(89 days)
Not Found
No
The summary describes a physical orthotic device that applies passive pressure and does not mention any computational or algorithmic components indicative of AI/ML.
Yes
The device is intended to improve cranial symmetry and/or shape in infants, which is a therapeutic purpose.
No
The device is described as an orthotic molding helmet intended to improve cranial symmetry and/or shape in infants with non-synostotic positional plagiocephaly by applying passive pressure. Its function is to reshape the skull as the brain grows, which is a treatment (therapeutic) function, not a diagnostic one.
No
The device description clearly describes a physical helmet made of foam and rigid plastic, indicating it is a 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 Precision Prosthetics and Orthotics, Inc. orthotic molding helmet is a physical device applied externally to an infant's head. It works by applying pressure to reshape the skull as the infant grows.
- Lack of Biological Sample Analysis: The device does not involve the analysis of any biological samples from the patient.
Therefore, based on the provided information, this device clearly falls outside the definition of an In Vitro Diagnostic. It is a therapeutic device used for physical intervention.
N/A
Intended Use / Indications for Use
The Precision Prosthetics and Orthotics, Inc. orthotic molding 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 synnned your er enappositional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Product codes
MV A
Device Description
The Precision Prosthetic and Orthotics, Inc. orthotic molding helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a foam-lined, lightweight, bivalve rigid plastic helmet with the anterior section overlapping the posterior section. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other open areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the open areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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)
Dynamic Orthotic Cranioplasty - DOC Band® Document Control No K964992
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
FEB 0 5 2002
510(k) Summary
KOI3700
Submitter
Precision Prosthetics and Orthotics, Inc. 9937 Lin-Ferry Dr. St. Louis, MO 63123
Telephone: 314-361-7800 Fax: 314-361-7888
Date Prepared November 7, 2001
Trade Name None
Common Name Cranial Orthosis
Predicate Device
Dynamic Orthotic Cranioplasty - DOC Band® Document Control No K964992
Device Description
The Precision Prosthetic and Orthotics, Inc. orthotic molding helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a foam-lined, lightweight, bivalve rigid plastic helmet with the anterior section overlapping the posterior section. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other open areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the open areas.
Intended Use
The Precision Prosthetics and Orthotics, Inc. orthotic molding 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 synnned your er enappositional 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 varying arous of the cranial helmet begins with creating a negative impression of the head. From this a plaster model of the head is made. The plaster model is modified so that the helmet will fit snugly in some areas, but will have open areas for the flattened portion of the skull to grow into. The helmet is made using the modified plaster model. The orthotic molding helmet has a foam lining and a rigid plastic outer shell, which controls
1
and directs cranial growth. As the child's brain grows, greater symmetry is achieved as the skull is slowly reshaped by growing into the open areas of the helmet.
Summary of Studies
Information was provided on the biocompatibility of the skin-contacting materials and on the safety and effectiveness of the helmet.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird in flight, with its wings and tail feathers represented by curved lines. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2002
Precision Prosthetics and Orthotics, Inc. C/O Connie Ficklin Regulatory Associate Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334
Re: K013700
Trade/Device Name: Precision Prosthetics and Orthotics, Inc Orthotic Molding Helmet Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: November 7, 2001 Received: November 8, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 promated 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,
Sincerely yours,
O Mark n Mullinss
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): K013700
Device Name:
Orthotic Molding Helmet
Indications for Use:
The Precision Prosthetics and Orthotics, Inc. orthotic molding 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 scaphocephalicshaped heads.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
A
Over-The-Counter Use
Mark N Milkern
013700
Division Sign-O . estorative Division of Gene and Neurological _ stices
510( Number