(75 days)
No
The device description and performance studies focus on the physical construction and passive mechanism of the cranial molding helmet, with no mention of AI/ML components or data processing.
Yes
The device is described as applying pressure to an infant's cranium to improve cranial symmetry and shape, which is a therapeutic intervention for positional plagiocephaly. Furthermore, the description mentions it being used as a "means of treating" this condition.
No
The device is a cranial molding helmet used to apply pressure to an infant's cranium to improve cranial symmetry and shape; it's a therapeutic device, not one that identifies, diagnoses, or measures a medical condition.
No
The device description clearly outlines a physical helmet that is custom-made from a cast of the infant's head, involving materials like plaster, a hard middle layer, padding, ventilation holes, and a chinstrap. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The O&P Cranial Molding Helmet is a physical device applied externally to the infant's head. It works by applying pressure and guiding bone growth.
- Intended Use: The intended use is to "apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape." This is a mechanical/physical intervention, not a diagnostic test performed on a biological sample.
The device description and intended use clearly indicate that this is a therapeutic device used to physically reshape the skull, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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 plagiocehalic and brachycephalic shaped heads.
Product codes
MVA
Device Description
O&P Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round. The finished helmet has a hard middle layer with a padded inner and outer laver. There are ventilation holes in the top of the helmet is held in place with a chinstrap.
O&P Cranial Molding Helmets work in two ways. The first way is that the helmet fits close to the head where the head sticks out, and loosely over the flattened area. The skull will grow into the loose area of the helmet, allowing the flattened parts of the head to "catch up" with the prominent areas. This type of helmet is known as a "passive" or "Clarren style" helmet. The second way the helmet is effective is by providing a rounded surface for the infant's head to lie on, removing the worry about proper positioning.
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 O&P Cranial Molding Helmet is substantially equivalent to Orthomerica's STARband (K011350). As such, the O&P Cranial Molding Helmet meets the same standards of performance as the STARband and the OPI Band for which the STARband claimed substantial equivalence.
Prior to cranial orthoses being classified and for the last nineteen years, an area hospital department in St. Louis has used O&P Cranial Molding Helmets as an effective and safe means of treating moderate to severe positional plagiocephaly. To date an estimated 4.256 infants have been treated with O&P Cranial Molding Helmets and they are now considered a routine part of the hospital's treatment plan for positional plagiocephaly.
Researchers studying the effects of treatment with cranial orthoses on infants have concluded that the devices are effective in correcting abnormal headshape, with evidence of relapse following treatment. The use of passive or Clarren style helmets dates back to the mid 1970's and their effectiveness is well documented in:
-
- Clarren S. Smith D. Hanson J. Helmet treatment for plagiocephaly and congenital muscular toricollis. Journal of Pediatrics 1979;94:443
- Clarren SK. Plagiocephaly and torticolis: etiology, natural history, and helmet treatment. 2. Journal of Pediatrics 1981:98L92-95
-
- Clarren SK, Smith DW. Congenital deformities. Pediatr Clin North Am 1977;24(4) : 665-667 Persing J. Nichter L. Jane J. Edgerton M. Extenal cranial vault molding after craniofacial surgery. Ann Plast Surgery 1986; 17:274-283
-
- Kane A. Mitchel L. Craven K. Marsh J. Observation on a recent increase in plagiocephaly without synostosis. Pedatrics 1996;97:877-885
The most comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over a span of nearly ten years. Results were recorded at the end of the treatment period and again at 12, 18, and 24 month follow-ups. The study documented complete or near complete correction of asymmetry for a wide variety of head shapes. The details of this study can be found at:
-
- Littlefield TR, Beals SP, Manwaring KH, Pomatto JK, Joganic EF, Golden KA, Ripley CE. Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty. Journal of Craniofacial Surgery. 1988; 11-17.
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
1 2002 ่งปีเป็นเ
Koo ldd l
page 1 of 3
510(K) SUMMARY
The following summary is provided in accordance with C.F.R. section 807.92.
APLICANT INFORMATION A.
-
Submitter: Orthotic & Prosthetic Lab, Inc. 748 Marshall Ave. Webster Groves, MO 63119
Phone (314) 968-8555 Fax (314) 968-0037 -
Contact: 에
피
Thomas L. Malone, Vice President of Administration Phone (314) 968-8555 Fax (314) 968-0037
- 미 Summary Date: April 17, 2002
B. DEVICE NAME AND CLASSIFICAITON
- 트 Common Name: Cranial Molding Helmet
- 에 Classification Name: Cranial Orthosis
- 트 Trade Name: O&P Cranial Molding Helmet
- 피 Class: Class II, Cranial Orthosis, Code MVA, CFR 882.5970
- i Predicate Device: STARband Cranial Orthosis by Orthomerica Products (K011350)
C. DEVICE DESCIPTION
O&P Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up
1
KQ21221
page 2 of 3
and made round. The finished helmet has a hard middle layer with a padded inner and outer laver. There are ventilation holes in the top of the helmet is held in place with a chinstrap.
O&P Cranial Molding Helmets work in two ways. The first way is that the helmet fits close to the head where the head sticks out, and loosely over the flattened area. The skull will grow into the loose area of the helmet, allowing the flattened parts of the head to "catch up" with the prominent areas. This type of helmet is known as a "passive" or "Clarren style" helmet. The second way the helmet is effective is by providing a rounded surface for the infant's head to lie on, removing the worry about proper positioning.
D. INTENDED USE
The O&P Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.
TCHNOLOGICAL CHARACTERISTICS COMPARISON E.
The O&P Cranial Molding Helmet and its predicate device have exactly the same purpose, are made from the same materials and work in exactly the same way. Both the O&P Cranial Molding Helmet and the Orthomerica STARband work by fitting close to the head where the head sticks out, and loosely over the flattened area. The infant's skull will grow into the loose area of the orthosis, allowing the flattened parts of the head to "catch up" with the prominent areas. The second way that both the O&P Molding Helmet and the predicate device work is by insuring that the infant is always lying on a rounded surface, removing the worry about proper positioning.
While the Orthomerica STARband is a "band" and the O&P Cranial Molding Helmet is a "helmet", both devices work on the same principals as describe in the above paragraph and function in the same way. The STARband is secured by means of a side-opening gap that is fastened with a Dacron strap over a bellow. The O&P Cranial Molding Helmet uses a padded Velcro chinstrap to secure the helmet to the infant's head. The use of a chinstrap and helmet combination is well documented and in use by companies already granted premarket approval by the FDA.
F. PERFORMANCE DATA
The O&P Cranial Molding Helmet is substantially equivalent to Orthomerica's STARband (K011350). As such, the O&P Cranial Molding Helmet meets the same standards of performance as the STARband and the OPI Band for which the STARband claimed substantial equivalence.
Prior to cranial orthoses being classified and for the last nineteen years, an area hospital department in St. Louis has used O&P Cranial Molding Helmets as an effective and safe means
2
021221
page 3 of 3
of treating moderate to severe positional plagiocephaly. To date an estimated 4.256 infants have been treated with O&P Cranial Molding Helmets and they are now considered a routine part of the hospital's treatment plan for positional plagiocephaly.
Researchers studying the effects of treatment with cranial orthoses on infants have concluded that the devices are effective in correcting abnormal headshape, with evidence of relapse following treatment. The use of passive or Clarren style helmets dates back to the mid 1970's and their effectiveness is well documented in:
-
- Clarren S. Smith D. Hanson J. Helmet treatment for plagiocephaly and congenital muscular toricollis. Journal of Pediatrics 1979;94:443
- Clarren SK. Plagiocephaly and torticolis: etiology, natural history, and helmet treatment. 2. Journal of Pediatrics 1981:98L92-95
-
- Clarren SK, Smith DW. Congenital deformities. Pediatr Clin North Am 1977;24(4) : 665-667 Persing J. Nichter L. Jane J. Edgerton M. Extenal cranial vault molding after craniofacial surgery. Ann Plast Surgery 1986; 17:274-283
-
- Kane A. Mitchel L. Craven K. Marsh J. Observation on a recent increase in plagiocephaly without synostosis. Pedatrics 1996;97:877-885
The most comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over a span of nearly ten years. Results were recorded at the end of the treatment period and again at 12, 18, and 24 month follow-ups. The study documented complete or near complete correction of asymmetry for a wide variety of head shapes. The details of this study can be found at:
-
- Littlefield TR, Beals SP, Manwaring KH, Pomatto JK, Joganic EF, Golden KA, Ripley CE. Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty. Journal of Craniofacial Surgery. 1988; 11-17.
G. SUMMARY
The safety and effectiveness data submitted to the FDA establishes that the O&P Cranial Molding Helmet is safe and effective for its intended use and is substantially equivalent to applicable predicate devices.
3
Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, creating a sense of depth and unity. The faces are rendered in a simple, abstract manner, and the overall design is clean and professional.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2002
Thomas L. Malone Orthotic & Prosthetic Lab, Inc. 748 Marshal Avenue Webster Grove, Missouri 63119
Re: K021221
Trade/Device Name: 0&P Cranial Molding Helmet Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: April 17, 2002 Received: April 17, 2002
Dear Mr. Malone:
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. Iisting 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.
4
Page 2 - Mr. Thomas L. Malone
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,
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
5
STATEMENT OF INDICATIONS FOR USE
DEVEICE NAME: O&P Cranial Molding Helmet
INDICATIONS FOR USE:
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 plagiocehalic and brachycephalic shaped heads.
Stypt. Church
(Division Sign-Off) Division of General, Restorative and Neurological Devices
长021亿元 1 510(k) Number --