(33 days)
The Ballert Cranial Molding Helmet is intended for use by or under the direction of a physician 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-and brachycephalic-shaped heads.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "Ballert Cranial Molding Helmet." This type of document does not contain the information requested regarding acceptance criteria, study details, and performance metrics because it is a clearance letter, not a study report or a technical datasheet.
A 510(k) clearance letter indicates that the FDA has determined a new device is "substantially equivalent" to a legally marketed predicate device. This determination is based on the manufacturer's submission which includes information like intended use, technological characteristics, and safety and effectiveness data, but the letter itself does not detail the specific performance study results.
Therefore, I cannot provide the requested information based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUN 1 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GEMA, Inc. Mr. Gene Bernardoni President c/o Ballert Orthopedic 2434 West Peterson Avenue Chicago, Illinois 60659
Re: K011433
Trade Name: Ballert Cranial Molding Helmet Regulation Number: 882.5970 Regulatory Class: II Product Code: MV A Dated: May 4, 2001 Received: May 10, 2001
Dear Mr. Bernardoni:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Mr. Gene Bernardoni
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
DSmtchell RUA tos
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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Indications for Use Statement
Applicant: Ballert Orthopedic
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Ballert Cranial Molding Helmet
Indications For Use:
The Ballert Cranial Molding Helmet is intended for use by or under the direction of a physician 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-and brachycephalic-shaped heads.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
OR Over The Counter Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Per 21 CFR, 801.109)
(Optional Format 1-2-96)
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(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011432
§ 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)).