DOC BAND

K014012 · Cranial Technologies, Inc. · OAN · Jan 28, 2002 · Neurology

Device Facts

• Record ID: K014012
• Device Name: DOC BAND
• Applicant: Cranial Technologies, Inc.
• Product Code: OAN · Neurology
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The DOC Band is intended for medical purposes to apply pressure to prominent regions of an infants cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic plagiocephaly, including infants with plagiocephaly-, brachycephalic-, and scaphocephalic-shaped heads. The C3D - Cranial Imaging System™ is used to improve the speed and accuracy of obtaining a 3D positive model of an infants' head.

Device Story

DOC Band is a cranial orthosis for treating nonsynostotic plagiocephaly in infants. Device input: 3D digital model of infant cranium acquired via C3D Cranial Imaging System using structured light and triangulated CCD cameras. System captures 3D head shape (including face/top) in 1/180th second with +/- 0.5 mm accuracy. Digital model sent to manufacturer; positive model created via computer-aided machining software and 5-axis CNC mill. Final orthosis applies gentle holding pressure to prominent skull regions while allowing growth in flattened areas. Used in clinical settings under supervision of trained technician. Output: custom-fitted cranial band. Benefits: improved cranial symmetry and shape. Clinical decision-making: technician monitors fit and progress to adjust treatment.

Clinical Evidence

No new clinical data provided. Safety and effectiveness were established in the original 510(k) (K964992) through clinical discussion and literature references.

Technological Characteristics

Cranial orthosis; custom-molded via 5-axis CNC milling from 3D digital models. Imaging system uses structured light and triangulated CCD cameras (non-laser). Accuracy +/- 0.5 mm. Software-driven manufacturing process.

Indications for Use

Indicated for infants 3-18 months old with moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic head 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

• DOC Band (K964992)
• Orthomerica Products (K011350)

Submission Summary (Full Text)

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KO14012

## JAN 2 8 2002

## XIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)

A. Submitter: Timothy Littlefield, Cranial Technologies Inc., 1395 West Auto Drive, Tempe, AZ 85284; phone [phone].

I. Classification: Class II.

II. Common or usual name: cranial orthosis, cranial band, helmet, molding helmet

III. Proprietary Name: DOC Band

IV. Registration No .: 9027902

V. Classification Name: Cranial Orthosis, Code MVA, CFR 882.5970

VI. Performance standards: None; Special Controls required.

VII. Description: The DOC Band is a cranial orthosis used to treat positional or deformational plagiocephaly in infants from 3 to 18 months of age. The devices works by applying a gentle holding pressure to the prominent regions of an infants' skull while leaving room for growth in the adjacent flattened regions.

The orthosis is made from a three-dimensional (3D) digital model of an infants' cranium acquired with the C3D - Cranial Imaging System™. This system was developed to capture an accurate, 3D image of an infants' head shape. It is based upon the well-established field of photogrammetry, and utilizes structured light and triangulated CCD cameras to digitally reproduce the 3D model. The system uses a noncoherent (i.e. non-laser light) light source, and captures a complete 3D image of the infants' head-shape, including the face and top of the head, in 1/180th of a second with an accuracy of +/- 0.5 mm. During acquisition, a 3D photograph of the child is also captured and precisely laid over the model for confirmation of the patient's identity. The digital model is then sent electronically to Cranial Technologies who creates a positive model using computer aided machining software and a 5-axis CNC mill. The positive model is then used to create the DOC Band, which is fit clinically and monitored as described in K-964992. Because the final fitting of the DOC Band is under the direct supervision of a carefully trained technician, the same safety aspects apply as in the original 510(k).

VIII. Labels and Labeling: Labeling were included in Appendix II of K964992. Competitive labels were supplied in Appendix III of the original 510(k).

IX. Indications for Use: The DOC Band is intended for medical purposes to apply pressure to prominent regions of an infants cranium in order to improve cranial symmetry and/or shape in

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infants from 3 to 18 months of age, with moderate to severe nonsynostotic plagiocephaly, including infants with plagiocephaly-, brachycephalic-, and scaphocephalic-shaped heads. The C3D - Cranial Imaging System™ is used to improve the speed and accuracy of obtaining a 3D positive model of an infants' head.

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X. Substantial Equivalence: The DOC Band is substantially equivalent and virtually identical to the original DOC Band described in K964992, to later products such as K011350 cleared by Orthomerica Products and to other products cleared as substantially equivalent to this pioneering predicate device.

The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.

XI. Clinical Discussion and Literature references and reprints showing the safety and effectiveness of this device when used under the Special Controls prescribed by the FDAwere provided in the original 510(k)-K964992.

(End of Summary)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, each in profile, facing to the right. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right side.

APR 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Cranial Technologies, Inc. % Mr. Timothy R. Littlefield 1395 West Auto Drive Tempe, Arizona 85284

Re: K014012 Trade/Device Name: DOC Band Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN Dated: December 4, 2001 Received: December 5, 2001

Dear Mr. Littlefield:

This letter corrects our substantially equivalent letter of January 28, 2002.

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 (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 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

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## Page 2 - Mr. Timothy R. Littlefield

(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 continue 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] (see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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 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 vours.

Barbara Buehr

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

Enclosure

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XI. Indications for Use: [Separate Page]

510(k) Number: 184 Ke14012

Device Name: DOC Band

Indications for Use:

This device is intended for medical purposes to apply 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 or hydrocephalus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
or
Over-

for Mark N Millken
(Division Sign Off)
Division of Gene al, Restorative
and Neurological Devices
6
Number K014012

Over-The-Counter Use_

(Optional Format 1-2-96)