(84 days)
003035
Not Found
No
The description focuses on the physical construction and mechanism of action (passive pressure) of a cranial orthosis, with no mention of AI, ML, image processing, or data-driven algorithms for diagnosis, treatment planning, or device function.
Yes
The device is described as a cranial orthosis that applies passive pressure to improve cranial symmetry and/or shape in infants with moderate to severe nonsynostotic positional plagiocephaly, indicating it is intended for a medical purpose to treat a condition.
No
The device is a cranial orthosis designed to improve head shape, not to diagnose a condition.
No
The device description explicitly states it is a physical helmet made of polypropylene and plastizote, which are hardware components.
No, 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.
- RHS Helmet Function: The RHS Helmet is a physical device applied externally to an infant's head. Its purpose is to physically reshape the skull through passive pressure, not to analyze biological samples for diagnostic purposes.
The provided information clearly describes a cranial orthosis used for treatment, not a diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MVA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Information was provided on the biocompatibility of the materials and the safety and effectiveness of helmet therapy.
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.
003035
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)).
0
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
1
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.
2
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.
3
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
4
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