STARBAND AND STARLIGHT

K140353 · Orthomerica Products, Inc. · MVA · Jun 6, 2014 · Neurology

Device Facts

• Record ID: K140353
• Device Name: STARBAND AND STARLIGHT
• Applicant: Orthomerica Products, Inc.
• Product Code: MVA · Neurology
• Decision Date: Jun 6, 2014
• 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 redirects infant head growth to improve symmetry/proportion. Practitioner captures head shape via plaster cast or 3D imaging (3dMDhead, 3dMDcranial, 3dMDflex systems). 3D data or cast used to create positive model; model modified to provide space for growth in depressed areas. Orthosis provides total contact over prominent areas to discourage growth, directing growth into areas of least resistance. Device worn ~23 hours/day. STARband/STARlight families include side-opening and bi-valve designs; materials include copolymer plastic, Surlyn, clear co-polyester, and foam liners (Pelite/Aliplast). Output is custom-fitted orthosis. Benefits include improved cranial symmetry for infants with positional plagiocephaly or post-operative synostosis deformities.

Clinical Evidence

Bench testing only. Repeatability and reproducibility (R&R) analysis performed using uniform shapes representing pediatric patients (3-18 months). Cranial Shape Capture Accuracy Study compared 3dMD systems to plaster casts and predicate devices across coordinate planes (A-P, M-L, P-D, radius, squareness, flatness). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed on all shell and liner materials.

Technological Characteristics

Custom-molded cranial orthosis. Materials: 5/32" copolymer plastic, 5/32"-1/4" Surlyn, 1/8"-7/32" clear co-polyester; liners of 1/2" Pelite or Aliplast foam. Closure: Velcro straps, chafe buckles, sliding/overlap mechanisms. Imaging: 3dMD structured light (non-coherent) systems. Fabrication: 5-axis routing of positive models. Biocompatible per ISO/FDA standards.

Indications for Use

Indicated for infants 3-18 months old with moderate-to-severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, or scaphocephalic shapes) or post-surgical correction of synostosis with residual moderate-to-severe 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 (K124023)
• STARlight (K133250)
• Doc Band (K014012)

Submission Summary (Full Text)

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## 510(k) Summary

# K140353 JUN 0 6 2014

### 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<br>Orlando, FL 32810 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | February 7, 2014 |

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

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 provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband 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 K124023 and K133250 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" polyethylenepolypropylene 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 (1 ½' 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 three new systems to use for 3dimensional shape capture, specifically, the 3dMDhead™ System, the 3dMDcranial™ System and the 3dMDflex™ System all distributed by 3dMD, Inc. These systems use a non-coherent (i.e. non-laser light) structured light source and triangulated cameras to

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capture shape data. Because these scanners utilize a non-coherent light source, they are safe to use on infant patients under all circumstances (equivalent to a Class 1 laser).

#### 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

- l STARband, Cranial Orthosis, K124023
- STARlight, Cranial Orthosis, K133250
- Doc Band, K014012

#### Summary of Technological Characteristics VI.

The 3dMD Systems proposed in this 510(k) are additional methods 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 3dMD Systems is the focus of this submission and that change is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.

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STARband® and STARIight® Cranial Orthosis

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| | of Predicate Devices cleared in K124023 and K133250 to the Proposed Device<br>From K124023 (STARband) | From K133250 (STARlight) | Proposed Device (STARband and STARlight) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | |
| Outer shell of 5/32 copoly plastic | 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 STARband Side Opening<br>design and STARband Bi-Valve design<br>Outer shell of 5/32" copolymer<br>plastic | Material for STARband Side Opening<br>design and STARband Bi-Valve design<br>Outer shell of 5/32" copolymer<br>plastic |
| An inner liner of ½" Pelite<br>polyethylene foam or ½" Aliplast<br>foam | Material for STARlight PRO design<br>1/4"-3/8" clear Surlyn | An inner liner of 1/2" pelite<br>polyethylene foam or 1/2"<br>Aliplast foam | An inner liner of 1/2" Pelite<br>polyethylene foam or 1/2"<br>Aliplast foam |
| A strap of 1 ½" Dacron | Material for STARband Bivalve design<br>Outer shell of 5/32" copolymer<br>plastic | 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 |
| A 1 ½" chafe buckle | An inner liner of 1/2" pelite<br>polyethylene foam or 1/2"<br>Aliplast foam | Material for STARlight PRO design<br>1/4"-3/8" clear Surlyn | Material for STARlight PRO design<br>1/4"-3/8" clear Surlyn |
| Large Flange, Blind Rivet | Closure for Bivalve design<br>Sliding/Overlap closure system<br>Chicago screw (or similar) for top<br>sliding mechanism | Closure for Bivalve design<br>Sliding/Overlap closure system<br>Chicago screw (or similar) for top<br>sliding mechanism | Closure for Bivalve design<br>Sliding/Overlap closure system<br>Chicago screw (or similar) for top<br>sliding mechanism |
| A Gap Block made from ½" firm<br>pelite polyethylene foam | 1" Velcro strap<br>1" chafe buckle<br>Speedy rivets | 1" Velcro strap<br>1" chafe buckle<br>Speedy rivets | 1" Velcro strap<br>1" chafe buckle<br>Speedy rivets |
| A nylon washer | Closure for Side Opening design and the<br>PRO design: | Closure for STARband Side Opening<br>design | Closure for STARband Side Opening<br>design |
| | 1" Velcro Strap<br>1" chafe buckle | 1" Velcro Strap | 1" Velcro Strap |
| Feature | From K124023 (STARband) | From K133250 (STARlight) | Proposed Device (STARband and STARlight) |
| Product Design | Custom made cranial orthosis, approximately 6oz. in weight | Optional tamper resistant strap (qty 2 for the STARlight PRO design)<br>Custom made cranial orthosis, approximately 7 to 10oz in weight. STARlight PRO weighs 12.5 to 18.5 oz. | 1 ½" chafe buckle<br>A Gap Block made from ½" firm Pelite polyethylene foam<br>Large Flange, Blind Rivet<br>Closure for STARlight Side Opening design and the STARlight PRO design:<br>1" Velcro Strap.<br>1" chafe buckle<br>Optional tamper resistant strap (qty 2 for the STARlight PRO design)<br>Custom made cranial orthosis, approximately 6 to 10oz in weight.<br>STARlight PRO weighs 12.5 to 18.5 oz. |
| Production | Form orthosis from a positive mold of infant's head<br>Positive mold is formed based upon measurements of the infant's head taken by an approved 3-dimensional imaging device from which a 3- dimensional image is made or from a traditional plaster cast | Form orthosis from a positive mold of infant's head<br>Positive mold is formed based upon measurements of the infant's head taken by an approved 3-dimensional imaging device from which a 3- dimensional image is made or from a traditional plaster cast | Form orthosis from a positive mold of infant's head<br>Positive mold is formed based upon measurements of the infant's head taken by an approved 3-dimensional imaging device from which a 3- dimensional image is made or from a traditional plaster cast |
| Approved 3- Dimensional Imaging Devices | The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine<br>STARscanner I<br>STARscanner II<br>Omega Scanner<br>scanGogh-II | The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine<br>STARscanner I<br>STARscanner II<br>Omega Scanner<br>scanGogh-II | The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine<br>STARscanner I<br>STARscanner II<br>Omega Scanner<br>scanGogh-II<br>3dMDhead System |
| Feature | From K124023 (STARband) | From K133250 (STARlight) | Proposed Device (STARband and<br>STARlight) |
| 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<br>cast and predicate device<br>Associated parameters includes<br>A-P and M-L<br>Proposed device is substantially<br>equivalent to predicate device | 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<br>cast and predicate device<br>Associated parameters includes<br>A-P and M-L<br>Proposed device is substantially<br>equivalent to predicate device | 3dMDcranial System<br>3dMDflex System<br>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<br>cast and predicate device<br>Associated parameters includes<br>A-P and M-L<br>Proposed device is substantially<br>equivalent to predicate device |
| | Cranial Shape Capture Accuracy Study<br>Utilized a representative cranial<br>shape that possesses a predefined<br>shape with known dimensions<br>Compared proposed device to<br>cast 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 | Cranial Shape Capture Accuracy Study<br>Utilized a representative cranial<br>shape that possesses a predefined<br>shape with known dimensions<br>Compared proposed device to<br>cast 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 | Cranial Shape Capture Accuracy Study<br>Utilized a representative cranial<br>shape that possesses a predefined<br>shape with known dimensions<br>Compared proposed device to<br>cast 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<br>Closed Patch Sensitization | Material Biocompatibility Testing<br>Cytotoxicity -Agar Diffusion<br>Closed Patch Sensitization | Material Biocompatibility Testing<br>Cytotoxicity-Agar Diffusion<br>Closed Patch Sensitization |

Comparison of Predicate Devices cleared in K124023 and K133250 to the Proposed Devi Table 1 -

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STARband® and STARlight® Cranial Orthosi

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STARband® and STARlight® Cranial Orthosis

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The use of a non-coherent structured light and triangulated cameras for a shape capture system for manufacturing Cranial Orthosis received FDA 510(k) clearance under K014012 (Cranial Technologies, Inc.). The STARband and STARlight Cranial Orthosis have similar indications for use as the predicate Cranial Orthosis (K014012) and the proposed shape capture device also has the same technological characteristics as the predicate shape capture device. Therefore, the STARband and STARlight Cranial Orthosis are substantially equivalent to the predicate 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 2.

| 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 2 - Biocompatibility Testing Summary for STARband and STARlight Cranial Orthosis

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

The 3dMDhead™ System, the 3dMDcranialTM System and the 3dMDflex™ System were all evaluated for safety and efficacy. The scanner uses a quick flash of structured white light which is equivalent to the flash from a consumer grade camera and shown that is safe to use on infants without any extra 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 3dMD Systems yield a safe and effective product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the scanner, the 3dMD Systems were determined safe and effective for scanning infants for STARband and STARlight Cranial Orthosis.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

June 6, 2014

Public Health Service

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

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

Re: K140353

> Trade/Device Name: STARband and STARlight Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: May 5, 2014 Received: May 6, 2014

Dear Mr. 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 With an the required (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. David Hooper

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Carlos L. Pena -S

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) K140353

Device Name

STARband and STARlight cranial orthosis

### Indications for Use (Describe)

The STARband and STARlight is 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 device is 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

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