(65 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical strength of the suture, with no mention of AI or ML.
No
The device, Dunamis Force DFX Tensile Tape Sutures, is described as being used for the "approximation and/or ligation of soft tissues" and is a "suture." While it is used in surgery, its function is mechanical support (holding tissues together), not active treatment (therapy) of a disease or condition.
No
Explanation: The device description states that the Dunamis Force DFX Tensile Tape Sutures are used for approximation and/or ligation of soft tissues in orthopedic surgeries. This describes a surgical tool, not a device used to diagnose medical conditions.
No
The device description clearly states it is a physical suture made of UHMWPE, a hardware component, and the performance studies focus on physical properties like tensile strength and dimensions.
Based on the provided information, the Dunamis Force DFX Tensile Tape Sutures are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical suture used for surgical purposes. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Dunamis Force DFX Tensile Tape Sutures are a surgical tool used to physically repair or connect tissues during surgery.
N/A
Intended Use / 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".
Product codes
GAT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, orthopaedic surgeries
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)
Test Methods include: Suture Average Width, Suture Average Height, Suture Length, Knot-Pull Tensile Strength, Needle Attachment Strength, Sterility test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human profile with three faces merging into a single form, suggesting unity and collaboration.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 White | |
| Size 2mm 30", C-7 Needle Taper Pt., | ||
| 1/2C, 38.9mm | Composed of undyed (white) Ultra High | |
| Molecular Weight Polyethylene (UHMWPE). | ||
| DFX0021S | Force DFX Tensile Tape Braided White | |
| Size 2mm 18", C-7 Needle Taper Pt., | ||
| 1/2C, 38.9mm | Composed of undyed (white) Ultra High | |
| Molecular Weight Polyethylene (UHMWPE). | ||
| DFX0022S | Force DFX Tensile Tape Braided Blue | |
| Size 2mm 30" C-7 ,Needle Taper Pt., | ||
| 1/2C, 38.9mm | Composed of Ultra High Molecular Weight | |
| Polyethylene (UHMWPE). Blue: Color: | ||
| chromium-cobalt-aluminum oxide |