(22 days)
K993714, 001219, 001353, 001354
Not Found
No
The device description details manual controls and basic circuitry for current delivery and feedback, with no mention of AI/ML terms or functionalities.
No.
The device is described as an "ancillary device" for the OSStaple" staple system and its function is to heat staples, not directly treat a medical condition or disease.
No
Explanation: The device is described as an "ancillary device" for a staple system, providing heat and indications of current delivery and contact. Its function is to assist in a procedure rather than to diagnose a medical condition.
No
The device description explicitly mentions hardware components such as an on/off switch, user-adjusted controls, a console, an electrode handle, and a button switch, indicating it is a physical device with electrical components, 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 "as an ancillary device for the OSStaple" staple system." This indicates a device used in a surgical or clinical setting to assist with a medical procedure (bone stapling), not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a device that heats a bone staple using electrical current. This is a physical intervention on a medical device (the staple) and ultimately on the patient's bone, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the BioWarm™ is a medical device used in a surgical context, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BioWarm" is indicated for use an an ancillary device for the OSStaple" staple system.
The Memograph® Staple is intended for:
- hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysic osteotomy, and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
JDR
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
hand, foot bone, proximal tibial metaphysic
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K04303 page 142
APPENDIX IV (510(k) Summary)
OCT 1 7 2002
Product: BioWarm
(Osstaple™ staple system)
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 ப்.
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
- b. Classification name: Staple, Fixation, Bone Common/Usual Name: Bone staple Proprietary Name: OSStaple™, BioWarm
- Intended Use: C.
The BioWarm" is indicated for use as an ancillary device for the OSStaple" staple system.
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
page 2 of 2
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.
9/24/02
(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 bold, serif font. The text is centered in the image and is the only element present.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. W. Casey Fox, Ph.D. P.E. President BioMedical Enterprises, Inc. 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
Re: K023203
Trade/Device Name: OSStaple™ Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: JDR Dated: September 24, 2002 Received: September 25, 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. Iisting 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.
3
Page 2 – Dr. W. Casey Fox
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 N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOL 3>03
APPENDIX III (Indication For Use)
Device Name: Memograph® Staple System
Indications for use: The Memograph® Staple is intended for:
- hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysic osteotomy, and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109) OR
Over-The-Counter Use
Mark A. Millan
(Optional Format 1-2-96)
(Division Sign-Off)
sion of General, Restorative and Neurological Devices
510(k) Number _K033203