(620 days)
Not Found
No
The description details a custom fabrication process using 3D scanning and CAD/CAM technology, which are standard digital design and manufacturing tools, not AI/ML. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
Yes
The device is intended for medical purposes to improve cranial symmetry or shape in infants with non-synostotic positional plagiocephaly, which is a therapeutic goal.
No
The device is a cranial remolding orthosis intended for treatment of cranial asymmetry or shape, not for diagnosis. It uses measurements from a 3D laser scanner to custom fabricate the orthosis, but the device itself does not perform any diagnostic function.
No
The device description clearly states it is comprised of an additive-manufactured outer shell and a polyethylene foam inner lining, which are physical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Function: The Hanger Cranial Band 3D is an external medical device that applies physical pressure to an infant's skull to reshape it. It does not analyze any biological samples.
- Intended Use: The intended use is to improve cranial symmetry and shape by applying external pressure, not by analyzing biological markers or substances.
Therefore, the Hanger Cranial Band 3D falls under the category of a medical device, specifically a cranial remolding orthosis, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
Contraindications for use: Infants with synostosis or hydrocephalus."
Product codes (comma separated list FDA assigned to the subject device)
MVA, OAN
Device Description
"The Hanger Cranial Band 3D is a cranial remolding orthosis comprised of an additivemanufactured outer shell with a polyethylene foam inner lining.
The device is custom fabricated for individual patients by obtaining measurements via a handheld 3D laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The scan is then modified utilizing a CAD/CAM technology package—to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial orthosis. The 3D image is used to produce a positive mold using a routing machine, to which the foam liner is pulled onto. The 3D file is also used manufacture the outer shell, which is then attached to the foam-lined positive model.
The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions. It is open at one side and closed with a fastener to provide the selected fit and proper stability."
Mentions image processing
"The scan is then modified utilizing a CAD/CAM technology package—to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial orthosis. The 3D image is used to produce a positive mold using a routing machine, to which the foam liner is pulled onto."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
handheld 3D laser scanner
Anatomical Site
Infant's cranium (head)
Indicated Patient Age Range
"infants from 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)
"Non-clinical test were performed based on typical handling of cranial orthoses.
- Both outer shell and inner foam lining were tested and found to be biocompatible (reference Section 15).
- Tensile stress testing was conducted on the outer shell material of the subject device, in comparison to typical tensile strength values of the predicate device's outer shell. Average tensile strength value of the Hanger Cranial Band 3D was found to be higher than the copoly plastic values.
- Drop and chemical tests were performed on the outer shell and had passed the attribute acceptance criteria.
- Validation activities were performed and demonstrated that the device can be reliably manufactured with the intended geometry and dimensional tolerances based upon patient-specific scan information."
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.
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)).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2022
Symbion Logistics, LLC Roselle Abad Quality Engineer 1119 W Geneva Dr Tempe, Arizona 85281
Re: K203134
Trade/Device Name: Hanger Cranial Band 3D Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: September 30, 2021 Received: October 4, 2021
Dear Roselle Abad:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203134
Device Name HANGER CRANIAL BAND 3D
Indications for Use (Describe)
Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
Contraindications for use: Infants with synostosis or hydrocephalus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K203134
- l. Application Information
- A. Applicant Name and Address
Symbiont Logistics, LLC (dba Hanger Fabrication Network) 302 E University Dr, Suite 301 Phoenix, AZ 85042 T: 480-894-1755 F: 480-921-9686
FDA Establishment Registration Number: 2032381
-
B. Submission Correspondent
Roselle Abad Quality Engineer, Hanger Fabrication Network (Symbiont Logistics, LLC) T: 480-894-1755, rabad@hanger.com -
C. Contact Person
Antonio Dias Engineering Director, Hanger Fabrication Network (Symbiont Logistics, LLC) T: 480-894-1755, adias@hanger.com -
D. Summary Date June 27, 2022
II. Submission Information
- A. Trade or Proprietary Name:
- B. Common Name:
- C. Regulation Classification:
- D. Regulation Number:
- E. Product Code:
- F. Panel:
- G. Device Class:
- H. Predicate Device 510(k):
Hanger Cranial Band 3D Cranial Orthosis, Helmet Orthosis, Cranial, Laser Scan 882.5970 MVA, OAN Neurology = Hanger Cranial Band, K072566
- lll. Device Description
The Hanger Cranial Band 3D is a cranial remolding orthosis comprised of an additivemanufactured outer shell with a polyethylene foam inner lining.
The device is custom fabricated for individual patients by obtaining measurements via a handheld 3D laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The scan is then modified utilizing a CAD/CAM technology package—to add or remove material, increase or decrease the circumference of model to aid in fit and
4
functionality of the cranial orthosis. The 3D image is used to produce a positive mold using a routing machine, to which the foam liner is pulled onto. The 3D file is also used manufacture the outer shell, which is then attached to the foam-lined positive model.
The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions. It is open at one side and closed with a fastener to provide the selected fit and proper stability.
- IV. Indication for Use Statement
Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
Contraindications for use: Infants with synostosis or hydrocephalus.
V. Substantial Equivalence Discussion
The comparison chart below provides evidence to facilitate the substantial equivalence determination between Hanger Cranial Band 3D to the predicate device, Hanger Cranial Band (K0272566) with respect to intended use, technological characteristics and principles of operation.
| Features | Predicate Device
Hanger Cranial Band, K072566 | Proposed Device
Hanger Cranial Band 3D |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | Intended for medical purposes to apply
static or gentle pressure to prominent
regions of an infant's cranium to improve
cranial symmetry or shape. To treat
infants from three to eighteen months of
age with moderate to severe non-
synostotic positional plagiocephaly,
including plagiocephalic-, brachycephalic-,
scaphocephalic-shaped heads. | Intended for medical purposes to apply
static or gentle pressure to prominent
regions of an infant's cranium to improve
cranial symmetry or shape. To treat infants
from three to eighteen months of age with
moderate to severe non-synostotic
positional plagiocephaly, including
plagiocephalic-, brachycephalic-,
scaphocephalic-shaped heads. |
| | Contraindications for use: Infants with
synostosis or hydrocephalus. | Contraindications for use: Infants with
synostosis or hydrocephalus. |
| OTC and/or Rx | Rx | Rx |
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Daily Wear Time | Up to 23 hrs/day | Up to 23 hrs/day |
| Materials | Outer shell of 5/32" copolymer plastic Inner liner of 1/2" polyethylene foam | Outer shell of 2mm thermoplastic resin, nylon polyamide Inner liner of 1/2" polyethylene foam |
Table 1 – Comparison of Characteristics
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| Velcro strap, 1 ½" Chafe and loop, 1 ½" Speedy rivet, 91X | Velcro strap, 1 ½" Chafe and loop, 1 ½" Speedy rivet, 91X | |
|---|---|---|
| Production | Measurement of infant's head taken by a 3D scanner from which a 3D image is made. The 3D image is used to produce a positive mold using a routing machine. Form orthosis from the positive mold of infant's head. | Measurement of infant's head taken by a 3D scanner from which a 3D image is made. The 3D image is used to produce a positive mold using a routing machine. Form orthosis from the positive mold of infant's head. |
VI. Technological Characteristics
The polyethylene foam liner used in both proposed and predicate devices remains identical-- this is the device component that maintains skin contact during treatment.
Hanger Cranial Band 3D differs from the predicate device through the material used for the outer shell. The material used comprises of a thermoplastic resin, nylon polyamide, with fusing and detailing agents, and has passed biocompatibility and non-clinical bench tests. Further discussion of the material can be found in Section 12 (Substantial Equivalence Discussion).
VII. Non-Clinical Performance Data
There are no performance standards applicable to the subject device as established by FDA under section 514. Non-clinical test were performed based on typical handling of cranial orthoses.
- . Both outer shell and inner foam lining were tested and found to be biocompatible (reference Section 15).
- Tensile stress testing was conducted on the outer shell material of the subject device, in comparison to typical tensile strength values of the predicate device's outer shell. Average tensile strength value of the Hanger Cranial Band 3D was found to be higher than the copoly plastic values.
- Drop and chemical tests were performed on the outer shell and had passed the attribute acceptance criteria.
- Validation activities were performed and demonstrated that the device can be reliably manufactured with the intended geometry and dimensional tolerances based upon patient-specific scan information.
VIII. Clinical Performance Data
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There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device has been on the market for years with a proven safety and efficacy for the use of the device.
IX. Conclusion/Statement of Substantial Equivalence
Hanger Cranial Band 3D has the same intended use as the predicate device, Hanger Cranial Band (K072566). The technological difference do not raise any questions regarding Hanger Cranial Band 3D's safety and effectiveness.
The information provided in this submission supports the substantial equivalence to the predicate device.