CRANIAL SOLUTION ORTHOSIS

K063133 · Cranial Solutions · MVA · Jul 2, 2007 · Neurology

Device Facts

• Record ID: K063133
• Device Name: CRANIAL SOLUTION ORTHOSIS
• Applicant: Cranial Solutions
• Product Code: MVA · Neurology
• Decision Date: Jul 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The CSO is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infants's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and or shape.

Device Story

Custom-made cranial orthosis for infants with non-synostotic positional plagiocephaly. Device fabrication involves taking a plaster cast of the infant's calvarium, creating a modified cranial model corrected for symmetry, and vacuum-forming the orthosis over this model. Device consists of a semi-rigid outer shell (polypropylene/polyethylene copolymer) and a soft inner foam liner. Used in a clinical setting under physician prescription; applied by caregivers. Operates as a dynamic orthotic by applying gentle, low-energy pressure to prominent cranial regions while providing space for growth in depressed regions. Caregivers monitor fit and skin integrity every 3-4 hours; practitioners perform biweekly follow-up measurements to track head circumference and growth. Improves cranial symmetry and shape over a standard 3-4 month treatment period.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material composition, and intended use similarities to the predicate device.

Technological Characteristics

Dynamic cranial orthosis. Materials: Orthopedic grade copolymer polypropylene (90%) and polyethylene (10%) outer shell; medium durometer polyethylene foam (Volara) inner liner. Construction: Vacuum-formed over a modified plaster cast model. Design: Semi-rigid shell with lateral opening and top ventilation. Biocompatibility: Inner lining tested for long-term skin contact.

Indications for Use

Indicated for infants 3-18 months old with moderate to severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, or scaphocephalic 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

• Dynamic Orthotic Cranioplasty (DOC) device

Submission Summary (Full Text)

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K063133 pg 1 of 4

JUL - 2 - 2 - 2007

Image /page/0/Picture/2 description: The image shows a black and white drawing of a human skull from a side view. The skull is detailed, showing the different bones and structures that make up the skull. The drawing is labeled with lines pointing to different parts of the skull, but the labels are illegible. The skull is set against a white background.

## CRANIAL SOLUTIONS

602 Lincoln Avenue Pompton Lakes, N.J. 07442-1309 Tel: ( 973) 835-7929

# 510(k) Summary

June 12 2007 Kirk A Lucyk, CO Trade Name: Cranial Solutions Orthosis (CSO) Classification Name: Cranial Orthosis Classification # 882.5970 Code:MVA

The CSO is a custom made medical device intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve symmetry and or shape. The device is of thermoplastic construct. A semi-rigid outer shell of Orthopedic grade copolymer polypropylene thermobonded to a medium durometer polyethylene foam inner liner(Volara). The formula for the outer shell is [ch(ch3)ch2-] 90% polypropylene and 10% polyethylene. By design the CSO is a dynamic orthotic device. As a predicate selection for substantial equivalence I would

like to reference the Dynamic Orthotic Cranioplasty (DOC) device and design.

The CSO and Cranial Technologies DOC device have the same indications for use: On infants three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly and other abnormal head shapes.

- Kirk A. Lucyk, C.O. - 602 Lincoln Avenue - Pompton Lakes, NJ 07442-1309 Email [e-mail]

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Image /page/1/Picture/1 description: The image shows a side view of a human skull. The skull is drawn in black and white, with various bones and features labeled with lines. The skull appears to be a simplified anatomical illustration, possibly for educational purposes. The details of the skull, such as the eye socket, nasal cavity, and teeth, are visible.

### CRANIAL SOLUTIONS

602 Lincoln Avenue Pompton Lakes, N.J. 07442-1309 Tel: ( 973) 835-7929

510(k) Summarv

Page 2

Both devices are Not intended for infant's with craniosynostosis or hydrocephalus. Both devices provide cranial orthotic treatment for infant's with nonsyndromic head deformity as a result of the utero process: e.g. compressional forces exerted by the lumbosacral spine, uterine malformation, fetal malpositioning, multiple fetuses oligohydramnios, and the current supine positioning recommendations. By design the CSO and DOC have a single lateral opening on the side adjacent to the flattened occipital-parieto region, provide a generous opening on top for air flow, and are very light in weight. Both devices can easily be adjusted for normal growth during the treatment process, and are easy to apply and remove by the care giver.

Both devices are of thermoplastic construction consisting of a semirigid outer shell bonded to a soft inner lining. Both outer shells are of Orthopedic grade plastic with hazard data all within OSHA permissible exposure limits with none know medical conditions aggravated by exposure. The CSO and DOC inner linings have been tested and approved by the FDA for long term skin contact. Both devices are of dynamic design , and when applied to an infant mild pressure, a low energy load , will constrain and correct abnormal growth . Normal growth will take place in the provided space and the cranial symmetry will be much improved.Standard treatment time for both cranial orthoses is three to four months.

- Kirk A. Lucyk, C.O. - 602 Lincoln Avenue - Pompton Lakes, NJ 07442-1309 Email [e-mail]

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K063133 pg 3 of 4

Image /page/2/Picture/1 description: This image shows a side view of a human skull. The skull is drawn in black and white, with various lines and shapes indicating the different bones and features of the skull. The skull is facing to the right, and the details of the eye socket, nasal cavity, and jaw are visible. The image appears to be a diagram or illustration, possibly from an anatomy textbook or educational resource.

# CRANIAL SOLUTIONS

602 Lincoln Avenue Pompton Lakes, N.J. 07442-1309 Tel: ( 973) 835-7929

510(k) Summarv

page 3

By design specifications and design intent the CSO is vacuum formed over a modified cranial model obtained from a plaster cast taken of the infant's calvarium . Both the cranial solutions orthosis and the predicate device are formed only after the cranial model has been corrected or restored to as near as complete symmetry as possible. This exact correction will produce a very accurate and effective fit.

In keeping with our goal: To provide the safest, effective, and most comfortable cranial orthosis on an individual, custom, and prescription basis we at Cranial Solutions employ an important clinical tool. Our CSO Anthropometric measurement form. After obtaining the plaster impression we complete this form and explain it to parent or care giver. By encouraging the parents to be involved in the measurements(progress) they will keep and understand the need for biweekly follow-up appointments. By having the cranial orthosis and head circumference evaluated and recorded at preset intervals by the practitioner the risk factors can be reduced and the infant will have a much improved clinical outcome with their cranial orthosis.

- Kirk A. Lucyk C.O. - 602 Lincoln Avenue - Pompton Lakes, NJ 07442-1309 Email [e-mail]

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### CRANIAL SOLUTIONS

602 Lincoln Avenue Pompton Lakes, NJ 07442 [phone]

## CRANIAL SOLUTIONS ORTHOSIS

The use of this device (CSO) is restricted to prescription use only by order of a Physician.

INTENDED USE: The CSO is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly , including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infants's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and or shape.

CONTRAINDICATIONS: The Cranial Solutions Orthosis (CSO) is contraindicated for infant's who have synostosis or hydrocephalus.

WARNINGS: All infants being treated with a cranial orthosis need to have their head circumference evaluated, measured, and recorded at preset intervals by a practitioner. eirounforous ovaluation and rate of head growth must be evaluated at age appropriate intervals to reduce the risk of restricting normal cranial growth and brain development. Into rate givers need to examine, evaluate, and monitor the infant's skin every r urone of our grover if skin irritation or breakdown occurs the orthosis must be removed and the practitioner must be called or consulted. Parents please remember that proper adherence to the care and usage instructions is necessary to reduce potential autherdrious to the barrywth, brain development, and your child's safety and comfort.

PRECAUTIONS: Parents or care giver be advised that if your child has torticollis it should also be treated additionally with the positional plagiocephaly. When receiving cranial orthotic treatment your child's device must be evaluated for fit and function on a preset and regular basis to avoid skin irritation, growth impairment, and assure normal brain development. It is also important to have your device checked or evaluated by your practitioner for structural integrity to reduce the potential to migrate out of place and cause asphyxiation, eye trauma, skin breakdown or prolonged discomfort.

ADVERSE EVENTS: Although your devices soft lining has been tested for long term direct skin contact; skin Irritation can occur when using this device. However most skin irritation can be avoided by strictly following the cleaning, drying, and care and usage instructions.Remember, check your child's skin every 3 to 4 hours.The Orthosis should fit snug, apply gentle pressure, and NOT be overly tight. Please follow the instructions that were provided with your child's CSO device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2007

Cranial Solutions % Kirk A. Lucyk, C.O. 602 Lincoln Ave. Pompton Lakes, New Jersey 07442-1309

Re: K063133/S2

Trade/Device Name: Cranial Solutions Orthosis (CSO) Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: MVA Dated: May 9, 2007 Received: May 14, 2007

Dear Dr. Lucyk:

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. Kirk A. Lucyk, C.O.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 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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#### Indications for Use

510(k) Number (if known): K063133

Device Name: CRANIAL SOLUTIONS ORTHOSIS (CSO)

Indications For Use:

The Cranial Solutions Orthosis is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly,including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and or shape.

Prescription Use
(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)

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| Division of General, Restorative, and Neurological Devices 1 of | |
| 510(k) Number | 1663113 |