(743 days)
Not Found
No
The 510(k) summary describes a physical cranial prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is intended to apply pressure to an infant's cranium to improve cranial symmetry and shape in cases of nonsynostotic positional plagiocephaly, which is a therapeutic intervention.
No
The device is described as an adjustive prosthesis used to apply pressure and improve cranial symmetry and shape. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is constructed with physical components (foam and plastic shell), indicating it is a hardware device, not software-only.
Based on the provided information, 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.
- Device Function: The Danmar Products Cranial Adjustive Prosthesis is a physical device applied externally to an infant's head to reshape the skull. It does not involve testing biological samples.
- Intended Use: The intended use clearly describes a physical intervention to improve cranial symmetry and shape, not a diagnostic test.
Therefore, this device falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Danmar Products Cranial Adjustive Prosthesis is intended for prescription use to be used 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 14 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.
Product codes
MVA
Device Description
The Danmar Products Cranial Adjustive Prosthesis is constructed with front and rear Fax sections that are comprised of an inner, soft foam that is %" to ¼" thick, and an outer shell made of a semi-rigid plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium/Head
Indicated Patient Age Range
infants from 3 to 14 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
The literature on this and similar devices demonstrates that the Danmar Products Cranial Adjustive Prosthesis performs as intended. Biocompatibility data demonstrates that the device's inner lining is nonirritating and nontoxic. Test data demonstrates that the device will not break or shatter when subjected to impact.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a black and white drawing of a stylized feather. The feather curves from left to right, tapering to a point on the left side. The right side of the feather has several curved lines extending from the main body, resembling barbs. The feather has a simple, minimalist design.
SPORTS/ME EQUIPMENT
DANMAR PRODUCTS, INC.
221 Jackson Industrial Drive • Ann Arbor, MI. 48103 • USA
KO13452
OCT 3 1 2003
510(k) SUMMARY
Danmar Products, Inc. Cranial Adjustive Prosthesis
October 17, 2001
Submitter Information:
Danmar Products, Inc. 221 Jackson Industrial Drive Ann Arbor, MI 48103
| Submitter's Name: | Karen A. Lindner |
|---|---|
| Phone: | 734-761-1990 |
Device Narne:
| Proprietary Name: | Cranial Adjustive Prosthesis |
|---|---|
| Common Name: | Cranial Band or Helmet |
| Classification Name: | Cranial Orthosis |
Predicate Device Equivalence:
Substantial equivalence is claimed to the Cranial Technologies Dynamic Orthotic Cranioplasty--DOC Band, cleared for commercial distribution through the approved evaluation of an automatic Class III designation, and to the Michigan Cranial Helmet cleared for commercial distribution per K003630.
(800) 783-1998 Device Description:
(734) 761-1990
The Danmar Products Cranial Adjustive Prosthesis is constructed with front and rear Fax sections that are comprised of an inner, soft foam that is %" to ¼" thick, and an outer (734) 761-8977 shell made of a semi-rigid plastic.
e-mail: danmarpro@aol.com
Internet: http://www. danmarproducts.com
• Creating Specialized Products for Special Needs Since 1968 •
1
Image /page/1/Picture/0 description: The image is a black and white drawing of a feather. The feather is curved and has a pointed tip. There are several barbs coming out of the feather's shaft. The barbs are also curved and pointed.
PORTS / MI EQUIPMENT
Image /page/1/Picture/19 description: The image shows a black and white drawing of a hand. The hand is drawn in a simple, cartoonish style, with thick black lines outlining the shape of the hand and fingers. The hand is curved, with the fingers pointing upwards and the thumb pointing downwards. The hand appears to be reaching out or gesturing.
DANMAR PRODUCTS, INC.
221 Jackson Industrial Drive • Ann Arbor, MI. 48103 • USA
Intended Use:
The Danmar Products Cranial Adjustive Prosthesis is intended for prescription use to be used to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry andlor shape in infants from 3 to 14 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.
Comparison of Technological Characteristics:
The Danmar Products Cranial Adjustive Prosthesis has the same technological characteristics as the predicate devices.
Summary of Device Evaluation:
The literature on this and similar devices demonstrates that the Danmar Products Cranial Adjustive Prosthesis performs as intended. Biocompatibility data demonstrates that the device's inner lining is nonirritating and nontoxic. Test data demonstrates that the device will not break or shatter when subjected to impact.
Conclusions:
Based on the above, we concluded that the Danmar Products Cranial Adjustive Prosthesis is substantially equivalent to a legally marketed predicate device and is safe and effective for its intended use.
(800) 783-1998
(734) 761-1990
Fax (734) 761-8977
e-mail: danmarpro@aol.com
Internet: http://www. danmarproducts.com
· Creating Specialized Products for Special Needs Since 1968 ·
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized design of a human figure, with flowing lines representing the body and head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Karen A. Lindner, C.E.O. Danmar Products, Inc. 221 Jackson Industrial Dr. Ann Arbor, MI 48103
Re: K013452
Trade/Device Name: Cranial Adjustive Prothesis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: October 15, 2003 Received: October 17, 2003
Dear Ms. Linder:
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
3
Page 2 - Ms. Karen A. Linder, C.E.O.
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.
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 (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.
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
SPORTS/ME EQUIPMENT
221 Jackson Industrial Drive • Ann Arbor, MI. 48103 • US
DANMAR PRODUCTS, IN
Image /page/4/Picture/3 description: The image is a black and white line drawing of a stylized feather. The feather curves from left to right, with the tip of the feather on the right side. There are four curved lines on the left side of the feather, which are meant to represent the barbs of the feather.
Device Name:
Danmar Products Cranial Adjustive Prosthesis
INDICATIONS FOR USE:
The Danmar. Products Cranial Adjustive Prosthesis is intended for prescription use to be used to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry andlor shape in infants from 3 to 14 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.
Mark n Milkern
Estorative
Number K013452
(800) 783-1998
(734) 761-1990
Fax (734) 761-8977
e-mail: danmarpro@aol.com
Internet: http://www. danmarproducts.com