CRANIAL HELMET

K041215 · Otto Bock Healthcare LP · MVA · Sep 9, 2004 · Neurology

Device Facts

• Record ID: K041215
• Device Name: CRANIAL HELMET
• Applicant: Otto Bock Healthcare LP
• Product Code: MVA · Neurology
• Decision Date: Sep 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Device Story

Custom-fabricated cranial orthosis; applies pressure to prominent regions of infant cranium to improve symmetry/shape. Input: physical cast of infant head. Fabrication: thermoplastic (Surlyn) shell; polyurethane foam strip for posterior suspension/anti-rotation; Velcro strap fastening. Used in clinical setting; fitted by orthotist under physician supervision. Output: physical helmet. Benefit: correction of cranial deformities in infants. No software or electronic components.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical materials, design, and intended use to the predicate device.

Technological Characteristics

Materials: Surlyn (1/8 to 3/8 inch thickness), polyurethane foam, silicone, Velcro. Custom-fabricated via head cast. No electronic components, energy sources, or software. Mechanical device.

Indications for Use

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

• Fit Well's P.A.P. Orthosis (K012804)

Submission Summary (Full Text)

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K04215

Otto Bock®

SEP - 9 2004

**QUALITY FOR LIFE**

# 510(k) SUMMARY of SAFETY and EFFECTIVENESS

## A. General Information

| 1. Submitter's Name: | OTTO BOCK HealthCare LP |
|-------------------------|--------------------------------------------------------------|
| 2. Address: | Two Carlson Parkway N., Suite 100 Minneapolis, MN 55447-4467 |
| 3. Telephone: | 763-489-5153 |
| 4. Contact Person: | Shelley Stockman |
| 5. Date Prepared: | September 4, 2004 |
| 6. Registration Number: | 2182293 |

B. Device#### 1. Name: Cranial Helmet 2. Trade Name: Cranial Helmet Cranial Orthosis 3. Common Name: Classification Name: Cranial Orthosis 4. 5. Product Code: MVA 6. Class: II 7. Regulation Number: 882.5970

North American Headquarters: Two Corlson Porkway N., Suite 100 • Plynouth, MN 55447 • B00.655.4963 Customer Support & Distribution Center: 14630 28th Avenue N. • Plymouth, MN 3547 • 800.320.400 • Fux 800.902.2549 Fabrication Services: 14800 28th Avenue N., Suite 110 . Plymouth, MN 55447 . 800.795.8846 . Fox 800.810.10.10. Utah Design & Manufacturing Center: 3820 W. Great Lokes Drive • Salı Lake City, UT 84120 • 801.956.2400 Minnesota Deslgn & Manufacturing Center: 820 Sundial Drive • Woite Park, MN 56387 • 800.377.0336 • Fax [phone] Customer Satisfaction Hatline: 877,627.6563 · www.ottobockus.com

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### C. Identification of Legally Marketed Devices

| 1. Name: | Fit Well's P.A.P. Orthosis |
|------------------|----------------------------|
| 2. K Number: | K012804 |
| 3. Date Cleared: | January 17, 2002 |

## D. Description of the Device

The Cranial Helmet is a cranial orthosis custom fabricated to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry and shape.

The Cranial Helmet is comprised of the same materials as the P.A.P. Orthosis (K012804). It is not packaged for sale, as it is custom fabricated. It will be fitted to the infant at the time of delivery. The Cranial Helmet has no accessories, and no options are available for the infant or the caregiver (parent).

Caregivers are instructed as to: wear, care, cautions, and risks.

The transparent thermoplastic is Surlyn which varies in thickness from 1/8 inch to 3/8 inch depending upon the desired characteristics. The helmet is fabricated from a cast taken of an infant's head. There are no standard sizes, models, variances, etc.

A polyurethane foam strip is applied to the posterior border at the base of the occipital to provide suspension and anti-rotation. Each Cranial Helmet is fastened with a Velcro strap.

Each infant with a Cranial Helmet must be under the care of a physician. The helmet is a Prescription Device.

### E. Intended Use Statement

The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

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# F. Technological Characteristics Summary

Similarities between both Cranial Orthosis' are the following

- Identical Indications for Use .
- . Same Materials (Surlyn, Polyurethane, Silicone and Velcro)
- . : Custom Fabrication
- Function Same ●
- Purpose Same �
- . Shape
- Diagnosis .
- Prescription Devices .
- Follow FDA Special Controls

Differences are the P.A.P. is fabricated by Fit-Well Prosthetic and Orthotic Center in Salt Lake City, Utah and the OTTO BOCK Cranial Helmet is fabricated at our technical center in Minneapolis, Minnesota.

### REVISION: 09/04/2004

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three horizontal lines that curve upwards, resembling a stylized human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2004

OTTO Bock HealthCare LP c/o Mr. William Jackson W.F. Jackson Associates, Limited 2247 Jennifer Lane St. Paul, Minnesota 55109-2851

Re: K041215

Trade/Device Name: Cranial Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: Class II Product Code: MVA Dated: August 6, 2004 Received: August 17, 2004

Dear Mr. Jackson:

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 erth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic reral in also qualisy of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. William Jackson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your of substantial equivalence of your device to a legally premated 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 if you tother 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 other general miletimational 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,

Mark A. Wilkinson

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 : K04215

Device Name: Cranial Helmet

#### Indications for Use:

- . Prescription Device
- The Cranial Helmet (cranial orthosis) is a device that is intended for medical . purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eightenn months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
- Contraindications: Infants with Synostosis or Hydroccphalus .

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)

Mark A. Milken

(Division Sign-G Division of General, Restorative, and Neurological Devices

510(k) Number.

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