(76 days)
The DOC Band is indicated for use on infants from three to eighteen months of age with moderate to severe nonsynostotic cranial deformation, infants with plagiocephalic-, and scaphocephalic-, and scaphocephalic-shaped heads, or a combination thereof.
The DOC Band 3D is also indicated for adjunctive use for infants from three to eighten months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-. brachycephalic-, and scaphocephalic-shaped heads, or a combination thereof.
The DOC Band 3D is a cranial orthosis intended to treat positional plagiocephaly in infants from 3 to 18 months of age. The band is intended to apply a mild pressure to the prominent regions of an infant's cranium and to improve cranial symmetry, proportion, and/or shape.
The provided text describes the DOC Band 3D, a cranial orthosis, and its substantial equivalence to predicate devices, focusing on changes in manufacturing processes and materials rather than a clinical performance study. Therefore, robust information regarding acceptance criteria and a detailed study proving the device meets those criteria, particularly for clinical effectiveness, is limited.
However, based on the non-clinical data provided, we can infer some "acceptance criteria" related to device properties and the "study" that addresses them.
1. Table of Acceptance Criteria and Reported Device Performance
Given the information, the acceptance criteria are largely focused on ensuring the new manufacturing process and material for the outer shell maintain the essential performance characteristics, biocompatibility, and clinical usability of the predicate devices.
| Feature/Parameter | Acceptance Criteria (Implied) | Reported Device Performance (DOC Band 3D) |
|---|---|---|
| Intended Use | Identical to predicate device (treating deformational plagiocephaly brachycephaly (DPB) as a cranial orthosis). | Met: "The DOC Band 3D (band) is a medical device known generically as a cranial orthosis. A cranial orthosis is used to treat a medical condition known as deformational plagiocephaly brachycephaly (DPB)." (Identical to predicate) |
| Indications for Use | Identical to predicate device (treatment of moderate to severe non-synostotic cranial deformation in infants 3-18 months, and adjunctive use post-surgical correction for synostosis). | Met: "The DOC Band 3D is indicated for use on infants from three to eighteen months of age with moderate to severe non-synostotic cranial deformation, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads, or a combination thereof. The DOC Band 3D is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected..." (Identical to predicate) |
| Outer Shell Material Biocompatibility | New material (polyamide 12 resin) must be biocompatible as per ISO 10993 standards. | Met: "It is a polyamide 12 resin, which was tested per ISO 10993 for cytotoxicity, irritation and sensitization, passing all tests per standards." |
| Mechanical Properties | Mechanical properties (shear, flexural, stiffness, fatigue, bond strength) must be substantially equivalent to or exceed predicate devices. | Met: "Bench testing has demonstrated that the device's mechanical properties meet or exceed those of the predicate devices." (Confirmed for shear, flexural, stiffness, fatigue, and bond strength). |
| Clinical Usability | Donning, doffing, trims, and adjustment procedures must be equivalent to predicate devices. | Met: "Senior clinicians evaluated the proposed device against the predicate device to confirm equivalent donning and doffing procedures, trims and adjustment procedures, demonstrating substantial equivalence in the fit and treatment protocols." |
| Safety | Device must be safe. | Met: "The DOC Band 3D is made from biocompatible materials that have undergone ISO 10993 testing to ensure safety." (Implied by biocompatibility and mechanical testing results). |
| Effectiveness | Expected to be comparable to predicate devices. | Met (by inference): "The clinical performance of the DOC Band 3D is expected to be comparable to the predicate devices in the treatment of deformational plagiocephaly." (This is an expectation based on substantial equivalence of design and non-clinical data, not a direct clinical effectiveness study.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on a clinical test set sample size or its data provenance. The evaluation for this submission focuses on non-clinical data.
- Mechanical Testing: The sample size for mechanical tests (shear, flexural, stiffness, fatigue, bond strength) is not specified.
- Clinician Evaluation: The number of "Senior clinicians" who evaluated the device for usability is not specified.
- Biocompatibility Testing: The sample size for materials tested per ISO 10993 is not specified.
All data described appears to be prospective bench testing and expert evaluation conducted by Cranial Technologies, Inc. (the applicant). The country of origin for this data is not explicitly stated but would presumably be the USA where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The text refers to "Senior clinicians" who evaluated the device for substantial equivalence in fit and treatment protocols. The exact number of these clinicians is not specified.
- Qualifications of Experts: The term "Senior clinicians" is used, implying experienced medical professionals relevant to the application of cranial orthoses. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set
Given that the evaluation described is one of "Senior clinicians" confirming equivalence in procedures, a formal adjudication method like MRMC (e.g., 2+1, 3+1) is not applicable or described. The assessment was likely a qualitative endorsement of equivalence in handling and fit by these clinicians.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. The device is cleared based on substantial equivalence to predicate devices, primarily through non-clinical testing of its modified manufacturing process and material, and an expectation of comparable clinical performance. There is no mention of human readers or AI assistance in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The DOC Band 3D is a physical cranial orthosis, not an algorithm or software device. Therefore, a standalone (algorithm-only) performance study is not applicable to this device.
7. The Type of Ground Truth Used
For the non-clinical evaluations:
- Mechanical Properties: The "ground truth" (or reference) for mechanical performance was the predicate DOC Band's mechanical properties. The new device's performance was measured against these established properties.
- Biocompatibility: The "ground truth" was established ISO 10993 standards for cytotoxicity, irritation, and sensitization.
- Clinical Usability: The "ground truth" for clinical usability (donning, doffing, trims, adjustments) was the established procedures and fit characteristics of the predicate DOC Band, as assessed by senior clinicians.
8. The Sample Size for the Training Set
This submission describes a medical device (cranial orthosis), not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not applicable to this device.
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March 17, 2025
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Cranial Technologies, Inc. Jeff Riggs Quality Manager 1405 W Auto Dr, Floor 2 Tempe, Arizona 85284
Re: K244056
Trade/Device Name: DOC Band 3D Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN Dated: December 31, 2024 Received: December 31, 2024
Dear Jeff Riggs:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
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Sincerely,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2025.03.17 Pierce -S 15:50:01 -04'00'
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) K244056
Device Name DOC Band 3D
Indications for Use (Describe)
The DOC Band is indicated for use on infants from three to eighteen months of age with moderate to severe nonsynostotic cranial deformation, infants with plagiocephalic-, and scaphocephalic-, and scaphocephalic-shaped heads, or a combination thereof.
The DOC Band 3D is also indicated for adjunctive use for infants from three to eighten months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-. brachycephalic-, and scaphocephalic-shaped heads, or a combination thereof.
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
Date: 03/17/2025
Applicant: Cranial Technologies, Inc.
Contact Person: Jeff Riggs
Phone: 480-403-6350
Address: 6511 W Frye Rd, Suite 3
Chandler, AZ 85226
Trade Name: DOC Band 3D
Common Name: Cranial Orthosis
Device Classification: Class II
Product Code: OAN
Requlation Number: 21 CFR 882.5970
Device Description: The DOC Band 3D is a cranial orthosis intended to treat positional plagiocephaly in infants from 3 to 18 months of age. The band is intended to apply a mild pressure to the prominent regions of an infant's cranium and to improve cranial symmetry, proportion, and/or shape.
Theory of Operation: The DOC Band 3D works by applying a mild holding pressure in regions where the head is already too prominent, while encouraging growth in the adjacent flattened regions. In this manner, the band is used to treat not only craniofacial asymmetry, but also proportionality (length to width ratio) of the head. The band is used from three to eighteen months of age because this is the period of rapid brain growth. After two years of age, skull growth stops, and any remaining growth of the cranium is primarily from thickening and hardening of the cranial bones,
Predicate Device(s):
Substantial Equivalence: The DOC Band 3D is substantially equivalent to the predicate devices. The primary difference is the manufacturing process: the DOC Band 3D utilizes 3D printing technology to fabricate the outer shell, while the predicate devices used vacuum forming. This change allows for greater precision and customization without affecting the device's intended use, safety, or effectiveness.
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Intended Use: The DOC Band 3D (band) is a medical device known generically as a cranial orthosis. A cranial orthosis is used to treat a medical condition known as deformational plagiocephaly brachycephaly (DPB).
Indications for Use: The DOC Band is indicated for use on infants from three to eighteen months of age with moderate to severe non-synostotic cranial deformation, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads, or a combination thereof.
The DOC Band 3D is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic/dolicocephalic- shaped heads, or a combination thereof.
Contraindications for Use: The DOC Band 3D is contraindicated for use on infants with craniosynostosis or hydrocephalus.
Summary of Safety and Effectiveness: The DOC Band 3D is made from biocompatible materials that have undergone ISO 10993 testing to ensure safety. Bench testing has demonstrated that the device's mechanical properties meet or exceed those of the predicate devices. The clinical performance of the DOC Band 3D is expected to be comparable to the predicate devices in the treatment of deformational plagiocephaly.
| Feature/Parameter | Predicate Device (DOC Band -K964992, K141012, K042385) | 3D Printed Cranial RemodelingOrthosis (DOC Band 3D) |
|---|---|---|
| Intended Use | The DOC Band (band) is amedical device knowngenerically as a cranialorthosis. A cranial orthosis isused to treat a medicalcondition known asdeformational plagiocephalybrachycephaly (DPB). | The DOC Band 3D (band) is amedical device knowngenerically as a cranialorthosis. A cranial orthosis isused to treat a medicalcondition known asdeformational plagiocephalybrachycephaly (DPB). |
| Indications for Use | The DOC Band is indicated foruse on infants from three toeighteen months of age withmoderate to severe non-synostotic cranial deformation,including infants withplagiocephalic-,brachycephalic-, and | The DOC Band 3D is indicatedfor use on infants from three toeighteen months of age withmoderate to severe non-synostotic cranial deformation,including infants withplagiocephalic-,brachycephalic-, and |
| Feature/Parameter | Predicate Device (DOC Band -K964992, K141012, K042385) | 3D Printed Cranial RemodelingOrthosis (DOC Band 3D) |
| scaphocephalic-shaped heads,or a combination thereof. | scaphocephalic-shaped heads,or a combination thereof. | |
| The DOC Band PostOp is alsoindicated for adjunctive use forinfants from three to eighteenmonths of age whosesynostosis has been surgicallycorrected, but who still havemoderate to severe cranialdeformities includingplagiocephalic-,brachycephalic-, andscaphocephalic/dolicocephalic-shaped heads. | The DOC Band 3D is alsoindicated for adjunctive use forinfants from three to eighteenmonths of age whosesynostosis has been surgicallycorrected, but who still havemoderate to severe cranialdeformities includingplagiocephalic-,brachycephalic-, andscaphocephalic/dolicocephalic-shaped heads. | |
| Materials: OuterShell | Semi-rigid copolymer(polypropylene-ethylene) | Semi-rigid polyamide (3Dprinted) |
| Materials: InnerLayer | Lightweight polyethylene foam | Lightweight polyethylene foam |
| ManufacturingProcess | Vacuum forming over a milledplaster model | 3D printing |
| Biocompatibility | Biocompatible materials tested | Biocompatible materials tested |
| Bench Testing | Mechanical properties tested | Mechanical properties tested;meets or exceeds predicateperformance |
| Sizing | Customized for each patient | Customized for each patient |
| Fitting andAdjustment | Custom-fit by clinician,adjustments as needed | Custom-fit by clinician,adjustments as needed |
Comparison of DOC Band 3D to Predicate Devices
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Test Summary of Non-Clinical Data
To ensure substantial equivalence of their mechanical forces, the predicate DOC Band and proposed DOC Band 3D both underwent mechanical testing of their shear, flexural, stiffness, fatigue and bond strength. Senior clinicians evaluated the proposed device against the predicate device to confirm equivalent donning and doffing procedures, trims and adjustment procedures, demonstrating substantial equivalence in the fit and treatment protocols. The new material in the proposed device (as compared to the predicate) is the outer shell. It is a polyamide 12 resin, which was tested per ISO 10993 for cytotoxicity, irritation and sensitization, passing all tests per standards.
Conclusion: The DOC Band 3D is substantially equivalent to the predicate device.
§ 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)).