(330 days)
No
The summary describes a physical cranial orthosis and its manufacturing process, with no mention of AI or ML being used in its function or design.
Yes.
The device's intended use is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape, which directly treats a medical condition (plagiocephaly).
No
Explanation: The device is a cranial orthosis designed to reshape an infant's cranium, not to diagnose a condition. It is used to treat plagiocephaly, which is presumably diagnosed prior to the use of this device.
No
The device description clearly states it is a cranial orthosis fabricated from physical materials (foam and plastic) and applied to the infant's head. While it may utilize a 3-D scan for mold creation, the device itself is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Danmar Products Michigan Cranial Reshaping Orthosis is a physical device that is worn externally on an infant's head. Its purpose is to apply pressure to reshape the skull, not to analyze biological samples.
- Intended Use: The intended use is to "apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape." This is a mechanical/physical intervention, not a diagnostic test performed on a specimen.
The device description and intended use clearly indicate that this is a therapeutic device used externally on the body, not a diagnostic device used to analyze samples.
N/A
Intended Use / 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.
Product codes
MVA, OAN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3-D scan, laser-scanning
Anatomical Site
cranium (infant's head)
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
prescription use, Orthotist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5970 Cranial orthosis.
(a)
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.(b)
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)).
0
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
| Contact Information: | 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
1
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:
2
| steps | Predicate Device
Manual Process Steps | Subject Device
Omega Process Steps | steps |
|-------|------------------------------------------------------------------------------|-----------------------------------------------------------------|-------|
| 1 | Orthotist makes negative mold
of baby's head | Orthotist scans baby's head using
Orthotist's Omega scanner | 1 |
| | | Scan file modified by Orthotist, as
needed for symmetry | 2 |
| 2 | Orthotist sends negative mold to Danmar | Orthotist sends scan file to Danmar
electronically | 3 |
| 3 | Danmar makes positive plaster mold | Danmar carves positive foam plastic
mold with Omega carver | 4 |
| 4 | Danmar modifies positive plaster mold
according to Orthotist instructions | | |
| 5 | Danmar wraps nylon stockinette over
plaster mold | Danmar wraps nylon stockinette over
foam plastic mold | 5 |
| 6 | Danmar fabricates orthosis according to
conventional process | Danmar fabricates orthosis according
to conventional process | 6 |
and the comments of the comments of the comments of
3
| Comparison
Criteria | Subject
Device | Predicate
Device
K003630 | Predicate Device
K072862 | Predicate Device
K072566 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code
Prescription Device | OAN, MVA
Yes | OAN
Yes | OAN, MVA
Yes | OAN, MVA
Yes |
| 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 3-D 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." | "The Danmar Products
Michigan Cranial
Helmet 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 18 months of
age, with moderate to
severe nonsynostotic
positional
plagiocephaly,
including infants with
plagiocephalic - and
brachycephalic-shaped
heads." | "The Boston Band Cranial Molding
Orthosis 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 from three to
eighteen months of age, with
nonsynostotic positional plagiocephaly,
including infants with plagiocephalic,
brachycephalic and scaphocephalic
patterned head shapes." | "Intended for medical purposes to apply
static or gentle 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 | Not for use in
patients with
craniosynostosis,
scaphocephalic-
shaped heads;
hydrocephalus | Not for use in
patients with
craniosynostosis,
hydrocephalus | Unknown | Unknown |
| Materials /
Biocompatibility | Same/similar as
Predicates | Hypo-allergenic,
non-irritating and
nontoxic inner
foam lining;
semi-rigid plastic
outer shell | Hypoallergenic polyethylene
foam; thermo-formable
plastic | Hypoallergenic
polyethylene foam;
polypropylene copolymer
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.
4
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.
6
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 (800) 638-2041 or (240) 276-3150 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_