(89 days)
No
The summary describes a custom-made physical orthosis (helmet) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the "treatment of abnormal head shape," which indicates a therapeutic purpose.
No
Explanation: The device is described as a "cranial orthosis helmet" used for "treatment of abnormal head shape," which indicates it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "custom made orthosis" and a "helmet," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Lerman & Son Cranial Orthosis Helmet is a physical device worn externally on the head to reshape the skull. It does not involve testing biological samples.
- Intended Use: The intended use is for the physical treatment of abnormal head shape, not for diagnostic testing.
Therefore, based on the provided information, the Lerman & Son Cranial Orthosis Helmet is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).
Product codes
MVA
Device Description
The Lerman & Son Cranial Orthosis Helmet is a custom made orthosis used to treat children between the ages of three and eighteen months for abnormal head shapes. Through the concavity formed during the design of this helmet, the skull is encouraged to grow in a more normal manner.
The Lerman & Son Cranial Orthosis Helmet is intended for use by or under the direction of a physician for treatment of abnormal infant head shape (positional/ deformational plagiocephaly).
The Lerman & Son Helmet is substantially equivalent to Orthomerica's STARband helmet cleared by FDA via K001167. A Substantial Equivalency table has been included within this submission.
Materials: Helmet-Copolymer plastic; Padding-Closed cell foam polypropylene
Straps: Velcro
Final shape: Dependant upon infant head shape
Size: Side to side - 4"-5-1/2" Front to back - 6"-7-1/2"
Weight: 8 - 12 ounces
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial / head
Indicated Patient Age Range
infants from 3-18 months of age
Intended User / Care Setting
Used by or under the direction of a physician
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)
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
K012830 PG1 of 3
NOV 2 0 2001
510(k) Summary Lerman & Son Cranial Orthosis Helmet Lerman & Son
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
Lerman & Son 8710 Wilshire Blvd. Beverly Hills, California 90211 Phone: (310) 659-2290 Facsimile: (310) 659-1601
Contact Persons: Max Lerman, President
Date: August 20, 2001
807.92(a)(2)
Trade Name:
Lerman & Son Cranial Orthosis Helmet
Common Name: Cranial Helmet
Classification Name(s): Orthosis, Cranial
Classification Number: MVA
807.92(a)(3)
Predicate Device(s)
Orthomerica
STARband
Additional substantial equivalence information is provided in the following Substantial Equivalence Comparison Table.
1
510(k) Summary Lerman & Son Cranial Orthosis Helmet Lerman & Son
807.92(a)(5)
Intended Use(s)
The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).
Device Description
The Lerman & Son Cranial Orthosis Helmet is a custom made orthosis used to treat children between the ages of three and eighteen months for abnormal head shapes. Through the concavity formed during the design of this helmet, the skull is encouraged to grow in a more normal manner.
The Lerman & Son Cranial Orthosis Helmet is intended for use by or under the direction of a physician for treatment of abnormal infant head shape (positional/ deformational plagiocephaly).
The Lerman & Son Helmet is substantially equivalent to Orthomerica's STARband helmet cleared by FDA via K001167. A Substantial Equivalency table has been included within this submission.
| Materials: | Helmet-Copolymer plastic; Padding-Closed cell foam polypropylene |
|---|---|
| Straps: | Velcro |
| Final shape: | Dependant upon infant head shape |
| Size: | Side to side - 4"-5-1/2" |
| Front to back - 6"-7-1/2" | |
| Weight: | 8 - 12 ounces |
2
)(012830 P&G of 3
510(k) Summary
Lerman & Son Cranial Orthosis Helmet
Lerman & Son
| Substantial Equivalence Comparison Table | ||
|---|---|---|
| Orthomerica STARband K001167 | Lerman & Son Cranial Orthosis Helmet This submission | |
| Indications for Use | Treatment of abnormal infant head shape (positional/deformational plagiocephaly) | Treatment of abnormal infant head shape (positional/deformational plagiocephaly) |
| Materials | Copolymer plastic/Closed Cell | |
| Polyethylene Foam/Velcro strap | Copolymer plastic/Closed Cell | |
| Polyethylene Foam/Velcro strap | ||
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Daily Wear Time | 23 hrs./day | 23 hrs./day |
| Avg. Time to Effectiveness (patients age 3-7 mos.) | 2 - 4 months | 2 - 4 months |
| Contraindications for Use | Craniosynostosis/ Hydrocephalus | Craniosynostosis/ Hydrocephalus |
| Method of Manufacture | Custom from mold | Custom from mold by Certified Orthotist |
4-1 P ..... . Comparison Tahle Cubet
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. Max Lerman President Lerman & Son 8710 Wilshire Boulevard Beverly Hills, California 90211
Re: K012830
Trade/Device Name: Lerman & Son Cranial Orthosis Helmet Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MVA Dated: August 20, 2001 Received: August 23, 2001
Dear Mr. Lerman:
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. Max Lerman
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 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 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,
Mark A. Millener
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
Applicant: Lerman & Son
NOV 2 0 2001 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Lerman & Son Cranial Orthosis Helmet
Indications For Use:
The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a 11te Lennan & Soll Cramar Of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over The Counter_ Prescription Use
(Per 21 CFR, 801.109)
(Optional Format 1-2-99)
Mark N Millerson
0 K017830
General, Restorative and Neurological Devices
510(k) Number K012830