(84 days)
The RHS 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 RHS 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 helmet, three-eighths of an inch thick, that 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.
The provided text is a 510(k) summary for the RHS Helmet, a cranial orthosis. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria for a novel device.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or not detailed in this document.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or provide a table of performance data against such criteria. The basis for clearance is "biocompatibility of the materials and the safety and effectiveness of helmet therapy," which are qualitative statements rather than specific metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study data on device performance is provided in this 510(k) summary. The document mentions "Performance Data: Information was provided on the biocompatibility of the materials and the safety and effectiveness of helmet therapy," but does not detail any particular study results or sample sizes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no specific test set or clinical study is detailed, there's no mention of experts establishing ground truth for performance.
4. Adjudication Method for the Test Set
Not applicable. No test set or clinical study is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This document does not describe an MRMC study. The focus is on demonstrating substantial equivalence to a predicate device, not on comparative effectiveness against humans or other devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The RHS Helmet is an orthotic device, not an algorithm, so a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to performance studies (e.g., pathology, outcomes data) is not explicitly discussed in this 510(k) summary. The device's effectiveness relies on the established principles of cranial orthosis therapy for nonsynostotic positional plagiocephaly, which is a recognized medical approach. The "effectiveness" mentioned refers to the general understanding of helmet therapy, not a specific ground truth derived from a novel study for this particular device.
8. The Sample Size for the Training Set
Not applicable. This device is a physical orthotic device, not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See #8.
In summary, the provided 510(k) documentation for the RHS Helmet primarily relies on the concept of "substantial equivalence" to a legally marketed predicate device (Clarren Helmet -- 510(k) # 003035). This means that the device's safety and effectiveness are supported by its similarity to an already cleared device, rather than through extensive, independent, novel performance studies with specific acceptance criteria as might be required for a completely new technology or a PMA application. The "Performance Data" mentioned likely refers to general information and existing knowledge about cranial helmet therapy and material biocompatibility, rather than data from a new, comprehensive clinical trial for the RHS Helmet itself.
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SEP 1 9 2001
APPENDIX E
510(k) SUMMARY RHS Helmet Restorative Health Services, Inc.
This 510(k) summary of safety and effectiveness for the Cranial Helmet 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:
Restorative Health Services, Inc. DBA Dillard Prosthetics-Orthotics
Cranial Orthosis (see 21 C.F.R. § 882.5970)
ventilation, and large holes for the child's ears.
Clarren Helmet -- 510(k) # 003035
Address:
Contact Person:
Telephone:
311 18th Avenue North Nashville, TN 37203
Aaron J. Sorensen. C.P.O.
President
(615) 327-1100 (telephone) (615) 327-1141 (fax)
Product Code: MVA
Preparation Date: June 2001
Device Trade Name: RHS Helmet
Common Name: Cranial Orthosis
Classification Name:
Predicate Device:
Device Description:
Intended Use:
The Cranial Helmet is a cranial orthosis that applies passive pressure to prominent regions of an infant's cranium in order
The RHS 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 helmet, three-eighths of an inch thick, that 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
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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.
Performance Data: Information was provided on the biocompatibility of the materials and the safety and effectiveness of helmet therapy.
CONCLUSIONS:
Based on the foregoing and other information in this application, RHS, Inc. believes that the Cranial Helmet is substantially equivalent to its claimed predicate under conditions of intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
SEP 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Restorative Health Services, Inc. c/o Mr. David J. Bloch Reed Smith 1301 K Street, N.W. Suite 1100-East Tower Washington, D.C. 20005
Re: K012007
Trade/Device Name: RHS Helmet Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MV A Dated: June 27, 2001 Received: June 27, 2001
Dear Mr. Bloch:
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 (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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Page 2 - Mr. David J. Bloch
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susa Walker, MD
Image /page/3/Picture/5 description: The image shows a simple, hand-drawn symbol. It resembles a stylized letter or a combination of shapes. The symbol consists of a curved line that forms a loop at the top and extends downward, ending in a small, curled tail on the right side. The overall impression is abstract and minimalist.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO12007 510(k) Number:
Device Name: RHS Helmet
INDICATIONS FOR USE:
The RHS 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-the-Counter Use
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO12007
§ 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)).