MICHIGAN CRANIAL RESHAPING ORTHOSIS

K090341 · Danmar Products, Inc. · MVA · Jan 6, 2010 · Neurology

Device Facts

• Record ID: K090341
• Device Name: MICHIGAN CRANIAL RESHAPING ORTHOSIS
• Applicant: Danmar Products, Inc.
• Product Code: MVA · Neurology
• Decision Date: Jan 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

Device Story

Cranial orthosis (helmet) provides passive pressure to prominent cranial regions to improve symmetry/shape. Input: 3D head scan (via Omega Scanner) or traditional manual plaster cast. Transformation: Orthotist modifies scan file; Danmar uses Omega carver to create positive foam mold; orthosis fabricated with inner hypoallergenic foam and semi-rigid plastic outer shell. Output: Custom-fitted cranial helmet. Used in clinical settings by orthotists; patient wears device to treat plagiocephaly. Benefits: Non-invasive correction of cranial deformities. Manufacturing process updated to include digital scanning/carving, replacing manual plaster mold steps for improved efficiency while maintaining identical clinical function to predicate.

Clinical Evidence

Bench testing only. Biocompatibility data confirms inner lining is non-irritating and nontoxic. Mechanical testing demonstrates device does not break or shatter under impact. No clinical trials performed; equivalence established via technological comparison and performance testing.

Technological Characteristics

Cranial orthosis; inner hypoallergenic foam (1/4" to 1/2" thick), semi-rigid plastic outer shell. 3D shape capture via Class 1 Laser (Omega Scanner). Automated fabrication via Omega Carver. Connectivity: electronic file transfer of scan data. Sterilization: not specified.

Indications for Use

Indicated for infants 3 to 18 months old with moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic and brachycephalic head shapes. Contraindicated for patients with craniosynostosis, scaphocephalic-shaped heads, 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

• Hanger Cranial Band (K072566)
• Boston Band Cranial Remolding Orthosis (K072862)
• Michigan Cranial Helmet (K003630)

Submission Summary (Full Text)

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## Danmar Products, Inc. Michigan Cranial Reshaping Orthosis

October 13, 2009

JAN - 6 2010

The following summary is provided pursuant to Section 513 (I) (3) (A) of the Federal Food Drug and Cosmetic Act:

Submitter Information:

Kay Fuller, RAC VCI, LLC on behalf of Danmar Products, Inc. 221 Jackson Industrial Drive Ann Arbor, MI 48103

| <b>Contact Information:</b> | Kay Fuller, RAC |
|-----------------------------|-----------------|
| | VCI, LLC |
| | 734-274-4680 |

Device Name:

Proprietary Name: Michigan Cranial Reshaping Orthosis

Cranial Reshaping Orthosis

Common Name: Cranial Helmet

Classification Name: Cranial Orthosis

Classification Code:

OAN, Cranial Orthosis, Laser-Scan MVA. Cranial Orthosis 21 CFR §882.5970

Predicate Device Equivalence:

The Danmar Products Michigan Cranial Reshaping Orthosis is substantially equivalent to the Hanger Cranial Band, cleared for US commercialization via K072566 on January 9, 2008, the Boston Band Cranial Remolding Orthosis, cleared for US commercialization via K072862 on January 22, 2008 and the Michigan Cranial Helmet, cleared for US commercialization via K003630, May 29, 2001.

Device Description:

The Danmar Products Michigan Cranial Reshaping Orthosis a cranial orthosis that provides passive pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is fabricated from a positive mold, obtained from traditional manual casting methods or a 3-D scan of the infant's head, with front and rear sections that are comprised of

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an inner, hypoallergenic, soft foam that is ½ " to ¼" thick, and an outer shell made of a, semi-rigid plastic. The Michigan Cranial Reshaping Orthosis is essentially identical to the predicate device known as the Danmar Products Michigan Cranial Helmet, (K003630) with exceptions only to the validated manufacturing improvements noted herein. The new manufacturing methods vield a substantially equivalent device as compared with the Danmar predicate device and manufacturing method.

The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

Comparison of Technological Characteristics:

The Danmar Products Michigan Cranial Reshaping Orthosis device incorporates the same technological characteristics as the legally marketed predicate devices noted in this Premarket Notification submission. The proposed fabrication changes noted in this submission include the addition of a 3-D shape capture method (Omega Scanner) and the Omega Carver. The Omega Scanner is labeled as a Class 1 Laser and therefore it may be utilized by a qualified user without eye protection when utilized under normal operating conditions. The finished subject device technological characteristics and principals of operations remain identical to the Danmar predicate device, noted herein. The following Tables illustrate the finished subject device remains identical to the Danmar predicate device (K003630).

## Intended Use:

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| steps | Predicate Device<br>Manual Process Steps | Subject Device<br>Omega Process Steps | steps |
|-------|------------------------------------------------------------------------------|-----------------------------------------------------------------|-------|
| 1 | Orthotist makes negative mold<br>of baby's head | Orthotist scans baby's head using<br>Orthotist's Omega scanner | 1 |
| | | Scan file modified by Orthotist, as<br>needed for symmetry | 2 |
| 2 | Orthotist sends negative mold to Danmar | Orthotist sends scan file to Danmar<br>electronically | 3 |
| 3 | Danmar makes positive plaster mold | Danmar carves positive foam plastic<br>mold with Omega carver | 4 |
| 4 | Danmar modifies positive plaster mold<br>according to Orthotist instructions | | |
| 5 | Danmar wraps nylon stockinette over<br>plaster mold | Danmar wraps nylon stockinette over<br>foam plastic mold | 5 |
| 6 | Danmar fabricates orthosis according to<br>conventional process | Danmar fabricates orthosis according<br>to conventional process | 6 |

and the comments of the comments of the comments of

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| Comparison<br>Criteria | Subject<br>Device | Predicate<br>Device<br>K003630 | Predicate Device<br>K072862 | Predicate Device<br>K072566 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code<br>Prescription Device | OAN, MVA<br>Yes | OAN<br>Yes | OAN, MVA<br>Yes | OAN, MVA<br>Yes |
| Indications for Use | "The Danmar Products<br>Michigan Cranial<br>Reshaping Orthosis is<br>intended for<br>prescription use to<br>apply pressure to<br>prominent regions of<br>an infant's cranium in<br>order to improve<br>cranial symmetry<br>and/or shape. A mold is<br>made of the baby's<br>head to create the<br>orthotic. A plaster cast<br>or a laser-scanning<br>accessory may be used<br>to create a 3-D scan of<br>the infant's head to<br>create the mold. The<br>device is indicated for<br>infants from 3 to 18<br>months of age, with<br>moderate to severe<br>nonsynostotic<br>positional<br>plagiocephaly,<br>including infants with<br>plagiocephalic and<br>brachycephalic shaped<br>heads." | "The Danmar Products<br>Michigan Cranial<br>Helmet is intended for<br>prescription use to be<br>used to apply pressure<br>to prominent regions of<br>an infant's cranium in<br>order to improve<br>cranial symmetry<br>and/or shape in infants<br>from 3 to 18 months of<br>age, with moderate to<br>severe nonsynostotic<br>positional<br>plagiocephaly,<br>including infants with<br>plagiocephalic - and<br>brachycephalic-shaped<br>heads." | "The Boston Band Cranial Molding<br>Orthosis is intended for medical<br>purposes to passively hold prominent<br>cranial regions of an infant's skull in<br>order to improve cranial symmetry<br>and/or shape in infants from three to<br>eighteen months of age, with<br>nonsynostotic positional plagiocephaly,<br>including infants with plagiocephalic,<br>brachycephalic and scaphocephalic<br>patterned head shapes." | "Intended for medical purposes to apply<br>static or gentle pressure to prominent<br>regions of an infant's cranium to<br>improve cranial symmetry or shape. To<br>treat infants from three to eighteen<br>months of age with moderate to severe<br>non-synostotic positional plagiocephaly,<br>including plagiocephalic,<br>brachycephalic, scaphocephalic-shaped<br>heads." |
| Contraindications | Not for use in<br>patients with<br>craniosynostosis,<br>scaphocephalic-<br>shaped heads;<br>hydrocephalus | Not for use in<br>patients with<br>craniosynostosis,<br>hydrocephalus | Unknown | Unknown |
| Materials /<br>Biocompatibility | Same/similar as<br>Predicates | Hypo-allergenic,<br>non-irritating and<br>nontoxic inner<br>foam lining;<br>semi-rigid plastic<br>outer shell | Hypoallergenic polyethylene<br>foam; thermo-formable<br>plastic | Hypoallergenic<br>polyethylene foam;<br>polypropylene copolymer<br>outer shell |

Summary of Device Evaluation:

The literature on this and similar predicate devices demonstrates that the Danmar Products Michigan Cranial Reshaping Orthosis performs as intended. Biocompatibility data demonstrates that the device's inner lining is non-irritating and nontoxic. The subject device validated fabrication modifications noted herein will yield a finished subject device equivalent to the Danmar predicate device (K003630). Performance testing results demonstrate that the device will not break or shatter when subjected to impact.

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Conclusions:

.

Based on the above information and the information contained in this Premarket Notification, we conclude the Danmar Products Michigan Cranial Reshaping Orthosis is substantially equivalent to the noted legally marketed predicate devices.

:

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Image /page/5/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 or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Validation & Compliance Institute c/o Ms. Kay Fuller, RAC Regulatory Consultant, VCI, LLC 537 Fort Dearborn St. Dearborn, MI 48124

JAN - 62010

Re: K090341

Trade/Device Name: Michigan Cranial Reshaping Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MVA, OAN Dated: December 12, 2009 Received: December 16, 2009

Dear Ms. Fuller:

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 interence 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, Dr to and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, isting 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 additional controls. Existing major regulations affecting your devin (1117) 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 not 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

. th, m

Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K090341

Device Name: Michigan Cranial Reshaping Orthosis

Indications For Use:

The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

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)

Jeffrey Toy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K090341 510(k) Number_