(43 days)
The O&P Bivalve Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.
O&P Bivalve Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.
The provided 510(k) summary for the O&P Bivalve Cranial Molding Helmet (K063395) describes the device's substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data for the new device. Therefore, much of the requested information regarding acceptance criteria and a dedicated study proving performance for this specific device is not present in the provided text.
However, I can extract information related to the predicate device and the general evidence used to support the effectiveness of cranial orthoses.
1. Table of Acceptance Criteria and Reported Device Performance
As this submission relies on substantial equivalence and does not establish new acceptance criteria for the O&P Bivalve Cranial Molding Helmet, a direct table of acceptance criteria and performance for this device cannot be generated.
Instead, the submission refers to the performance of its predicate device and the general effectiveness of cranial orthoses. The "performance" in this context refers to clinical outcomes observed with similar devices.
| Acceptance Criteria (Implied from Predicate/Literature) | Reported Device Performance (Reference to Predicate/Literature) |
|---|---|
| Effectiveness in correcting abnormal head shape | "effective and safe means of treating moderate to severe positional plagiocephaly." (Referring to Precision Prosthetics' helmet, the direct predicate) |
| Improvement of cranial symmetry and/or shape | "effective in correcting abnormal headshape, with no evidence of relapse following treatment." (General conclusion from researchers studying cranial orthoses) |
| Treatment of moderate to severe nonsynostotic positional plagiocephaly | "The study documented complete or near complete correction of asymmetry for a wide variety of head shapes." (Referring to the Littlefield et al. 1998 study, which monitored treatment of >750 infants over nearly ten years with cranial orthoses). |
| Safety | "effective and safe" (Referring to Precision Prosthetics' helmet). No specific safety endpoints or metrics are provided beyond this general statement. The 510(k) process typically assumes safety if the new device is substantially equivalent to a device with a known safety profile. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. There was no specific "test set" for the O&P Bivalve Cranial Molding Helmet, as its performance was not evaluated through a new clinical study.
- Data Provenance: The submission references:
- Retrospective clinical experience with the predicate device (Precision Prosthetics' Orthotic Molding Helmet), stating "Precision Prosthetics treated over 2,340 children with their orthotic molding helmet" over nine years. No specific country of origin is mentioned for this experience, but given the company's location (Missouri, USA), it's highly likely to be US-based.
- Published scientific literature on cranial orthoses by Clarren et al. (1979, 1981, 1977), Persing et al. (1986), Kane et al. (1996), and especially Littlefield et al. (1998). These studies describe general findings on the effectiveness of cranial orthoses. The Littlefield et al. study described monitoring "more than 750 infants." Specific country of origin for these studies is not detailed in the summary, but given the journals and authors often published in English, they are likely from Western countries (e.g., USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No specific test set was created for this device where expert ground truth was established. The effectiveness claims are based on prior clinical experience with a substantially equivalent device and existing scientific literature on the general class of devices.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated test set was used for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This submission does not describe an MRMC comparative effectiveness study, as it is centered on substantial equivalence rather than a new clinical trial comparing human readers with and without AI assistance. This device is a physical medical device, not an AI/software device that would involve human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical cranial orthosis, not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the effectiveness claims cited comes from:
- Clinical outcomes data: From the past 9 years of treating over 2,340 children with the predicate device, implying observed improvement in cranial shape.
- Published clinical studies: Which documented "complete or near complete correction of asymmetry" based on measurements or assessments of infants' head shapes over time (e.g., Littlefield et al. 1998 study). This would typically involve clinical assessment and anthropometric measurements by medical professionals.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. If interpreted as the "experience" pool for the predicate device, it would be "over 2,340 children" and "more than 750 infants" from the cited studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/ML device. For the clinical experience and studies cited, the "ground truth" (i.e., whether the treatment was effective) was established through clinical observation, anthropometric measurements, and follow-up assessments by medical professionals involved in the treatment of positional plagiocephaly.
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510(K) SUMMARY
The following summary is provided in accordance with C.F.R. section 807.92.
A. APPLICANT INFORMATION
- 비 Submitter :
Orthotic & Prosthetic Lab, Inc. 748 Marshall Ave. Webster Groves, MO 63119
Phone (314) 968-8555 Fax (314) 968-0037
-
Contact: 피
Thomas L. Malone, Chief Operating Officer Phone (314) 968-8555 Fax (314) 968-0037 -
를 Summary Date: November 1, 2006
B. DEVICE NAME AND CLASSIFICAITON
- 에 Common Name: Cranial Molding Helmet
- 페 Classification Name: Cranial Orthosis
- 트 Trade Name: O&P Bivalve Cranial Molding Helmet
- Class: 매 Class II, Cranial Orthosis, Code MVA, CFR 882.5970
- 트 Predicate Device: Precision Prosthetic and Orthotics, Inc., Orthotic Molding Helmet (K013700)
C. DEVICE DESCIPTION
O&P Bivalve Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up
DEC 2 2 2006
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and made round creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.
D. INTENDED USE
The O&P Bivalve Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.
E. TCHNOLOGICAL CHARACTERISTICS COMPARISON
The O&P Bivalve Cranial Molding Helmet and its predicate device have exactly the same purpose, are made from the same materials and work in exactly the same way. When Precision Prosthetics and Orthotics, Inc. went out of business in October of 2006, O&P Lab hired their orthotist responsible for the design and fitting of their orthotic molding helmet. Both the O&P Bivalve Cranial Molding Helmet and the Precision Orthotic Molding Helmet work by fitting close to the head where the head sticks out, and loosely over the flattened area. The infant's skull will grow into the loose area of the orthosis, allowing the flattened parts of the head to "catch up" with the prominent areas. The second way that both the O&P Bivalve Molding Helmet and the predicate device work is by insuring that the infant is always lying on a rounded surface, removing the worry about proper positioning.
F. PERFORMANCE DATA
The O&P Bivalve Cranial Molding Helmet is substantially equivalent to Precisions Orthotic Molding Helmet (K013700). As such, the O&P Cranial Molding Helmet meets the same standards of performance as Precision's Orthotic Molding Helmet and the DOC Band (K964992) for which the Orthotic Molding Helmet claimed substantial equivalence.
Prior to cranial orthoses being classified and for the last nine years, Precision Prosthetics treated over 2,340 children with their orthotic molding helmet as an effective and safe means of treating moderate to severe positional plagiocephaly. This same helmet is now being produced by Orthotic & Prosthetic Lab, Inc. using the helmets original designer and fabrication director.
Researchers studying the effects of treatment with cranial orthoses on infants have concluded that the devices are effective in correcting abnormal headshape, with no evidence of relapse following treatment. The use of passive cranial remolding orthosis dates back to the early 1970's and their effectiveness is well documented in:
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- Clarren S, Smith D, Hanson J. Helmet treatment for plagiocephaly and congenital muscular toricollis. Journal of Pediatrics 1979;94:443
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- Clarren SK. Plagiocephaly and torticolis: etiology, natural history, and helmet treatment. Journal of Pediatrics 1981;98L92-95
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- Clarren SK, Smith DW. Congenital deformities. Pediatr Clin North Am 1977:24(4) : 665-667 Persing J, Nichter L, Jane J, Edgerton M. Extenal cranial vault molding after craniofacial surgery. Ann Plast Surgery 1986; 17:274-283
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- Kane A, Mitchel L, Craven K, Marsh J. Observation on a recent increase in plagiocephaly without synostosis. Pedatrics 1996;97:877-885
The most comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over a span of nearly ten years. Results were recorded at the end of the treatment period and again at 12, 18, and 24 month follow-ups. The study documented complete or near complete correction of asymmetry for a wide variety of head shapes. The details of this study can be found at:
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- Littlefield TR, Beals SP, Manwaring KH, Pomatto JK, Joganic EF, Golden KA, Ripley CE. Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty. Journal of Craniofacial Surgery. 1988; 11-17.
G. SUMMARY
The safety and effectiveness data submitted to the FDA establishes that the O&P Bivalve Cranial Molding Helmet is safe and effective for its intended use and is substantially equivalent to applicable predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2006
Orthotic & Prosthetic Lab, Inc. % Mr. Thomas L. Malone 748 Marshall Avenue Webster Groves, Missouri 63119
Re: K063395
Trade/Device Name: O&P Bivalve Cranial Molding Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: November 1, 2006 Received: November 9, 2006
Dear Mr. Malone:
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. 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 such 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 (OS) 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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Page 2- Mr. Thomas L. Malone
This letter will allow you to begin 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. 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/industry/support/index.html.
Sincerely yours.
Barbara Buehrig
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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Indications for Use
510(k) Number (if known): K063395
Device Name: O&P Bivalve Cranial Molding Helmet
Indications For Use: The O&P Bivalve Cranial Molding Helmet 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.
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)
138110
(Division Signet 2) Division and Neurological Devices
510(k) Number K063395
Page 8
§ 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)).