(44 days)
No
The description focuses on the physical construction and application of a cranial orthosis, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning. The use of a 3D scan is for creating a physical model, not for AI/ML processing.
Yes
The device is a cranial orthosis designed to improve cranial symmetry and shape in infants with positional plagiocephaly, which is a therapeutic purpose.
No
The Clarren Helmet is described as a cranial orthosis that applies passive pressure to improve cranial symmetry and/or shape, functioning as a treatment device, not for diagnosing conditions.
No
The device description explicitly details physical components like a polypropylene sheet, Plastizote liner, holes, and a Velcro chinstrap, indicating it is a physical medical device, not software-only.
Based on the provided information, the Clarren Helmet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Clarren Helmet Function: The Clarren Helmet is a physical device applied externally to an infant's head. Its purpose is to apply pressure to reshape the skull, not to analyze biological samples.
- Intended Use: The intended use clearly states it's a "cranial orthosis" to improve cranial symmetry and shape. This is a therapeutic/corrective function, not a diagnostic one based on in vitro analysis.
The device description and intended use focus on the physical application and mechanical action of the helmet on the infant's head. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
The Clarren Helmet is a cranial orthosis that applies passive 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.
Product codes
MVA, OAN
Device Description
The Clarren Helmet is a cranial orthosis that applies passive 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. It consists of a polypropylene sheet, three-eights of an inch thick, which is vacuum formed over a plaster model of a baby's head to produce a helmet. A liner for the helmet is made of Plastizote, one-fourth of an inch in thickness. Small holes are bored in the helmet for ventilation and large holes for the child's ears A Velero chinstrap is attached to help keep the helmet in place on the baby's head. It is manufactured from a positive model, obtained via traditional manual casting methods or a three-dimensional scan of the infant's head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium / head
Indicated Patient Age Range
3 to 18 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)
The Clarren Helmet (Orthomerica) – Clarren, Sterling, M.D., "Plagiocephaly and torticollis: Etiology, natural history, and helmet treatment," Journal of Pediatrics, 98:1 (92-95) (Jan. 1981); Clarren, et al., "Helmet treatment for plagiocephaly and congenital muscular torticollis," Journal of Pediatrics, 94:1 (43-46) (Jan. 1979).
The STARscanner – The STARscanner has previously received FDA clearance when used in conjunction with Orthomerica's STARband cranial remolding orthosis (K011350). The performance data demonstrates that the proposed automation of measuring for and carving a positive mold of the patient's head yields more accurate results than the manual process used for the predicate device.
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
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
Clarren Helmet (Orthomerica) and the STARscanner™
Orthomerica Products, Inc.
This 510(k) summary of safety and effectiveness for the Clarren Helmet and STARscanner is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 N. Orange Blossom Trail |
| Orlando, FL 32810 | |
| Contact Person: | Deanna Fish, MS, CPO |
| Clinical Education Manager | |
| (801) 265-1801 (telephone) | |
| (801) 265-1815 (fax) | |
| dfishcpo@aol.com | |
| Preparation Date: | June 2002 |
| Device Trade Name: | Clarren Helmet (Orthomerica) |
| Common Name: | Cranial Orthosis |
| Classification Name: | Cranial Orthosis (see 21 C.F.R. § 882.5970) |
| Product Code: | MVA |
| Device Description: | The Clarren Helmet is a cranial orthosis that applies passive |
| 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. It consists of a polypropylene | |
| sheet, three-eights of an inch thick, which is vacuum formed | |
| over a plaster model of a baby's head to produce a helmet. | |
| A liner for the helmet is made of Plastizote, one-fourth of an | |
| inch in thickness. Small holes are bored in the helmet for ventilation and large holes for the child's ears A Velero | |
| Intended Use: | The Clarren Helmet is a cranial orthosis that applies passive |
| 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. |
chinstrap is attached to help keep the helmet in place on the
baby's head. It is manufactured from a positive model,
obtained via traditional manual casting methods or a three-
dimensional scan of the infant's head. |
| Performance Data: | The Clarren Helmet (Orthomerica) –
Clarren, Sterling, M.D., "Plagiocephaly and torticollis:
Etiology, natural history, and helmet treatment," Journal of
Pediatrics, 98:1 (92-95) (Jan. 1981); Clarren, et al., "Helmet
treatment for plagiocephaly and congenital muscular
torticollis," Journal of Pediatrics, 94:1 (43-46) (Jan. 1979).
The STARscanner –
The STARscanner has previously received FDA clearance
when used in conjunction with Orthomerica's STARband
cranial remolding orthosis (K011350). The performance
data demonstrates that the proposed automation of
measuring for and carving a positive mold of the patient's
head yields more accurate results than the manual process
used for the predicate device. Specific information regarding
the STARscanner is attached at Appendix D. |
| Conclusions: | The Clarren Helmet (Orthomerica) is safe and effective and
identical to the Clarren Helmet (Children's Hospital). FDA
has already reviewed and cleared the Clarren Helmet
(Children's Hospital) based on performance data. FDA has
also approved the use of the STARscanner in the fabrication
of other cranial orthoses. Therefore, use of the scanner to
fabricate the Clarren Helmet (Orthomerica) at Orthomerica's
fabrication facility in Orlando, Florida raises no new issues of
safety and effectiveness.
Based on the foregoing and other information in this
application, Orthomerica Products, Inc. believes that the
performance data provide reasonable assurance of the
safety and effectiveness of the Clarren Helmet (Orthomerica)
for its proposed indications for use. Further, the Clarren
Helmet (Orthomerica) is substantially equivalent to its |
1
2
Clarren Helmet and STARscanner™
claimed predicate, the Clarren Helmet (Children's Hospital) under conditions of intended use.
3
Image /page/3/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 three human profiles facing right, stacked on top of each other. The profiles are connected and appear as a single, flowing shape. Encircling the profile image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
APR 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Deanna Fish Orthomerica Products, Inc. 6333 North Orange Blossom Trail Orlando, FL 32810
Re: K021918
Trade/Device Name: Clarren Helmet (Orthomerica) Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN Dated: June 7, 2002 Received: June 11, 2002
Dear Ms. Fish:
This letter corrects our substantially equivalent letter of July 25, 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
4
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 yours,
Cabare Buchers
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ب
Page
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Indications for Use: The Clarren Helmet is a cranial orthosis that applies passive 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
for Mark N. Millman
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K021918