(11 days)
Gillette Children's Specialty Healthcare - CranioCap™
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No
The description focuses on the mechanical function of a cranial orthosis and does not mention any AI/ML components or processes.
Yes
The device is intended to treat a medical condition (positional plagiocephaly) by reshaping the infant's cranium, which is a therapeutic purpose.
No
The device is described as a cranial orthosis intended to apply passive pressure to reshape an infant's cranium, which is a therapeutic function, not a diagnostic one. Its purpose is to correct a condition, not to identify or characterize it.
No
The device description clearly states it is a "lightweight, semi-rigid plastic helmet with a foam lining," indicating it is a physical hardware device, 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.
- Device Function: The Children's Hospital cranial helmet is a physical device applied externally to the infant's head. It works by applying pressure to reshape the skull as the infant grows. It does not analyze any biological samples.
- Intended Use: The intended use is to improve cranial symmetry and shape, not to diagnose a disease or condition through the analysis of biological samples.
Therefore, based on the provided information, this device clearly falls outside the definition and function of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Product codes
MVA
Device Description
The Children's Hospital cranial helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a lightweight, semi-rigid plastic helmet with a foam lining. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other recessed areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
cranium
Indicated Patient Age Range
from three to eighteen months of age
Intended User / Care Setting
Not Found
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)
Information was provided on the biocompatibility of the skin-contacting materials and on the safety and effectiveness of the helmet.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Gillette Children's Specialty Healthcare - CranioCap™
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
K013458
lop-2
510(k) Summary
Submitter
Children's Hospital 8200 Dodge Street Omaha, NE 68114-4113
Telephone: (402) 955-4173 Fax: (402) 955-6030
Date Prepared October 17, 2001
Trade Name None
Common Name Cranial Orthosis
Predicate Device
Gillette Children's Specialty Healthcare - CranioCap™
Device Description
The Children's Hospital cranial helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a lightweight, semi-rigid plastic helmet with a foam lining. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other recessed areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.
Intended Use
The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Technological Characteristics
Each child with deformational plagiocephaly has a unique skull shape and size, with varying areas of the skull affected. Therefore, each cranial helmet is custom-made. The assembly of the cranial helmet begins with creating a negative impression of the head. From this a plaster model of the head is made. The plastic helmet with its foans lining is made using the plaster model, and is designed to fit snugly in some areas and is recessed in others. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.
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K013458
2 OF 2
Summary of Studies
1000 - 1000
:
Summary of Studies
Information was provided on the biocompatibility of the skin-contacting materials and on the safety and effectiveness of the helmet.
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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
OCT 2 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Children's Hospital c/o Ms. Connie Ficklin Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416
Re: K013458
Trade/Device Name: Cranial Helmet Regulation Number: 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: MVA Dated: October 17, 2001 Received: October 18, 2001
Dear Ms. Ficklin:
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.
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Page 2 - Ms. Connie Ficklin
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
l. Male n. Melburn
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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Indications for Use
:
.
:
| 510(k) Number (if known): | K013458 |
|---|---|
| Device Name: | Cranial Helmet |
| Indications for Use: | The Children's Hospital cranial helmet is intended to |
| apply passive pressure to prominent regions of an | |
| infant's cranium in order to improve cranial symmetry | |
| and/or shape in infants from three to eighteen months of | |
| age with moderate to severe non-synostotic positional | |
| plagiocephaly, including infants with plagiocephalic-, | |
| brachycephalic-, and scaphocephalic-shaped heads. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over-The-Counter Use |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K013455 |
|---|---|
| --------------- | --------- |