STARband, STARlight, St. Louis Band

K203098 · Orthomerica Products, Inc. · OAN · Apr 27, 2021 · Neurology

Device Facts

• Record ID: K203098
• Device Name: STARband, STARlight, St. Louis Band
• Applicant: Orthomerica Products, Inc.
• Product Code: OAN · Neurology
• Decision Date: Apr 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The STARband®, STARlight®, and St. Louis Band are 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®, STARlight®, or St. Louis Band for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband®, STARlight®, and St. Louis Band have also been cleared to treat unresolved head deformities in patients who have undergone surgery to correct craniosynostosis. The same principles of cranial remolding apply to positional deformities and post-operative patients.

Device Story

Cranial orthosis (STARband, STARlight, St. Louis Band) treats infant head deformities; redirects growth to improve symmetry. Practitioner captures head shape via plaster cast or 3D scanner (e.g., SmartSoc); creates positive model via 5-axis routing. Device provides total contact over prominent areas; voids over depressed areas. Worn ~23 hours/day. New software component, Measurement Comparison Utility (MCU), allows practitioners to compare 3D digital models over treatment period to track progress. MCU presents measurements derived from 3D models; used for assessment, not manufacturing. Benefits include non-invasive correction of cranial deformities.

Clinical Evidence

Bench testing only. Accuracy and capability studies conducted on the MCU software compared measurements against manual measurements and 3D-CAD software. Previous R&R and accuracy studies for the SmartSoc Data Acquisition System and cranial orthosis fabrication were leveraged.

Technological Characteristics

Custom-molded cranial orthosis. Materials: polyethylene-polypropylene copolymer, Pelite/Aliplast polyethylene foam, Surlyn, or Co-Polyester. Energy: None (passive). Connectivity: MCU software is a standalone program for 3D model measurement/comparison. Sterilization: Not provided sterile.

Indications for Use

Indicated for infants 3-18 months with moderate-to-severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, scaphocephalic) to improve cranial symmetry/shape via mild pressure on prominent regions. Also indicated for adjunctive use in infants 3-18 months with moderate-to-severe cranial deformities post-surgical correction of synostosis.

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 and STARlight with Cranial Comparison Utility (CCU) (K142141)

Reference Devices

• St. Louis Band Cranial Orthosis (K161138)
• STARband and STARlight with SmartSoc (K141842)

Submission Summary (Full Text)

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April 27, 2021

Orthomerica Products Inc. Colton Carter Regulatory and Compliance Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K203098

Trade/Device Name: STARband, STARlight, St. Louis Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: January 27, 2021 Received: January 28, 2021

Dear Colton Carter:

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 medical devices and radiation-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,

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

Enclosure

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## Indications for Use

510(k) Number (if known) K203098

### Device Name

STARband, STARlight, and St. Louis Band Cranial Orthosis

### Indications for Use (Describe)

The STARband, STARlight, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including 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. These devices are also indicated for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">✖</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |

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AND THE A

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# 510(k) Summary K203098

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#### 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: | Colton Carter, Regulatory and Compliance Engineer |
|-----------------|------------------------------------------------------|
| Address: | 6333 North Orange Blossom Trail<br>Orlando, FL 32810 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Email: | [e-mail] |
| Date: | April 27th, 2021 |

#### II. Submission Information

| Type: | Traditional 510(k) Submission |
|----------------------|--------------------------------------------------------|
| Proprietary Name: | STARband®, STARlight®, and St. Louis Band |
| Classification: | Class II (special controls); OAN; MVA; 21 CFR 882.5970 |
| Classification Name: | Cranial Orthosis |

#### III. Manufacturer Site

| 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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#### IV. Description of Device/Modification

The STARband® and STARlight® redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured inage of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provide 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 and STARlight 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 and STARlight product families as it was last cleared in K180109 are essentially still the same devices. The STARband® Side Opening design and STARband® Bi-Valve design is 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 STARlight Side Opening design and the STARlight® Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband® Side Opening design and the STARlight 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 and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist 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 St. Louis Band (formally known as the O&P Bivalve Molding Helmet in K063395) was last cleared in K180109 by Orthomerica Products Inc. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit.

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The Cranial Comparison Utility (CCU) is a software component for a previously cleared shape capture method, the STARscanner Data Acquisition System, distributed by Orthomerica Products, Inc. The CCU is a separate software program that is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.

The proposed addition is a new software component for a previously cleared shape capture method, the NetVirta SmartSoc Data Acquisition System, distributed by Orthomerica Products, Inc. The new software component is the Measurement Comparison Utility (MCU). The MCU is a separate software program, not used in manufacturing, which is designed to present specific measurements derived from a threedimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.

#### V. Indications for Use and Intended Use

### Indications for Use:

The STARband®, STARlight®, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe nonsynostotic positional plagiocephaly, including 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. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

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## Intended Use:

The STARband®, STARlight®, and St. Louis Band are 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®, STARlight®, or St. Louis Band for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband®, STARlight®, and St. Louis Band have also been cleared to treat unresolved head deformities in patients who have undergone surgery to correct craniosynostosis. The same principles of cranial remolding apply to positional deformities and post-operative patients.

#### VI. Predicate and Reference Devices

### Predicate Device:

- STARband and STARlight with Cranial Comparison Utility (CCU) K142141 ■
## Reference Devices:

- I St. Louis Band Cranial Orthosis - K161138
- I STARband and STARlight with SmartSoc - K141842

#### VII. Summary of Technological Characteristics

The MCU proposed in this 510(k) is an added software program for a previously cleared shape capture method, the SmartSoc Data Acquisition System, that was cleared for use in the fabrication of the STARband , STARlight , and St. Louis Band Cranial Orthosis. The technological characteristics and the underlying principles of operation of the STARband , STARlight , and St. Louis Band Cranial Orthosis shall remain exactly the same. The inclusion of the MCU is the focus of this submission and the resulting change is indicated in Table 1 within the feature section Reporting Software. The addition of the accuracy and capabilities study conducted on the MCU is also indicated in the Testing section.

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| Feature | K142141 | K203098 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Maintains total contact over areas of<br>bossing or protrusion and creates voids<br>over areas of depression or flattening to<br>redirect cranial growth toward greater<br>symmetry. | Maintains total contact over areas of<br>bossing or protrusion and creates voids<br>over areas of depression or flattening to<br>redirect cranial growth toward greater<br>symmetry. |
| Indications | The STARband and STARlight are<br>intended for medical purposes for use<br>on infants from 3 to 18 months of age,<br>with moderate-to-severe non-synostotic<br>positional plagiocephaly, including<br>infants with plagiocephalic-,<br>brachycephalic- and scaphocephalic-<br>shaped heads by applying mild pressure<br>to prominent regions of the infant's<br>cranium in order to improve cranial<br>symmetry and/or shape. The devices<br>are also indicated for adjunctive use for<br>infants from 3 to 18 months of age<br>whose synostosis has been surgically<br>corrected, but who still have moderate-<br>to-severe cranial deformities including<br>plagiocephalic-, brachycephalic- and<br>scaphocephalic-shaped heads. | The STARband and STARlight are<br>intended for medical purposes for use<br>on infants from 3 to 18 months of age,<br>with moderate-to-severe non-synostotic<br>positional plagiocephaly, including<br>infants with plagiocephalic-,<br>brachycephalic- and scaphocephalic-<br>shaped heads by applying mild pressure<br>to prominent regions of the infant's<br>cranium in order to improve cranial<br>symmetry and/or shape. The devices<br>are also indicated for adjunctive use for<br>infants from 3 to 18 months of age<br>whose synostosis has been surgically<br>corrected, but who still have moderate-<br>to-severe cranial deformities including<br>plagiocephalic-, brachycephalic- and<br>scaphocephalic-shaped heads. |
| Materials | Material for STARband Side Opening<br>design and STARband Bi-Valve design<br>- Outer shell of 5/32" copolymer<br>plastic<br>- An inner liner of 1/2" Pelite<br>polyethylene foam or 1/2"<br>Aliplast foam<br><br>Material for STARlight Side Opening<br>design and STARlight Bi-Valve design<br>- 5/32" - 1/4" clear Surlyn or<br>1/8" - 7/32" Clear Co-<br>Polyester plastic shell<br><br>Material for STARlight PRO design<br>- 1/4" - 3/8" clear Surlyn<br><br>Closure for Bivalve design<br>- Sliding/Overlap closure system<br>- Chicago screw (or similar) for<br>top sliding mechanism<br>- 1" Velcro strap<br>- 1" chafe buckle<br>- Speedy rivets<br><br>Closure for STARband Side Opening<br>design<br>- 1 ½" Velcro Strap<br>- 1 ½" chafe buckle | Material for STARband Side Opening<br>design and STARband Bi-Valve design<br>- Outer shell of 5/32" copolymer<br>plastic<br>- An inner liner of 1/2" Pelite<br>polyethylene foam or 1/2"<br>Aliplast foam<br><br>Material for STARlight Side Opening<br>design and STARlight Bi-Valve design<br>- 5/32" - 1/4" clear Surlyn or<br>1/8" - 7/32" Clear Co-<br>Polyester plastic shell<br><br>Material for STARlight PRO design<br>- 1/4" - 3/8" clear Surlyn<br><br>Closure for Bivalve design<br>- Sliding/Overlap closure<br>system<br>- Chicago screw (or similar) for<br>top sliding mechanism<br>- 1" Velcro strap<br>- 1" chafe buckle<br>- Speedy rivets<br><br>Closure for STARband Side Opening<br>design<br>- 1 ½" Velcro Strap |
| | | - 1 ½" chafe buckle |
| Feature | K142141 | K203098 |
| | A Gap Block made from ½"<br>firm Pelite polyethylene foam<br>Large Flange, Blind Rivet | 1 ½" chafe buckle<br>A Gap Block made from ½"<br>firm Pelite polyethylene foam<br>Large Flange, Blind Rivet |
| | Closure for STARlight Side Opening<br>design and the STARlight PRO design:<br>1" Velcro Strap<br>1" chafe buckle<br>Optional tamper resistant<br>strap (qty 2 for the STARlight<br>PRO design) | Closure for STARlight Side Opening<br>design and the STARlight PRO design:<br>1" Velcro Strap<br>1" chafe buckle<br>Optional tamper resistant strap<br>(qty 2 for the STARlight PRO<br>design) |
| Biocompatibility | All materials have been used<br>extensively in Orthotics and Prosthetics | All materials have been used<br>extensively in Orthotics and Prosthetics |
| Sterility | Not provided Sterile | Not provided Sterile |
| Product Design | Custom made cranial orthosis,<br>approximately 6 to 10oz in weight.<br>STARlight PRO weighs 12.5 to 18.5 oz. | Custom made cranial orthosis,<br>approximately 6 to 10oz in weight.<br>STARlight PRO weighs 12.5 to 18.5 oz. |
| Production | Form orthosis from a positive<br>mold of infant's head<br>Positive mold is formed based<br>upon measurements of the<br>infant's head taken by an<br>approved 3-dimensional<br>imaging device from which a<br>3-dimensional image is made<br>or from a traditional plaster<br>cast<br>The 3-dimensional image is<br>used to produce a positive<br>mold using a 5-axis routing<br>machine | Form orthosis from a positive<br>mold of infant's head<br>Positive mold is formed based<br>upon measurements of the<br>infant's head taken by an<br>approved 3-dimensional<br>imaging device from which a<br>3-dimensional image is made<br>or from a traditional plaster<br>cast<br>The 3-dimensional image is<br>used to produce a positive<br>mold using a 5-axis routing<br>machine |
| Approved 3-<br>Dimensional<br>Imaging Devices | STARscanner I<br>STARscanner II<br>Omega Scanner<br>scanGogh-II<br>3dMDhead System<br>3dMDcranial System<br>3dMDflex System | STARscanner I<br>STARscanner II<br>Omega Scanner<br>scanGogh-II<br>3dMDhead System<br>3dMDcranial System<br>3dMDflex System<br>M4DScan/BodyScan System<br>Spectra 3D Scanner<br>SmartSoc System for Android<br>Device<br>SmartSoc System for iOS<br>Device |
| Reporting<br>Software | Cranial Comparison Utility<br>(CCU) | Cranial Comparison Utility<br>(CCU)<br>Measurement Comparison<br>Utility (MCU) |
| Feature | K142141 | K203098 |
| Testing | Repeatability and Reproducibility<br>(R&R) Analysis<br>- Utilized uniform shapes with<br>known dimensions that<br>represent various sizes of<br>pediatric patients between ages<br>3 to 18 months of age<br>- Compared proposed device to<br>cast and predicate device<br>- Associated parameters includes<br>A-P and M-L<br>- Proposed device is<br>substantially equivalent to<br>predicate device | Repeatability and Reproducibility<br>(R&R) Analysis<br>- Utilized uniform shapes with<br>known dimensions that<br>represent various sizes of<br>pediatric patients between ages<br>3 to 18 months of age<br>- Compared proposed device to<br>cast and predicate device<br>- Associated parameters<br>includes A-P and M-L<br>- Proposed device is<br>substantially equivalent to<br>predicate device |
| | Cranial Shape Capture Accuracy Study<br>- Utilized a representative<br>cranial shape that possesses a<br>predefined shape with known<br>dimensions<br>- Compared proposed device to<br>cast and predicate device<br>- Associated Coordinate Planes<br>(A-P; M-L; P-D and various<br>Radius Parameters;<br>Squareness; Flatness)<br>- Proposed device is<br>substantially equivalent to<br>predicate device | Cranial Shape Capture Accuracy Study<br>- Utilized a representative<br>cranial shape that possesses a<br>predefined shape with known<br>dimensions<br>- Compared proposed device to<br>cast and predicate device<br>- Associated Coordinate Planes<br>(A-P; M-L; P-D and various<br>Radius Parameters;<br>Squareness; Flatness)<br>- Proposed device is<br>substantially equivalent to<br>predicate device |
| | CCU Accuracy and Capabilities Study<br>- Utilized a representative<br>cranial shape that possesses a<br>predefined shape with known<br>dimensions<br>- Compared CCU to manual<br>measurements and 3D-CAD<br>software<br>- Accessed accuracy of<br>measurements and capabilities<br>of model alignment,<br>differential maps, calculations<br>and reporting | CCU Accuracy and Capabilities Study<br>- Utilized a representative<br>cranial shape that possesses a<br>predefined shape with known<br>dimensions<br>- Compared CCU to manual<br>measurements and 3D-CAD<br>software<br>- Accessed accuracy of<br>measurements and capabilities<br>of model alignment,<br>differential maps, calculations<br>and reporting |
| | Material Biocompatibility Testing<br>- Cytotoxicity -Agar Diffusion<br>- Closed Patch Sensitization<br>- Primary Dermal Irritation | MCU Accuracy and Capabilities Study<br>- Utilized representative cranial<br>shapes that reflect symmetrical<br>and asymmetrical cranial<br>shapes<br>- Compared MCU to manual<br>measurements and 3D-CAD<br>software<br>- Accessed accuracy of<br>measurements and capabilities<br>of modal alignmont |
| Feature | K142141 | K203098 |
| | | differential maps, calculations<br>and reporting |

Table 1.a – Comparison of Predicate Device cleared in K142141 to K203098

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Table 1.b – Comparison of Reference Device cleared in K161138 to K203098

| Table 1.b - Comparison of Reference Device cleared in K161138 to K203098 | | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | From K161138 | K203098 |
| Intended Use | Maintains total contact over areas of<br>bossing or protrusion and creates voids<br>over areas of depression or flattening to<br>redirect cranial growth toward greater<br>symmetry. | Maintains total contact over areas of<br>bossing or protrusion and creates voids<br>over areas of depression or flattening to<br>redirect cranial growth toward greater<br>symmetry. |
| Indications | The St. Louis Band is intended for medical<br>purposes for use on infants from 3 to 18<br>months of age, with moderate-to-severe<br>non-synostotic positional plagiocephaly,<br>including infants with plagiocephalic-,<br>brachycephalic- and scaphocephalic-<br>shaped heads by applying mild pressure to<br>prominent regions of the infant's cranium<br>in order to improve cranial symmetry<br>and/or shape. This device is also indicated<br>for adjunctive use for infants from 3 to 18<br>months of age whose synostosis has been<br>surgically corrected, but who still have<br>moderate-to-severe cranial deformities<br>including plagiocephalic-, brachycephalic-<br>and scaphocephalic-shaped heads. | The St. Louis Band is intended for medical<br>purposes for use on infants from 3 to 18<br>months of age, with moderate-to-severe<br>non-synostotic positional plagiocephaly,<br>including infants with plagiocephalic-,<br>brachycephalic- and scaphocephalic-<br>shaped heads by applying mild pressure to<br>prominent regions of the infant's cranium<br>in order to improve cranial symmetry<br>and/or shape. This device is also indicated<br>for adjunctive use for infants from 3 to 18<br>months of age whose synostosis has been<br>surgically corrected, but who still have<br>moderate-to-severe cranial deformities<br>including plagiocephalic-, brachycephalic-<br>and scaphocephalic-shaped heads. |
| Materials | St. Louis Band<br>- Sliding/Overlap Closure System<br>- Outer shell of 1/4" copolymer<br>- plastic<br>- An inner liner of 1/4" Aliplast<br>- foam<br>- Bi-Valve Closure<br>- Sliding/Overlap Closure<br>- System<br>- 1" Velcro strap<br>- 1" chafe buckle<br>- Speedy rivets | St. Louis Band<br>- Sliding/Overlap Closure System<br>- Outer shell of 1/4" copolymer<br>- plastic<br>- An inner liner of 1/4" Aliplast<br>- foam<br>- Bi-Valve Closure<br>- Sliding/Overlap Closure<br>- System<br>- 1" Velcro strap<br>- 1" chafe buckle<br>- Speedy rivets |
| Product Design | Custom made cranial orthosis,<br>approximately 7 to 10oz in weight. | Custom made cranial orthosis,<br>approximately 7 to 10oz in weight. |
| Production | Form orthosis from a positive<br>mold of infant's head<br>-<br>Positive mold is formed based<br>upon measurements of the<br>infant's head taken by an<br>approved 3-dimensional imaging<br>device from which a 3-<br>dimensional image is made or<br>from a traditional plaster cast | Form orthosis from a positive<br>mold of infant's head<br>-<br>Positive mold is formed based<br>upon measurements of the infant's<br>head taken by an approved 3-<br>dimensional imaging device from<br>which a 3-dimensional image is<br>made or from a traditional plaster<br>cast |
| Feature | From K161138 | K203098 |
| | - The 3-dimensional image is used | - The 3-dimensional image is used |
| | to produce a positive mold using a | to produce a positive mold using a |
| | 5-axis routing machine | 5-axis routing machine |
| Approved 3-<br>Dimensional<br>Imaging<br>Devices | - STARscanner II<br>- SmartSoc System | - STARscanner II<br>- SmartSoc System |
| Reporting<br>Software | None | - Measurement Comparison Utility<br>(MCU) |
| Testing | Repeatability and Reproducibility (R&R)<br>Analysis<br>- Utilized uniform shapes with<br>known dimensions that represent<br>various sizes of pediatric patients<br>between ages 3 to 18 months of<br>age<br>- Compared proposed device to cast<br>and predicate device<br>- Associated parameters includes<br>A-P and M-L<br>- Proposed device is substantially<br>equivalent to predicate device<br><br>Cranial Shape Capture Acc…