(304 days)
The DPR Cable is intended for:
- Spinal applications include 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.
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.
The provided text is a 510(k) Premarket Notification for a medical device called the "DPR Cable." This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than detailing a clinical study with acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested details regarding acceptance criteria, study design for proving device performance (especially for an AI/algorithm), ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies do not apply to this type of regulatory submission for this medical device.
The document discusses biomechanical testing to show equivalence in performance characteristics to predicate devices, but this is not an AI/algorithm study.
Here's an attempt to extract relevant information, highlighting where the requested details are not applicable based on the provided text's context as a 510(k) for a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating equivalence to predicate devices through biomechanical testing, rather than explicit criteria for an AI's accuracy or clinical performance. The table in the document (Page 5) compares the technological characteristics and certain performance metrics with the predicate device.
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (DPR Cable K143716) | Predicate Device Performance (Titanium Alloy Songer Cable System/Atlas™ Cable System K920201) |
|---|---|---|---|
| Indications for Use | Similar to predicate | See "Indications for Use Statement" | See table |
| Materials of Composition | Biocompatible, suitable for intended use | Dyneema Purity® UHMWPE and Bi2O3 | Titanium Steel and Titanium Alloy |
| Device Characteristics | Functional, strong | Flexible, high strength | High strength |
| Radiopaque | Yes | Yes | Yes |
| Fixation | Secure/effective | Knot | Integral Crimp |
| Dimensions | Suitable for application | 4 mm | 1 mm diameter |
| Tensile Strength of fixated loop | Equivalent to or better than predicate | 2289+/-35 | 1005+/-49 |
| Fatigue Strength | Equivalent to or better than predicate | 1559N | <44.5N |
| Biocompatible | Yes | Yes | Yes |
| Reusable | Single Use Only | Single Use Only | Single Use Only |
| Sterilization Method | Effective and safe | EtO | Irradiation |
| Packaging | Sterile, protective | Double layer | Not available |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for biomechanical tests like tensile strength or fatigue strength, only the results of these tests. This is not a clinical "test set" in the context of an AI/algorithm.
- Data Provenance: Not applicable. The data comes from in-vitro biomechanical testing of the device itself, not from clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI studies, refers to expert labeling of data. For this physical device, "ground truth" would be established by validated engineering tests and measurements, comparing against known standards or predicate device performance. No human experts are detailed for "ground truth" establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert labeling of data, which is not relevant for biomechanical testing of a physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biomechanical testing, the "ground truth" is provided by established engineering standards and measurements for properties like tensile strength, fatigue strength, creep, and knot strength. It's an objective measurement of physical properties.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established:
- Not applicable.
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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.
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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
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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)
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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 Biomedical735 Pennsylvania DriveExton, PA 19341 |
| Contact Person: | Tom MaguireSr. Director, Global Clinical & Regulatory AffairsE: Tom.Maguire@dsm.comP: 484-713-2146F: 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
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(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.
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Technological Characteristics:
| Characteristic | DSM BiomedicalDPR CableK143716 | Medtronic Sofamor DanekTitanium Alloy Songer CableSystem/Atlas™ Cable SystemK920201 |
|---|---|---|
| Indications forUse | The DPR Cable is intended:Spinal applications includingsublaminar and intraspinousprocess wiring for traumaapplications. Trochanteric reattachment aftertrochanteric osteotomy followingtotal hip arthroplasty. Sternotomy indications includingthe “rewiring” of osteomizedsternums. Trauma surgery indicationsincluding the olecranon, ankle,patella and some shoulderfracture rewiring. The device is intended for singlepatient use only. | The Atlas™ Cable System can be utilizedanywhere monofilament wires have beenpreviously found to be indicated. Theindications are:Spinal applications would includesublaminar and intraspinousprocess wiring for traumaapplications. Anotherapplication would be the use ofAtlas™ Cable System forinstrumentation involved in thecorrection of scoliotic,kyphoticand lordotic deformities. Thestainless steel system may alsobe used with other stainless steelspinal implants such as the UnitRod or Luque Rod or wherever"wiring" may help secure theattachment of other implants.The titanium system may also beused with other titaniumimplants. Trochanteric reattachment aftertrochanteric osteotomy following |
| Characteristic | DSM BiomedicalDPR CableK143716 | Medtronic Sofamor DanekTitanium Alloy Songer CableSystem/Atlas™ Cable SystemK920201 |
| 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 ofComposition | Dyneema Purity® UHMWPE and Bi2O3 | Titanium Steel and Titanium Alloy |
| DeviceCharacteristics | Flexible, high strength | High strength |
| Radiopaque | Yes | Yes |
| Fixation | Knot | Integral Crimp |
| Dimensions | 4 mm | 1 mm diameter |
| Tensile Strengthof fixated loop | 2289+/-35 | 1005+/-49 |
| Fatigue Strength | 1559N | <44.5N |
| Biocompatible | Yes | Yes |
| Reusable | Single Use Only | Single Use Only |
| SterilizationMethod | EtO | Irradiation |
| Packaging | Double layer | Not available |
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Biocompatibility and Performance Data:
Biocompatibility testing
The biocompatibility of the materials used in the manufacturer of the DPR Cable, Dyneema Purity® fibers and bismuth trioxide, are established by their long historical clinical use in medical devices and the combination of these materials does not raise any new questions of safety and effectiveness. 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.
Substantial Equivalence:
The DPR Cable is substantially equivalent in intended use, tensile strength, and fixation strength to the predicate device (Titanium Alloy Songer Cable System/Atlas™ Cable System, Medtronic Sofamor Danek, K920201). The DPR Cable is substantially equivalent to the material characteristics and creep and wear performance of the reference devices (Iso-Elastic Cable, Kinamed Inc., K102834 and Orthopedic Polyethylene Cable, Smith & Nephew, K924141).
§ 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.