STARLIGHT

K082945 · Orthomerica Products, Inc. · OAN · Oct 31, 2008 · Neurology

Device Facts

• Record ID: K082945
• Device Name: STARLIGHT
• Applicant: Orthomerica Products, Inc.
• Product Code: OAN · Neurology
• Decision Date: Oct 31, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The STARlight is intended for medical purposes for use on infants from three 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 adjunctive use for infants from three to eighteen 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

STARlight is a custom-fabricated cranial orthosis designed to correct head shape and symmetry in infants. The device functions by applying mild, targeted pressure to prominent areas of the cranium, directing growth into areas of least resistance. Practitioners capture the infant's head shape via plaster casting or 3D laser scanning (STARscanner or Ohio Willow Wood Omega Scanner). This data creates a positive model, which is modified to provide space for growth in flattened regions. The orthosis is a plastic shell (Surlyn, Co-Polyester, or copolymer) with optional foam lining, secured by straps. It is worn approximately 23 hours per day. The device is prescribed by clinicians to treat positional plagiocephaly, brachycephaly, and scaphocephaly, or as an adjunct following craniosynostosis surgery. By guiding cranial growth, the orthosis improves head proportion and symmetry, potentially reducing the severity of deformities.

Clinical Evidence

Bench testing only. The OWW Omega Scanner was evaluated for safety (Class 1 laser classification) and effectiveness (accuracy, reproducibility, and repeatability). The scanner met all predetermined acceptance criteria.

Technological Characteristics

Custom-molded cranial orthosis. Materials: 5/32"-1/4" clear Surlyn, 1/8"-7/32" clear Co-Polyester, or 5/32" polyethylene-polypropylene copolymer with 1/2" pelite polyethylene foam liner. Closure: Velcro straps, chafe buckles, and rivets. Principle: Passive mechanical pressure to guide cranial growth. Data acquisition: 3D laser scanning (Class 1 laser) or plaster casting. Manufacturing: 5-axis routing machine.

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 craniosynostosis 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

• STARlight, Cranial Orthosis (K081994)

Reference Devices

• STARscanner Laser Data Acquisition system (K021207)
• STARscanner Laser Data Acquisition system (K081994)

Submission Summary (Full Text)

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K082445 pg 1 of 5

STARlight® Cranial Orthosis

## 510(k) Summary

OCT 3 1 2008

- I. Applicant Information
- 트 Applicant's Name and Address: Orthomerica Products Inc. 505 318 Street. P.O. Box 2927, Newport Beach, CA 92659, Telephone: [phone], Facsimile: [phone]

FDA Establishment Registration Number 1058152

- 에 Contact: David C. Kerr, Chief Executive Officer, Telephone: [phone], Facsimile: [phone]
- 페 Submission Correspondent: Alan T. Sandifer, Director of Research and Development, 6333 North Orange Blossom Trail, Orlando, FL 32810, Telephone: [phone], Facsimile: [phone], [e-mail]
- 트 Summary Date - October 1, 2008
- II. Submission Information
- Type: 510(k) Device Modification (Special)
- I Proprietary Name: STARlight
- Common Name: Cranial Orthosis
- 피 Classification: Class II (special controls): OAN; MVA: 21 CFR 882.5970
- 1 Classification Name: Cranial Orthosis
- I Predicate Device: STARlight, Cranial Orthosis, K081994
- III. Manufacturing Site: 6333 North Orange Blossom Trail, Orlando, FL 32810, Telephone: [phone], Facsimile: [phone], FDA Establishment Registration Number 1058152

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K0854945 pg 2 of 5

STARlight® Cranial Orthosis

#### IV. Description of Device

The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape 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 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 modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the 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 STARlight Side Opening design, STARlight Bi-Valve design and the STARlight Cap design are all made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands.

The STARlight Cap design is made of the above plastic and contains no straps. The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight Bivalve 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 shape capture method, specifically the Ohio Willow Wood (OWW) Omega Scanner. Like the STARscanner Laser Data Acquisition system cleared with the STARlight (K021207 and K081994), the OWW Omega Scanner is a class 1 laser device. The OWW Omega Scanner is a handheld scanner consisting of two cameras, one laser, and eight LED lights.

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Kärry 545 pg 3 of 5

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

### Statement of Indications:

The STARlight is intended for medical purposes for use on infants from three 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 adjunctive use for infants from three to eighteen 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 intended use is the same as it was for the STARlight in K081994; to correct head shape and proportion deformities. The STARlight is available by prescription only and is designed to treat infants with abnormal head shapes from age 3 to 18 months. Since growth is the driving factor in head shape correction, the infants wear the STARlight for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. Recently the STARlight has 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.

#### Summary of Technological Characteristics VI.

The modification proposed is a change in how the infants head shape is captured; the technological characteristics and the underlying principles of operation of the STARlight cranial orthosis will remain exactly the same. This table illustrates that the device will in fact remain the same.

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K082445 P7 4 of 5
STARLight® Cranial Orthosis

| | Note: No changes will be made to the currently marketed device as a result of the proposed changes in this submission | |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | From K081994 | Proposed Device |
| Indications | The STARlight is intended for medical<br>purposes for use on infants from three to 18<br>months of age, with moderate to severe non-<br>synostotic positional plagiocephaly, including<br>infants with plagiocephalic-, brachycephalic-<br>and scaphocephalic-shaped heads by applying<br>mild pressure to prominent regions of the<br>infant's cranium in order to improve cranial<br>symmetry and/or shape. The device is also<br>indicated for adjunctive use for infants from<br>three to eighteen months of age whose<br>synostosis has been surgically corrected, but<br>who still have moderate to severe cranial<br>deformities including plagiocephalic-,<br>brachycephalic-, and scaphocephalic-shaped<br>heads. | The STARlight is intended for medical<br>purposes for use on infants from three to 18<br>months of age, with moderate to severe non-<br>synostotic positional plagiocephaly, including<br>infants with plagiocephalic-, brachycephalic-<br>and scaphocephalic-shaped heads by applying<br>mild pressure to prominent regions of the<br>infant's cranium in order to improve cranial<br>symmetry and/or shape. The device is also<br>indicated for adjunctive use for infants from<br>three to eighteen months of age whose<br>synostosis has been surgically corrected, but<br>who still have moderate to severe cranial<br>deformities including plagiocephalic-,<br>brachycephalic-, and scaphocephalic-shaped<br>heads. |
| Mechanism | Applies pressure to the prominent regions<br>of the infants cranium in order to improve<br>cranial symmetry and/or shape | Applies pressure to the prominent regions<br>of the infants cranium in order to improve<br>cranial symmetry and/or shape |
| Materials | Material for STARlight Side Opening,<br>STARlight Bi-Valve, STARlight Cap<br>- 5/32" - 1/4" clear Surlyn or 1/8" –<br>7/32" Clear Co-Polyester plastic<br>shell<br><br>Material for STARband Bivalve<br>- Outer shell of 5/32" copolymer<br>plastic<br>- An inner liner of 1/2" pelite<br>polyethylene foam<br><br>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>- 91X speedy rivets<br><br>Closure for Side Opening design:<br>- 1" Velcro Strap | Material for STARlight Side Opening,<br>STARlight Bi-Valve, STARlight Cap<br>- 5/32" - 1/4" clear Surlyn or 1/8" –<br>7/32" Clear Co-Polyester plastic<br>shell<br><br>Material for STARband Bivalve<br>- Outer shell of 5/32" copolymer<br>plastic<br>- An inner liner of 1/2" pelite<br>polyethylene foam<br><br>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>- 91X speedy rivets<br><br>Closure for Side Opening design:<br>- 1" Velcro Strap |
| Product<br>Design | Custom made cranial orthosis, approx 7 to<br>10oz. in weight | Custom made cranial orthosis, approx 7 to<br>10oz. in weight |
| Production | - Form orthosis from a positive mold of infant's head | - Form orthosis from a positive mold of infant's head |
| | - Positive mold is formed based upon measurements of the infant's head taken by the STARscanner from which a 3-dimensional image is made or from a traditional plaster cast | - Positive mold is formed based upon measurements of the infant's head taken by the STARscanner or the OWW Omega Scanner from which a 3-dimensional image is made or from a traditional plaster cast |
| | - The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine | - The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine |

Table 1 – Comparison of Predicate Device cleared in K081994 to proposed device
Note: No changes will be made to the currently marketed device as a result of the proposed chan

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ﻟﺴﻨ

The inclusion of the OWW Omega Scanner is the focus of this submission and that change is indicated in the table under the production section.

Summary and Conclusions of Non-Clinical Performance Data VII.

The OWW Omega Scanner was evaluated for safety and efficacy. The primary safety concern is the laser. The STARscanner and the OWW Omega Scanner are both class 1 laser devices and as such are inherently safe without eye protection under all normal operating conditions. The effectiveness of the OWW Omega Scanner was evaluated through accuracy, reproducibility, and repeatability testing. The OWW Omega Scanner met the predetermined acceptance criteria and was found safe and effective for use with Cranial Orthoses.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 eagle symbol, with its wings forming three distinct lines.

Public Health Service

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CARTER COMPANIE PAR BALL A LEAST A LEAST AND AND

Orthomerica Products, Inc. % Mr. Alan T. Sandifer Director of Research and Development 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K082945

Trade/Device Name: STARlight® Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: October 1, 2008 Received: October 2, 2008

Dear Mr. Sandifer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

OCT 3 1 2008

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Page 2 - Mr. Alan T. Sandifer

Comments of the contribution of the securities and with the results of the

るというとしているというとなってきていました。このことです。です。

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

に出版がある。これらなお気をさせたりますが、いつくなるのです。その時間ができるというという

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark W. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Indications for Use

The state the contribution of the security of the county of the county of the may

510K Number (if known): KO82945

Device Name: STARlight®

Indications for Use:

The STARlight is intended for medical purposes for use on infants from three 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 adjunctive use for infants from three to eighteen 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.

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

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

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

Concurrence of CDRH. Office of Device Evaluation (ODE) (Division Sign-Off)

Division of General, Restorative. and Neurological Devices

**510(k) Number**