(149 days)
No
The summary describes a physical orthosis for cranial molding and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an orthosis that applies pressure to an infant's cranium to improve cranial symmetry and shape, treating plagiocephaly, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device described is an orthosis used for treatment (applying pressure to an infant's cranium to improve shape), not for diagnosing medical conditions. It is indicated to treat plagiocephaly, which is a diagnosis that would be made by a physician prior to prescription of this device.
No
The device description explicitly states it is a "proprietary transparent ionomer based thermoplastic molded orthosis," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a physical orthosis (a helmet or band) that is applied externally to an infant's head. Its purpose is to physically reshape the skull by applying pressure.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens from the patient.
The description clearly indicates a therapeutic device used for physical intervention, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The indications for use would include infants from three to eighteen months of age to be 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.
Product codes (comma separated list FDA assigned to the subject device)
MVA
Device Description
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.
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 three to eighteen 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)
Not Found
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.
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
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 #1 | ||
| Salt 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.
1
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.
2
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
3
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)