(44 days)
The Clarren Helmet is a cranial orthosis that applies passive 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.
The Clarren Helmet is a cranial orthosis that applies passive 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. It consists of a polypropylene sheet, three-eights of an inch thick, which is vacuum formed over a plaster model of a baby's head to produce a helmet. A liner for the helmet is made of Plastizote, one-fourth of an inch in thickness. Small holes are bored in the helmet for ventilation and large holes for the child's ears A Velero chinstrap is attached to help keep the helmet in place on the baby's head. It is manufactured from a positive model, obtained via traditional manual casting methods or a three-dimensional scan of the infant's head.
The submission describes the Clarren Helmet (Orthomerica) and its use in conjunction with the STARscanner.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantifiable acceptance criteria for the Clarren Helmet or the STARscanner. Instead, it relies on substantial equivalence to previously cleared devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The submission relies on substantial equivalence. | The Clarren Helmet (Orthomerica) is stated to be "safe and effective and identical to the Clarren Helmet (Children's Hospital)." The STARscanner's performance data "demonstrates that the proposed automation of measuring for and carving a positive mold of the patient's head yields more accurate results than the manual process used for the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Clarren Helmet (Orthomerica): No specific test set or sample size is mentioned for the Orthomerica version of the Clarren Helmet. The claim is based on its identity to the Clarren Helmet (Children's Hospital), which presumably had supporting data in its original clearance.
- STARscanner: No specific test set or sample size is mentioned for the STARscanner in this submission. It refers to its previous FDA clearance (K011350) and states that data "demonstrates more accurate results than the manual process." This implies a comparison, but details about the comparison's sample size or provenance (country of origin, retrospective/prospective) are not provided in this excerpt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Clarren Helmet (Orthomerica): Not applicable, as no dedicated test set for this specific device is described. The original Clarren Helmet's studies (if they involved expert ground truth) are referenced, but details are not here.
- STARscanner: Not applicable. The submission mentions "more accurate results" but does not detail the method of establishing ground truth or expert involvement for the STARscanner's performance evaluation.
4. Adjudication Method for the Test Set
- Clarren Helmet (Orthomerica) / STARscanner: Not applicable, as no specific test set requiring adjudication is described in this excerpt.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Clarren Helmet (Orthomerica) / STARscanner: No MRMC comparative effectiveness study is mentioned in this document. The focus for the Clarren Helmet is on substantial equivalence to a predicate, and for the STARscanner, on automation accuracy compared to manual processes.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Clarren Helmet (Orthomerica): Not applicable. The Clarren Helmet is a physical cranial orthosis, not an algorithm.
- STARscanner: The description of the STARscanner states it "yields more accurate results than the manual process," implying a standalone assessment of its automated measurement and carving capability. However, the details of how this accuracy was measured and whether it was without human intervention in the loop of the measurement phase are not provided. The previous FDA clearance (K011350) for the STARscanner likely contains these details.
7. Type of Ground Truth Used
- Clarren Helmet (Orthomerica): The references provided for the Clarren Helmet (Children's Hospital) are medical journal articles from 1979 and 1981, suggesting that the ground truth for its efficacy might have been based on clinical outcomes data (e.g., improvement in cranial symmetry/shape, as assessed by clinicians or objective measurements over time) observed in those studies.
- STARscanner: For the STARscanner, the claim of "more accurate results than the manual process" suggests the ground truth would be based on highly precise physical measurements of the infant's head model or actual head, against which both the STARscanner's output and the manual process's output are compared. The exact nature of this "ground truth" (e.g., gold standard precision measurement tools) is not specified.
8. Sample Size for the Training Set
- Clarren Helmet (Orthomerica) / STARscanner: The submission does not mention any training sets, as it is focused on demonstrating substantial equivalence and the performance of a physical device/scanner, not on a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Clarren Helmet (Orthomerica) / STARscanner: Not applicable, as no training set is mentioned.
Summary of the Study and Its Limitations (based on provided text):
The submission does not present a new, comprehensive study with explicit acceptance criteria for the Clarren Helmet (Orthomerica). Instead, it relies on two primary arguments:
- Substantial Equivalence to a Predicate Device: The Clarren Helmet (Orthomerica) is deemed "safe and effective and identical" to the predicate, the Clarren Helmet (Children's Hospital), which had prior FDA clearance based on published studies (Clarren, 1979, 1981). This implies the acceptance criteria and proof of effectiveness for the Orthomerica version are derived from the prior clearance of the Children's Hospital version.
- Previous Clearance and Demonstrated Performance of the STARscanner: The STARscanner had already received FDA clearance (K011350) when used with another cranial orthosis (STARband). The submission asserts that the STARscanner's "performance data demonstrates that the proposed automation of measuring for and carving a positive mold of the patient's head yields more accurate results than the manual process used for the predicate device."
Key Missing Information: The document lacks specific details regarding quantitative acceptance criteria, new clinical study data for the Orthomerica Clarren Helmet, or detailed technical study data for the STARscanner's accuracy (including sample sizes, ground truth establishment, or expert involvement) within this specific submission. It heavily leverages previous clearances and external publications for its justification.
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510(k) SUMMARY
Clarren Helmet (Orthomerica) and the STARscanner™
Orthomerica Products, Inc.
This 510(k) summary of safety and effectiveness for the Clarren Helmet and STARscanner is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 N. Orange Blossom TrailOrlando, FL 32810 |
| Contact Person: | Deanna Fish, MS, CPOClinical Education Manager(801) 265-1801 (telephone)(801) 265-1815 (fax)dfishcpo@aol.com |
| Preparation Date: | June 2002 |
| Device Trade Name: | Clarren Helmet (Orthomerica) |
| Common Name: | Cranial Orthosis |
| Classification Name: | Cranial Orthosis (see 21 C.F.R. § 882.5970) |
| Product Code: | MVA |
| Device Description: | The Clarren Helmet is a cranial orthosis that applies passivepressure to prominent regions of an infant's cranium in orderto improve cranial symmetry and/or shape in infants from 3to 18 months of age with moderate to severe nonsynostoticpositional plagiocephaly. It consists of a polypropylenesheet, three-eights of an inch thick, which is vacuum formedover a plaster model of a baby's head to produce a helmet.A liner for the helmet is made of Plastizote, one-fourth of aninch in thickness. Small holes are bored in the helmet for ventilation and large holes for the child's ears A Velero |
| Intended Use: | The Clarren Helmet is a cranial orthosis that applies passivepressure to prominent regions of an infant's cranium in orderto improve cranial symmetry and/or shape in infants from 3to 18 months of age with moderate to severe nonsynostoticpositional plagiocephaly, including infants withplagiocephalic, brachycephalic, and scaphocephalic- shapedheads.chinstrap is attached to help keep the helmet in place on thebaby's head. It is manufactured from a positive model,obtained via traditional manual casting methods or a three-dimensional scan of the infant's head. |
| Performance Data: | The Clarren Helmet (Orthomerica) –Clarren, Sterling, M.D., "Plagiocephaly and torticollis:Etiology, natural history, and helmet treatment," Journal ofPediatrics, 98:1 (92-95) (Jan. 1981); Clarren, et al., "Helmettreatment for plagiocephaly and congenital musculartorticollis," Journal of Pediatrics, 94:1 (43-46) (Jan. 1979).The STARscanner –The STARscanner has previously received FDA clearancewhen used in conjunction with Orthomerica's STARbandcranial remolding orthosis (K011350). The performancedata demonstrates that the proposed automation ofmeasuring for and carving a positive mold of the patient'shead yields more accurate results than the manual processused for the predicate device. Specific information regardingthe STARscanner is attached at Appendix D. |
| Conclusions: | The Clarren Helmet (Orthomerica) is safe and effective andidentical to the Clarren Helmet (Children's Hospital). FDAhas already reviewed and cleared the Clarren Helmet(Children's Hospital) based on performance data. FDA hasalso approved the use of the STARscanner in the fabricationof other cranial orthoses. Therefore, use of the scanner tofabricate the Clarren Helmet (Orthomerica) at Orthomerica'sfabrication facility in Orlando, Florida raises no new issues ofsafety and effectiveness.Based on the foregoing and other information in thisapplication, Orthomerica Products, Inc. believes that theperformance data provide reasonable assurance of thesafety and effectiveness of the Clarren Helmet (Orthomerica)for its proposed indications for use. Further, the ClarrenHelmet (Orthomerica) is substantially equivalent to its |
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Clarren Helmet and STARscanner™
claimed predicate, the Clarren Helmet (Children's Hospital) under conditions of intended use.
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Public Health Service
APR 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Deanna Fish Orthomerica Products, Inc. 6333 North Orange Blossom Trail Orlando, FL 32810
Re: K021918
Trade/Device Name: Clarren Helmet (Orthomerica) Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN Dated: June 7, 2002 Received: June 11, 2002
Dear Ms. Fish:
This letter corrects our substantially equivalent letter of July 25, 2002.
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 (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 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
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This letter will allow you to continue 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 Office of Compliance at (240) 276-0120 {see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.
Sincerely yours,
Cabare Buchers
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ب
Page
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Indications for Use: The Clarren Helmet is a cranial orthosis that applies passive 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
for Mark N. Millman
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K021918
§ 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)).