(137 days)
K 011433
Not Found
No
The description focuses on the physical construction and mechanism of action of a cranial orthosis, with no mention of AI or ML technologies.
Yes
The device is used for the treatment of positional plagiocephaly by applying pressure to improve cranial symmetry and shape, which is a therapeutic purpose.
No
Explanation: The device is used for treatment by applying pressure to an infant's cranium to improve cranial symmetry and shape, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical cranial orthosis made of polypropylene and foam, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Providence Molding Helmet is a physical device that is applied externally to the infant's head. It works by applying pressure to reshape the skull. It does not perform any tests on biological samples.
- Intended Use: The intended use is for the physical treatment of a condition (positional plagiocephaly) by applying external pressure, not for diagnosing or monitoring a condition through laboratory testing.
Therefore, based on the provided information, the Providence Molding Helmet is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Providence Molding Helmet is intended for medical purposes to improve cranial symmetry and/or shape. This device is prescribed by a physician to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age.
The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.
Product codes (comma separated list FDA assigned to the subject device)
MVA
Device Description
The Providence Molding Helmet consists of a 5/32 polypropylene outer shell and two (2) layers of 3/16 volara foam inner lining. The helmet is split posteriorly and an elastic Velcro strap is attached to the back of the helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape.
The Providence Molding Helmet is custom designed and custom fitted for each patient from a plaster mold of the infants' head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium, skull
Indicated Patient Age Range
3 to 18 months of age, children from three (3) to eighteen (18) months
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ballert Molding Helmet (K 011433)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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)).
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510(k) Summary of Safety and Effectiveness
Submitter: D. Barry McCoy C.P.O. Northeast Orthotics and Prosthetics Inc. Rhode Island Hospital, 2 Dudley St, Providence, RI 02903 and Custom Composite Mfg. Inc. 170 Macklin St. Cranston, RI 02920
Contact: D. Barry McCoy C.P.O. Telephone (401) 275-2230 Fax 401-275-4901 Date: June 9, 2003
- Classification: Class II I .
- Common or Usual Name: cranial orthosis, cranial band, helmet, Molding helmet II.
- Classification Name: Cranial Orthosis, Code MVA CFR 882.5970 III.
- Predicate Device: Ballert Molding Helmet (K 011433) IV.
- V. Performance Standards: None, Special Controls required
- VI. Description:
- A. The Providence Molding Helmet is a cranial orthosis used to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brachyecephalic-, and scaphocephalic- shaped heads. This device works by applying gentle holding pressure to the prominent regions of the infant's skull while leaving room for growth in the adjacent flattened regions.
- B. The Providence Molding Helmet consists of a 5/32 polypropylene outer shell and two (2) layers of 3/16 volara foam inner lining. The helmet is split posteriorly and an elastic Velcro strap is attached to the back of the helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape.
- C. The Providence Molding Helmet is custom designed and custom fitted for each patient from a plaster mold of the infants' head.
- Labels and Labeling: Labels and instructions for use are provided including VII. precautions, and materials required by the special controls to which this product is subject.
- Indications for Use: The Providence Molding Helmet is intended for medical VIII. purposes to improve cranial symmetry and/or shape. This device is prescribed by a physician to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age.
- IX. Substantial Equivalence: The Providence Molding Helmet is substantially equivalent to the Ballert Molding Helmet (K 011433)
- Clinical Review and Discussion: A review of the literature was provided. X.
- Indications for Use: The Providence Molding Helmet is a cranial orthosis used to XI. treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brach vecephalic -, and scaphocephalic - shaped heads.
- Contraindications for Use: Infants with synostosis, or hydrocephalus. XII.
(End of Summary)
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
D. Barry McCoy, C.P.O. 170 Macklin St. Cranston, Rhode Island 02920
Re: K030669
Trade/Device Name: Providence Molding Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: June 19, 2003 Received: June 13, 2003
Dear Mr. McCoy:
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 - Mr. D. Barry McCoy, C.P.O.
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), 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Millan
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: K030669
Device Name: Providence Molding Helmet
Indications for Use:
The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.
Contradictions for Use: Infants with synostosis or hydrocephalus.
Mark N Milkerso
(Division Sign-Off) Dision of General, Restorative and Neurological Devices
510(k) Number -