(301 days)
Not Found
No
The description focuses on the physical design and function of a cranial orthosis and mentions 3D imaging for custom fitting, but there is no mention of AI or ML being used in the device's operation, design process beyond custom fitting, or analysis of patient data. The performance studies described are related to scanner accuracy, software validation for device specifications, and manufacturing process validation, not AI/ML model performance.
Yes.
The device is intended to treat moderate-to-severe non-synostotic positional plagiocephaly and cranial deformities by reshaping the cranium, indicating a therapeutic purpose.
No
Explanation: The device is described as a "non-sterile temporary orthosis to aid in the correction of head shape." Its purpose is to apply pressure and guide growth, not to diagnose a condition.
No
The device description explicitly states it is a "non-sterile temporary orthosis" made of "thermoplastic material with a soft, washable lining," which are physical hardware components.
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.
- Device description: The Ottobock MyCRO Band is an orthosis (a brace or support) applied externally to the infant's head. It works by applying pressure to guide cranial growth.
- Intended Use: The intended use is to improve cranial symmetry and/or shape by applying pressure to the head, not by analyzing biological samples.
- Lack of mention of biological samples: The description and intended use do not mention the collection or analysis of any biological samples.
Therefore, the Ottobock MyCRO Band is a medical device, specifically an orthosis, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 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.
Product codes (comma separated list FDA assigned to the subject device)
MVA
Device Description
The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium/head
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Prescription Use Only
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
Scanner Evaluation utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility. Scanners were compared to those previously cleared for use for the predicate device as well as internal acceptance criteria.
Software Validation demonstrated software performance, interoperability, and ability to meet internal device specifications. In addition to IQ, OQ, and PQ studies, a Fit Assessment was performed using test samples which were additively manufactured from 3D images of representative simulated cranial shapes using a previously cleared scanner.
Process Validation included dimensional analysis and mechanical testing of test samples to evaluate the additive manufacturing process performance, which was compared to the process used for the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were conducted and successfully met the pre-determined acceptance criteria (where testing was performed according to a recognized consensus standard, the designation number of the standard is referenced):
-
- Cytotoxicity testing per ISO 10993-5:2009 (Recognition Number: 2-245)
-
- Irritation and Sensitization testing per ISO 10993-10:2010 (Recognition Number: 2-174)
-
- Scanner evaluation, including repeatability/reproducibility study
-
- Validation of software workflow
-
- Simulated Cranial Fit Assessment
-
- Validation of additive manufacturing process
All testing passed acceptance criteria and demonstrate that the subject device is substantially equivalent to the predicate device.
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 26, 2021
Otto Bock Healthcare LP % Adrienne Von Foller Consultant Strategic Quality Solutions, LLC 1594 E Monaco Ave Salt Lake City, Utah 84121
Re: K201426
Trade/Device Name: MyCRO Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: February 25, 2021 Received: February 26, 2021
Dear Adrienne Von Foller:
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
1
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 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 (OS) 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) K201426
Device Name MyCRO Band
Indications for Use (Describe)
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 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.
| 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
| Name of 510(k) Owner: | Otto Bock HealthCare LP |
|---|---|
| Address of Submitter: | 3820 West Great Lakes Drive |
| Salt Lake City, UT 84120 | |
| Telephone: (801) 956-2400 | |
| Submitter Contact: | Caleb Beck, |
| Director, Regulatory and Quality Compliance - North America | |
| Adrienne von Foller | |
| Regulatory Affairs Consultant | |
| Telephone: (801) 916-8188 | |
| Email: Adrienne.SQS@gmail.com | |
| Date Prepared: | March 26, 2021 |
| Submission Number: | K201426 |
| Proprietary Name: | MyCRO Band |
| Common Name(s): | Cranial orthosis, cranial helmet |
| Classification: | 21 CFR 882.5970, Cranial orthosis |
| Device Class: | Class II |
| Device Product Code: | MVA |
| Predicate Device: | K180109 – Orthomerica Products, Inc., STARband® |
Device Description
The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.
4
Indications for Use
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, and scaphocephalicshaped heads.
Basis for Substantial Equivalence
The Ottobock MyCRO Band has the following technological characteristics which are the same as the predicate device. These include:
-
- Indications for use
-
- Intended use
-
- Basic principles of operation
-
- Basic design
| Comparison of the Subject and Predicate Devices | ||
|---|---|---|
| Device | ||
| Characteristic | Subject Device | Predicate Device |
| Trade Name | MyCRO Band | STARband |
| Common Name | Cranial Helmet, Cranial Orthosis | Cranial Helmet, Cranial Orthosis |
| Manufacturer | Otto Bock HealthCare LP | Orthomerica Products, Inc. |
| 510(k) Number | K201426 | K180109 |
| Product Code | MVA | OAN, MVA |
| Intended Use | Redirects head growth by maintaining contact over | |
| cranial areas which protrude and by creating voids | ||
| over areas of depression or flattening in order to | ||
| improve symmetry. | Maintains total contact over areas of bossing or | |
| protrusion and creates voids over areas of | ||
| depression or flattening to redirect cranial growth | ||
| toward greater symmetry. | ||
| Contraindications | Not for use on infants with pre-surgical | |
| craniosynostosis or hydrocephalus | Not for use on infants with synostosis or | |
| hydrocephalus | ||
| Prescription | ||
| required? | Prescription Use Only | Prescription Use Only |
| Size Options | Patient-matched sizing by scanning an image of | |
| patient's head shape | Patient-matched sizing by scanning an image of | |
| patient's head shape or plaster mold to make | ||
| positive mold of head shape | ||
| Software Used for | ||
| Shape | CAD software is used to modify the shape of the | |
| scanned image to improve symmetry and shape of | ||
| the helmet to be manufactured | Customized and/or CAD software may be used to | |
| modify the shape of the scanned image to improve | ||
| symmetry and shape of the helmet to be | ||
| manufactured | ||
| Design | ||
| Components | Polymer helmet with side opening closure and | |
| padded lining | Polymer helmet with side opening closure and | |
| padded lining | ||
| Approximate | ||
| Weight | 4 – 6.5 oz | 6 – 10 oz |
| Manufacturing Process | ||
| Additively manufacture the orthosis based | ||
| upon measurements of the infant's head taken | ||
| by a previously cleared 3-dimensional imaging | ||
| device | - Form orthosis from a positive mold of infant's | |
| head |
- Positive mold is formed based upon
measurements of the infant's head taken by an
approved 3-dimensional imaging device from
which a 3-dimensional image is made or from a
traditional plaster cast - The 3-dimensional image is used to produce a
positive mold using a 5-axis routing machine | |
| Approved 3-
Dimensional
Imaging Devices | Creaform HCP
Creaform Peel1
Creaform Peel 3D
Rodin4D M4D Scan
TechMed3D
BodyScan OMEGA
Scanner 3D Artec Eva
Artec Eva Lite | Spectra 3D Scanner
M4DScan/BodyScan System
Omega Scanner
3dMDhead System
3dMDcranial System
3dMDflex System
scanGogh-II
STARscanner I
STARscanner II
SmartSoc System for Android and iOS devices |
| Testing | Scanner Evaluation utilized a worst-case challenge
reference object of known dimensions to assess 3D
imaging devices for adequate accuracy,
repeatability, and reproducibility. Scanners were
compared to those previously cleared for use for
the predicate device as well as internal acceptance
criteria.
Software Validation demonstrated software
performance, interoperability, and ability to meet
internal device specifications. In addition to IQ, OQ,
and PQ studies, a Fit Assessment was performed
using test samples which were additively
manufactured from 3D images of representative
simulated cranial shapes using a previously cleared
scanner.
Process Validation included dimensional analysis
and mechanical testing of test samples to evaluate
the additive manufacturing process performance,
which was compared to the process used for the
predicate device. | Cranial Shape Capture Accuracy Study utilized a
representative cranial shape that possesses a
predefined shape with known dimensions, which
compared proposed device to cast and predicate
device. Associated parameters analyzed included
coordinate planes (A-P; M-L; P-D) and various
radius parameters, squareness, and flatness. |
| Biocompatibility | Biocompatibility Testing
- Cytotoxicity
- Sensitization | Biocompatibility Testing
- Cytotoxicity
- Sensitization |
5
In addition, the subject device complies with the special controls for cranial orthoses under 21 CFR 882.5970 for the FDA product classification, including labeling and biocompatibility test requirements.
6
Summary of Testing
The following non-clinical tests were conducted and successfully met the pre-determined acceptance criteria (where testing was performed according to a recognized consensus standard, the designation number of the standard is referenced):
-
- Cytotoxicity testing per ISO 10993-5:2009 (Recognition Number: 2-245)
-
- Irritation and Sensitization testing per ISO 10993-10:2010 (Recognition Number: 2-174)
-
- Scanner evaluation, including repeatability/reproducibility study
-
- Validation of software workflow
-
- Simulated Cranial Fit Assessment
-
- Validation of additive manufacturing process
Conclusion
The MyCRO Band has identical indications for use as the predicate device in K180109. The fundamental technological characteristics of the MyCRO Band are the previously cleared predicate device. All testing passed acceptance criteria and demonstrate that the subject device is substantially equivalent to the predicate device.
Based on similarities in indications for use, basic design, and the principle of operation, the Ottobock MyCRO Band is substantially equivalent to the previously cleared predicate device.