LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET

K023572 · Rehabilitation Institute,Loma Linda University Med · MVA · Jan 13, 2003 · Neurology

Device Facts

• Record ID: K023572
• Device Name: LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
• Applicant: Rehabilitation Institute,Loma Linda University Med
• Product Code: MVA · Neurology
• Decision Date: Jan 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Cranial Remolding Helmet is a cranial orthosis that is intended for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephally in patients of 3-18 months of age. It is intended to provide gentle pressure over prominent areas of the infant's cranium to slow the growth in these areas in order to improve cranial symmetry and/or shape. The Cranial Remolding Helmet is provided by a Certified Orthotist (CO) solely on the order (prescription) of a licensed physician and fabricated by a Registered Orthotic Technician (RTO).

Device Story

Custom-fabricated cranial orthosis; treats moderate to severe non-synostotic plagiocephaly, brachycephaly, and scaphocephaly in infants (3-18 months). Process: Certified Orthotist (CO) creates negative cast of infant's cranium; Registered Orthotic Technician (RTO) creates positive mold, rectifies shape, and forms helmet over mold. Materials: 1/4" polyethylene foam (Volara) liner; 3/16" polyethylene plastic outer shell. Operation: Helmet provides gentle pressure on prominent cranial areas to restrict growth; voids allow growth in flattened areas. Clinical use: CO fits device; monthly evaluations monitor growth and adjust fit. Benefits: Improves cranial symmetry and shape. Used in clinical settings by orthotic professionals.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Custom-fabricated cranial orthosis. Materials: 3/16" polyethylene plastic outer shell, 1/4" polyethylene foam (Volara) liner. Principle: Passive mechanical pressure via rigid shell and internal voids to direct cranial growth. Form factor: Patient-specific custom mold. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for infants 3-18 months of age with moderate to severe non-synostotic positional plagiocephaly, including brachycephaly and scaphocephaly. Contraindicated for synostosis and hydrocephalus. Prescription use only.

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

• Clarren Helmet (K003035)

Submission Summary (Full Text)

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i(023572

## Section E - 510(k) Summary

JAN 1 3 2003

1. Applicant: Michael J. Davidson, MPH, CPO Rehabilitation Institute, Loma Linda University Medical Center Department of Orthotics and Prosthetics 11406 Loma Linda Drive, Suite 407 Loma Linda, CA 92354 Telephone: [phone] Fax: e-mail: [e-mail]

Submission Correspondent:

Lynn D. Fleisher, PhD, JD Sidley Austin Brown & Wood Bank One Plaza, 10 S. Dearborn Street Chicago, IL 60603 Telephone: [phone] Fax: [phone] e-mail: [e-mail]

- 2. Trade name: LLUMC Cranial Remolding Helmet Common name: Cranial Orthosis Classification: orthosis, cranial 882.5970 MVA
- 3. Predicate Device: Clarren Helmet K003035 MVA
- 4. Description of Device: The LLUMC Cranial Remolding Helmet is a cranial orthosis used to treat children 3-18 months of age for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephally. The LLUMC Cranial Remolding Helmet is fabricated from a cast impression of the infant's cranium, taken by a certified orthotist (CO). The negative cast impression is converted by the CO into a positive impression and rectified into the desired corrected shape. The helmet is then formed over the corrected positive mold by a registered orthotic technician (RTO). A 1/4" polyethylene form (Volara) is used as an interface (liner) material, and 3/16" sheet of polyethylene plastic is used as the outer shell. The helmet is then trimmed by the RTQ, as necessary to not obstruct the infant's vision, hearing, ability to breathe or restrict movement of the head and neck. Ventilation holes are added to reduce heat retention. The CO fits the Cranial Remolding Helmet to the infant. The Cranial Remolding Helmet provides a gentle pressure over the

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prominent areas of the cranium in an effort to slow the growth in these areas. Voids are provided in an effort to encourage growth over the flat areas and reduce deformity. The infant is then evaluated monthly by the CO to monitor growth and insure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the helmet.

- ડ. Intended Use: The Cranial Remolding Helmet is a cranial orthosis that is intended for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephaly in patients of 3-18 months of age. It is intended to provide gentle pressure over prominent areas of the infant's cranium to slow the growth in these areas in order to improve cranial symmetry and/or shape. The Cranial Remolding Helmet is provided by a Certified Orthotist (CO) solely on the order (prescription) of a licensed physician and fabricated by a Registered Orthotic Technician (RTO).
- 6. Technological Characteristics: The LLUMC Cranial Remolding Helmet has the same technological characteristics as the predicate device, the Clarren Helmet, K003035. Both cranial helmets are custom-made to the requirements of each individual infant. The assembly of both helmets begins with creating a negative cast impression of the infant's head, which is converted to a plaster model. The plaster model is then modified so that the cranial helmet will fit snugly over prominent areas to provide gentle pressure, and will have open areas (voids) to encourage growth over the flattened portion of the skull.

Each cranial helmet is formed over the modified plastic mold. Each helmet has a soft foam lining and a rigid thermoplastic shell which controls and directs cranial growth.

- 7. Biocompatibility: Information is provided on the biocompatability of the skin-contacting materials.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single, abstract shape. The text is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2003

Rehabilitation Institute, Loma Linda University Medical Center C/O Lynn D. Fleisher, Ph.D., J.D. Sidley Austin Brown & Wood Bank One Plaza 10 S. Dearborn Street Chicago, Illinois 60603

Re: K023572

Trade/Device Name: Loma Linda University Medical Center (LLUMC) Cranial Remolding Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: October 23, 2002 Received: October 24, 2002

Dear Dr. Fleisher:

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

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## Page 2 - Lynn D. Fleisher, Ph.D., J.D.

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. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely vours,

Mark M Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section D - Statement of Indications for Use

Device Name: LLUMC Cranial Remolding Helmet 510(k) Number: Not known

Indications for use: The LLUMC Cranial Remolding Helmet is a cranial orthosis that is intended for use on infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The device is intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. It is indicated for prescription use.

Contraindications: synostosis and hydrocephalus

for Mark A. Millman

Division Sign-Division of General. Restorative and Neurological Devices

510(k) Number K0235+2