(107 days)
Not Found
No
The device description and intended use describe a physical band and its application, with no mention of software, algorithms, or data processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended for medical purposes to improve cranial symmetry or shape in infants with cranial deformities, which falls under therapeutic use.
No
The device is a therapeutic device designed to apply pressure to an infant's cranium to improve cranial symmetry or shape, not to diagnose a condition.
No
The device description explicitly states it consists of a plastic band, a fastener with Velcro strap, and a strut, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body. This device is a physical band applied externally to the infant's head.
- IVD devices are used to provide information for diagnosis, monitoring, or treatment. While this device is used for treatment (improving cranial shape), it does not analyze biological samples to provide diagnostic or monitoring information.
- The description clearly states its purpose is to apply pressure to the cranium. This is a mechanical action, not an in vitro diagnostic test.
The device description and intended use clearly indicate it is a medical device used for external treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.
Product codes
MVA
Device Description
The DOC Band-PostOp consists of a plastic band, a fastener with Velcro strap, and, in some models, a strut to hold height at the top of the head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium
Indicated Patient Age Range
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)
Clinical data demonstrate that the DOC Band-PostOp, as indicated for use post-operatively, in the absence of craniosynostosis, is as safe and effective as the DOC Band.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
KD42385
DEC 17 2004
510(k) SUMMARY
Cranial Technologies, Inc.'s DOC Band Post-Op™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Cranial Technologies, Inc. 1395 West Auto Drive Tempe, AZ 85284 Phone: (480) 505-1840 Facsimile: (480) 505-1844
Timothy R. Littlefield Contact Person:
August 5, 2004 Date Prepared:
Name of Device and Name/Address of Sponsor
DOC Band-PostOp™
Cranial Technologies, Inc. 1395 West Auto Drive Tempe, AZ 85284 Phone: (480) 505-1840 Facsimile: (480) 505-1844
Common or Usual Name
Cranial Remodeling Band, Cranial Helmet, Molding Helmet
Classification Name
Cranial Orthosis, 21 C.F.R. § 882.5970
Predicate Devices
Cranial Technologies, Inc.'s DOC Band (K964992)
1
Intended Use / Indications for Use
This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.
Technological Characteristics
The DOC Band-PostOp consists of a plastic band, a fastener with Velcro strap, and, in some models, a strut to hold height at the top of the head.
Substantial Equivalence
The DOC Band-PostOp has the same intended uses, technological characteristics, and principles of operation as its predicate device, the cleared DOC Band, and very similar indications. The new indication for use does not raise any new questions of safety or effectiveness. Furthermore, clinical data demonstrate that the DOC Band-PostOp, as indicated for use post-operatively, in the absence of craniosynostosis, is as safe and effective as the DOC Band. Thus, the DOC Band-PostOp is substantially equivalent. A summary of substantial equivalence between the devices is provided in the following Substantial Equivalence Chart.
2
CRANIAL TECHNOLOGIES, INC.'S DOC BAND-POSTOP SUBSTANTIAL EQUIVALENCE CHART
| | DOC Band-PostOp™ | DOC Band®
(K964992) |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The device is intended for medical
purposes to apply pressure to
prominent regions of an infant's
cranium to improve cranial
symmetry or shape. | The device is intended for medical
purposes to apply pressure to
prominent regions of an infant's
cranium to improve cranial symmetry
or shape. |
| Indications for Use | Indicated "for adjunctive use in
infants from three to eighteen
months of age whose synostosis
has been surgically corrected, but
who still have moderate to severe
cranial deformities including
plagiocephalic-, brachycephalic-,
or scaphocephalic-shaped heads." | Indicated "to treat infants from three
to eighteen months of age with
moderate to severe non-synostotic
positional plagiocephaly, including
plagiocephalic-, brachycephalic-,
scaphocephalic-shaped heads." |
| Contraindications | Infants with craniosynostosis or
hydrocephalus. | Infants with craniosynostosis or
hydrocephalus. |
| Technological
Characteristics | Band (constructed of USP Class
VI semi-rigid polypropylene-
polyethylene copolymer outer
surface thermobonded to a
medium density polyethylene
foam (Pelite) inner lining)
Plastic and Steel Fastener with
Velcro Strap
Strut (in Bi-Cal design only)
Elastic Bands (in Bi-Cal design
only) | Band constructed of USP Class VI
semi-rigid polypropylene-polyethylene
copolymer outer surface
thermobonded to a medium density
polyethylene foam (Pelite) inner
lining)
Plastic and Steel Fastener with Velcro
Strap
Elastic Bands (in Bi-Cal design only) |
| Biocompatibility | Yes. | Yes. |
| Sterilization | Not provided sterile. | Not provided sterile. |
| Standards with
which the Device
Complies | No performance standards apply.
The device complies with FDA's
special controls for cranial
orthosis devices. | No performance standards apply. The
device complies with FDA's special
controls for cranial orthosis devices. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Mr. Timothy R. Littlefield, MS Vice President Cranial Technologies, Inc. 1395 West Auto Drive Tempe, Arizona 85284
Re: K042385
Trade/Device Name: DOC Band-PostOp™ Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MVA Dated: December 9, 2004 Received: December 10, 2004
Dear Mr. Littlefield:
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.
4
Page 2 - Mr. Timothy R. Littlefield, MS
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 (240) 276-0120. 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 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,
Alan Watts
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 Statement
510(k) Number (if known): K042385
Device Name: DOC Band-PostOp™
Indications for Use:
This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off
Page
Division of General, Restorative. and Neurological Devices
510(k) Number 1(012365