(743 days)
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.
The Danmar Products Cranial Adjustive Prosthesis is constructed with front and rear sections that are comprised of an inner, soft foam that is %" to ¼" thick, and an outer shell made of a semi-rigid plastic.
The provided document is a 510(k) summary for the Danmar Products Cranial Adjustive Prosthesis. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics as would typically be found for a diagnostic or AI-driven device.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving quantitative performance metrics, the submission aims to show that the new device is as safe and effective as a device already legally marketed.
Here's a breakdown of the requested information based solely on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated/Inferred) | Reported Device Performance |
|---|---|
| The device performs as intended. | "The literature on this and similar devices demonstrates that the Danmar Products Cranial Adjustive Prosthesis performs as intended." |
| Biocompatibility: nonirritating and nontoxic. | "Biocompatibility data demonstrates that the device's inner lining is nonirritating and nontoxic." |
| Durability: will not break or shatter when subjected to impact. | "Test data demonstrates that the device will not break or shatter when subjected to impact." |
| Substantial equivalence to predicate devices (Cranial Technologies Dynamic Orthotic Cranioplasty—DOC Band, Michigan Cranial Helmet). | "The Danmar Products Cranial Adjustive Prosthesis has the same technological characteristics as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- The document mentions "The literature on this and similar devices," "Biocompatibility data," and "Test data." However, no specific sample sizes for any test sets are provided.
- Data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of evaluation is common for diagnostic devices where "truth" is often expert consensus or pathology. The Cranial Adjustive Prosthesis is a physical medical device (orthosis).
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI Assistance
- Not applicable. The device is a Cranial Adjustive Prosthesis, not an AI-driven or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For biocompatibility: Likely laboratory test results (e.g., cytotoxicity, sensitization tests) demonstrating non-irritating and non-toxic properties. The "ground truth" is established by the results adhering to predefined safety thresholds in these tests.
- For durability: Likely mechanical stress tests (e.g., impact tests) demonstrating the device's structural integrity. The "ground truth" is the device surviving these tests without breaking or shattering.
- For "performs as intended": This typically refers to the mechanism of action and clinical function being consistent with the intended use. In the context of a 510(k), this is often supported by technical characteristics matching those of predicate devices and general understanding of how such devices work. No specific "ground truth" (like pathology or outcomes data) is explicitly described in terms of a clinical study for this device. The "literature" serves as the evidence.
8. The Sample Size for the Training Set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8.)
Summary of the Study Discussed in the Document:
The document describes the "Summary of Device Evaluation" as:
- Review of literature on this and similar devices to demonstrate intended performance.
- Biocompatibility data to show the inner lining is non-irritating and non-toxic.
- Test data to demonstrate the device will not break or shatter when subjected to impact.
This is a traditional 510(k) submission, where the focus is on showing equivalence to predicate devices and fulfilling basic safety tests, rather than conducting complex clinical trials with defined acceptance criteria and ground truths as would be expected for novel diagnostic technologies or AI/ML devices.
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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 •
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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 ·
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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
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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
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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
§ 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)).