STARband, STARlight

K151147 · Orthomerica Products, Inc. · OAN · Jul 1, 2015 · Neurology

Device Facts

• Record ID: K151147
• Device Name: STARband, STARlight
• Applicant: Orthomerica Products, Inc.
• Product Code: OAN · Neurology
• Decision Date: Jul 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The STARband and STARlight 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 moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Device Story

Cranial orthosis for infants; redirects head growth to improve symmetry/proportion. Practitioner captures head shape via plaster impression or 3D imaging (e.g., M4DScan/BodyScan). 3D data used to create positive model via 5-axis routing; model modified to provide space for growth in flattened areas. Device provides total contact over prominent areas; directs growth into areas of least resistance. Worn ~23 hours/day. Orthosis consists of plastic shell (polyethylene-polypropylene copolymer, Surlyn, or Co-Polyester) with foam liner (Pelite or Aliplast). Side-opening or bi-valve designs secured with Velcro straps. M4DScan/BodyScan uses structured white LED light (non-coherent) to capture surface geometry. Benefits include non-invasive correction of cranial deformities.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via Repeatability and Reproducibility (R&R) analysis and Cranial Shape Capture Accuracy study comparing the M4DScan/BodyScan system to plaster casting and predicate devices using uniform shapes and representative cranial models. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed on all patient-contact materials (Surlyn, Copolymer, Pelite, Aliplast).

Technological Characteristics

Custom-molded cranial orthosis. Materials: 5/32"-3/8" polyethylene-polypropylene copolymer, Surlyn, or Co-Polyester shells; Pelite or Aliplast (closed-cell polyethylene) foam liners. Sensing: Structured white LED light (non-coherent) for 3D surface capture. Manufacturing: 5-axis routing of positive models. Connectivity: Standalone imaging system. Sterilization: Not applicable (custom-fabricated device).

Indications for Use

Indicated for infants 3-18 months old with moderate-to-severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, or scaphocephalic head shapes) 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 and STARlight, Cranial Orthosis (K141842)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

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

July 1, 2015

Orthomerica Products, Inc. David Hooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K151147

Trade/Device Name: Starband® and Starlight® Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: April 27, 2015 Received: Mav 5. 2015

Dear David Hooper:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS 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) K151147

Device Name STARband® and STARlight®

### Indications for Use (Describe)

The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. 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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# 510(k) Summary

#### I. Applicant Information

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

## FDA Establishment Registration Number

1058152

# Contact Information

| Contact Person: | David Hooper, Manufacturing Engineer | |
|-----------------|--------------------------------------|--|
| Address: | 6333 North Orange Blossom Trail | |
| | Orlando, FL 32810 | |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |
| Email: | [e-mail] | |
| Date Prepared: | April 27th, 2015 | |

#### II. Submission Information

| Type: | Traditional 510(k) Submission |
|----------------------------------------|--------------------------------------------------------|
| Proprietary Name: | STARband® and STARlight® |
| Common Name: | Cranial Orthosis |
| 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 |
| | 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 image 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 released in K141842 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 proposed device modification is the addition of a new 3-dimensional shape capture method, specifically, the Rodin4D M4DScan System and the BodyScan System. The BodyScan System is the same as the M4DScan System (Hardware and Software included) except it is distributed in the United States by TechMed 3D, Inc. on behalf of Rodin4D. This system uses a structured white light projector and a single camera to detect the shape of the surface captured. This system utilizes LED white light which is a

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non-coherent (i.e. non-laser) light source. Because this system utilizes a non-coherent light source, it is safe to use on infant patients under all circumstances.

#### V. Statement of Indications and Intended Use

### Statement of Indications:

The STARband and STARlight 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 moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

### Intended Use:

The STARband and STARlight 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 or STARlight for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband and STARlight 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 Devices

- I STARband and STARlight, Cranial Orthosis, K141842

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#### VII. Summary of Technological Characteristics

The M4DScan/BodyScan System proposed in this 510(k) is an additional method to capture the infant's head shape for the fabrication of the STARband and STARlight Cranial Orthosis. The technological characteristics and the underlying principles of operation of the STARband and STARlight Cranial Orthosis shall remain exactly the same. The inclusion of the M4DScan /BodyScan System is the focus of this submission and that change is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.

| Feature | From K141842 | Proposed Device |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>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 - Outer shell of 5/32" copolymer<br>plastic - 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 - Outer shell of 5/32" copolymer<br>plastic - 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 - 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 - 5/32" - 1/4" clear Surlyn or 1/8" –<br>7/32" Clear Co-Polyester plastic<br>shell |
| | Material for STARlight PRO design - 1/4" - 3/8" clear Surlyn | Material for STARlight PRO design - 1/4"-3/8" clear Surlyn |
| | Closure for Bivalve design - Sliding/Overlap closure system - Chicago screw (or similar) for top<br>sliding mechanism - 1" Velcro strap - 1" chafe buckle - Speedy rivets | Closure for Bivalve design - Sliding/Overlap closure system - Chicago screw (or similar) for top<br>sliding mechanism - 1" Velcro strap - 1" chafe buckle - Speedy rivets |
| | Closure for STARband Side Opening<br>design - 1 ½" Velcro Strap - 1 ½" chafe buckle - A Gap Block made from ½" firm<br>Pelite polyethylene foam | Closure for STARband Side Opening<br>design - 1 ½" Velcro Strap - 1 ½" chafe buckle - A Gap Block made from ½" firm<br>Pelite polyethylene foam |

| | | | Table 1 - Comparison of Predicate Device cleared in K141842 to the Proposed Device | | | | | | |
|--|--|--|------------------------------------------------------------------------------------|--|--|--|--|--|--|
|--|--|--|------------------------------------------------------------------------------------|--|--|--|--|--|--|

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| Feature | From K141842 | Proposed Device |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Large Flange, Blind Rivet | - 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 strap<br>(qty 2 for the STARlight PRO<br>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) |
| Product | Custom made cranial orthosis, | Custom made cranial orthosis, |
| Design | approximately 6 to 10oz in weight. | approximately 6 to 10oz in weight. |
| | STARlight PRO weighs 12.5 to 18.5 oz. | 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- | - STARscanner I | - STARscanner I |
| Dimensional | - STARscanner II | - STARscanner II |
| Imaging | - Omega Scanner<br>- scanGogh-II | - Omega Scanner<br>- scanGogh-II |
| Devices | - 3dMDhead System | - 3dMDhead System |
| | - 3dMDcranial System | - 3dMDcranial System |
| | - 3dMDflex System | - 3dMDflex System |
| | - SmartSoc System | - SmartSoc System<br>- M4DScan/BodyScan System |
| Testing | Repeatability and Reproducibility (R&R) | Repeatability and Reproducibility (R&R) |
| | Analysis | Analysis |
| | - Utilized uniform shapes with | - Utilized uniform shapes with |
| | known dimensions that represent | known dimensions that represent |
| | various sizes of pediatric patients<br>between ages 3 to 18 months of | various sizes of pediatric patients<br>between ages 3 to 18 months of |
| | age | age |
| | - Compared proposed device to cast | - Compared proposed device to cast |
| | and predicate device | and predicate device |
| | - Associated parameters includes | - Associated parameters includes |
| | A-P and M-L<br>- Proposed device is substantially | A-P and M-L<br>- Proposed device is substantially |
| | equivalent to predicate device | equivalent to predicate device |
| | Cranial Shape Capture Accuracy Study | Cranial Shape Capture Accuracy Study |
| | Utilized a representative cranial | - Utilized a representative cranial |

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| Feature | From K141842 | Proposed Device |
|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | shape that possesses a predefined<br>shape with known dimensions<br>- Compared proposed device to cast<br>and predicate device<br>- Associated Coordinate Planes (A-<br>P; M-L; P-D and various Radius<br>Parameters; Squareness; Flatness)<br>- Proposed device is substantially<br>equivalent to predicate device | shape that possesses a predefined<br>shape with known dimensions<br>- Compared proposed device to cast<br>and predicate device<br>- Associated Coordinate Planes (A-<br>P; M-L; P-D and various Radius<br>Parameters; Squareness; Flatness)<br>- Proposed device is substantially<br>equivalent to predicate device |
| | Material Biocompatibility Testing<br>- Cytotoxicity -Agar Diffusion | Material Biocompatibility Testing<br>- Cytotoxicity -Agar Diffusion |
| | - Closed Patch Sensitization<br>- Primary Dermal Irritation | - Closed Patch Sensitization<br>- Primary Dermal Irritation |

The STARband and STARlight Cranial Orthosis have already received FDA 510(k) clearance under K141842 for being manufactured from a 3-dimensional imaging device that utilizes a non-coherent light source and takes 2-dimensional (2D) images for shape capture (3dMD Systems and SmartSoc System). The M4DScan/BodyScan System utilizes the same technology as the FDA 510(k) cleared 3dMD and SmartSoc Systems of a non-coherent light source and takes continuous 2D images from triangulated positions for shape capture. Considering that STARband and STARlight 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 and STARlight Cranial Othosis are substantially equivalent to the predicate device.

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| Test | Test Method Summary | Results |
|-------------------|-----------------------------------------|-----------------------------------|
| Repeatability and | The purpose of this test is to analyze | The shape capture device passed |
| Reproducibility | the repeatability and reproducibility | the acceptance criteria. The |
| (R&R) Analysis | (components of precision) of the | relevancy of the test determined |
| | proposed shape capture device. The | substantial equivalence of the |
| | data obtained is compared to the | proposed shape capture device. |
| | casting process and the predicate | |
| | device. | |
| | Utilized uniform shapes with known | |
| | dimensions that represent various sizes | |
| | of pediatric patients between ages 3 to | |
| | 18 months of age. Associated test | |
| | parameters include A-P and M-L. | |
| Cranial Shape | The purpose of this test is to analyze | The shape capture device passed |
| Capture Accuracy | the accuracy of the proposed shape | the acceptance criteria for all |
| Study | capture device. The data obtained is | parameters. The relevancy of the |
| | compared to the casting process and | test determined substantial |
| | the predicate device. | equivalence of the proposed shape |
| | Utilized a representative cranial shape | capture device. |
| | that possesses a predefined shape with | |
| | known dimensions. Associated | |
| | parameters analyzed include A-P, M- | |
| | L, P-D, various radius parameters, | |
| | squareness, and flatness. | |

Table 2 - Performance Testing Summary for STARband and STARlight Cranial Orthosis

The STARband and STARlight are essentially the same Cranial Orthosis. The main difference between the STARband and STARlight are the materials used to produce them. The STARband and STARlight materials have been biocompatibility tested, and the results of the tests are listed below in Table 3.

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| Material | Test | Results | Conclusion |
|---------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Surlyn | Closed Patch<br>Sensitization | A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in 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 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 given for both Incidence and Severity in 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 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 given for both Incidence and Severity in 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 exhibited slight reactivity (Grade 1) | Non-cytotoxic |

Table 3 - Biocompatibility Testing Summary for STARband and STARlight Cranial Orthosis

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

The M4DScan/BodyScan System was evaluated for substantial equivalence. The system uses flashes of structured light which is equivalent to the flash from a consumer grade camera and is safe to use on infants without eye protection. The shape capture repeatability and reproducibility was evaluated and determined to be acceptable. An additional, Cranial Shape Capture Accuracy Study was performed concluding that the M4DScan/BodyScan System yields a product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the system, the M4DScan/BodyScan System was determined to have a safety and effectiveness profile similar to the predicate device for capturing infant head shape data to manufacture the STARband and STARlight Cranial Orthosis.