Not Found
No
The document describes a mechanical implant for fracture fixation and does not mention any AI or ML components or functionalities.
Yes
The device is used as an aid to fracture fixation for skeletal fractures, which directly treats injuries and restores function.
No
Explanation: The device, "TriMed tension band sleds," is described as a "wire implant" used for "fracture fixation." It is a treatment device, not one that diagnoses conditions.
No
The device description clearly states it is a physical implant made of stainless steel or titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the fixation of skeletal fractures through tension band wiring. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "wire implant" used as an "aid to fracture fixation." This further reinforces its role as a surgical implant.
- 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) as a surgical implant.
N/A
Intended Use / Indications for Use
The TriMed tension band sleds are intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. They are intended to be used in conjunction with screws, washers, and/or plates of the same material. Any fracture that is applicable to the approach of tension band wiring currently being done with separate component pins and wires is a suitable indication for this single component implant.
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, of application malleolus, distal ulna, distal ulna, distal humerus, and proximal humerus.
Product codes (comma separated list FDA assigned to the subject device)
LRN, NDL
Device Description
The TriMed tension band sleds are double 'U' shaped wire implants that are used as an aid to fracture fixation. They are manufactured from either medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy and vary in diameter from .028" to .250". Detailed dimensional characteristics of the devices has been provided in enclosure 1 of the original 510(k) application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fractures of the olecranon, patella, malleolus, distal ulna, distal humerus, and proximal humerus.
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
May 29, 2001
Food and Drug Administration Center for Devices and Radiologic Health 510(k) Document Mail Center, HFZ-401 9200 Corporate Blvd Rockville, MD 20850
Robert J Medoff, MD 159 Ku'ukama St Kailua, HI 96734 Phone: 808-261-4658 Fax: 808-263-2036 email: rmedoff@lava.net
510(k) Submission, supplemental information Re: Tension band wire forms 510(k) number: K010545
Attention: Document Control Clerk
Dear Ms. Zimmerman:
Thank-you for the information regarding the 510(k) summary. I was unable to find the exact statute, but I did find some information on your web site that discusses the requirements of 21CFR 807.92.
I have attached the summary sheet as you have requested. Please let me know if there is any other information that you require.
Yours truly,
Rc Muddy
Robert J. Medoff, MD
ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ 340710g57 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------្រីឲ្យ
1
Page 1 of 2 510(k) summary
May 29, 2001
510(k) SUMMARY.
510(k) nmbr: K010545
Submitted by: TriMed. Inc. Prepared by: Contact person: Date prepared: Proprietary Name: Classification Name: Common/Usual Name:
25768 Parada Drive Valencia, California 91355 800-633-7221 Robert J. Medoff, MD Robert J. Medoff, MD May 29, 2001 TriMed tension band sled Tension band wire TriMed tension band wire TriMed Patellar tension band wire TriMed Olecranon tension band wire TriMed Malleolar tension band wire TriMed Ulnar Styloid tension band wire TriMed Proximal humerus tension band wire TriMed Distal humerus tension band wire TriMed Patellar sled TriMed Olecranon sled TriMed Malleolar sled TriMed Ulnar Styloid sled (other names reserved for future sites of application)
Sample Predicate Devices:
TriMed small fragment clamp and buttress pin (510(k) K951303) Smith and Nephew Kirschner wires and Steinman pins Zimmer Kirschner wires and Steinman pins
Class: II, Sec. 888.3040 Smooth or threaded metallic bone fixation fastener.
Classification Panel: These devices are reviewed by an orthopaedic panel (888)
Product Code: LRN
2
.
Description of the device:
The TriMed tension band sleds are double 'U' shaped wire implants that are used as an aid to fracture fixation. They are manufactured from either medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy and vary in diameter from .028" to .250". Detailed dimensional characteristics of the devices has been provided in enclosure 1 of the original 510(k) application.
Intended use of the Device:
The TriMed tension band sleds are intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. They are intended to be used in conjunction with screws, washers, and/or plates of the same material. Any fracture that is applicable to the approach of tension band wiring currently being done with separate component pins and wires is a suitable indication for this single component implant.
Technological characteristics:
The TriMed tension band wires sleds have identical characteristics to existing pins and wires commonly in use. Sample existing implant sales literature is supplied with enclosure 5 of the original 510(k) application, and material specification sheets are supplied with enclosure 6 of the original 510(k) application.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three horizontal lines forming its wings and a curved line representing its body.
JUN - 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert J. Medoff, M.D. Tri-Med, Inc. 159 Ku'ukama Street Kailua, Hawaii 96734
Re: K010545
Trade Name: TBW (Tension Band Wire) Regulation Number: 888.3040 Regulatory Class: II Product Codes: NDL Dated: February 17, 2001 Received: February 23, 2001
Dear Dr. Medoff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
4
Page 2 – Robert J. Medoff, M.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
hheeeermsto
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
Page_supplemental 1 of 3
510(k) Nmber: K010545
Device Name: Tension Band Wire
Indication for use:
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, of application malleolus, distal ulna, distal ulna, distal humerus, and proximal humerus.
The decision to use a specific implant as well as the size and shape of the implant used I he uccision to use a specific xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx the circumstances and configuration of the injury.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Precscription use: X (Per 21 CFS 801.109) OR
Over-the-counter Use __
(Optional Format 1-2-96)
Bstmhrellos for cam
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative
Division of General, Devices Division of South of Cources
1010945 510(k) Number