HANGER CRANIAL BAND

K072566 · Hanger Prosthetics & Orthotics, Inc. · OAN · Jan 9, 2008 · Neurology

Device Facts

• Record ID: K072566
• Device Name: HANGER CRANIAL BAND
• Applicant: Hanger Prosthetics & Orthotics, Inc.
• Product Code: OAN · Neurology
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Device Story

Hanger Cranial Band is a custom-fabricated thermoplastic helmet (polypropylene/polyethylene copolymer shell with polyethylene foam lining) used to treat infant cranial deformities. Device uses hand-held 3D laser scanner to capture infant head measurements; digital files processed via CAD/CAM software to design orthosis. Modifications include relief areas for cranial bossing, circumference adjustments for growth, and rotational corrections. Modified digital files sent to central facility for carving of positive model and fabrication of definitive orthosis. Practitioner fits device to patient. Device applies static/gentle pressure to prominent cranial regions to improve symmetry/shape. Digital records of scans and modifications maintained for each patient.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Thermoplastic helmet; USP Class VI materials; polypropylene or polypropylene-polyethylene copolymer outer shell; medium density polyethylene foam inner lining. Custom-fabricated via 3D laser scanning and CAD/CAM software. No change to fundamental scientific technology.

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

• Cranial Technologies the Doc Band (K014012)

Submission Summary (Full Text)

{0}------------------------------------------------

K072566 pg 1 of 5

## 510(k) Summary

The following summary is provided in pursuant to Section 513 of the Federal Food, Drug and Cosmetic Act.

## 1. DATE PREPARED

December 27, 2007

# 2. APPLICANT INFORMATION

Hanger Prosthetics & Orthotics, Inc. 2 Bethesda Metro Center Bethesda, MD 20814

JAN - 9 2008

Contact Person:

Kaia Busch C.P.O.

(206). 923.0476 (telephone) (206).923.0366 (facsimile)

Outside Regulatory Counsel:

Ivan J. Wasserman Manatt, Phelps, & Phillips, LLP 700 12th Street, NW Suite 1100 Washington, D.C. 20005 Tel. [phone]

#### 3. DEVICE NAME

Proprietary Name:

Hanger Cranial Band™

Common/Usual Name:

Cranial Orthosis

Classification Names and numbers:

Cranial Orthosis, laser scan, OAN Cranial Orthosis, MVA 21 CFR § 882.5970

{1}------------------------------------------------

# 4. DEVICE DESCRIPTION AND INTENDED USE

The Hanger Cranial Band™ is a thermoplastic helmet prepared with USP Class VI materials; a polypropylene or polypropylene-polyethylene copolymer outer shell. The Hanger Cranial Band™ was initially cleared on December 8, 2000, under 510(k) K001669. This submission provides for the use of a hand held 3-dimensional laser scanner to acquire accurate measurements and a CAD/CAM system to fabricate the orthosis.

A medium density polyethylene foam inner lining is thermo-bonded to this shell. The device is custom fabricated for individual patients by obtaining accurate measurements via a hand held 3-dimensional laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The addition of digital imaging allows for increased clinical accuracy and objective clinical documentation. The scan is then modified utilizing a CAD/CAM technology package. The 3-dimensional cranial scan is modified utilizing computer aided design tools to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial band/orthosis. Modifications include but are not limited to: relief areas opposite of cranial bossing, circumference modifications for growth and remolding, suspension, and rotational modifications. The modified file is then emailed to the central manufacturing facility for fabrication and delivery. The modified file measurements are validated and a positive model carved for fabrication.

{2}------------------------------------------------

K072566 pg 3 of 5

The carved model is evaluated for clinical accuracy and used to fabricate the definitive orthosis. The definitive Hanger Cranial Orthosis is processed through a quality control check list to ensure clinical accuracy, appropriate fabrication techniques, and quality assurance. The Hanger Cranial Band is sent to the practitioner for patient fit and delivery. A digital record of each patient scan and modifications will be maintained on file at Hanger for each patient.

## Indications for Use:

Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

### Contraindications for Use:

Infants with synostosis and or hydrocephalus

#### 5. PREDICATE DEVICE

- K014012 (Cranial Technologies the Doc Band) പ.
- b. Substantial Equivalence Comparison

Hanger's device is custom fabricated for individual patients by obtaining accurate measurements via a hand held 3-dimensional laser scanner.

{3}------------------------------------------------

K072566 pg 4 of 5

Clinical measurements of the infant's cranium are taken from the digital file. The addition of digital imaging allows for increased clinical accuracy and objective clinical documentation. The scan is then modified utilizing a CAD/CAM technology package. The 3-dimensional cranial scan is modified utilizing computer aided design tools to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial band/orthosis. Modifications include but are not limited to: relief areas opposite of cranial bossing, circumference modifications for growth and remolding, suspension, and rotational modifications. The modified file is then emailed to the central manufacturing facility for fabrication and delivery. The modified file measurements are validated and a positive model carved for fabrication. The carved model is evaluated for clinical accuracy and used to fabricate the definitive orthosis. The definitive Hanger Cranial Orthosis is processed through a quality control check list to ensure clinical accuracy, appropriate fabrication techniques, and quality assurance. The Hanger Cranial Band is sent to the practitioner for patient fit and delivery. A digital record of each patient scan and modifications will be maintained on file at Hanger for each patient.

Cranial Technologies uses a different system, the C3D Cranial Imaging System to obtain patient head shape measurements and a different CAD/CAM System to create a model used in fabricating the device.

{4}------------------------------------------------

KU7A566 pg 5 of 5

#### PERFORMANCE CHARACTERISTIC SUMMARY 6.

There has been no change to the performance characteristics of the device system.

#### TECHNOLOGICAL CHARACTERISTICS 7.

·

There has been no change to the fundamental scientific technology.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a distinctive design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation. The logo is presented in black and white.

Public Health Service

JAN - 9 2008

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Manatt, Phelps & Phillips % Mr. Ivan J. Wasserman 700 12th Street. NW Washington, DC 20005

K072566 Re: Trade/Device Name: Hanger Cranial Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: January 3, 2008 Received: January 3, 2008

Dear Mr. Wasserman:

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.

{6}------------------------------------------------

Page 2 - Mr. Ivan J. Wasserman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely vours,

Mark N Mulkersan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

# Indications for Use

510(k) Number (if known): K072566

Device Name: Hanger Cranial BandTM

Indications for Use:

Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

× Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Number.

AND/OR

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

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

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices