(490 days)
No
The device description details a mechanical clamping device with a ratcheted locking system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is described as a fixation and stabilization device for sternal fractures and sternotomy, which is a supportive rather than therapeutic function.
No
Explanation: The device is described as a "stabilization and fixation" device for anterior chest wall fractures, including sternal fixation. Its function involves providing mechanical support (clamping and interlocking) to stabilize the sternum, not to diagnose a condition.
No
The device description clearly states it is a "two-piece clamping device" manufactured from "TI-6AL-4V Titanium Alloy," indicating it is a physical hardware device, not software.
Based on the provided information, the KLS-Martin Sternal Talon is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the stabilization and fixation of anterior chest wall fractures, specifically sternal fixation. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical clamping device made of titanium alloy, designed to be implanted or used externally to hold bone fragments together.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The Sternal Talon does not interact with or analyze biological specimens.
Therefore, the KLS-Martin Sternal Talon is a surgical device used for mechanical fixation, not an in vitro diagnostic device.
No
Explanation: There is no mention of "Predetermined Change Control Plan" (PCCP) in the provided clearance letter. PCCP is a specific program for managing future modifications to a device, and its authorization would be explicitly stated if applicable.
Intended Use / Indications for Use
The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy Sternal and reconstructive procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw. The KLS Martin Sternal Talon is manufactured from TI-6AL-4V Titanium Alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, sternum
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.
Ethi-Pack Surgical Stainless Steel Suture (K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K930015), Lorenz Sternal Closure System (K033740)
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.
KLS Martin Sternal Plating System (K032413)
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
0.1/3
510(K) SUMMARY
SEP - 7 2006
| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director RA/QA |
| Date of Summary: | 4 May 2005 |
| Device Name: | KLS Martin Sternal Talon |
| Trade Name: | Sternal Talon |
| Common Name: | Sternal Closure System |
| Classification
Name and Number: | Single/Multiple Component Metallic Bone
Fixation Appliances and Accessories (21 CFR
888.3030) |
| Regulatory Class: | II |
| Predicate Devices: | Ethi-Pack Surgical Stainless Steel Suture
(K931271) |
| | Pioneer Silicoat Sternal Cable (K993286) |
| | PectoFix DSF System (K000694) |
| | Synthes Sternal Fixation System
(K010943) |
| | Synthes (USA) Sterile Sternal Fixation System
(K050041) |
| | Sternal Band (K930015) |
| | Lorenz Sternal Closure System (K033740) |
1
051165
Intended Use:
Device
Description:
The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy Sternal and reconstructive procedures.
The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw.
The KLS Martin Sternal Talon is manufactured from TI-6AL-4V Titanium Alloy
Technological Characteristics:
Similarities to Predicate:
The KLS-Martin Sternal Talon is similar in intended use and indications for use as the Ethi-Pack Surgical Stainless Steel Suture (K931271), Pioneer Silicoat Stemal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Stemal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413)
Differences to Predicate:
The KLS-Martin Sternal Talon is a two-piece interlocking system that does not utilize stainless steel sutures, titanium plates or titanium screws for fixation that are utilized in the Ethi-Pack Surgical Stainless Steel Suture C-2
2
(K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413). The KLS Martin Sternal Talon uses curved foot plates to apply pressure medially to ensure fixation.
Substantial Equivalence:
The KLS-Martin Sternal Talon is substantially equivalent in intended use and indications for use as the Ethi-Pack Surgical Stainless Steel Suture (K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413)
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
SEP - 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KLS Martin L.P. % Ms. Jennifer Damato Director, Regulatory Affairs and Quality Assurance 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Rc: K051165
Trade/Device Name: KLS Martin Sternal Talon Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 16, 2006 Received: June 20, 2006
Dear Ms. Damato:
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 r rease of a result 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 - Ms. Jennifer Damato
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Brudno
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
051165
510(k) Number (if known):
KLS Martin Sternal Talon Device Name:
Indications For Use:
The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aulana buclins for Mayn
(Division Sign Off)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K051145
B-1