(122 days)
The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Contraindications: Infants with Synostosis or Hydroccphalus.
Prescription Device.
The Cranial Helmet is a cranial orthosis custom fabricated to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry and shape. The Cranial Helmet is comprised of the same materials as the P.A.P. Orthosis (K012804). It is not packaged for sale, as it is custom fabricated. It will be fitted to the infant at the time of delivery. The Cranial Helmet has no accessories, and no options are available for the infant or the caregiver (parent). Caregivers are instructed as to: wear, care, cautions, and risks. The transparent thermoplastic is Surlyn which varies in thickness from 1/8 inch to 3/8 inch depending upon the desired characteristics. The helmet is fabricated from a cast taken of an infant's head. There are no standard sizes, models, variances, etc. A polyurethane foam strip is applied to the posterior border at the base of the occipital to provide suspension and anti-rotation. Each Cranial Helmet is fastened with a Velcro strap. Each infant with a Cranial Helmet must be under the care of a physician. The helmet is a Prescription Device.
This 510(k) premarket notification for the Otto Bock Cranial Helmet does not include a study that proves the device meets specific performance acceptance criteria.
Instead, the submission relies on demonstrating substantial equivalence to a previously legally marketed device (the Fit Well's P.A.P. Orthosis, K012804). This means that the Cranial Helmet is deemed safe and effective because it has the same intended use and similar technological characteristics (materials, function, purpose, etc.) as the predicate device, which has already been cleared by the FDA.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not applicable to this type of submission.
Here's a breakdown of the information that is available based on the provided document:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on substantial equivalence rather than fulfilling specific performance metrics through a new study.
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. No new performance study with a test set was conducted for this 510(k) submission.
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. No new performance study with a test set was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. No new performance study with a test set was conducted.
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 physical orthosis, not an AI software, and no comparative effectiveness study of this nature was conducted.
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. As no new performance study was conducted, there was no specific ground truth established for a test set. The "ground truth" for regulatory clearance is the substantial equivalence to the predicate device, implicitly relying on the established safety and effectiveness of that predicate.
8. The sample size for the training set:
Not Applicable. No AI model or algorithm was developed for this device; therefore, there is no training set.
9. How the ground truth for the training set was established:
Not Applicable. As no AI model or algorithm was developed, there is no training set or corresponding ground truth establishment.
Summary of Device Acceptance (based on provided text):
The Otto Bock Cranial Helmet was accepted by the FDA on the basis of Substantial Equivalence to the predicate device, Fit Well's P.A.P. Orthosis (K012804). The similarities cited for substantial equivalence include:
- Identical Indications for Use
- Same Materials (Surlyn, Polyurethane, Silicone and Velcro)
- Custom Fabrication
- Same Function
- Same Purpose
- Same Shape
- Same Diagnosis
- Prescription Devices
- Follow FDA Special Controls
The differences noted were minor (manufacturing location), which did not alter the fundamental safety and effectiveness profile compared to the predicate.
{0}------------------------------------------------
K04215
Otto Bock®
SEP - 9 2004
QUALITY FOR LIFE
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
| 1. Submitter's Name: | OTTO BOCK HealthCare LP |
|---|---|
| 2. Address: | Two Carlson Parkway N., Suite 100 Minneapolis, MN 55447-4467 |
| 3. Telephone: | 763-489-5153 |
| 4. Contact Person: | Shelley Stockman |
| 5. Date Prepared: | September 4, 2004 |
| 6. Registration Number: | 2182293 |
B. Device#### 1. Name: Cranial Helmet 2. Trade Name: Cranial Helmet Cranial Orthosis 3. Common Name: Classification Name: Cranial Orthosis 4. 5. Product Code: MVA 6. Class: II 7. Regulation Number: 882.5970
North American Headquarters: Two Corlson Porkway N., Suite 100 • Plynouth, MN 55447 • B00.655.4963 Customer Support & Distribution Center: 14630 28th Avenue N. • Plymouth, MN 3547 • 800.320.400 • Fux 800.902.2549 Fabrication Services: 14800 28th Avenue N., Suite 110 . Plymouth, MN 55447 . 800.795.8846 . Fox 800.810.10.10. Utah Design & Manufacturing Center: 3820 W. Great Lokes Drive • Salı Lake City, UT 84120 • 801.956.2400 Minnesota Deslgn & Manufacturing Center: 820 Sundial Drive • Woite Park, MN 56387 • 800.377.0336 • Fax 320.251.01.10 Customer Satisfaction Hatline: 877,627.6563 · www.ottobockus.com
{1}------------------------------------------------
C. Identification of Legally Marketed Devices
| 1. Name: | Fit Well's P.A.P. Orthosis |
|---|---|
| 2. K Number: | K012804 |
| 3. Date Cleared: | January 17, 2002 |
D. Description of the Device
The Cranial Helmet is a cranial orthosis custom fabricated to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry and shape.
The Cranial Helmet is comprised of the same materials as the P.A.P. Orthosis (K012804). It is not packaged for sale, as it is custom fabricated. It will be fitted to the infant at the time of delivery. The Cranial Helmet has no accessories, and no options are available for the infant or the caregiver (parent).
Caregivers are instructed as to: wear, care, cautions, and risks.
The transparent thermoplastic is Surlyn which varies in thickness from 1/8 inch to 3/8 inch depending upon the desired characteristics. The helmet is fabricated from a cast taken of an infant's head. There are no standard sizes, models, variances, etc.
A polyurethane foam strip is applied to the posterior border at the base of the occipital to provide suspension and anti-rotation. Each Cranial Helmet is fastened with a Velcro strap.
Each infant with a Cranial Helmet must be under the care of a physician. The helmet is a Prescription Device.
E. Intended Use Statement
The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
{2}------------------------------------------------
F. Technological Characteristics Summary
Similarities between both Cranial Orthosis' are the following
- Identical Indications for Use .
- . Same Materials (Surlyn, Polyurethane, Silicone and Velcro)
- . : Custom Fabrication
- Function Same ●
- Purpose Same �
- . Shape
- Diagnosis .
- Prescription Devices .
- Follow FDA Special Controls
Differences are the P.A.P. is fabricated by Fit-Well Prosthetic and Orthotic Center in Salt Lake City, Utah and the OTTO BOCK Cranial Helmet is fabricated at our technical center in Minneapolis, Minnesota.
REVISION: 09/04/2004
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three horizontal lines that curve upwards, resembling a stylized human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2004
OTTO Bock HealthCare LP c/o Mr. William Jackson W.F. Jackson Associates, Limited 2247 Jennifer Lane St. Paul, Minnesota 55109-2851
Re: K041215
Trade/Device Name: Cranial Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: Class II Product Code: MVA Dated: August 6, 2004 Received: August 17, 2004
Dear Mr. Jackson:
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 erth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic reral in also qualisy of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Mr. William Jackson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your of substantial equivalence of your device to a legally premated 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 if you tother of Compliance at (301) 594-4648. 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 other general miletimational 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,
Mark A. Wilkinson
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
{5}------------------------------------------------
Indications for Use
510(k) Number : K04215
Device Name: Cranial Helmet
Indications for Use:
- . Prescription Device
- The Cranial Helmet (cranial orthosis) is a device that is intended for medical . purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eightenn months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
- Contraindications: Infants with Synostosis or Hydroccphalus .
Prescription Use X (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)
Mark A. Milken
(Division Sign-G Division of General, Restorative, and Neurological Devices
510(k) Number.
Page 1 of 1
04 1215
§ 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)).