COPC BAND

K021594 · Center For Orthotic and Prosthetic Care,Llc · MVA · Nov 13, 2003 · Neurology

Device Facts

• Record ID: K021594
• Device Name: COPC BAND
• Applicant: Center For Orthotic and Prosthetic Care,Llc
• Product Code: MVA · Neurology
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The COPC Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants initiating treatment from three to 14 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.

Device Story

COPC Band is a custom-fabricated cranial orthosis for infants with positional plagiocephaly. Device input consists of physical measurements and a plaster mold of the infant's head. Fabrication involves plaster modification techniques to create a custom shell. The orthosis features a thermoformable plastic outer shell, hypoallergenic foam lining, and securing straps. It functions by applying static pressure to prominent cranial regions while providing voids for flattened areas to guide skull growth. Used in clinical settings under practitioner supervision; prescribed by physicians. The device includes a natural corrugated stop in the clamshell design to prevent overtightening. Clinical practitioners monitor fit and alignment. The device benefits patients by passively correcting cranial asymmetry through controlled growth guidance.

Clinical Evidence

No clinical trials were performed. Safety and effectiveness were established through bench testing, including biocompatibility assessments of materials and pressure analysis. Pressure sensor testing on a cranial model demonstrated that the device maintains contact with cranial prominences while avoiding pressure on cranial depressions, confirming performance analogous to the predicate device.

Technological Characteristics

Custom-fabricated cranial orthosis. Materials: thermoformable modified polyethylene outer shell, hypoallergenic foam (aliplast) lining. Energy source: none (passive). Form factor: custom-molded clamshell with two-strap closure system. Includes integrated corrugated stop for pressure regulation. Sterilization: not specified.

Indications for Use

Indicated for infants aged 3 to 14 months with nonsynostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic head shapes, to improve cranial symmetry and 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

• DOC™ Band, Cranial Orthosis (K964992)

Submission Summary (Full Text)

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# NOV 1 3 2003

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

#### Applicant Information A.

- Submitter: Center for Orthotic and Prosthetic Care of KY, LLC. 1010 Clarks Lane, Louisville, KY 40217. Phone: [phone], Fax: [phone], Email: [e-mail]
- Contact: Keith Senn, Bob Havens, Center for Orthotic and Prosthetic Care of K Y, LLC 1010 Clarks Lane, Louisville, KY 40217. Email: copc(@bluegrass.net, Phone: [phone]
- . Summary Date: October 15, 2003

#### Device Name and Classification (K021594) B.

- Proprietary Name: COPC Band
- Common Name: Cranial Orthosis ●
- Classification Name: Cranial Orthosis ●
- Predicate Device: DOC™ Band, Cranial Orthosis, K964992, classified ● under 21 CFR § 882.5970

. . . : "

#### C. Device Description

The COPC Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to 14 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened areas of the skull into the created spaces. The COPC Band is only available through a prescription issued by a physician.

The orthosis is custom designed for each patient from a modified model and measurements of the infant's head. The mold is prepared for fabrication using advanced plaster modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, an inner lining of hypoallergenic foam, and a strap for securing Optimum fit and alignment is insured and monitored by the clinical the orthosis. practitioner.

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#### Intended Use D.

The COPC Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants initiating treatment from three to 14 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.

#### Comparison to Predicate Device E.

The COPC Band and the predicate device are very similar with respect to production, instructions for use, materials, safety and effectiveness, and special controls. The COPC Band combines an outer shell of thermo-formable polymer and hypoallergenic foam lining in an analogous fashion as the predicate device fits the child in a similar fashion as the predicate device, with trim lines terminating over the same points. The primary difference between the proposed and predicate devices is the side closure strap of the orthosis, where the COPC Band incorporates two straps and the DOC Band utilizes a single strap. The COPC Band utilizes modified polyethylene and aliplast as the composite materials, and the DOC Band utilizes copolymer and aliplast as its composite materials. MSDS sheets for these materials confirm that they are safe, non-hazardous, and non-reactive with human skin under normal contact conditions and environments. The material is handled in an identical manner to the polymer used in the predicate device, incorporating all of the safety and standards of practice. The proposed indications of use are analogous to those presented by the predicate device, and biocompatibility, function, and effectiveness further parallel those of the predicate device.

#### F. Performance Data

The safety of the COPC Band is established under standard biocompatibility assessments for each material used. These assessments reveal that the device and the materials used are not expected to adversely affect the infants under the intended conditions of wear, which are analogous to those for the DOC Band. The materials are not reported to cause skin irritation or any toxic effects. Further, the product is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no significant threat to the child during application within the normal scope of its intended use. The COPC Band has incorporated within its clamshell design a natural corrugated stop, which prevents overtightening and harmful pressure upon the infant's skull. This safety feature heightens the COPC Band's safety above that of the predicate device in that the predicate device has no such inherent safeguard. The COPC Band's performance has been demonstrated and compared to the predicate device through an analysis of pressure exerted by the device upon the child's skull. Pressure sensors applied to a cranial model with a COPC Band applied, demonstrates quantifiably that intimate contact exists between the regions of cranial prominences, while no pressure exists in the regions of the cranial depressions as they are positioned over the corrective voids. This data and device performance is directly analogous with the regions of contact between the predicate device and the patient using the device.

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#### G. Summary

The safety and effectiveness data submitted to the FDA establishes that the COPC Band is safe and effective for its intended use and is substantially equivalent to applicable predicate devices.

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Image /page/3/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 eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Center for Orthotic and Prosthetic Care, LLC C/O Joseph Terpenning, CO 2525 North Tenth St., #804 Arlington, Virginia 22201

Re: K021594

Trade/Device Name: COPC Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: undated Received: October 31, 2003

Dear Mr. Terpenning:

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 - Mr. Joseph Terpenning, CO

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark M Millerson

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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510(k) Number (if known);

Device Name: COPC Band

Indications for Use:

## Indications for Use Statement:

The COPC Band is intended for medical purposes to passively hold prominent cranial regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants initiating treatment from three to 14 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

OR

Over the Counter Use

R. Mark A. Milken

(Division Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number K021544