(217 days)
Not Found
No
The description details a CAD/CAM system used to create a positive mold from scanned or cast data, which is a standard manufacturing process and does not mention or imply the use of AI or ML for analysis, decision-making, or adaptation.
Yes
The device is intended to apply pressure to an infant's cranium to improve cranial symmetry and shape, which is a therapeutic purpose.
No
The device is a cranial orthosis helmet used for treatment by applying pressure to improve cranial symmetry and shape. It does not perform any diagnostic functions like analyzing or interpreting data to identify a medical condition.
No
The device description clearly outlines physical components (plastic outer shell, foam inner shell, strap, fastener) and a manufacturing process involving creating a positive mold and orthosis from scanned data. While software is used in the design process (CAD/CAM system), the final device is a physical orthosis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The CAMLab Cranial Orthosis Helmet is a physical device that is applied externally to an infant's head. Its purpose is to physically reshape the cranium by applying pressure.
- No Biological Samples: The device does not involve the analysis of any biological samples from the patient.
- Physical Intervention: The device's mechanism of action is physical intervention (applying pressure), not diagnostic testing of biological material.
The device is a medical device, specifically a cranial orthosis, used for treatment (reshaping the head) rather than diagnosis.
N/A
Intended Use / Indications for Use
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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.
Product codes
OAN, MVA
Device Description
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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. This orthosis is only available if prescribed by a physician.
The initial geometry of the patient is acquired from either laser scanned measurements using the BioScanner (a.k.a. Polhemus Fastscan handheld laser scanner) or via traditional casting methods. If a cast is taken, the cast will be scanned with the BioScanner as well.
The resulting three dimensional model along with a digital order form and any other pertinent information is then sent to BioSculptor Corporation via email or secured internet application. Utilizing this information, the BioSculptor CAD/CAM system will then create a positive mold representative of the patient scan. This positive model will then be used to create the orthosis.
Each orthosis consist of a plastic outer shell, a foam inner shell, a strap and fastener to secure the orthosis. The practitioner modifies the orthosis to achieve an accurate fit and monitors the progress to ensure that no adverse effects occur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
laser scanned measurements
Anatomical Site
Cranium / head
Indicated Patient Age Range
infants from 3 to 18 months of age
Intended User / Care Setting
Prescription Use
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)
Not Found
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
510(k) Summary CAMLab Cranial Orthosis Helmet BioSculptor Corporation
K081787. '/2
JAN 2 7 2009
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807,92(a).
807.92(a)(1)
Submitter Information
BioSculptor Corporation 2480 West 82nd Street, #8 Bay 1A Hialeah, Florida 33016
(305) 556-5815 Phone: Fax: (305) 823-8304 Contact: Mark Mazloff
Date: June 18, 2008
807.92(a)(2)
Proprietary Name: Common or Usual Name: Regulation Number: Classification Name(s):
Classification Code: OAN Secondary Classification Code: MVA
807.92(a)(3)
Predicated Device(s)
Cranial Orthosis Helmet
Orthosis, Cranial Laser Scan
21 CFR 882.5970
Cranial Orthosis
CAMLab Cranial Orthosis Helmet
STARband Orthomerica
Classified under 21 CFR 882.570
Additional substantial equivalence information is provided in the following Substantial Equivalence Comparison Table.
807.92(a)(4)
Device Description
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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. This orthosis is only available if prescribed by a physician.
The initial geometry of the patient is acquired from either laser scanned measurements using the BioScanner (a.k.a. Polhemus Fastscan handheld laser scanner) or via traditional casting methods. If a cast is taken, the cast will be scanned with the BioScanner as well.
1
K081787. 2/2
510(k) Summary CAMLab Cranial Orthosis Helmet BioSculptor Corporation
The resulting three dimensional model along with a digital order form and any other pertinent information is then sent to BioSculptor Corporation via email or secured internet application. Utilizing this information, the BioSculptor CAD/CAM system will then create a positive mold representative of the patient scan. This positive model will then be used to create the orthosis.
Each orthosis consist of a plastic outer shell, a foam inner shell, a strap and fastener to secure the orthosis. The practitioner modifies the orthosis to achieve an accurate fit and monitors the progress to ensure that no adverse effects occur.
807.92(a)(5)
Intended Use(s)
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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.
807.92(a)(6)
| | Orthomerica STARband
Cranial Orthosis
K011350 | CAMLab Cranial
Orthosis Helmet
(This submission) |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Indications for Use | Treatment of abnormal
infant head shape
(positional/deformational
plagiocephaly) | Treatment of abnormal
infant head shape
(positional/deformational
plagiocephaly) |
| Materials | Copolymer plastic/closed
cell polyethylene
foam/Velcro strap | Copolymer plastic/closed
cell polyethylene
foam/Velcro strap |
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Daily Wear Time | 23 hrs./day | 23 hrs./day |
| Average Time to Effectiveness
(patients age 3-7 months) | 2-4 months | 2-4 months |
| Contradictions for Use | Craniosynostosis/Hydrocephalus | Craniosynostosis/Hydrocephalus |
| Method of Manufacture | Custom from mold using
a laser scanner,
CAD/CAM system and
5-axis router machine | Custom from mold using
a laser scanner,
CAD/CAM system and
5-axis router machine |
Substantial Equivalence Comparison Table
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2-7 2009
BioSculptor Corporation % Mr. Mark Mazloff 2480 West 82nd Street, #8 Hialeah, Florida 33016
Re: K081787
Trade/Device Name: CAMLab Cranial Orthosis Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: January 6, 2009 Received: January 7, 2009
Dear Mr. Mazloff:
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 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.
3
Page 2 - Mr. Mark Mazloff
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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
Applicant:
BioSculptor Corporation
(08)78 510(k) Number (if known):
Device Name:
CAMLab Cranial Orthosis Helmet
Indications for Use:
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V Over the Counter
(Per 21 CFR,801.109)
(Optional Format 1-2-96)
N
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Confidential Information BioSculptor Corporation
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