(330 days)
The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.
The Danmar Products Michigan Cranial Reshaping Orthosis a cranial orthosis that provides passive pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is fabricated from a positive mold, obtained from traditional manual casting methods or a 3-D scan of the infant's head, with front and rear sections that are comprised of an inner, hypoallergenic, soft foam that is ½ " to ¼" thick, and an outer shell made of a, semi-rigid plastic. The Michigan Cranial Reshaping Orthosis is essentially identical to the predicate device known as the Danmar Products Michigan Cranial Helmet, (K003630) with exceptions only to the validated manufacturing improvements noted herein. The new manufacturing methods vield a substantially equivalent device as compared with the Danmar predicate device and manufacturing method.
The provided text describes a 510(k) premarket notification for the Danmar Products Michigan Cranial Reshaping Orthosis. A 510(k) submission does not typically involve novel studies to prove device efficacy or pre-defined acceptance criteria with performance measurement against them in the same way a PMA (Premarket Approval) submission would. Instead, substantial equivalence to a predicate device is the primary pathway.
Therefore, the requested information elements related to device performance studies, acceptance criteria, sample sizes, expert involvement, and ground truth establishment are largely not applicable or not explicitly detailed in this type of submission. The focus is on demonstrating that the new device shares the same technological characteristics and intended use as an already legally marketed predicate device, with any modifications not raising new questions of safety or effectiveness.
Here's an analysis based on the provided document, addressing the points where information is available or indicating where it is not:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission for the Danmar Products Michigan Cranial Reshaping Orthosis declares substantial equivalence to predicate devices rather than presenting specific acceptance criteria and a study demonstrating performance against those criteria. The "study" in this context refers to the comparison of technological characteristics and intended use with predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use Equivalence: To apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape for 3-18 months of age with moderate to severe nonsynostotic positional plagiocephaly. | The subject device's Indications for Use Statement is nearly identical to the predicate device K003630, and highly similar to K072862 and K072566. The only difference noted is the explicit mention of "laser-scanning accessory" and "3-D scan" as an option for mold creation in the subject device, which aligns with the technological changes presented. This demonstrates equivalence in intended use. |
| Technological Characteristics Equivalence: | The device incorporates the same technological characteristics (materials, principle of operation) as the predicate devices. The fabrication changes (addition of 3-D shape capture method - Omega Scanner and Omega Carver) are presented as "validated manufacturing improvements" that "yield a substantially equivalent device." |
| Safety and Performance: No new questions of safety or effectiveness. | - Biocompatibility: "Biocompatibility data demonstrates that the device's inner lining is non-irritating and nontoxic." (This data is not detailed further in the summary).- Mechanical Performance: "Performance testing results demonstrate that the device will not break or shatter when subjected to impact." (Details of this testing are not provided in the summary).- The claim is that the "validated fabrication modifications noted herein will yield a finished subject device equivalent to the Danmar predicate device (K003630)." The approval by the FDA via 510(k) implies that these claims were sufficient to establish substantial equivalence without raising new safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. A formal "test set" for performance evaluation in the context of efficacy for patients (like a clinical trial) is not described in this 510(k) summary. The evaluation relies on comparison to predicate devices and general performance testing (biocompatibility, impact resistance), the details of which are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not provided. The concept of "ground truth" established by experts for a test set (e.g., for diagnostic accuracy) is not relevant to this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is described as there is no specific test set of cases requiring such a process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a cranial orthosis, not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study is completely irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical orthosis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Implicit. The "ground truth" in a substantial equivalence submission is primarily the established safety and effectiveness of the predicate devices. The assessment relies on a comparison of characteristics and intended use. For the performance testing mentioned (biocompatibility, impact), the "ground truth" would be standard engineering and material science specifications, but details are not provided. Clinical outcomes data to prove efficacy for patients is not typically required or presented in detail for a 510(k) where substantial equivalence is demonstrated.
8. The sample size for the training set
- Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. No training set is used for this device.
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Danmar Products, Inc. Michigan Cranial Reshaping Orthosis
October 13, 2009
JAN - 6 2010
The following summary is provided pursuant to Section 513 (I) (3) (A) of the Federal Food Drug and Cosmetic Act:
Submitter Information:
Kay Fuller, RAC VCI, LLC on behalf of Danmar Products, Inc. 221 Jackson Industrial Drive Ann Arbor, MI 48103
| Contact Information: | Kay Fuller, RAC |
|---|---|
| VCI, LLC | |
| 734-274-4680 |
Device Name:
Proprietary Name: Michigan Cranial Reshaping Orthosis
Cranial Reshaping Orthosis
Common Name: Cranial Helmet
Classification Name: Cranial Orthosis
Classification Code:
OAN, Cranial Orthosis, Laser-Scan MVA. Cranial Orthosis 21 CFR §882.5970
Predicate Device Equivalence:
The Danmar Products Michigan Cranial Reshaping Orthosis is substantially equivalent to the Hanger Cranial Band, cleared for US commercialization via K072566 on January 9, 2008, the Boston Band Cranial Remolding Orthosis, cleared for US commercialization via K072862 on January 22, 2008 and the Michigan Cranial Helmet, cleared for US commercialization via K003630, May 29, 2001.
Device Description:
The Danmar Products Michigan Cranial Reshaping Orthosis a cranial orthosis that provides passive pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is fabricated from a positive mold, obtained from traditional manual casting methods or a 3-D scan of the infant's head, with front and rear sections that are comprised of
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an inner, hypoallergenic, soft foam that is ½ " to ¼" thick, and an outer shell made of a, semi-rigid plastic. The Michigan Cranial Reshaping Orthosis is essentially identical to the predicate device known as the Danmar Products Michigan Cranial Helmet, (K003630) with exceptions only to the validated manufacturing improvements noted herein. The new manufacturing methods vield a substantially equivalent device as compared with the Danmar predicate device and manufacturing method.
The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.
Comparison of Technological Characteristics:
The Danmar Products Michigan Cranial Reshaping Orthosis device incorporates the same technological characteristics as the legally marketed predicate devices noted in this Premarket Notification submission. The proposed fabrication changes noted in this submission include the addition of a 3-D shape capture method (Omega Scanner) and the Omega Carver. The Omega Scanner is labeled as a Class 1 Laser and therefore it may be utilized by a qualified user without eye protection when utilized under normal operating conditions. The finished subject device technological characteristics and principals of operations remain identical to the Danmar predicate device, noted herein. The following Tables illustrate the finished subject device remains identical to the Danmar predicate device (K003630).
Intended Use:
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| steps | Predicate DeviceManual Process Steps | Subject DeviceOmega Process Steps | steps |
|---|---|---|---|
| 1 | Orthotist makes negative moldof baby's head | Orthotist scans baby's head usingOrthotist's Omega scanner | 1 |
| Scan file modified by Orthotist, asneeded for symmetry | 2 | ||
| 2 | Orthotist sends negative mold to Danmar | Orthotist sends scan file to Danmarelectronically | 3 |
| 3 | Danmar makes positive plaster mold | Danmar carves positive foam plasticmold with Omega carver | 4 |
| 4 | Danmar modifies positive plaster moldaccording to Orthotist instructions | ||
| 5 | Danmar wraps nylon stockinette overplaster mold | Danmar wraps nylon stockinette overfoam plastic mold | 5 |
| 6 | Danmar fabricates orthosis according toconventional process | Danmar fabricates orthosis accordingto conventional process | 6 |
and the comments of the comments of the comments of
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| ComparisonCriteria | SubjectDevice | PredicateDeviceK003630 | Predicate DeviceK072862 | Predicate DeviceK072566 |
|---|---|---|---|---|
| Product CodePrescription Device | OAN, MVAYes | OANYes | OAN, MVAYes | OAN, MVAYes |
| Indications for Use | "The Danmar ProductsMichigan CranialReshaping Orthosis isintended forprescription use toapply pressure toprominent regions ofan infant's cranium inorder to improvecranial symmetryand/or shape. A mold ismade of the baby'shead to create theorthotic. A plaster castor a laser-scanningaccessory may be usedto create a 3-D scan ofthe infant's head tocreate the mold. Thedevice is indicated forinfants from 3 to 18months of age, withmoderate to severenonsynostoticpositionalplagiocephaly,including infants withplagiocephalic andbrachycephalic shapedheads." | "The Danmar ProductsMichigan CranialHelmet is intended forprescription use to beused to apply pressureto prominent regions ofan infant's cranium inorder to improvecranial symmetryand/or shape in infantsfrom 3 to 18 months ofage, with moderate tosevere nonsynostoticpositionalplagiocephaly,including infants withplagiocephalic - andbrachycephalic-shapedheads." | "The Boston Band Cranial MoldingOrthosis is intended for medicalpurposes to passively hold prominentcranial regions of an infant's skull inorder to improve cranial symmetryand/or shape in infants from three toeighteen months of age, withnonsynostotic positional plagiocephaly,including infants with plagiocephalic,brachycephalic and scaphocephalicpatterned head shapes." | "Intended for medical purposes to applystatic or gentle pressure to prominentregions of an infant's cranium toimprove cranial symmetry or shape. Totreat infants from three to eighteenmonths of age with moderate to severenon-synostotic positional plagiocephaly,including plagiocephalic,brachycephalic, scaphocephalic-shapedheads." |
| Contraindications | Not for use inpatients withcraniosynostosis,scaphocephalic-shaped heads;hydrocephalus | Not for use inpatients withcraniosynostosis,hydrocephalus | Unknown | Unknown |
| Materials /Biocompatibility | Same/similar asPredicates | Hypo-allergenic,non-irritating andnontoxic innerfoam lining;semi-rigid plasticouter shell | Hypoallergenic polyethylenefoam; thermo-formableplastic | Hypoallergenicpolyethylene foam;polypropylene copolymerouter shell |
Summary of Device Evaluation:
The literature on this and similar predicate devices demonstrates that the Danmar Products Michigan Cranial Reshaping Orthosis performs as intended. Biocompatibility data demonstrates that the device's inner lining is non-irritating and nontoxic. The subject device validated fabrication modifications noted herein will yield a finished subject device equivalent to the Danmar predicate device (K003630). Performance testing results demonstrate that the device will not break or shatter when subjected to impact.
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Conclusions:
.
Based on the above information and the information contained in this Premarket Notification, we conclude the Danmar Products Michigan Cranial Reshaping Orthosis is substantially equivalent to the noted legally marketed predicate devices.
:
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Validation & Compliance Institute c/o Ms. Kay Fuller, RAC Regulatory Consultant, VCI, LLC 537 Fort Dearborn St. Dearborn, MI 48124
JAN - 62010
Re: K090341
Trade/Device Name: Michigan Cranial Reshaping Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MVA, OAN Dated: December 12, 2009 Received: December 16, 2009
Dear Ms. Fuller:
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 interence 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, Dr to and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, isting 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 additional controls. Existing major regulations affecting your devin (1117) 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 not 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 (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
. th, m
Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090341
Device Name: Michigan Cranial Reshaping Orthosis
Indications For Use:
The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jeffrey Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K090341 510(k) Number_
§ 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)).