STARBAND

K082950 · Orthomerica Products, Inc. · OAN · Dec 5, 2008 · Neurology

Device Facts

• Record ID: K082950
• Device Name: STARBAND
• Applicant: Orthomerica Products, Inc.
• Product Code: OAN · Neurology
• Decision Date: Dec 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The STARband 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

STARband is a custom-fabricated cranial orthosis for infants 3-18 months. Practitioner captures head shape via plaster cast or laser scanning (STARscanner or OWW Omega Scanner); 3D image used to create positive mold via 5-axis router. Orthosis consists of rigid copolymer outer shell and soft foam liner (pelite or Aliplast). Device provides total contact over prominent areas to discourage growth and creates voids over depressed areas to encourage growth, redirecting cranial development toward symmetry. Worn ~23 hours/day. Practitioner modifies interior over time to accommodate growth. Benefits include improved cranial symmetry and proportion in infants with positional or post-surgical deformities.

Clinical Evidence

Bench testing only. No clinical data. Performance testing focused on scanner accuracy, reproducibility, and repeatability using cylindrical shapes of varying diameters. Biocompatibility and pressure distribution testing performed for material changes.

Technological Characteristics

Custom-molded cranial orthosis. Materials: .156 copolymer outer shell; 1/2" pelite or Aliplast (closed-cell polyethylene) foam liner; Dacron/Velcro straps. Production: 5-axis routing from 3D scan or plaster cast. Class 1 laser scanners (STARscanner, OWW Omega) used for data acquisition. Non-powered, passive device.

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, Cranial Orthosis (K011350)
• STARlight Cranial Orthosis (K081994)

Submission Summary (Full Text)

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Ko82950 1/7

STARband® Cranial Orthosis

## 510(k) Summary

DEC 0 5 2008

#### I. Applicant Information

- Applicant's Name and Address: Orthomerica Products Inc, 505 31" Street, 트 P.O. Box 2927. Newport Beach, CA 92659. Telephone: [phone], Facsimile: [phone]
FDA Establishment Registration Number 1058152

- Contact: David C. Kerr, Chief Executive Officer, Telephone: (949) 723-미 4500, Facsimile: [phone]
- Submission Correspondent: Alan T. Sandifer, Director of Research and 트 Development, 6333 North Orange Blossom Trail, Orlando, FL 32810, Telephone: [phone], Facsimile: [phone], 1 [e-mail]
- 미 Summary Date - October 1, 2008
- II. Submission Information
- 트 Type: Traditional 510(k) Submission
- 트 Proprietary Name: STARband
- 해 Common Name: Cranial Orthosis
- 트 Classification: Class II (special controls); OAN; 21 CFR 882.5970
- Classification Name: Cranial Orthosis 트
- Predicate Devices: STARband, Cranial Orthosis, K011350 미

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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K082950

#### IV. Description of Device

The STARband 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 STARband 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 STARband 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 as it was released in K011350 is essentially still the same device. The STARband consists of a 5/32" outer copolymer shell with an inner liner made of 1/2" pelite polyethylene foam. There is a top opening and a side opening. The strap across the side opening is 1 ½" Dacron and Velcro and is attached to the STARband with a chafe and loop. A 1/2" pelite polyethylene foam gap block fills any gap in the side opening. Since the original clearance, a variation of the STARband has been released. It is identical in design; however, the inner liner is made of 1/2" Aliplast foam (closed cell polyethylene).

V. Statement of Indications and Intended Use

Statement of Indications:

The STARband 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.

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STARband® Cranial Orthosis

Intended Use:

The STARband is design to treat infants with abnormal head shapes from age 3 months to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the STARband for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. However, due to new minimally invasive surgical techniques for infants with craniosynostosis, post-surgical plagiocephaly, brachycephaly, and scaphocephaly are emerging as a growing patient group.

Craniosynostosis is caused by the premature fusion of one or more cranial sutures of the skull, causing the head to grow into an unusual shape. Some types of craniosynostosis have a clinical presentation similar to deformational (positional) plagiocephaly. Therefore in cases where the physician cannot make a definitive diagnosis, patients are referred to specialists such as neurosurgeons or cranio-facial surgeons. These specialists will order a test like a CT scan or MRI to confirm the diagnosis of craniosynostosis. If a baby has craniosynostosis, surgery is indicated to realign the plates of the skull and allow normal brain and skull growth to occur.

In general, the first year of life is the optimum time frame for surgical correction since infants are growing at such an accelerated rate during that time. No matter which surgical technique is used, the end result is a patient with no fused sutures. At this point the same principles that guide cranial remolding of deformational head shapes are applicable. In both deformational head shapes and post-surgical head shapes the STARband is designed to maintain total contact over areas where growth is not desired, and allow for space over areas where growth is desired. The STARband provides a pathway for the baby's head growth, directing it toward a more normal shape.

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#### Summary of Technological Characteristics VI.

The proposed changes involve the indications for use and how the infants head shape is captured. Despite these changes the STARband cranial orthosis design will remain the same. However, there have been changes made to the STARband through the Orthomerica Engineering Change Order process that were minor and determined to not require a 510(k) submission. The following table illustrates the minor differences between the cleared device (K011350) and the device as it is currently marketed.

| Feature | From K011350 | Current Product |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | - Outer shell of .156 copoly plastic<br><br>- An inner liner of ½" pelite<br>polyethylene foam<br><br>- A strap of 1 ½" Dacron<br><br>- A 1 ½" chafe buckle<br><br>- A 91X speedy rivet<br><br>- A bellows made from 1/16" firm<br>pelite polyethylene;<br><br>- A nylon washer | - Outer shell of .156 copoly plastic<br><br>- An inner liner of ½" pelite<br>polyethylene foam or ½" Aliplast<br>foam<br><br>- A strap of 1 ½" Dacron<br><br>- A 1 ½" chafe buckle<br><br>- Large Flange, Blind Rivet<br><br>- A Gap Block made from ½" firm<br>pelite polyethylene foam<br><br>- A nylon washer |
| Product<br>Design | Custom made cranial orthosis, approx 6oz.<br>in weight | Custom made cranial orthosis, approx 6oz.<br>in weight |
| Production | - Form orthosis from a positive<br>mold of infant's head<br><br>- Positive mold is formed based<br>upon measurements of the<br>infant's head taken by the<br>STARscanner from which a 3-<br>dimensional image is made or<br>from a traditional plaster cast<br><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><br>- Positive mold is formed based<br>upon measurements of the infant's<br>head taken by the STARscanner,<br>the OWW Omega Scanner from<br>which a 3-dimensional image is<br>made or from a traditional plaster<br>cast<br><br>- The 3-dimensional image is used<br>to produce a positive mold using a<br>5-axis routing machine |

Table 1 - Comparison of Predicate Device cleared in K011350 to currently marketed device made to the current device as a result of the proposed indications and shape capture change in this submisslon res will be

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K082950 5/7

STARband® Cranial Orthosis

In reference to the technological characteristics, the inclusion of the Ohio Willow Wood (OWW) Omega Scanner is the main difference and is located under the production section of the table. Like the STARscanner Laser Data Acquisition system cleared with the original STARband (K011350), the OWW Omega Scanner is a class 1 laser device and as such is safe for use without eye protection under all normal operating conditions. The OWW Omega Scanner is a handheld scanner consisting of two cameras, one laser, and eight LED lights. Through testing, the OWW Omega Scanner was found to be safe and effective.

In addition, there are three minor changes indicated in the table: The inner liner may be made with either pelite polyethylene foam or Aliplast foam, the speedy rivet used to attach the strap and chafe to the STARband has been changed to a pop-rivet, and the bellows used to fill the side opening gap has been changed to a solid foam block. The Aliplast foam option was added at the request of Orthomerica's customers after biocompatibility testing and pressure distribution testing to confirm its equivalence to the pelite polyethylene foam. There are no clinical advantages or disadvantages to using Aliplast foam; however some customers were more experienced with Aliplast foam than Pelite foam and requested the switch. The speedy rivet was changed to the pop-rivet so that the inner liner of the band would be completely smooth and blemish free against the baby's head. The bellows device served an important purpose of bridging the gap in the side opening; however, it was found to be cumbersome for parents to deal with on a daily basis. The solid foam gap block is much easier to manage and is customizable by the practitioner for the best fit on the baby. The foam gap block is attached to the strap with Velcro.

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The STARband is also substantially equivalent to the STARlight cranial orthosis (K081994). Although the materials may differ between the orthoses, the same intended use, underlying operating principles, and production processes apply.

. . .

| Feature | From K081994 (STARlight) | Current Product |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Maintains total contact over areas of bossing or protrusion and creates voids over areas of depression or flattening to redirect cranial growth toward greater symmetry. | Maintains total contact over areas of bossing or protrusion and creates voids over areas of depression or flattening to redirect cranial growth toward greater symmetry. |
| Materials | Material for STARlight Side Opening, STARlight Bi-Valve, STARlight Cap<br>- 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester plastic shell<br><br>Material for STARband Bivalve<br>- Outer shell of 5/32" copolymer plastic<br>- An inner liner of 1/2" pelite polyethylene foam<br><br>Closure for Bivalve design<br>- Sliding/Overlap closure system<br>- Chicago screw (or similar) for tope 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 | Outer shell of .156 copoly plastic<br><br>- An inner liner of ½" pelite polyethylene foam or ½" Aliplast foam<br><br>- A strap of 1 ½" Dacron<br><br>- A 1 ½" chafe buckle<br><br>- Large Flange, Blind Rivet<br><br>- A Gap Block made from ½" firm pelite polyethylene foam<br><br>- A nylon washer |
| Product<br>Design | Custom made cranial orthosis, approx 7 to 10oz. in weight | Custom made cranial orthosis, approx 6oz. in weight |
| Production | Form orthosis from a positive mold of infant's head<br><br>- 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<br><br>- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine | Form orthosis from a positive mold of infant's head<br><br>- Positive mold is formed based upon measurements of the infant's head taken by the STARscanner, the OWW Omega Scanner from which a 3-dimensional image is made or from a traditional plaster cast<br><br>- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine |

Table 2 - Comparison of Predicate Device cleared in K081994 to currently marketed device

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

The STARband cranial orthosis has been used successfully in clinical practice since its original clearance in 2001. The minor changes mentioned in the preceding technical characteristics section involved standard orthotic fabrication and materials that have undergone biocompatibility testing. However, the STARscanner™ Data Acquisition System used to capture the infant's head shape has had minor technical changes and with due diligence performance testing was conducted. The changes made to the STARscanner were to improve ease of use for the practitioner and to update components to the state of the art.

In addition, the OWW Omega Scanner was evaluated for safety and efficacy. The primary safety issue is the laser. The STARscanner and the OWW Omega Scanner are both class 1 laser devices and as such are inherently safe for use without eye protection under all normal operating conditions. The effectiveness of each scanning device was evaluated through accuracy, reproducibility, and repeatability testing.

The accuracy, reproducibility, and repeatability of the STARscanner was evaluated by scanning three different cylindrical shapes ( 100mm, 125mm, 150mm diameters) five times at five different positions within the scan volume. Standard measurement systems statistical process control procedures were utilized to evaluate STARscanner errors, error standard deviations, repeatability of multiple scans, and reproducibility of multiple scans at multiple locations within the scan volume. The OWW Omega Scanner was evaluated by scanning three different cylindrical shapes (100mm, 125mm, 150mm diameters) five times while in random motion. These 15 scan files were then converted to .aop files 3 times to create a total of 45 scan files. Standard measurement systems statistical process control procedures were utilized to evaluate scan errors, error standard deviations, repeatability of multiple scans, and reproducibility of multiple scans in random motion.

Each device met the predetermined acceptance criteria and was found acceptable.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K082950

Trade/Device Name: STARband® Regulation Number: 21 CFR 882,5970. Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: October 2, 2008 Received: October 3, 2008

# DEC 0 5 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.

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Page 2 - Mr. Alan T. Sandifer

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.

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 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 M. Millman

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

510K Number (if known): K0829SO

Device Name: STARband®

Indications for Use:

The STARband 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)

![Image of signature]

Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number k082950