defined as a malformation of the skull resulting in an "oblique", "crooked", or "parallelogram" shaped head. Other similar conditions which are positional in nature are Brachycephaly and Scaphocephaly, and they result in heads that are well out of proportion to the normal width versus length. Medically diagnosed non-synostotic deformational plagiocephaly is typically assessed by a combination of clinical observation, xray, CT scan, and possibly an MRI to rule out craniosynostosis.

Craniosynostosis:

This conditions is caused by the premature fusion of one or more cranial sutures of the skull; causing the head to grow into a usual shape. It presents in a dissimilar way to deformational (positional) plagiocephaly. However, in cases where the physician cannot make a definitive diagnosis, patients are referred to specialists such as neurosurgeons or craniofacial surgeons. These specialists will order a test such as a CT scan or MRI to confirm the diagnosis of craniosynostosis.

Following surgery to release the diseased suture, the same principles that guide cranial remolding of deformational head shapes are applicable. A prescription will be provided if the craniofacial surgeon deems that a helmet is medically necessary. In both deformational head shapes and post-surgical head shapes the Cranial Remolding Orthosis is designed to maintain total contact over the areas where growth is not desired while providing space over areas where growth is desired.

Causes:

Cranial asymmetries or disproportions are commonly caused by external forces to the head and are influenced by many differing factors that include supine sleeping positions (Back to Sleep campaign in 1992), preferred head orientation, torticollis (limited head rotation), increased incidence of multiple births, low tone (hypotonia), and extended supine positioning.

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Material Specifications:

Materials	3/16" outer shell of copolymer plastic ½" hypoallergenic polyethylene foam (Pelite, Plastazote or Aliplast) 1 1/2" strap of dacron 1 1/2" chafe buckle Large flange, blind rivet or 89X speedy rivet ½" hypoallergenic polyethylene foam spacer (Pelite or Aliplast)
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5.) Intended Use of Device

6.) Comparison to Predicate Device

The Cranial Remolding Orthosis is a custom orthosis used to treat an infant's abnormally shaped head from three to eighteen months of age, This condition is clinically known as positional or deformational plagiocephaly. The Cranial Remolding Orthosis contains and limits growth of these bossed and protruding areas while promoting growth of the flattened areas of the skull as facilitated by the voids and spaces created within the helmet. The Cranial Remolding Orthosis is only available when prescribed by a physician, a certified pediatric nurse practitioner or other qualified medical professional.

The Cranial Remolding Orthosis' design has been illustrated in Table 5.1 below. There is not a significant difference between the helmets' materials selections, and the processes for fabrication are substantially equivalent. The inner liner is made with hypoallergenic polyethylene foam. These materials can safely come into contact with the skin and not cause redness, rash or irritation. A speedy rivet or pop-rivet will be used to attach the strap and chafe 3

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to the Cranial Remolding Orthosis. The rivet system used provides a cosmetically appealing product.

Similarities in the Cranial Remolding Orthosis and the STARband device are design, production, intended use and special controls. Both devices consist of outer plastic shells and an inner foam lining. The materials used and processes of manufacturing the device are handled in an identical manner to the predicate device, incorporating all the safety and standards of practice. The proposed indications of use, biocompatibility, function and effectiveness are equivalent to those presented by the predicate device.

	Cranial Remolding Orthosis	STARband
Intended Use	Maintains total contact over areasof bossing or protrusion andcreates voids over areas ofdepression or flattening to redirectcranial growth toward greatersymmetry.	Maintains total contact overareas of bossing or protrusionand creates voids over areas ofdepression or flattening toredirect cranial growth towardgreater symmetry.
Materials	• 5/32" outer shell of copolymerplastic• ½" hypoallergenic polyethylenefoam (Pelite, Plastazote orAliplast)• 1 1/2" strap of dacron• 1 1/2" chafe buckle• Large flange, blind rivet or 89Xspeedy rivet• ½" hypoallergenic polyethylenefoam spacer (Pelite or Aliplast)	• Outer shell of .156 copolyplastic• An inner liner of ½" Pelitepolyethylene foam or ½"Aliplast foam.• A strap of 1 ½" Dacron• A 1 ½" chafe buckle• Large Flange, Blind Rivet• A Gap Block made from ½"firm pelite polyethylenefoam• A nylon washer
Product design	Custom fabricated cranialremolding orthosisApproximate weight: 6oz.	Custom made cranial orthosis,approx 6oz. in weight
Production	Form orthosis from a positivemold of the patient's head:• A positive scanned model iscaptured using the WillowWood Omega Scanner.• A 3-dimentional model iscarved using a 5-axis routingmachine carver in-houseand/or a central fabrication siteprior to modification andfabrication of the device.• The 3-dimentional model ismodified by a technician underthe direction of a clinician.Plaster buildups are added toareas of flattening to createsymmetry and/or properproportions of the head.	• Form orthosis from apositive mold ofinfant's head.• Positive mold isformed based uponmeasurements of theinfant's head taken bythe STARscanner,which a 3-dimensionalimage is made or froma traditional plastercast.• The 3-dimensionalimage is used toproduce a positivemold using a 5-axisrouting machine.

Table 5.1 – Cranial Remolding Orthosis Design vs. STARband

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Comparison of Willow Wood OMEGA Scanner vs. STARscanner

The predicate STARScanner and the OMEGA Scanner are equivalent in many ways. They both achieve the same result through slightly different means while maintaining the highest levels of safety for the patient. Both scanners are Class I FDA approved laser imaging devices that provide a 3D digital image of the patient's head that is accurate to .5mm. The both used the same computer OMEGA Tracer Software. The STARScanner uses eight cameras and four lasers to capture the image, while the OMEGA Scanner uses two cameras, one laser, and reflective stickers to capture an image that is just as accurate. The accuracy, reproducibility, and repeatability of the STARScanner and the OMEGA scanner were evaluated by scanning three cylindrical shapes five times and downloading the files three times to the digital image. Standard measurement system statistical process control procedures were used to evaluate the scan rate of error, standard deviation, repeatability, and reproducibility of multiple scans. Both devices met the predetermined acceptable criteria. Both devices are approved by the FDA to be used in scanning an infant. No eye protection is necessary as the FDA as deemed these devices as Class 1 lasers.

There are some differences between the STARScanner and the OMEGA scanner. One of the major differences between the two devices is that the predicate STARScanner is much less portable than the OMEGA scanner is; with the STARScanner the patient laying on a sled type table and has the measurement devise passed over the patients cranium when they are laying in the appropriate position. This requires the infant to lay as still as possible. The OMEGA scanner takes it readings by waving the hand wand around the infant's reflective cap; the patient can be held or sitting up.

6.)Performance Standards and Data

The predicate device designed by Orthomerica (K011350) using the same techniques and materials. It incorporates an outer copolymer shell lined on its interior with a medium durometer cross linked polyethylene foam: Pelite or Volara (AliPlast) lining. (Orthomerica Retrieved April 4, 2011 from http://www.orthomerica.com/products Products, Inc. /cranial/starband.htm).

Description of Orthosis:

Side-opening helmet .
Proximal opening .
3/16" Copolymer shell .
1/2" Polyethylene foam liner .
1 ½" Velcro® strap and chafe closure .

The safety of the cranial orthosis has been demonstrated through past biocompatibility assessments which revealed that this type of device is not expected to adversely affect children under intended conditions of wear/use. Though, our Cranial Remolding Orthosis has not undergone its own individual clinical trials with respect to biocompatibility. This is in compliance with ISO 10993-11 in that after review of the production methods and materials involved, "no testing is needed if the material has a demonstrated history of use in a specified role to that of the device under design."

These assessments reveal that the device and the materials used are not expected to adversely affect the infants under the intended conditions of wear.2 The materials are not reported to cause skin irritation or any toxic effects. Furthermore, it is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no threat to the child during application within the normal scope of its intended use.

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Also, the proposed device is not in any quantifiable way different from the predicate device with regard to manufacture or materials used, thus when looking at the predicate device we can see that the helmet has been effectively used for years without complications of this sort.

Special controls are required. 21 C.F.R. § 882.5970; 63 Fed. Reg. 40, 650-651 (July 30, 1998)

1 http://www.iso.org/iso/iso_catalogue.htm

2 Littlefield TA, Beals S, Manwaring KH, Pomnatto JK, Joganic EF, Golden KA, Ripley CE. Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty, Journal of Cranio facial Surgery, 1988; 11-17.

7.) Summary

റ

The safety and effectiveness data submitted to the FDA establishes that the Cranial Remolding Orthosis is substantially equivalent to applicable predicate devices. Based on the technological characteristics and performance testing the device has been determined to be substantially equivalent to the predicate devices.

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Image /page/6/Picture/1 description: The image shows a seal or logo. The logo is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the seal is a stylized image of an eagle or other bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Scott Hinshon, CO Orthotic Care Services, LLP 360 Sherman Street, Suite 299 St. Paul, MN 55102

AUG 1 5 2011

Re: K111247

Trade/Device Name: Cranial Remolding Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: June 17, 2011 Received: June 24, 2011

Dear Mr. Hinshon:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Scott Hinshon, CO

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notfication" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffre mumber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ruchan, M.D.
Melvin R. Feldman, M.D.

Malvina B. Eydelman, M.E Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K111247

Device Name: Cranial Remodeling Orthosis

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

KRISTEN BOWSHER (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________

510(k) Number_K III 247

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)).