(65 days)
The Dunamis Force DFX Tensile Tape Sutures are indicated for use in approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries".
The Dunamis Force DFX Tensile Tape Sutures are sterile single use sutures used in approximation and/or ligation of soft tissues, including use in allograft tissue for orthopaedic surgeries. Force DFX Tensile Tape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force DFX Tensile Tape suture is flat in shape and differs from USP requirements (not USP). It is available in 1.5mm, 2mm, tape width sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE). Force DFX Tensile Tape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.
This document describes a 510(k) premarket notification for the "Dunamis Force DFX Tensile Tape Sutures". It compares the new device to a legally marketed predicate device, the "Teleflex Force Fiber OrthoTape Polyethylene Non-Absorbable Surgical Sutures (K150438)".
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets in this document. Instead, the document claims that the Dunamis device's performance is "identical to the Teleflex device characteristics" and meets "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture." The reported performance for the Dunamis device is that it meets these requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suture Average Width (equivalent to predicate and USP #2) | Meets requirements (identical to predicate) |
| Suture Average Height (equivalent to predicate and USP #2) | Meets requirements (identical to predicate) |
| Suture Length (equivalent to predicate) | Meets requirements (identical to predicate) |
| Knot-Pull Tensile Strength (meets USP #2 requirements) | Meets USP tensile strength requirements for USP size #2 suture |
| Needle Attachment Strength (meets USP #2 requirements) | Meets USP needle attachment requirements for USP size #2 suture |
| Sterility (maintains sterility) | Sterility test performed, implied to meet criteria for sterile product |
| Biocompatibility (equivalent to predicate) | Risk profile identical to predicate, no changes related to biocompatibility |
| Physical/performance characteristics (equivalent to predicate) | Identical to predicate characteristics |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that "Dunamis LLc. has established a contract manufactured product specifications that has been accepted by Teleflex Medical which documents and secures the product configuration and required test methods to assure the device is equivalent in performance and to all the elements of Teleflex 510k K150438." This suggests that the testing likely followed the same or similar protocols as the predicate device, but specific details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device submission focused on physical and mechanical properties, not diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device submission focused on physical and mechanical properties.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support systems where human interpretation is a key factor. This submission concerns the physical properties and performance of a surgical suture.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device submission for a physical surgical suture, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be established by:
- USP (United States Pharmacopeia) standards: Specifically, "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture."
- Predicate device characteristics: The Dunamis device claims to have "identical" characteristics and "risk profile identical" to the Teleflex Force Fiber OrthoTape (K150438). This implies that the performance established for the predicate device serves as the benchmark.
8. The Sample Size for the Training Set
Not applicable. This is a medical device submission for a physical surgical suture, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Dunamis LLC Mr. Robert O. Dean Compliance Systems International, LLC 1083 Delaware Avenue Buffalo, NY 14209
Re: K153746
Trade/Device Name: Dunamis Force DFX Tensile Tape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: December 21, 2015 Received: December 29, 2015
Dear Mr. Dean:
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
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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.
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.
David Krause -S
- for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153746
Device Name
Dunamis Force DFX Tensile Tape Sutures
Indications for Use (Describe)
The Dunamis Force DFX Tensile Tape Sutures are indicated for use in approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries".
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K Summary
-
- Submitter: Dr. Prithvi Raj Chavan Dunamis, LLc. 693 Sherling Lake Rd. Apt. 122 Greenville, AL. 36037 (p) 731-217-2533 Email: dr.raj76@gmail.com
2. Date Prepared: 03/02/16
3. Name of Device:
- Proprietary Trade Name: Dunamis Force DFX Tensile Tape Suture -
- -Common Name: Suture, Polyethylene Synthetic Non-Absorbable Surgical Suture
- -Classification Name: Non-absorbable poly (ethylene terephthalate) surgical suture
- Code: GAT -
- -Regulation:878.5000
4. Identification of the legally marketed device (predicate):
Teleflex Force Fiber OrthoTape Polyethylene Non-Absorbable Surgical Sutures, K150438.
-
- Description of the device: The Dunamis Force DFX Tensile Tape Sutures are sterile single use sutures used in approximation and/or ligation of soft tissues, including use in allograft tissue for orthopaedic surgeries. Force DFX Tensile Tape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force DFX Tensile Tape suture is flat in shape and differs from USP requirements (not USP). It is available in 1.5mm, 2mm, tape width sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE). Force DFX Tensile Tape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.
| ldentifier | Size & Construct | Color |
|---|---|---|
| DFX0020S | Force DFX Tensile Tape Braided WhiteSize 2mm 30", C-7 Needle Taper Pt.,1/2C, 38.9mm | Composed of undyed (white) Ultra HighMolecular Weight Polyethylene (UHMWPE). |
| DFX0021S | Force DFX Tensile Tape Braided WhiteSize 2mm 18", C-7 Needle Taper Pt.,1/2C, 38.9mm | Composed of undyed (white) Ultra HighMolecular Weight Polyethylene (UHMWPE). |
| DFX0022S | Force DFX Tensile Tape Braided BlueSize 2mm 30" C-7 ,Needle Taper Pt.,1/2C, 38.9mm | Composed of Ultra High Molecular WeightPolyethylene (UHMWPE). Blue: Color:chromium-cobalt-aluminum oxide <2% byweight |
| DFX0023S | Force DFX Tensile Tape Braided BlueSize 2mm 18" C-7, Needle Taper Pt.,1/2C, 38.9mm | Composed of Ultra High Molecular WeightPolyethylene (UHMWPE). Blue: Color:chromium-cobalt-aluminum oxide <2% byweight |
| DFX0024S | Force DFX Tensile Tape Braided WhiteSize 1.5mm 30", HC-5 Needle 1/2 C,Taper Point, 25.9mm | Composed of undyed (white) Ultra HighMolecular Weight Polyethylene (UHMWPE). |
| DFX0025S | Force DFX Tensile Tape Braided WhiteSize 1.5mm 18" HC-5 Needle 1/2 C,Taper Point, 25.9mm | Composed of undyed (white) Ultra HighMolecular Weight Polyethylene (UHMWPE). |
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| DFX0026S | Force DFX Tensile Tape Braided BlueSize 1.5mm 30", HC-5 Needle 1/2 C,Taper Point, 25.9mm | Composed of Ultra High Molecular WeightPolyethylene (UHMWPE). Blue: Color:chromium-cobalt-aluminum oxide <2% byweight |
|---|---|---|
| DFX0027S | Force DFX Tensile Tape Braided BlueSize 1.5mm 18", HC-5 Needle 1/2 C,Taper Point, 25.9mm | Composed of Ultra High Molecular WeightPolyethylene (UHMWPE). Blue: Color:chromium-cobalt-aluminum oxide <2% byweight |
-
- Indications for Use: "The Dunamis Force DFX Tensile Tape Sutures are indicated for use in approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries".
- 7 . Identification of Risk Analysis: The risk profile is identical to the risk analysis and profile generated by Teleflex Force Fiber Polyethylene Non-Absorbable Surgical Sutures, K150438. There are no changes or new concerns related to safety and effectiveness including biocompatibility, sterility, physical/performance characteristics, and clinical studies or labeling (other than brand name, part numbers and "manufactured for" indication).
-
- Discussion of the device characteristics: The Dunamis device characteristics are identical to the Teleflex device characteristics as established in Teleflex 510k K150438 and as contract manufactured by Teleflex for Dunamis.
-
- Description of Device Design and Test Methods: Dunamis LLc. has established a contract manufactured product specifications that has been accepted by Teleflex Medical which documents and secures the product configuration and required test methods to assure the device is equivalent in performance and to all the elements of Teleflex 510k K150438. Test Methods include:
- Suture Average Width
- . Suture Average Height
- Suture Length
- Knot-Pull Tensile Strength
- Needle Attachment Strength
- Sterility test
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.