(56 days)
Not Found
No
The device description details a passive cranial orthosis (helmet) fabricated from standard materials based on a physical mold of the infant's skull. There is no mention of any computational analysis, algorithms, or learning processes involved in the device's function or design beyond the physical molding process.
Yes
The device is described as "intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly." This explicitly states a medical purpose to improve a medical condition, which aligns with the definition of a therapeutic device.
No.
The device is described as a cranial orthosis helmet intended to improve cranial symmetry in infants, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details the physical components of the device, including a helmet, outer shell, inner liner, chinstrap, and air holes, indicating it is a hardware-based medical device.
Based on the provided information, the Cranial Symmetry System 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 about a person's health.
- Cranial Symmetry System Function: The description clearly states that the Cranial Symmetry System is a physical device (a helmet) that provides passive pressure to the infant's skull to improve cranial symmetry. It interacts directly with the body externally.
- No Specimen Analysis: There is no mention of analyzing any biological specimens from the infant.
Therefore, the Cranial Symmetry System falls under the category of a medical device that is applied externally to the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.
The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.
The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109
Product codes (comma separated list FDA assigned to the subject device)
MVA
Device Description
The Cranial Symmetry System provides passive pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths inch Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium / infants' skull
Indicated Patient Age Range
three to eighteen months of age / 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)
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). Conclusions: Based on the foregoing and all information included in this 510(k) application, Beverly Hills Prosthetics Orthotics, Inc. believes that the performance data provides reasonable assurance of the safety and effectiveness of the Cranial Symmetry System for its proposed indications for use. Further, the Cranial Symmetry System is substantially equivalent to its claimed predicate device under the conditions of intended use.
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.
Clarren Helmet, 510(k) number 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
Beverly Fills Prosthetics Orthotics, Inc.
9 2002 SEP
6300 Wilshire Boulevard, Suite 150 Los Angeles, CA 90048 (323) 866-2555 Fax (323) 866-2560
K022273 510(k) Number:
15230 Burbank Boulevard, Suite 103 Van Nuys, CA 91411 (818) 988-0033 Fax (818) 988-7219
510(k) SUMMARY (as required by section 807.92(c)) CRANIAL SYMMETRY SYSTEM
BEVERLY HILLS PROSTHETICS ORTHOTICS, INC.
This 510(k) summary of safety and effectiveness for the Cranial Symmetry System helmet is submitted in accordance with requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
- Applicant: Beverly Hills Prosthetics Orthotic
- 6300 Wilshire Blvd., Suite 150 Address: Los Angeles, CA 90048
Keith E. Vinnecour, President, C.P.O. Contact Person:
Telephone: 323-866-2555 (telephone) 323-866-2560 (facsimile)
March 21, 2002 Preparation date:
- Cranial Symmetry System Device Trade Name:
- Common Name: Cranial Orthosis
Classification Name: Cranial Orthosis (see C.F.R. 882.5970)
MVA Product Code:
1
Predicate Device: Clarren Helmet, 510(k) number K003035 Beverly Hills Prosthetics Orthotics, Inc. is claiming substantial equivalence with Cranial Symmetry System to the legally marketed device Clarren Helmet (K003035) per 807.92(a)(3).
The Cranial Symmetry System provides passive Device Description: pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths inch Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.
Intended Use: The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.
2
Indications For Use:
The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109
The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with plagiocephalic and brachycephalic shaped heads.
Technological Characteristics
Compared to Predicate Device: The Cranial Symmetry System and the predicate device (The Clarren Helmet) are both classified as cranial orthosis (21CFR882.5970). The Cranial Symmetry System uses a 3/16" thickness polypropylene and the Clarren Helmet uses a 3/8" thickness polypropylene. The padded lining in the Cranial Symmetry System helmet is a 3/16" thickness Aliplast and the Clarren Helmet uses a 1/4" thick Plastizote. Both are closed cell copolymer foams. Both helmets are custom fabricated by vacuum forming the materials over the modified cast mold of the infant's skull. There are cutouts for the ears in bot designs, as well as air holes for ventilation. Helmet therapy was introduced to Beverly Hills Prosthetics Orthotics, Inc. by Sterling Clarren M.D. and therefore the methodology and technique for measurements and casting gleaned is still used in practice today.
3
Performance Data: 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). Conclusions: Based on the foregoing and all information included in this 510(k) application, Beverly Hills Prosthetics Orthotics, Inc. believes that the performance data provides reasonable assurance of the safety and effectiveness of the Cranial Symmetry System for its proposed indications for use. Further, the Cranial Symmetry System is substantially equivalent to its claimed predicate device under the conditions of intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are rendered in black and have a flowing, abstract design. Encircling the profile graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 9 2002
Keith E. Vinnecour, President, C.P.O. Beverly Hills Prosthetics Orthotics, Inc. 6300 Wilshire Blvd., Suite 150 Los Angeles, California 90048
Re: K022273
Trade/Device Name: Cranial Symmetry System Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: July 11, 2002 Received: July 25, 2002
Dear Mr. Vinnecour:
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. Ilsting 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.
5
Page 2 - Mr. Keith E. Vinnecour
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,
Stipt Rwdrs
Dr. Colin McWee Ph.D., M.P.
a 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
6
510(k)Number: K022273
INDICATIONS FOR USE OF THE CRANIAL SYMMETRY SYSTEM HELMET
11.000
The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.
The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109
Stipt Ruvde
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO22273