(81 days)
The LLUMC Cranial Remolding Helmet is a cranial orthosis that is intended for use on infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The device is intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. It is indicated for prescription use.
The LLUMC Cranial Remolding Helmet is a cranial orthosis used to treat children 3-18 months of age for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephally. The LLUMC Cranial Remolding Helmet is fabricated from a cast impression of the infant's cranium, taken by a certified orthotist (CO). The negative cast impression is converted by the CO into a positive impression and rectified into the desired corrected shape. The helmet is then formed over the corrected positive mold by a registered orthotic technician (RTO). A 1/4" polyethylene form (Volara) is used as an interface (liner) material, and 3/16" sheet of polyethylene plastic is used as the outer shell. The helmet is then trimmed by the RTQ, as necessary to not obstruct the infant's vision, hearing, ability to breathe or restrict movement of the head and neck. Ventilation holes are added to reduce heat retention. The CO fits the Cranial Remolding Helmet to the infant. The Cranial Remolding Helmet provides a gentle pressure over the prominent areas of the cranium in an effort to slow the growth in these areas. Voids are provided in an effort to encourage growth over the flat areas and reduce deformity. The infant is then evaluated monthly by the CO to monitor growth and insure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the helmet.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the LLUMC Cranial Remolding Helmet, which focuses on:
- Applicant information and device identification.
- Description of the device and its intended use.
- Comparison to a predicate device (Clarren Helmet) to establish substantial equivalence based on technological characteristics.
- Biocompatibility information.
- FDA's letter confirming substantial equivalence and allowing the device to be marketed.
- Statement of Indications for Use and Contraindications.
There is no mention of:
- Numerical acceptance criteria for device performance.
- A study specifically designed to demonstrate that the device meets such criteria.
- Sample sizes for test sets, data provenance, expert numbers and qualifications, or adjudication methods for ground truth establishment.
- Details about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Details regarding the training set for the device (as this is a physical medical device, not an AI/software product).
The substantial equivalence determination is based on the LLUMC Cranial Remolding Helmet having the same technological characteristics (custom-made, soft foam lining, rigid thermoplastic shell, method of operation to direct cranial growth) and intended use as the predicate device, the Clarren Helmet (K003035). The document implies that the device is considered effective for its intended use because its fundamental design and mechanism of action are consistent with a device already on the market and cleared by the FDA.
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i(023572
Section E - 510(k) Summary
JAN 1 3 2003
- Applicant: Michael J. Davidson, MPH, CPO Rehabilitation Institute, Loma Linda University Medical Center Department of Orthotics and Prosthetics 11406 Loma Linda Drive, Suite 407 Loma Linda, CA 92354 Telephone: (909) 558-6272 Fax: e-mail: MDavidson@ahs.llumc.edu
Submission Correspondent:
Lynn D. Fleisher, PhD, JD Sidley Austin Brown & Wood Bank One Plaza, 10 S. Dearborn Street Chicago, IL 60603 Telephone: (312) 853-2065 Fax: (312) 853-7036 e-mail: Ifleisher@sidley.com
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- Trade name: LLUMC Cranial Remolding Helmet Common name: Cranial Orthosis Classification: orthosis, cranial 882.5970 MVA
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- Predicate Device: Clarren Helmet K003035 MVA
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- Description of Device: The LLUMC Cranial Remolding Helmet is a cranial orthosis used to treat children 3-18 months of age for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephally. The LLUMC Cranial Remolding Helmet is fabricated from a cast impression of the infant's cranium, taken by a certified orthotist (CO). The negative cast impression is converted by the CO into a positive impression and rectified into the desired corrected shape. The helmet is then formed over the corrected positive mold by a registered orthotic technician (RTO). A 1/4" polyethylene form (Volara) is used as an interface (liner) material, and 3/16" sheet of polyethylene plastic is used as the outer shell. The helmet is then trimmed by the RTQ, as necessary to not obstruct the infant's vision, hearing, ability to breathe or restrict movement of the head and neck. Ventilation holes are added to reduce heat retention. The CO fits the Cranial Remolding Helmet to the infant. The Cranial Remolding Helmet provides a gentle pressure over the
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prominent areas of the cranium in an effort to slow the growth in these areas. Voids are provided in an effort to encourage growth over the flat areas and reduce deformity. The infant is then evaluated monthly by the CO to monitor growth and insure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the helmet.
- ડ. Intended Use: The Cranial Remolding Helmet is a cranial orthosis that is intended for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephaly in patients of 3-18 months of age. It is intended to provide gentle pressure over prominent areas of the infant's cranium to slow the growth in these areas in order to improve cranial symmetry and/or shape. The Cranial Remolding Helmet is provided by a Certified Orthotist (CO) solely on the order (prescription) of a licensed physician and fabricated by a Registered Orthotic Technician (RTO).
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- Technological Characteristics: The LLUMC Cranial Remolding Helmet has the same technological characteristics as the predicate device, the Clarren Helmet, K003035. Both cranial helmets are custom-made to the requirements of each individual infant. The assembly of both helmets begins with creating a negative cast impression of the infant's head, which is converted to a plaster model. The plaster model is then modified so that the cranial helmet will fit snugly over prominent areas to provide gentle pressure, and will have open areas (voids) to encourage growth over the flattened portion of the skull.
Each cranial helmet is formed over the modified plastic mold. Each helmet has a soft foam lining and a rigid thermoplastic shell which controls and directs cranial growth.
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- Biocompatibility: Information is provided on the biocompatability of the skin-contacting materials.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single, abstract shape. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2003
Rehabilitation Institute, Loma Linda University Medical Center C/O Lynn D. Fleisher, Ph.D., J.D. Sidley Austin Brown & Wood Bank One Plaza 10 S. Dearborn Street Chicago, Illinois 60603
Re: K023572
Trade/Device Name: Loma Linda University Medical Center (LLUMC) Cranial Remolding Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: October 23, 2002 Received: October 24, 2002
Dear Dr. Fleisher:
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
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Page 2 - Lynn D. Fleisher, Ph.D., J.D.
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 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 (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 vours,
Mark M Milken
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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Section D - Statement of Indications for Use
Device Name: LLUMC Cranial Remolding Helmet 510(k) Number: Not known
Indications for use: The LLUMC Cranial Remolding Helmet is a cranial orthosis that is intended for use on infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The device is intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. It is indicated for prescription use.
Contraindications: synostosis and hydrocephalus
for Mark A. Millman
Division Sign-Division of General. Restorative and Neurological Devices
510(k) Number K0235+2
§ 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)).