(54 days)
K-964992
No
The description details a process based on photogrammetry and computer-aided manufacturing, with no mention of AI or ML algorithms for image analysis, diagnosis, or treatment planning.
Yes
The device is intended for medical purposes to improve cranial symmetry or shape to treat infants with non-synostotic positional plagiocephaly, which indicates a therapeutic use.
No.
The device (DOC Band) is a cranial orthosis used for treatment (applying pressure to improve cranial symmetry or shape), not for diagnosis. The imaging system mentioned (C3D - Cranial Imaging System) is used to capture a 3D image of the infant's head for the creation of the orthosis, which is a measurement tool for treatment, not a diagnostic tool for identifying a medical condition.
No
The device description clearly details the manufacturing of a physical cranial orthosis (the DOC Band) from a 3D digital model. While software is used in the process (C3D - Cranial Imaging System™, computer aided machining software), the final medical device is a physical product, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, the DOC Band, is a cranial orthosis. It is a physical device applied externally to the infant's head to reshape it. It does not analyze any biological samples from the body.
- Intended Use: The intended use is to apply pressure to the cranium to improve shape and symmetry, treating a physical condition (positional plagiocephaly). This is a mechanical intervention, not a diagnostic test.
The device description clearly outlines a physical orthosis and the process of creating it based on external imaging of the head shape. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / 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.
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.
Product codes
MVA, OAN
Device 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photogrammetry (structured light and triangulated CCD cameras)
Anatomical Site
Cranium/Head
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Under the direct supervision of a carefully trained technician (clinical setting)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
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 480-505-1840.
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
9
1
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.
- 2/2
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)
2
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
3
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 (240) 276-0120 (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 (800) 638-2041 or (240) 276-3150 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
4
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)