AOI CRANIAL HELMET

K103362 · Advanced Orthopro, Inc. · MVA · Apr 18, 2011 · Neurology

Device Facts

• Record ID: K103362
• Device Name: AOI CRANIAL HELMET
• Applicant: Advanced Orthopro, Inc.
• Product Code: MVA · Neurology
• Decision Date: Apr 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The AOI Cranial Helmet 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 age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads.

Device Story

Custom-fabricated cranial orthosis; designed to apply mild pressure to prominent cranial regions to restrict growth while providing voids for flattened areas to expand. Fabrication involves creating a plaster mold of the infant's head; positive model modified by adding plaster to flattened areas to create growth voids. Device consists of a rigid thermoformable copolymer outer shell and polyethylene foam inner liner; secured with a Velcro strap. Used in clinical settings under supervision of a Certified Orthotist; requires physician prescription. Orthotist monitors fit and alignment at bi-monthly re-evaluation appointments. Output is the physical shaping of the skull over time; benefits patient by improving cranial symmetry. No electronic components or automated processing.

Clinical Evidence

Bench testing only. No clinical trials performed. Biocompatibility supported by ISO 10993-1 compliance and historical use of materials (copolymer plastics and polyethylene foams) in similar pediatric medical devices. Safety further supported by custom-fit design and ongoing monitoring by certified orthotists.

Technological Characteristics

Custom-fabricated cranial orthosis. Materials: 5/32 inch copolymer plastic outer shell, 1/2 inch polyethylene foam inner liner, Dacron strap, nylon washer. Sensing/actuation: Passive mechanical pressure via custom-molded voids. No energy source. Non-sterile. No software or connectivity.

Indications for Use

Indicated for infants aged 3 to 18 months with moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic and brachycephalic head shapes. Contraindicated for infants with craniosynostosis or hydrocephalus.

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

• OPIBand by Orthomerica (K001167)

Submission Summary (Full Text)

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## K103362

Image /page/0/Picture/1 description: The image shows the letters "AOI" in white against a black, hexagonal background. The letters are in a bold, sans-serif font and are evenly spaced. The hexagon is oriented with two flat sides at the top and bottom, and pointed corners on the sides.

APR 1 8 2011

## AOI 510(K) Summary of Effectiveness and Safety

The summary contained hereinafter is provided pursuant to Section 513(1)(3)(A) of the Federal Food, Drug and Cosmetic Act.

A. Applicant Information

1. Submitter Name: Advanced OrthoPro Inc. (AOI)

- 2. Address: 1820 N. Illinois St., Indianapolis, IN 46202
- 3. Telephone: [phone]
- 4. Contact Person: Keon Mansoori
- 5. Date Prepared: February 8, 2011
- 6. Registration Number:

B. Device Name and Classification

- 1. Name: Cranial Helmet
- 2. Trade Name: AOI Cranial Remolding Helmet
- 3. Common Name: Cranial Orthosis
- 4. Classification Name: Cranial Orthosis
- 5. Product Code: MVA
- 6. Class: II
- 7. Regulation Number: 21 CFR § 882.5970
- C. Identification of Legally Marketed Devices
- 1. Name: OPIBand by Orthomerica
- 2. K Number: K001167
- 3. Date Cleared: July 7, 2000

D. Device Description

The AOI Cranial Helmet is a cranial orthosis which is made through a custom fabrication process to apply mild pressure to prominent regions of a young child's cranium to slow further growth in that area while allowing flattened portions of the cranium to grow into voids built into the helmet in order to improve overall cranial symmetry.

The helmet itself, once finished and delivered, covers the majority of the head and is trimmed as follows. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above the ears. The posterior inferior is trimmed low to capture the occiput. A Velcro strap is attached to one side of the helmet to keep it

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securely in place. The details of the materials used in this helmet and process are found below.

The AOI Cranial Helmet is not packaged for sale due to the fact that it is a custom fabricated device. The device is fitted to the child's head at the time of delivery. The AOI device has no accessories, and no options are available for the infant or the caregiver.

The AOI Cranial Helmet is custom made by first having a Certified Orthotist take a plaster mold of the patient's head. Since this device is custom fabricated for each patient there is no such thing as a standard size, model variance or otherwise. This individual's mold is then filled with plaster and a positive model of the child's head is made. The prominent areas are left alone on the model while the flattened areas of the model (which correspond to flat areas of the child's head) are built up with plaster to create rounded and symmetrical voids. As the child grows and the head fills the voids, which are made for just that purpose, the skull is slowly shaped into a more symmetrical shape. All steps of fabrication and production are done under the supervision of a Certified Orthotist.

The AOI Cranial Helmet is made of substantially the same materials as the predicate. The finished AOI Cranial Helmet is composed of a hard outer shell, made of thermoform-able plastic (Copolymer 5/32 inch) and an inner layer of polyethylene foam ( 1/2 inch). These materials are the exact same materials used on many types of medical devices and come into protracted contact with the skin of adults and children every day. Throughout the duration of use, the fit and alignment of the device are monitored by the Certified Orthotist on at least a bi-monthly basis at re-evaluation appointments. Instructions on the care and use of the device, including wearing schedule and helpful hints are provided to caregiver at time of delivery of the product. In addition to the evaluations by the Orthotist the AOI Cranial Helmet is only provided to person's with a prescription from their physician for the device, and therefore this device is also only provided to persons whom are under the care of a physician who has decided to apply this product. Please see the Figures below which show the AOI Cranial Helmet.

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Image /page/2/Picture/0 description: The image contains three figures of a medical helmet. The helmet is white with a pattern of black and gray designs. The helmet has a strap on the side and is sitting on a white surface. The figures are labeled as Figure 1, Figure 2, and Figure 3.

E. Intended Use and Indications of Use

The AOI Cranial Helmet 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 age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalicshaped heads.

F. Comparison to Predicate Device

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The AOI Cranial Helmet and the predicate device it is based on are very similar with respect to the production processes, the instructions for use which are provided to the patient, the materials used to produce the items, safety and effectiveness and special controls used in production. In fact, the AOI Cranial Helmet and its predicate device have exactly the same purposes, are made from the same materials and work in exactly the same way, as will be shown below.

The material in the production of the AQI Cranial Helmet is handled in the exact same manner as the polymer used in the predicate, incorporating all of the safety and standards of practice. The proposed indications of use are analogous to those presented by the predicate device, and biocompatibility, function and effectiveness also closely shadow those of the predicate device.

| Comparison<br>Criteria | Subject Device | Predicate Device<br>(OPIBand K001167) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | MVA | MVA |
| Prescription<br>Device | YES | YES |
| Materials | 1. Outer rigid shell made of 5/32<br>inch copolymer plastic.<br>2. Inner liner of 1/2 inch<br>polyethelene foam.<br>3. 1 1/2 inch Dacron Strap.<br>4. 1 1/2 inch Chafe with roller loop.<br>5. Nylon Washer<br>6. Gap Block 1/2 inch firm pelite<br>polyethelene foam. | 1. Outer shell of 5/32 inch<br>copolymer plastic.<br>2. An inner liner liner of 1/2 inch<br>pelite polyethelene foam or<br>Aliplast foam.<br>3. 1 1/2 in. Dacron Strap<br>4. Gap block 1/2 inch firm pelite<br>polyethelene foam.<br>5. Nylon Washer |
| Product<br>Design | Custom made cranial orthosis.<br>approx. 6 oz. | Custom made cranial orthosis,<br>approx 6 oz. |
| Production | 1. Form orthosis from positive<br>mold of infant's head. | 1. Form orthosis from a positive<br>mold of infant's head. |

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| Comparison<br>Criteria | Subject Device | Predicate Device<br>(OPIBand K001167) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | The AOI Cranial Helmet is<br>intended for medical purposes to<br>apply pressure to prominent<br>regions of an infant's cranium in<br>order to improve cranial symmetry<br>and/or shape in infants from age 3<br>to 18 months of age, with<br>moderate to severe nonsynostotic<br>positional plagiocephaly, including<br>infants with plagiocephalic- and<br>brachycephalic- shaped heads. | "The OPIBand is intended for<br>medical purposes to apply<br>pressure to prominent regions of<br>an infant's cranium in order to<br>improve cranial symmetry and/or<br>shape in infants from 3 to 18<br>months of age, with moderate to<br>severe nonsynostotic positional<br>plagiocephaly, including infants<br>with plagiocephalic- and<br>brachycephalic- shaped heads." |
| Contraindicat<br>ions | The AOI Cranial Helmet is not for<br>use on infants with<br>craniosynostosis or<br>hydrocephalus. | "This device is not for use on<br>infants with pre-surgical<br>craniosynostosis or<br>hydrocephalus." |

See Table (supra)

## G. Performance Data

The safety of cranial helmets has also been shown through past biocompatibility assessments which reveal that this type of device is not expected to adversely affect children under intended conditions of wear.1 The AOI Cranial Helmet has not undergone its own individual clinical trials with respect to biocompatibility. This is in compliance with ISO 10993-1 in that after review of the production methods and materials involved "no testing is needed if the material has a demonstrable history of use in a specified role that is equivalent to that of the device under design." In the case of the AOI Cranial helmet the materials used in the manufacture and completed product are copolymer plastics and polvethelene foams that are used in devices which are used directly against the skin of children and even infants. Devices such as custom night AFOs or custom made Cervical devices are fabricated using the same methods and materials and contact the skin for protracted wear periods. They are prepared using the same vacuum forming and glueing method. The only surface contacting the skin is the foam. These materials are provided to AOI by companies which certify that their

¹ Littlefield TR. Beals SP. Manwaring KH. Pomatto JK. Joganic EF, Golden KA, Ripley CE. Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty. Journal of Craniofacial Surgery. 1988; 11-17.

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products are manufactured and delivered in a manor which is compliant with ISO standards.2

Importantly, the only part of the device which contacts the patient's skin is the foam liner which is made of polvethelene foam. This foam is not reported to cause skin irritation or abrasion and is used widely in the medical device field as a safe interface between derma and device. Also, the safety of these helmets is furthered by the fact the each device is custom made to the individual patient, this prevents excessive slipping or migration of the helmet or excessive pressure on the child's cranium. Most importantly all patients wearing helmets are closely monitored by AOI personnel who are certified and have had years of experience as orthotists, including bi-monthly evaluations of the helmet and patient and an open dialoque with the treating physicians and caregivers. Also. the proposed device is not in any quantifiable way different from the predicate device with regard to manufacture or materials used, thus when looking at the predicate device we can see that the helmet has been effectively used for years without complications of this sort.

## H. Summarv

As can be seen from the 510(K) Summary supra the proposed AOI Cranial Helmet does not differ substantially from the predicate device. The predicate is made of the same materials and in the same fashion as the AOI proposed device. Based on a comparison of the technological specifications of the predicate device and the AOI Cranial Helmet it is believed that the AOI Helmet has been shown to be substantially equivalent to the predicate device.

² O&P Enterprises, Inc. and American Plastics Inc.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

Advanced OrthoPro, Inc. c/o Keon Mansoori B.A., J.D. Counsel 1820 N. Illinois St. Indianapolis, IN 46202

Re: K103362

Trade/Device Name: AOI Cranial Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: February 15, 2011 Received: February 15, 2011

APR 1 8 2011

Dear Mr. Mansoori:

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. Iisting 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.

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Page 2 - Keon Mansoori B.A., J.D

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K103362 Device Name: AOI Cranial Helmet Indications for Use:

The AOI Cranial Helmet 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 age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

OR

JEFFREY Toy

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K103362 510(k)

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