(109 days)
No
The description focuses on traditional molding and fabrication techniques based on scans and mathematical analyses performed by practitioners, with no mention of AI or ML algorithms for design or analysis.
Yes.
The device is intended to treat a medical condition (positional plagiocephaly) by passively holding and guiding the growth of an infant's skull to improve cranial symmetry and shape. This aligns with the definition of a therapeutic device which is used to treat or prevent a disease or condition.
No
Explanation: The device is a cranial molding orthosis used to treat abnormally shaped craniums in infants by passively holding and guiding growth. It does not diagnose conditions; it implements a treatment.
No
The device description clearly outlines the physical components of the orthosis (thermoformable plastic, polyethylene foam, strap) and the fabrication process which involves physical modification of a mold or scan data to create a physical device. While scanning technology is used in the process, the final device is a physical orthosis, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Boston Band Cranial Molding Orthosis is a physical device that is worn externally on an infant's head. Its purpose is to physically reshape the skull through passive pressure and guidance of growth.
- Lack of Sample Testing: The device does not involve the testing of any biological samples from the patient.
The device is a therapeutic medical device used for physical intervention, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Boston Band Cranial Molding Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.
Product codes
OAN, MVA
Device Description
The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened-areas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician.
The orthosis is custom designed for each patient from a cast of the infant's head , a scan using the STARscanner from Orthomerica, or a scan from the Hand held FastScan Handheld Laser Scanner. The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathernmatical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium / Skull
Indicated Patient Age Range
three to eighteen 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 effectiveness of the Static Cranioplasty Orfoxihas been established through climical trials. (Orthotic Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s). The effects of treatment with crarial orthoses on infants have concluded that the devices are significantly effective in correcting abnormal head shape, without evidence of relapse following treatment. Treatment with cranial orthoses is reported to improve the results of surgical correction of severe cases, often eliminating the need for further surgical intervention.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 of Effectiveness and Safety
The following summary is provided in pursuant to Section 513 (1)(3)(A) of the Federal Food, Drug and Cosmetic Act
1) Applicant Information
- i) Submitter: Boston Brace International, Inc., 20 Ledin Drive, Avon, MA 02322
- ii) Contact: James Wynne, CPO, Director of Education, Boston Brace International, Telephone (508) 588-6060 ext. 244
- iii) Summary Date. October 1, 2007
2) Device Name and Classification:
- i) Proprietary Name: Boston Band Cranial remolding Orthosis
- ii) Common Name: Cranial Orthosis
- iii) Classification Name: Cranial Orthosis
- iv) Predicate Device: STARband Cranial Remolding Orthosis, (K011350), classified under 21 CFR £ 882.5970
- v) Laser scan- oan
3) Device Description
The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened-areas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician.
The orthosis is custom designed for each patient from a cast of the infant's head , a scan using the STARscanner from Orthomerica, or a scan from the Hand held FastScan Handheld Laser Scanner. The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathernatical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
JAN 22 2003
1
The Static Cranioplasty Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiccephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.
5) Comparison to Predicate Device and K063098
The Static Cranioplasty Orthosis and the predicate device are very similar with respect to production, instructions for use, materials, safety and effectiveness and special controls. The main difference is the use of Velcro hook strap attached to a self adhesive loop, versus a chafe loop system, and the thickness and layers of the polyethylene foam. The thin layers of foam allow selective voids to aid in the ability to guide gowth.
The material is handled in an identical manner to the polymer used in the predicate device, incorporating all of the safety and standards of practice. The proposed indications of use are analogous to those presented by the predicate device, and biocompaibility, function and effectiveness further parallel those of the predicate device.
See table next page.
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6) New Performance Data
- The effectiveness of the Static Cranioplasty Orfoxishas been established through climical trials. (Orthotic Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s). The effects of treatment with crarial orthoses on infants have concluded that the devices are significantly effective in correcting abnormal head shape, without evidence of relapse following treatment. Treatment with cranial orthoses is reported to improve the results of surgical correction of severe cases, often eliminating the need for further surgical intervention. The predicated using th same techniques and materials ( From Biccompatability: The predicate device designed by Orthomerica( K011350) incorporates an outer 3/16 Copolymer shell lined on its interior with a medium durometer crosslinked Polyethylene Foam, Volara(Aliplast) lining. (Per web site www.orthomerica.com/products/cranial/starband.htm) Description of Orthosis
The safety of the cranial orthoses is established under standard biocompatibility assessments for each material used. These assessments • 3/16" copolymer shell reveal that the device and the materials used are not expected to adversely affect the infants under the intended conditions of
ar.(Polyethylene foam is commonly used to line orthoses) The
- · Side-opening band
- · Proximal Opening
- · 1/2" polyethylene foam liner
- · 1 1/2" Velcro® strap and chafe closure
materials are not reported to cause skin irritation or any toxic effects. Further, the product is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no significant threat to the child during application within the normal scope of its intended use.
7) Summary
The safety and effectiveness information submitted to the FDA establishes that the Boston Band Cranial Remolding Orthosis is safe and effective for its intended use and is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
JAN 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Brace International, Inc. % Mr. James H. Wynne 20 Ledin Drive Avon, MA 02322
Re: K072862
Trade/Device Name: Boston Band Cranial Remolding Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: January 14, 2008 Received: January 14, 2008
Dear Mr. Wynne:
We have reviewed your Section 510(k) premarket notification of intent to market the device wformed 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 your 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 r hat 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.
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Page 2 - Mr. James H. Wynne
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.
Sincerely yours,
Mark M. Mulkern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K072862
Device Name: Boston Band Cranial Remolding Orthosis Indications For Use: The Boston Band Cranial Molding Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.
x AND/OR Prescription Use _ CFR 801 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Houbare MuchenD
Division Sign Off
Division of General, Restorative. and Neurological Devices
Page 1 of
510(k) Number K072862