(14 days)
K993714, 001219, 001353, 001354
No
The device description focuses on user-adjusted controls and automatic cessation based on circuitry, with no mention of AI or ML technologies.
Yes
The device is used for the fixation of maxillofacial and mandibulofacial fractures and osteotomies, which is a therapeutic intervention.
No
The device, BioWarm™, is described as a system that heats bone staples for fixation of fractures and osteotomies. Its function is to deliver current for heating, not to diagnose a medical condition or disease.
No
The device description explicitly details hardware components such as an on/off switch, user-adjusted controls, a console, an electrode handle, and a button switch. It describes the physical interaction and function of these hardware elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "fixation of maxillofacial and mandibulofacial fractures and osteotomies." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "BioWarm™" which is a heating unit used with a bone staple system. It delivers current to heat staples for surgical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Original indications for the Memograph® Staple System are as defined in 510(k) K993714. Additional indications fro the OSStaple" are the fixation of maxillofacial and mandibulofacial fractures and osteotomies.
Product codes
JEY, HRS
Device Description
The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm™ electrode and will cease if the button is released prior to the automatic cessation by the circuitry
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial and mandibulofacial
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K993714, 001219, 001353, 001354
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K023486". The characters are written in a cursive style with thick, dark lines. A horizontal line is drawn beneath the string.
APPENDIX IV (510(k) Summary)
OCT 31 2002
BioWarm™ Product:
BioMedical Enterprises, Inc. (BME) intends to introduce a device modification to the original approved Warmsystem to heat shape memory Nitinol staples (the "OSStaple™") to achieve compression.
- Submittor Information a.
BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 Contact: Dr. W. Casey Fox (President)
Date Prepared: September 25, 2002
- Classification name: Staple, Fixation, Bone b. Common/Usual Name: Bone staple Proprietary Name: OSStaple™, BioWarm™
- Intended Use: C.
Original indications for the Memograph® Staple System are as defined in 510(k) K993714. Additional indications fro the OSStaple" are the fixation of maxillofacial and mandibulofacial fractures and osteotomies.
d. Device Description
The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm™ electrode and will cease if the button is released prior to the automatic cessation by the circuitry
1
Substantial Equivalence: e.
The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are represented with the BioWarm™ modification.
(Signature)
W. Casey Fox, Ph.D. P.E.
President BioMedical Enterprises, Inc.
10/19/02
(Date)
**2**
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered in the image. The background is white.
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized eagle-like symbol in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central symbol consists of three curved lines that resemble the head and wing of an eagle.
### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# OCT 31 2002
Dr. W. Casey Fox President BioMedical Enterprises, Incorporated 14785 Omicron Drive, Suite 205 San Antonio. Texas 78245
Re: [K023486](https://510k.innolitics.com/search/K023486)
Trade/Device Name: Memograph® Staple System Regulation Number: 872.4760 and 888.3030 Regulation Name: Bone Plate and Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: II Product Code: JEY and HRS Dated: October 15, 2002 Received: October 17, 2002
Dear Dr. Fox:
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.
**3**
## Page 2 - Dr. Fox
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.
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) 594-4613. 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,
Timothy A. Ulatowski
Timothy Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
**4**
[K023486](https://510k.innolitics.com/search/K023486)
## APPENDIX III (Indication For Use)
Device Name: Memograph® Staple System
Original indications for the Memograph® Staple System are as defined in 510(k) [K993714](https://510k.innolitics.com/search/K993714). Additional indications fro the OSStaple™ are the fixation of maxillofacial and mandibulofacial fractures and osteotomies.
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
Susan Rumer
Division of Anesthesiolo , General Hospitar, Infection Control, Denta
510(k) Number _
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