(304 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a cerclage cable, with no mention of AI or ML.
Yes.
The device is intended to provide stabilization of bony segments for various trauma and surgical applications, which is a therapeutic purpose.
No
The device is a cerclage cable, used for stabilization of bony segments after surgical procedures. Its function is to provide mechanical support, not to diagnose medical conditions.
No
The device description clearly states it is a physical cable made of UHMWPE and bismuth trioxide, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DPR Cable is a surgical implant used to stabilize bony segments within the body. It is a physical device used during surgery, not a test performed on a sample outside the body.
- Intended Use: The intended uses listed are all related to surgical procedures for stabilizing bones after trauma or surgery.
- Device Description: The description details the material and physical properties of the cable, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status. The radiographic visualization is for surgical guidance and post-operative assessment of the implant's position, not for diagnosing a disease.
Therefore, the DPR Cable falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DPR Cable is intended for:
- Spinal applications include sublaminar and intraspinous process wiring for trauma ● applications.
- o Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- Sternotomy indications including the "rewiring" of osteomized sternums.
- Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
The device is intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene (UHMWPE) cerclage cable. The device is intended to provide stabilization of bony segments.
The DPR Cable is made of woven ultra-high molecular weight polyethylene fibers which incorporate bismuth trioxide (Bi₂O₃). The addition of bismuth trioxide allows for radiographic visualization both during and after surgical procedures. The device is supplied sterile in double-layer packages. The DPR Cable is intended for single patient use only. DPR Cable is MR safe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, trochanteric, sternotomy, olecranon, ankle, patella, shoulder
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)
Biocompatibility testing: Cytotoxicity and leaching was performed on the Dyneema Purity® RP material.
Biomechanical testing: Included fatigue strength, tensile force, creep and wear-debris and knot strength. Testing results indicate that the device is equivalent to the predicate device.
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.
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
DSM Biomedical Mr. Tom Maguire Senior Director Global Clinical and Regulatory 735 Pennsylvania Drive Exton, Pennsylvania 19341
Re: K143716
Trade/Device Name: DSM Biomedical DPR Cable Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: September 16, 2015 Received: September 17, 2015
Dear Mr. Maguire:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
Page 2 – Mr. Tom Maguire
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Original 510(k) Premarket Notification DSM Biomedical DPR Cable
Image /page/2/Picture/2 description: The image shows the logo for DSM, a company focused on health, nutrition, and materials. The logo features a colorful, abstract circular design on the left, composed of overlapping shapes in shades of blue, purple, green, and orange. To the right of the circular design is the company name, "DSM," in bold, blue letters. Below the company name is the tagline, "BRIGHT SCIENCE. BRIGHTER LIVING."
Indications for Use Statement
The DPR Cable is intended for:
- Spinal applications include sublaminar and intraspinous process wiring for trauma ● applications.
- o Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- Sternotomy indications including the "rewiring" of osteomized sternums.
- Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
The device is intended for single patient use only.
Prescription Use
Over-The-Counter Use__
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
3
Image /page/3/Picture/1 description: The image shows the DSM logo. The logo consists of a colorful abstract design on the left and the letters "DSM" in bold blue on the right. Below the letters, there is a tagline that reads "BRIGHT SCIENCE. BRIGHTER LIVING." in a smaller blue font.
510(k) Summary
| K143716 | |
|---|---|
| Submitted By: | DSM Biomedical |
| 735 Pennsylvania Drive | |
| Exton, PA 19341 | |
| Contact Person: | Tom Maguire |
| Sr. Director, Global Clinical & Regulatory Affairs | |
| E: Tom.Maguire@dsm.com | |
| P: 484-713-2146 | |
| F: 484-713-2903 | |
| Date Prepared: | October 26, 2015 |
| Device: | |
| Trade Name: | DPR Cable |
| Common/Usual Name: | Orthopedic Wire |
| Classification Name: | Bone Fixation Cerclage |
| Classification Regulation: | 21 CFR 888.3010 |
| Device Class: | Class II |
| Device Code: | JDQ |
| Advisory Panel: | General and Plastic Surgery |
| Predicate: | Titanium Alloy Songer Cable System/ Atlas Cable System |
| (Medtronic Sofamor Danek , K920201) | |
| Reference Devices: | Iso-Elastic Cable (Kinamed Inc., K102834) |
| Orthopedic Polyethylene Cable (Smith&Nephew, | |
| K924141) |
Device Description:
The DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene
4
(UHMWPE) cerclage cable. The device is intended to provide stabilization of bony segments.
The DPR Cable is made of woven ultra-high molecular weight polyethylene fibers which incorporate bismuth trioxide (Bi₂O₃). The addition of bismuth trioxide allows for radiographic visualization both during and after surgical procedures. The device is supplied sterile in double-layer packages. The DPR Cable is intended for single patient use only. DPR Cable is MR safe.
Intended Use:
The DPR Cable is intended:
- Spinal applications including sublaminar and intraspinous process wiring for . trauma applications.
- . Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- . Sternotomy indications including the "rewiring" of osteomized sternums.
- Trauma surgery indications including olecranon, ankle, patella and some shoulder . fracture rewiring.
The device is intended for single patient use only.
5
Technological Characteristics:
| Characteristic | DSM Biomedical
DPR Cable
K143716 | Medtronic Sofamor Danek
Titanium Alloy Songer Cable
System/Atlas™ Cable System
K920201 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The DPR Cable is intended:
Spinal applications including
sublaminar and intraspinous
process wiring for trauma
applications. Trochanteric reattachment after
trochanteric osteotomy following
total hip arthroplasty. Sternotomy indications including
the “rewiring” of osteomized
sternums. Trauma surgery indications
including the olecranon, ankle,
patella and some shoulder
fracture rewiring. The device is intended for single
patient use only. | The Atlas™ Cable System can be utilized
anywhere monofilament wires have been
previously found to be indicated. The
indications are:
Spinal applications would include
sublaminar and intraspinous
process wiring for trauma
applications. Another
application would be the use of
Atlas™ Cable System for
instrumentation involved in the
correction of scoliotic,kyphotic
and lordotic deformities. The
stainless steel system may also
be used with other stainless steel
spinal implants such as the Unit
Rod or Luque Rod or wherever
"wiring" may help secure the
attachment of other implants.
The titanium system may also be
used with other titanium
implants. Trochanteric reattachment after
trochanteric osteotomy following |
| Characteristic | DSM Biomedical
DPR Cable
K143716 | Medtronic Sofamor Danek
Titanium Alloy Songer Cable
System/Atlas™ Cable System
K920201 |
| | | total hip arthroplasty.
Sternotomy indications would include the “re-wiring” of osteomizing sternums. Trauma surgery indications would include olecranon, ankle, patella and some shoulder rewiring. |
| Materials of
Composition | Dyneema Purity® UHMWPE and Bi2O3 | Titanium Steel and Titanium Alloy |
| Device
Characteristics | Flexible, high strength | High strength |
| Radiopaque | Yes | Yes |
| Fixation | Knot | Integral Crimp |
| Dimensions | 4 mm | 1 mm diameter |
| Tensile Strength
of fixated loop | 2289+/-35 | 1005+/-49 |
| Fatigue Strength | 1559N |