(89 days)
K-9644992, K-001167, K-000861, K-010273
Not Found
No
The device description details a physical, custom-molded helmet fabricated using traditional methods based on a plaster impression and manual correction of a mold. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
Yes
The device is intended to treat infants with moderate to severe non-synostotic positional plagiocephaly, which is a medical condition, by applying pressure to improve cranial symmetry or shape. This aligns with the definition of a therapeutic device as it is used for the treatment or management of a medical condition.
No.
The device description indicates that its purpose is to apply pressure to an infant's cranium to improve cranial symmetry or shape due to positional plagiocephaly. It describes a treatment device (an orthosis) and does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it is a thermoplastic helmet made of physical materials (polypropylene, polyethylene foam) and fabricated using a physical mold of the infant's head. It is a physical orthosis, not software.
No, 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 BeckerBand™ is a physical device (a helmet) that is applied externally to the infant's head. It works by applying pressure to reshape the skull.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the infant. Its function is purely mechanical and external.
The description clearly indicates that this is a medical device used for treatment (applying pressure to improve cranial symmetry), not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. 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 for use: Infants with synostosis or hydrocephalus.
Product codes
MVA
Device Description
The BeckerBand™ is a thermoplastic helmet prepared with USP Class VI materials, consisting of a polypropylene or polypropylene-polyethylenc copolymer outer sholl. To this shell is thermobonded a modium density polychylone form inner lining. The device is fabricated by talany a plaster-of-paris impression of the infants head. This immession is filled with a plaster shorize a positive mold of the skull. The deformity is corrected to the desired configuration by building the inold up in selected areas with molding material. This corrected model serves as a template for pregaration of the Bocker Band orthosis, The completed device applies gentle pressure to the clovated arcus of the skull while leaving space for cranial growth in the depressed regions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium (infant's head)
Indicated Patient Age Range
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)
K-9644992, K-001167, K-000861, K-010273
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
FEB 0 5 2002 510(k) SUMMARY OF SAFETY AND EFFECTIVENISS
I. Submitter; Dr. James H. Campbell, Becker Orthopedic, Troy, Michigan, Ph. 248-588-6961
II. Classification: Class II.
III. Common or usual name: Cranial orthosis
IV, Proprictary Name: BeckerBand™ Cranial Remolding Orthosis
IV. Registration No.: 1824252
V. Classification Name: Cranial Orthosis, Code MVA, CFR 882.5970
VI. Performance standards: None, Special Controls required.
VII, Description: The BeckerBand™ is a thermoplastic helmet prepared with USP Class VI materials, consisting of a polypropylene or polypropylene-polyethylenc copolymer outer sholl. To this shell is thermobonded a modium density polychylone form inner lining. The device is fabricated by talany a plaster-of-paris impression of the infants head. This immession is filled with a plaster shorize a positive mold of the skull. The deformity is corrected to the desired configuration by building the inold up in selected areas with molding material. This corrected model serves as a template for pregaration of the Bocker Band orthosis, The completed device applies gentle pressure to the clovated arcus of the skull while leaving space for cranial growth in the depressed regions.
VIII. Labels and Labels and Instructions for Use are provided including precautions, and materials required by the special controls to which this product is subject.
IX. Instructions for Use: For treatment of positional plagiocephaly.
X. Substantial Equivalence: The BockerBand 146 is substantially equivalent to the classified device (Cranial Orthosis), to the Doc Band device of Cranial Technology, cleared under K-9644992, the OPI Band cleared by Orthouserica Products, Inc. in K-001167, the Craniocap cleared by Gilette Childrens, in K-000861, and the Cranial Molding Orthosis cleared by Orthotic Solutions in K-010273. The devices are made of similar if not identical materials widely used in the orthotic industry, by well-known technology, under carefully controlled conditions, The BeckerBand" complies with the Class II special controls cstablished for this device in the classification process to provide assurance of safety and effectiveness.
The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.
Xf. Clinical Discussion and Literature: A comprehensive review of the Sierature was provided.
XII. Indications for Use
Intended for medical purposes to apply pressure to prominant regions of an inforts crazing to inprove cranial symmetry or shape. To treat inflants from the of are with moderate to severe non-synostonal playiocuphaly, including plagiocophalic- brachycephalic- scaphocophalic-shaped heads.
Contraindications for use: Infants with synostosis or hydrocephalus.
(End of Summary)
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The stylized image resembles a bird or abstract human figure, composed of three curved lines. The logo is printed in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2002
James H. Campbell, Ph.D. Director, Product Development Engineering & Tech Services Becker Orthopedic Appliance Company 635 Executive Dr. Troy, Michigan 48083
Re: K013719
Trade/Device Name: BeckerBand™ Cranial Remolding Orthosis Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: November 3, 2001 Received: November 8, 2001
Dear Dr. Campbell:
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 - Dr. James H. Campbell
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wif anow you to ough finding of substantial equivalence of your device to a legally prematics notification. The 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 If you desire spoonly at not 10- 75- 10-2 in vitro diagnostic devices), please contact the Office of additionally 21 Of ICT Car 3659. Additionally, for questions on the promotion and advertising of Compliance at (201) 27 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 Oinsion 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,
Sincerely yours,
Mark N Melkersen
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
Indications for Use
KOLIZ 719 510(k) Number: NA
Device Name: BeckerBand™
Indications for Use:
Intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. 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 for use: Infants with synostosis or hydrocephalus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
ದ
Concurrence of CDRH, Office of Device, Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The-Counter Use (Optional Format 1-2-96)
I CFR 801.109)
(Division Sign-Off)
:
Division of General, Restorative
013719
and Neurological Devices
510(k) Number