DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

K013452 · Danmar Products, Inc. · MVA · Oct 31, 2003 · Neurology

Device Facts

• Record ID: K013452
• Device Name: DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
• Applicant: Danmar Products, Inc.
• Product Code: MVA · Neurology
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Danmar Products Cranial Adjustive Prosthesis is intended for prescription use to be used 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 14 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.

Device Story

Cranial orthosis designed to apply pressure to prominent regions of an infant's cranium; improves cranial symmetry and shape. Device consists of front and rear sections; inner soft foam lining; outer semi-rigid plastic shell. Used by infants 3 to 14 months of age under prescription. Clinical benefit derived from corrective pressure application to address nonsynostotic positional plagiocephaly.

Clinical Evidence

No clinical data provided. Evidence based on literature review of similar devices, biocompatibility testing (nonirritating/nontoxic), and bench testing for structural integrity (impact resistance).

Technological Characteristics

Cranial orthosis; front and rear sections; inner soft foam (1/8" to 1/4" thick); outer semi-rigid plastic shell. Passive mechanical device.

Indications for Use

Indicated for infants 3 to 14 months of age with moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic- and brachycephalic-shaped heads, to improve cranial symmetry and/or 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

• Cranial Technologies Dynamic Orthotic Cranioplasty--DOC Band
• Michigan Cranial Helmet (K003630)

Submission Summary (Full Text)

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SPORTS/ME EQUIPMENT

# DANMAR PRODUCTS, INC.

221 Jackson Industrial Drive • Ann Arbor, MI. 48103 • USA

KO13452

OCT 3 1 2003

510(k) SUMMARY

Danmar Products, Inc. Cranial Adjustive Prosthesis

October 17, 2001

# Submitter Information:

Danmar Products, Inc. 221 Jackson Industrial Drive Ann Arbor, MI 48103

| Submitter's Name: | Karen A. Lindner |
|-------------------|------------------|
| Phone: | 734-761-1990 |

# Device Narne:

| Proprietary Name: | Cranial Adjustive Prosthesis |
|----------------------|------------------------------|
| Common Name: | Cranial Band or Helmet |
| Classification Name: | Cranial Orthosis |

# Predicate Device Equivalence:

Substantial equivalence is claimed to the Cranial Technologies Dynamic Orthotic Cranioplasty--DOC Band, cleared for commercial distribution through the approved evaluation of an automatic Class III designation, and to the Michigan Cranial Helmet cleared for commercial distribution per K003630.

# [phone] Device Description:

[phone]

The Danmar Products Cranial Adjustive Prosthesis is constructed with front and rear Fax sections that are comprised of an inner, soft foam that is %" to ¼" thick, and an outer [phone] shell made of a semi-rigid plastic.

e-mail: [e-mail]

Internet: http://www. danmarproducts.com

• Creating Specialized Products for Special Needs Since 1968 •

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Image /page/1/Picture/0 description: The image is a black and white drawing of a feather. The feather is curved and has a pointed tip. There are several barbs coming out of the feather's shaft. The barbs are also curved and pointed.

PORTS / MI EQUIPMENT

Image /page/1/Picture/19 description: The image shows a black and white drawing of a hand. The hand is drawn in a simple, cartoonish style, with thick black lines outlining the shape of the hand and fingers. The hand is curved, with the fingers pointing upwards and the thumb pointing downwards. The hand appears to be reaching out or gesturing.

DANMAR PRODUCTS, INC.

221 Jackson Industrial Drive • Ann Arbor, MI. 48103 • USA

#### Intended Use:

The Danmar Products Cranial Adjustive Prosthesis is intended for prescription use to be used to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry andlor shape in infants from 3 to 14 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 Cranial Adjustive Prosthesis has the same technological characteristics as the predicate devices.

# Summary of Device Evaluation:

The literature on this and similar devices demonstrates that the Danmar Products Cranial Adjustive Prosthesis performs as intended. Biocompatibility data demonstrates that the device's inner lining is nonirritating and nontoxic. Test data demonstrates that the device will not break or shatter when subjected to impact.

# Conclusions:

Based on the above, we concluded that the Danmar Products Cranial Adjustive Prosthesis is substantially equivalent to a legally marketed predicate device and is safe and effective for its intended use.

[phone]

[phone]

Fax [phone]

e-mail: [e-mail]

Internet: http://www. danmarproducts.com

· Creating Specialized Products for Special Needs Since 1968 ·

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2003

Karen A. Lindner, C.E.O. Danmar Products, Inc. 221 Jackson Industrial Dr. Ann Arbor, MI 48103

Re: K013452

Trade/Device Name: Cranial Adjustive Prothesis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: October 15, 2003 Received: October 17, 2003

Dear Ms. Linder:

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

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Page 2 - Ms. Karen A. Linder, C.E.O.

forth in the quality systems (OS) 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 yours.

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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SPORTS/ME EQUIPMENT

221 Jackson Industrial Drive • Ann Arbor, MI. 48103 • US

DANMAR PRODUCTS, IN

Image /page/4/Picture/3 description: The image is a black and white line drawing of a stylized feather. The feather curves from left to right, with the tip of the feather on the right side. There are four curved lines on the left side of the feather, which are meant to represent the barbs of the feather.

Device Name:

Danmar Products Cranial Adjustive Prosthesis

#### INDICATIONS FOR USE:

The Danmar. Products Cranial Adjustive Prosthesis is intended for prescription use to be used to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry andlor shape in infants from 3 to 14 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.

Mark n Milkern

Estorative

Number K013452

[phone]

[phone]

Fax [phone]

e-mail: [e-mail]

Internet: http://www. danmarproducts.com