STARband, STARlight, St. Louis Band

K180109 · Orthomerica Products, Inc. · OAN · Mar 1, 2018 · Neurology

Device Facts

• Record ID: K180109
• Device Name: STARband, STARlight, St. Louis Band
• Applicant: Orthomerica Products, Inc.
• Product Code: OAN · Neurology
• Decision Date: Mar 1, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 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. The 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 moderateto-severe cranial deformities including plagiocephalic- and scaphocephalic- and scaphocephalicshaped heads.

Device Story

Device is a custom-molded cranial orthosis for infants. Input: 3D head shape data captured via SmartSoc system using a consumer-grade iOS device camera and flexible fabric sock. Process: Video footage processed in cloud to generate 3D digital model; model used by 5-axis router to create positive mold; orthosis fabricated over mold. Output: Custom cranial band providing total contact over prominent areas and voids over flat areas to redirect growth. Used in clinical settings by practitioners. Benefit: Improves cranial symmetry and proportion in infants. Modification: Addition of iOS-compatible CurveCapture application to existing SmartSoc system.

Clinical Evidence

Bench testing only. Accuracy verification study compared the iOS-based SmartSoc system against traditional casting and predicate device methods using a representative cranial shape with known dimensions. Metrics included coordinate planes (A-P, M-L, P-D), radius parameters, squareness, and flatness. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed on shell and liner materials (Surlyn, copolymer, Pelite, Aliplast) showed no significant reactivity or irritation.

Technological Characteristics

Custom-molded cranial orthosis. Materials: Polyethylene-polypropylene copolymer, Surlyn, or Co-Polyester shells; Pelite or Aliplast foam liners. Energy: Non-coherent light source (camera flash). Connectivity: Cloud-based processing of 3D image data. Fabrication: 5-axis routing from positive mold. Software: iOS-based CurveCapture application for 3D shape acquisition.

Indications for Use

Indicated for infants 3-18 months with moderate-to-severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, scaphocephalic) or post-surgical synostosis with residual cranial deformities.

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, STARlight (K151979)
• St. Louis Band (K161138)

Submission Summary (Full Text)

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March 1, 2018

Orthomerica Products, Inc J. Schulte Design Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K180109

Trade/Device Name: STARband, STARlight, and St. Louis Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: January 9, 2018 Received: January 16, 2018

Dear J. Schulte:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - J. Schulte

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

# Sincerely, Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180109

### Device Name

STARband®, STARlight®, and St. Louis Band

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

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# K180109 510(k) Summary

#### I. Submitter Information

| Name: | Orthomerica Products, Inc. |
|------------|------------------------------------------------------|
| Address: | 6333 North Orange Blossom Trail<br>Orlando, FL 32810 |
| Telephone: | [phone] |
| Fax: | [phone] |

## Contact Information

| Contact Person: | Tyler Schulte, Design Engineer |
|-----------------|--------------------------------|
| Email: | [e-mail] |
| Date Prepared: | March 1, 2018 |

#### II. Subject Device Information

| Submission Type: | Special 510(k) |
|-------------------|---------------------------------------------|
| Proprietary Name: | STARband®, STARlight®, and St. Louis Banc |
| Common Name: | Cranial Orthosis |
| Product Code: | OAN (Orthosis, Cranial, Laser Scan) |
| Secondary: | MVA (Cranial Orthosis) |
| Classification: | 21 CFR 882.5970, Cranial Orthosis, Class II |

#### III. Predicate Device

| K151979 | STARband, STARlight |
|--------------|---------------------|
| Product Code | OAN, MVA |
| K161138 | St. Louis Band |
| Product Code | OAN, MVA |

## IV. Description of Device Modification

The proposed device modification is the addition of the CurveCapture application for iOS enabled device for a previously cleared shape capture method, the Net Virta SmartSoc™ System distributed by Orthomerica Products, Inc, used with the STARband, STARlight, and St. Louis Band devices. The system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade mobile phone device with a camera and a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Because the system utilizes a consumer grade camera with a non-coherent light source for a flash, it is safe to use on infant patients under all circumstances.

The proposed modification allows the CurveCapture™ application to be run on an iOS enabled device.

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The CurveCapture™ application uses the camera on the device to take video footage of the patient wearing the SmartSoc. Specific images are then selected and sent to the cloud to be processed into a detailed 3D digital model of the patient's cranium. The proposed CurveCapture™ system for iOS enabled device functions the same way as the previously CurveCapture™ system for Android™ enabled devices.

The STARband® and STARlight® redirect head growth to improve proportion and symmetry in infants with moderate-to-severe non-synostotic positional plagiocephaly. The practitioner takes a plaster impression or 3-dimensional captured image the 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 cleared in K151979 and are fundamentally the same devices cleared in that 510(k). 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 STARligh® 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) was first cleared in K063395 and later in K161138 and remains fundamentally the same device. 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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#### V. Intended 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 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. The 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 moderateto-severe cranial deformities including plagiocephalic- and scaphocephalic- and scaphocephalicshaped heads.

Since growth is the driving factor in head shape correction, the infants wear the STARband® or STARlight® for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. 1 The STARband®, STARlight®, and St. Louis Band are also intended for unresolved head deformities in patients who have undergone surgery to correct craniosynostosis.2 The same principles of cranial remolding apply to positional deformities and post-operative patients.

#### Summary of Technological Characteristics VII.

The iOS compatible CurveCapture™ application for the SmartSoc™ System proposed in this Special 510(k) is a firmware expansion of a previously cleared shape capture method used for the fabrication of the STARband®, STARlight®, and St. Louis Band Cranial Orthosis. The technological characteristics and the underlying principles of operation of the SmartSoc™ System, the STARband®, the STARlight®, and the St. Louis Band Cranial Orthosis shall remain exactly the same. The inclusion of the iOS compatible CurveCapture™ application is the focus of this submission and the resulting change is indicated in Table 2 below within the feature section Approved 3-Dimensional Imaging Devices. The addition of the accuracy and capabilities study conducted on the iOS compatible CurveCapture™ application is also indicated in the Accuracy Verification section of the Design Controls Summary.

¹ For a discussion of positional plagiocephaly, please reference the OPI Band 510(k) Summary for K001167, and the STARlight 510(k) Summary for K021207

² For a discussion on Cranial Remolding after Corrective Craniosynostosis surgery, please reference the STARband 510(k) Summary for K082950 and the STARlight 510(k) Summary for K081994

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| Feature | Predicate K151979 | K180109 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| 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 | 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 |
| | Material for STARlight® Side Opening<br>design and STARlight® Bi-Valve design<br>- 5/32" - 1/4" clear Surlyn or 1/8" -<br>7/32" Clear Co-Polyester plastic<br>shell | Material for STARlight® Side Opening<br>design and STARlight® Bi-Valve design<br>- 5/32" - 1/4" clear Surlyn or 1/8" -<br>7/32" Clear Co-Polyester plastic<br>shell |
| | Material for STARlight® PRO design<br>- 1/4" – 3/8" clear Surlyn | Material for STARlight® PRO design<br>- 1/4" – 3/8" clear Surlyn |
| | Closure for Bivalve design<br>- Sliding/Overlap closure system<br>- Chicago screw (or similar) for top<br>sliding mechanism<br>- 1" Velcro strap<br>- 1" chafe buckle<br>- Speedy rivets | Closure for Bivalve design<br>- Sliding/Overlap closure system<br>- Chicago screw (or similar) for top<br>sliding mechanism<br>- 1" Velcro strap<br>- 1" chafe buckle<br>- Speedy rivets |
| | Closure for STARband® Side Opening<br>design<br>- 1 ½" Velcro Strap<br>- 1 ½" chafe buckle<br>- A Gap Block made from ½" firm<br>Pelite polyethylene foam<br>- Large Flange, Blind Rivet<br>Closure for STARlight® Side Opening | Closure for STARband® Side Opening<br>design<br>- 1 ½" Velcro Strap<br>- 1 ½" chafe buckle<br>- A Gap Block made from ½" firm<br>Pelite polyethylene foam<br>- Large Flange, Blind Rivet<br>Closure for STARlight® Side Opening |
| | design and the STARlight® PRO design: | design and the STARlight® PRO design: |

| Table 1 - Comparison of Predicate Device cleared in K151979 to the Subject Device | |
|-----------------------------------------------------------------------------------|--|
|-----------------------------------------------------------------------------------|--|

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| Feature | Predicate K151979 | K180109 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1" Velcro Strap<br>1" chafe buckle<br>Optional tamper resistant strap<br>(qty 2 for the STARlight PRO<br>design) | 1" Velcro Strap<br>1" chafe buckle<br>Optional tamper resistant strap<br>(qty 2 for the STARlight PRO<br>design) |
| 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 | Form orthosis from a positive<br>mold of infant's head |
| | 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 | 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 |
| | The 3-dimensional image is used<br>to produce a positive mold using a<br>5-axis routing machine | The 3-dimensional image is used<br>to produce a positive mold using a<br>5-axis routing 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<br>M4DScan/BodyScan System<br>Spectra 3D Scanner<br>SmartSoc System for Android<br>Device | 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 Device |
| SmartSoc System<br>Mobile Device<br>Characteristics | Image Sensor<br>10.0 Mega Pixels<br>Lens focal length | Image Sensor<br>10.0 Mega Pixels<br>Lens focal length |
| | F=24 mm (minimum)<br>Focusing | F=24 mm (minimum)<br>Focusing |
| | Auto- Focus (Center AF, Multi<br>AF, Face Detection AF)<br>Shooting | Auto- Focus (Center AF, Multi<br>AF, Face Detection AF)<br>Shooting |
| | Still images automatic<br>Video automatic<br>Image Stabilization | Still images automatic<br>Video automatic<br>Image Stabilization |
| | Optical Image Stabilization<br>Capability | Optical Image Stabilization<br>Capability |
| Feature | Predicate K151979 | K180109 |
| | Storage | Storage |
| | 4 Gb Total (minimum)<br>1 Gb (minimum) for normal utilization<br>Wireless Connectivity | 4 Gb Total (minimum)<br>1 Gb (minimum) for normal utilization<br>Wireless Connectivity |
| | Wi-Fi, 3G, 4G<br>HTML Browser<br>WAP Browser<br>CPU/Processor | Wi-Fi, 3G, 4G<br>HTML Browser<br>WAP Browser<br>CPU/Processor |
| | 1.04 GHz or faster<br>Operating System | 1.04 GHz or faster<br>Operating System |
| | Android 2.3.3 or Newer | Android 2.3.3 or Newer<br>iOS 10.3 or Newer |
| Testing | Cranial Shape Capture Accuracy Study<br>Utilized a representative cranial shape that possesses a predefined shape with known dimensions<br>Compared proposed device to cast and predicate device<br>Associated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)<br>Proposed device is substantially equivalent to predicate device | Cranial Shape Capture Accuracy Study<br>Utilized a representative cranial shape that possesses a predefined shape with known dimensions<br>Compared proposed device to cast and predicate device<br>Associated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)<br>Proposed device is substantially equivalent to predicate device |
| | Material Biocompatibility Testing | Material Biocompatibility Testing |
| | Cytotoxicity -Agar Diffusion<br>Closed Patch Sensitization<br>Primary Dermal Irritation | Cytotoxicity -Agar Diffusion<br>Closed Patch Sensitization<br>Primary Dermal Irritation |
| Feature | Predicate K161138 | K180109 |
| 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. |
| 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>- 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<br>- The 3-dimensional image is used<br>to produce a positive mold using a<br>5-axis routing machine | - Form orthosis from a positive<br>mold of infant's head<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<br>- The 3-dimensional image is used<br>to produce a positive mold using a<br>5-axis routing machine |
| Approved 3-<br>Dimensional<br>Imaging Devices | - STARscanner II<br>- SmartSoc System for Android<br>Device | - STARscanner II<br>- SmartSoc System for Android<br>Device<br>- SmartSoc System for iOS Device |
| SmartSoc System<br>Mobile Device<br>Characteristics | - Image Sensor<br>- 10.0 Mega Pixels<br>- Lens focal length<br>- F=24 mm (minimum)<br>- Focusing<br>- Auto- Focus (Center AF, Multi<br>AF, Face Detection AF)<br>- Shooting<br>- Still images automatic<br>- Video automatic<br>- Image Stabilization | - Image Sensor<br>- 10.0 Mega Pixels<br>- Lens focal length<br>- F=24 mm (minimum)<br>- Focusing<br>- Auto- Focus (Center AF, Multi<br>AF, Face Detection AF)<br>- Shooting<br>- Still images automatic<br>- Video automatic<br>- Image Stabilization |
| Feature | Predicate K161138 | K180109 |
| | Optical Image Stabilization<br>-<br>Capability<br>Storage | Optical Image Stabilization<br>-<br>Capability<br>Storage |
| | 4 Gb Total (minimum)<br>-<br>1 Gb (minimum) for normal<br>-<br>utilization<br>Wireless Connectivity | 4 Gb Total (minimum)<br>-<br>1 Gb (minimum) for normal<br>-<br>utilization<br>Wireless Connectivity |
| | Wi-Fi, 3G, 4G<br>-<br>HTML Browser<br>-<br>WAP Browser<br>-<br>CPU/Processor | Wi-Fi, 3G, 4G<br>-<br>HTML Browser<br>-<br>WAP Browser<br>-<br>CPU/Processor |
| | 1.04 GHz or faster<br>CPU/Processor | 1.04 GHz or faster<br>CPU/Processor |
| | Android 2.3.3 or Newer<br>-<br>Operating System | Android 2.3.3 or Newer<br>-<br>iOS 10.3 or Newer<br>-<br>Operating System |
| Testing | Material Biocompatibility Testing<br>-<br>Cytotoxicity -Agar Diffusion<br>-<br>Closed Patch Sensitization<br>-<br>Primary Dermal Irritation | Material Biocompatibility Testing<br>-<br>Cytotoxicity -Agar Diffusion<br>-<br>Closed Patch Sensitization<br>-<br>Primary Dermal Irritation |

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Since the St. Louis Band relies on the same materials and fundamental technology and has the same intended use as the STARband® and STARlight® Cranial Orthosis, it is substantially equivalent to the device cleared in K151979. However, when the St. Louis Band was cleared in K161138, it was approved to use the STARscannerII and the SmartSoc System for Android Device as 3D imaging devices. The proposed change would only add the SmartSoc System for iOS device as an approved 3D imaging device as shown in Table 2, not all the approved 3D imaging devices used for STARband® and STARlight® shown above in Table 1.

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Table 2 – Comparison of Predicate Device cleared in K161138 to the Subject Device

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The STARband® and STARlight® Cranial Orthosis and the St. Louis Band Cranial Orthosis have already received FDA 510(k) clearance under K151979 and K161138 respectively to be manufactured from a 3-dimensional image captured using the SmartSoc™ System for android enabled devices. The expansion of the SmartSoc™ System to include a CurveCapture application iOS enabled devices does not alter any of the fundamental technological principals of the SmartSoc™ System. Considering that STARband®, STARlight®, and St. Louis Band are still the same device as it was in the predicate device and that the shape capture devices have the same technological characteristics; the STARband®, STARlight®, and St. Louis Band Cranial Othosis are substantially equivalent to the predicate device.

The STARband®, STARlight®, and St. Louis Band are essentially the same Cranial Orthosis. The main difference between the STARband®, STARlight®, and St. Louis Band are the materials used to produce them. The STARband®, STARlight®, and St. Louis Band materials have demonstrated biocompatibility through testing, and the results of the tests are listed below in Table 3 below.

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| Material | Test | Results | Conclusion |
|---------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Surlyn | Closed Patch<br>Sensitization | A score of 0.00/0.00 (Test/Control) was<br>given for both Incidence and Severity in<br>the 24 hour and 48 hour scoring interval. | Not a Sensitizer<br>No Erythema or<br>Edema Formation |
| Surlyn | Primary Dermal<br>Irritation | Primary Irritation Index: 0.00 | Negligible Dermal<br>Response |
| Surlyn | Cytotoxicity -<br>Agar Diffusion | Cell culture treated with test sample<br>exhibited no reactivity (Grade 0). | Non-cytotoxic |
| Copolymer with<br>Pelite Foam | Closed Patch<br>Sensitization | A score of 0.00/0.00 (Test/Control) was<br>given for both Incidence and Severity in<br>the 24 hour and 48 hour scoring interval. | Not a Sensitizer<br>No Erythema or<br>Edema Formation |
| Copolymer with<br>Pelite Foam | Primary Dermal<br>Irritation | Primary Irritation Index: 0.06 | Negligible Dermal<br>Response |
| Copolymer with<br>Pelite Foam | Cytotoxicity -<br>Agar Diffusion | Cell culture treated with test sample<br>exhibited no reactivity (Grade 0). | Non-cytotoxic |
| Copolymer with<br>Aliplast Foam | Closed Patch<br>Sensitization | A score of 0.00/0.00 (Test/Control) was<br>given for both Incidence and Severity in<br>the 24 hour and 48 hour scoring interval. | Not a Sensitizer<br>No Erythema or<br>Edema Formation |
| Copolymer with<br>Aliplast Foam | Primary Dermal<br>Irritation | Primary Irritation Index: 0.00 | Negligible Dermal<br>Response |
| Copolymer with<br>Aliplast Foam | Cytotoxicity -<br>Agar Diffusion | Cell culture treated with test sample<br>exhibited slight reactivity (Grade 1). | Non-cytotoxic |

Table 3 - Biocompatibility Testing Summary for STARband, STARlight, and St. Louis Band Cranial Orthosis

#### Summary and Conclusions of Non-Clinical Performance Data VII.

The SmartSoc™ System for iOS device was evaluated for safety and efficacy. The system uses a consumer grade camera and is safe to use on infants without any eye protection. Cranial Shape Capture Accuracy Verification was performed concluding that the SmartSoc™ System for iOS enabled device yields a safe and effective product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the system, the SmartSoc™ System for iOS enabled device was determined safe and effective for capturing infant head shape data to manufacture the STARband®, STARlight®, and St. Louis Band Cranial Orthosis.