CRANIAL HELMET

K013458 · Children'S Hospital · MVA · Oct 29, 2001 · Neurology

Device Facts

• Record ID: K013458
• Device Name: CRANIAL HELMET
• Applicant: Children'S Hospital
• Product Code: MVA · Neurology
• Decision Date: Oct 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in 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.

Device Story

Cranial orthosis for treatment of deformational plagiocephaly; custom-made lightweight, semi-rigid plastic helmet with foam lining. Fabrication involves creating negative impression of infant's head, casting plaster model, and forming helmet to fit snugly on prominent areas while providing recessed areas. Device functions by applying passive pressure to prominent regions; as infant's brain grows, skull is reshaped and rounded by growth into recessed areas. Used in clinical setting; prescribed by physician. Benefits patient by correcting cranial asymmetry and shape.

Clinical Evidence

Bench testing only. Information provided on biocompatibility of skin-contacting materials and general safety/effectiveness of the helmet design.

Technological Characteristics

Custom-made cranial orthosis; semi-rigid plastic shell with foam lining. Form factor is patient-specific based on plaster model of infant head. Passive pressure mechanism; no energy source. Non-sterile.

Indications for Use

Indicated for infants 3-18 months old with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic head shapes, to improve cranial symmetry/shape.

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

• Gillette Children's Specialty Healthcare - CranioCap™

Submission Summary (Full Text)

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K013458
lop-2

### 510(k) Summary

#### Submitter

Children's Hospital 8200 Dodge Street Omaha, NE 68114-4113

Telephone: [phone] Fax: [phone]

Date Prepared October 17, 2001

Trade Name None

Common Name Cranial Orthosis

#### Predicate Device

Gillette Children's Specialty Healthcare - CranioCap™

#### Device Description

The Children's Hospital cranial helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a lightweight, semi-rigid plastic helmet with a foam lining. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other recessed areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.

#### Intended Use

The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

#### Technological Characteristics

Each child with deformational plagiocephaly has a unique skull shape and size, with varying areas of the skull affected. Therefore, each cranial helmet is custom-made. The assembly of the cranial helmet begins with creating a negative impression of the head. From this a plaster model of the head is made. The plastic helmet with its foans lining is made using the plaster model, and is designed to fit snugly in some areas and is recessed in others. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.

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K013458
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## Summary of Studies

1000 - 1000

:

Summary of Studies
Information was provided on the biocompatibility of the skin-contacting materials and on the safety and effectiveness of the helmet.

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OCT 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Children's Hospital c/o Ms. Connie Ficklin Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416

Re: K013458

Trade/Device Name: Cranial Helmet Regulation Number: 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: MVA Dated: October 17, 2001 Received: October 18, 2001

Dear Ms. Ficklin:

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 - Ms. Connie Ficklin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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 yours,

l. Male n. Melburn

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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# Indications for Use

:

.

:

| 510(k) Number (if known): | K013458 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Cranial Helmet |
| Indications for Use: | The Children's Hospital cranial helmet is intended to<br>apply passive pressure to prominent regions of an<br>infant's cranium in order to improve cranial symmetry<br>and/or shape in infants from three to eighteen months of<br>age with moderate to severe non-synostotic positional<br>plagiocephaly, including infants with plagiocephalic-,<br>brachycephalic-, and scaphocephalic-shaped heads. |

(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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| Prescription Use | OR Over-The-Counter Use |
|----------------------|-------------------------|
| (Per 21 CFR 801.109) | |

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

| 510(k) Number | K013455 |
|---------------|---------|
|---------------|---------|