(149 days)
The indications for use would include infants from three to eighteen months of age to be treated for Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of the P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. This device is to be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.
It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly.
This 510(k) summary (K012804) for the Plagiocephalic Applied Pressure (P.A.P.) Orthosis does not provide the detailed information requested regarding acceptance criteria, study design, or performance metrics in the way that would be expected for a device proving performance against specific acceptance criteria. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets predefined performance benchmarks through a clinical study.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on substantial equivalence based on function, purpose, and intended use to existing predicate devices (D.O.C. band K964992 and STARband K001167). There are no specific performance criteria or benchmarks listed for the P.A.P. Orthosis itself.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. As this is a substantial equivalence submission, it does not detail a clinical study with a test set.
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):
This information is not provided. There is no mention of a test set or ground truth establishment by experts for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. No test set is described.
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:
This information is not provided. The device is an orthosis, not an AI-assisted diagnostic tool, so an MRMC study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is an orthosis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as there is no described study with a ground truth. The "ground truth" in a substantial equivalence submission is essentially the proven safety and efficacy of the predicate devices.
8. The sample size for the training set:
This information is not provided. There is no mention of a training set as would be found in an algorithm-based device.
9. How the ground truth for the training set was established:
This information is not provided. No training set is described.
Summary based on the provided text:
The submission for the P.A.P. Orthosis (K012804) is a 510(k) premarket notification demonstrating substantial equivalence to two legally marketed predicate devices: the D.O.C. band (K964992) and the STARband (K001167).
- Acceptance Criteria & Performance: The document does not specify quantitative acceptance criteria or detailed performance data for the P.A.P. Orthosis itself. Instead, it argues that the device is "similar in function and purpose" and has the "same intended use" as the predicate devices, implying that their established safety and effectiveness are the basis for acceptance. The performance is indirectly "reported" by stating it "more completely encompasses the cranium with clear copolymer plastic" compared to the predicate, while serving the same purpose.
- Study Data: No specific study data, sample sizes, or ground truth establishment methods are detailed because this type of submission relies on demonstrating similarity to existing, approved devices rather than presenting novel clinical study results.
- Ground Truth (Implicit): The "ground truth" for the P.A.P. Orthosis's suitability is the regulatory history and proven safety/efficacy of the predicate devices (D.O.C. band and STARband) for treating moderate to severe nonsynostotic positional plagiocephaly, brachycephaly, or scaphocephaly in infants aged three to eighteen months.
In essence, the "study" proving the device meets "acceptance criteria" here is the comparison made by the applicant to existing predicate devices, and the FDA's subsequent determination that this comparison is valid for substantial equivalence.
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JAN 1 7 2002
510 (k) Section - E-1
510(k) Summary
Application Date: August 14, 2001
| Applicant Name: | Scott E. Allen, C.P. | Phone No: | (801)364-3100 |
|---|---|---|---|
| Address: | 50 South 900 East #1Salt Lake City, UT 84102 | Fax No: | (801)575-5462 |
Scott E. Allen, C.P. Contact Person Trade Name: Plagiocephalic Applied Pressure Orthosis P.A.P. Orthosis Common Name: Orthosis Classification: Cranial Orthosis
The P.A.P. is similar in function and purpose to both the D.O.C. band, manufactured by cranial Technologies Inc. and is classified by the FDA as a cranial Orthosis #510 (k) K964992. And the STARband, manufactured by Orthomerica and is classified by the FDA as a cranial Orthosis #510 (k) K001167. It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly. The D.O.C. band (K964992) is a band that goes around the infants head made from copolymer plastic lined with a single thickness of aliplast foam. The intended use is to treat moderate to severe nonsynostotic positional plagiocephaly. The STARband (K001167) is more encompassing than the D.O.C. band it goes around the infant's head made from copolymer plastic lined with one or more pieces of aliplast foam. The intended use is to treat moderate to severe nonsynostotic positional Plagiocephaly. The P.A.P orthosis more completely encompasses the cranium with clear copolymer plastic. The intended use is the same as the D.O.C. and STARband orthoses. s. This material has been widely used in upper and lower extremity orthotics, body jackets, and flexible prosthetic sockets.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three horizontal lines forming its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Scott E. Allen President Personal Performance Medical Corp. Fit-Well Prosthetic and Orthotic Center 50 South, 900 East #1 Salt Lake City, UT 84102
Re: K012804
Trade/Device Name: Plagiocephalic Applied Pressure (P.A.P.) Orthosis Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: October 20, 2001 Received: October 24, 2001
Dear Mr. Allen:
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. Scott E. Allen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally premiures noticated 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 Oinsi gonetar in 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,
Sincerely yours,
Mark N. Melkerson
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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Section D-2
Page_1_of_1_
Applicant: Scott E. Allen C.P.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Plagiocephalic Applied Pressure Orthosis (P.A.P. orthosis)
The indications for use would include infants from three to eighteen months of age to be The Indications for accombalic, Brachycephalic, or scaphocephalic shaped heads by a diagnosed with Flagloophalls, Brathy P.A.P. Orthosis is to apply pressure to prominent medical physiolan: The pulpose or an to improve cranial symmetry and/or shape. This regions of an intent of cribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
for
| (Division Sign-Off) |
|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K012804 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- |
(Per 21 CFR 801.109) (Optional Format 1-2-96)
§ 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)).