CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)

K070694 · Mike Miner · MVA · Sep 10, 2007 · Neurology

Device Facts

• Record ID: K070694
• Device Name: CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
• Applicant: Mike Miner
• Product Code: MVA · Neurology
• Decision Date: Sep 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.

Device Story

Passive cranial orthosis; treats nonsynostotic positional plagiocephaly in infants 3-18 months. Device consists of vacuum-formed polypropylene, copolymer, or polyethylene outer shell with multiple inner polypropylene foam liners and optional support strap. Custom-fabricated using impression of infant's head to create positive mold. Orthosis provides contact areas to guide cranial growth, allowing head to fill in and achieve symmetry. Used in clinical setting; managed by orthotic professionals. Follow-up protocols involve adjusting liner system to maintain precision during growth. Benefits include improved cranial symmetry through natural growth guidance.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, material composition, and established clinical use of similar cranial orthoses.

Technological Characteristics

Passive cranial orthosis; vacuum-formed polypropylene, copolymer, or polyethylene shell; multiple inner polypropylene foam liners; custom-molded to patient anatomy; non-powered; mechanical guidance of cranial growth.

Indications for Use

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

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

• LLUMC (K023572)
• Ballert (K030669)
• Clarren (K003035)

Submission Summary (Full Text)

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

K070694

# 510(k) Summary (I.A.W. 21 CFR 807.87(h)

# Applicant Information

| Owner: | Mike Miner<br>1098 E Mutton Hollow<br>Kaysville, Utah 84037<br>[phone] |
|--------------------------------|-------------------------------------------------------------------------------|
| Contact: | (As above) |
| Date: | SEP 10 2007 |
| Device Name and Classification | |
| Proprietary name: | Craniocephalic Custom Remolding Orthosis |
| Common name: | Cranial Helmet |
| Classification name: | Cranial Orthosis |
| Predicate Device: | LLUMC k023572, Ballert k030669, Clarren k003035 |

## Device Description

'he CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head.

The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.

#### Intended Use

The CCRO is appropriate for improving cranial symmetry in infants from 3 to 18 months. The Craniocephalic Custom Remolding Orthosis (CCRO) is applicable for moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads.

#### Comparison to Pediatric Device

The devices are made of the same materials, (all of which are also all widely used in the orthotic industry). The devices are also all fabricated through vacuum forming process, utilize the same csting/impression taking style, the same mold creation and modification regimens, and all function the ame way.

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

With the Craniocephalic Custom Remolding Orthtosis, the multipule liner system allows for increased precision and accuracy in adjustments during the ongoing follow up protocols.

These comparisons are presented in the comparison table found in the executive summary.

## Conclusions

In comparison of the CCRO to its counterpart predicates, it is believed that the Craniocephalic Custom Remolding Orthtosis is equivalent if not an enhancement in effectiveness for patient care, and will perform as-well-as, if not better than its helmet counterparts to address treatment of nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, depicted with flowing, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2007

Mr. Mike Miner 1098 East Mutton Hollow Kaysville, UT 84037

Re: K070694

Trade/Device Name: Cranial Custom Remodeling Orthosis (CCRO) Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: June 12, 2007 Received: June 12, 2007

Dear Mr. Miner:

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. 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

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

Page 2 - Mr. Mike Miner

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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. 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 your

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

Enclosure

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

Indications for Use Statement

# Indications for Use

510(k) Number (if known): _K070694 ___ Device Name: ___Craniocephalic Custom Remolding Orthosis -----------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use:

The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.

Prescription Use required Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

меского полнение поставления по пристеменные пристикам семетрические мести по полнение котории словенности полнение стоимание станиемовника композии местические местиче

DL
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** / K070694