(181 days)
Not Found
No
The description focuses on a passive mechanical device and does not mention any computational or algorithmic components related to AI/ML.
Yes
The device is indicated to improve cranial symmetry in infants with nonsynostotic positional plagiocephaly, which is a medical condition. Its function is to facilitate the correction of an abnormal head shape.
No
Explanation: This device is a passive cranial orthosis used to improve cranial symmetry, which is a treatment rather than a diagnostic function.
No
The device description clearly states that the device is a "passive cranial orthosis" consisting of a physical outer shell, foam liners, and an optional support strap, all of which are physical components.
Based on the provided information, 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 Description: The Craniocephalic Custom Remolding Orthosis (CCRO) is a physical device worn externally on an infant's head. It works by passively guiding cranial growth.
- Intended Use: The intended use is to improve cranial symmetry in infants with positional plagiocephaly. This is a physical intervention, not a diagnostic test performed on a biological sample.
The description clearly indicates a physical orthosis used for treatment/correction of a physical condition, not a diagnostic test.
N/A
Intended Use / Indications for Use
The CCRO is appropriate for improving cranial symmetry in infants from 3 to 18 months. The Craniocephalic Custom Remolding Orthosis (CCRO) is applicable for moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads.
The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.
Product codes (comma separated list FDA assigned to the subject device)
MVA
Device Description
'he CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head.
The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium / infant's head
Indicated Patient Age Range
3 to 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.
LLUMC K023572, Ballert K030669, Clarren K003035
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)).
0
510(k) Summary (I.A.W. 21 CFR 807.87(h)
Applicant Information
| Owner: | Mike Miner
1098 E Mutton Hollow
Kaysville, Utah 84037
(801) 547-0369 |
|--------------------------------|-------------------------------------------------------------------------------|
| Contact: | (As above) |
| Date: | SEP 10 2007 |
| Device Name and Classification | |
| Proprietary name: | Craniocephalic Custom Remolding Orthosis |
| Common name: | Cranial Helmet |
| Classification name: | Cranial Orthosis |
| Predicate Device: | LLUMC K023572, Ballert K030669, Clarren K003035 |
Device Description
'he CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head.
The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.
Intended Use
The CCRO is appropriate for improving cranial symmetry in infants from 3 to 18 months. The Craniocephalic Custom Remolding Orthosis (CCRO) is applicable for moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads.
Comparison to Pediatric Device
The devices are made of the same materials, (all of which are also all widely used in the orthotic industry). The devices are also all fabricated through vacuum forming process, utilize the same csting/impression taking style, the same mold creation and modification regimens, and all function the ame way.
1
With the Craniocephalic Custom Remolding Orthtosis, the multipule liner system allows for increased precision and accuracy in adjustments during the ongoing follow up protocols.
These comparisons are presented in the comparison table found in the executive summary.
Conclusions
In comparison of the CCRO to its counterpart predicates, it is believed that the Craniocephalic Custom Remolding Orthtosis is equivalent if not an enhancement in effectiveness for patient care, and will perform as-well-as, if not better than its helmet counterparts to address treatment of nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, depicted with flowing, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2007
Mr. Mike Miner 1098 East Mutton Hollow Kaysville, UT 84037
Re: K070694
Trade/Device Name: Cranial Custom Remodeling Orthosis (CCRO) Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: June 12, 2007 Received: June 12, 2007
Dear Mr. Miner:
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. 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
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Page 2 - Mr. Mike Miner
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. 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 your
Mark Melkerson 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 Statement
Indications for Use
510(k) Number (if known): _K070694 ___ Device Name: ___Craniocephalic Custom Remolding Orthosis -----------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use:
The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.
Prescription Use required Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use N/A_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
меского полнение поставления по пристеменные пристикам семетрические мести по полнение котории словенности полнение стоимание станиемовника композии местические местиче
DL
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number / K070694