(14 days)
K993714, 001219, 001353, 001354
Not Found
No
The device description details a system for heating bone staples with user-adjusted controls for current and time, and provides visual and audible feedback. There is no mention of AI, ML, or any form of intelligent processing or learning from data.
No.
The device is described as a heating unit for a bone staple system, used for fixation of fractures, not for treating a disease or condition itself.
No
The device description indicates that the BioWarm™ is used to heat bone staples for fixation of craniofacial bone fractures. It provides current delivery, visual and audible indications of current flow and completion. This is a therapeutic device, not a diagnostic one.
No
The device description explicitly details hardware components like an on/off switch, user-adjusted controls, a console, an electrode handle, and a button switch, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of unloaded craniofacial bone fractures". 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 "OSStaple™ bone staple system". It applies heat to a staple for fixation. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Indications for the OSStaple" are fixation of unloaded craniofacial bone fractures and cranioplasty. The OSStaple™ is contraindicated for craniofacial patients with a skull thickness less than the selected prong length.
Product codes (comma separated list FDA assigned to the subject device)
76 JEY, 87 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
Craniofacial bone
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 (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.
K993714, 001219, 001353, 001354
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
§ 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 the text "APPENDIX IV (510(k) Summary)" along with a handwritten number above it. The number appears to be K023488. There is a line drawn underneath the number. The text is in a standard font and is left-aligned.
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 ટા.
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.
Indications for the OSStaple" are fixation of unloaded craniofacial bone fractures and The OSStaple™ is contraindicated for craniofacial patients with a skull cranioplasty. thickness less than the selected prong length.
- Device Description d.
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.
10/14/02
(Date)
2
Image /page/2/Picture/0 description: The image shows a logo with a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, wave-like quality. The logo is surrounded by text that curves along the perimeter of a circle, with the words "PUBLIC HEALTH SERVICE" visible at the top and "DEPARTMENT OF HEALTH" at the bottom. The text is also in black, and the overall design has a formal and official appearance.
GEPARTMENT OF HEALTH & HUMAN SERVICES
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: K023488
Trade/Device Name: Memograph® Staple System (OSStaple™) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: 76 JEY and 87 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 (OS) 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 Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX III (Indication For Use)
Device Name: Memograph® Staple System (OSStaple
Indications for the OSStaple™ are fixation of unloaded craniofacial bone fractures and cranioplasty. The OSStaple™ is contraindicated for craniofacial patients with a skull thickness less than the selected prong length.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Curry
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K031188
Page 12 of 14