(139 days)
Not Found
No
The device description and intended use are for surgical sutures, which are physical medical devices and do not involve software or data processing that would typically incorporate AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
A therapeutic device is one that treats a disease or condition. This device is a suture, used for approximation or ligation of soft tissues, which is a supportive rather than therapeutic function.
No
Explanation: The device is described as "sutures" used for "approximation and or ligation of soft tissues," which indicates a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly states it is a physical surgical suture made of UHMWPE and polypropylene, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "approximation and or ligation of soft tissues including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant/tool used inside the body during a procedure.
N/A
Intended Use / Indications for Use
The Dunamis Force DFX Sutures, Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and or ligation of soft tissues including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Dunamis Force DFX Sutures are sterile single use sutures are used in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries. The technical design configuration for both USP Size 2 and Size 5 are as follows:
USP Size 2 (metric 5)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 2 (oversized) x 36" length, single armed HC-5 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile.
USP Size 5 (metric 7)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 5 (oversized) x 36" length, single armed HS48 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile
Materials:
Co-Braid of UHMWPE and Blue Monofilament Polypropylene Non-absorbable Surgical Sutures meets USP requirements except for diameter.
Polymer/Colorant: Ultra High Molecular Weight Polyethylene (white): None
Polypropylene (blue): [bhthalocyaninato (2-)] copper with a concentration not to exceed 0.5% by weight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Dunamis has established contract manufactured product specifications with Telefical that documents the product configuration and required test methods to assure the device is identical in performance and to all the elements of Teleflex 510(k) K063778. Because the sutures are manufactured to the same specifications as those cleared in K063778, data provided in K063778 may be leveraged to support equivalence, including testing in accordance to the USP for non-absorbable sutures, biocompatibility testing performed in accordance with ISO 10993-1, and stability testing. No additional testing was performed on the contractmanufactured product.
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.
Not Found
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
§ 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2015
Dunamis, LLC % Mr. Robert O. Dean Lexamed 705 Front Street Toledo, Ohio 43605
Re: K150327
Trade/Device Name: Dunamis Force DFX Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture. Regulatory Class: Class II Product Code: GAT Dated: March 25, 2015 Received: March 31, 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 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
1
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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Dunamis Force DFX Suture
Indications for Use (Describe)
The Dunamis Force DFX Sutures, Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and or ligation of soft tissues including use in cardiovascular surgeries and the 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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Pollohing Samlowi (JWD #45-6749 EIF
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Image /page/3/Picture/0 description: The image shows the logo for Dunamis Medical. The word "Dunamis" is in gray, with the word "Medical" in a smaller font below it. To the right of "Dunamis" is an orange swoosh above the words "inspiring movement" in orange.
510K Summary - Rev. 2
-
- Submitter: Dr. Prithvi Raj Chavan
Dunamis, LLC. 693 Sherling Lake Rd. Greenville, AL. 36037 (p) 731-217-2533 Email: dr.raj76@gmail.com
- Submitter: Dr. Prithvi Raj Chavan
-
- Date Prepared: 04/21/15
3. Name of Device:
- Proprietary Trade Name: Dunamis Force DFX Suture —
- Common Name: Suture, Polyethylene Synthetic Non-Absorbable Surgical Suture
- Classification Name: Non-absorbable poly (ethylene terephthalate) surgical suture
- Code: GAT ー
- Regulation:878.5000
4. Identification of the legally marketed device (predicate):
Teleflex Force Fiber Polyethylene Non-Absorbable Surgical Sutures, K063778.
-
- Description of the device: The Dunamis Force DFX Sutures are sterile single use sutures are used in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries. The technical design configuration for both USP Size 2 and Size 5 are as follows:
USP Size 2 (metric 5)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 2 (oversized) x 36" length, single armed HC-5 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile.
USP Size 5 (metric 7)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 5 (oversized) x 36" length, single armed HS48 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile
Materials:
Co-Braid of UHMWPE and Blue Monofilament Polypropylene Non-absorbable Surgical Sutures meets USP requirements except for diameter.
Polymer/Colorant: Ultra High Molecular Weight Polyethylene (white): None
Polypropylene (blue): [bhthalocyaninato (2-)] copper with a concentration not to exceed 0.5% by weight.
-
- Indications for Use: The Dunamis Force DFX Sutures, Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
4
- 7 . Comparison of Technological Characteristics: The Dunamis Force DFX Sutures are contract manufactured for Dunamis by Teleflex Medical to the same specifications for the Force Fiber sutures cleared in K063778; therefore, the device characteristics are identical to the predicate. The only differences between the Dunamis device and the predicate device are the brand name, part number, and "manufactured for" indication on the product labeling.
-
- Description of Device Design and Test Methods: Dunamis LLC. has established a contract manufactured product specifications that has been accepted by Teleflex 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 K063778.
USP Size 2 (metric 5)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 2 (oversized) x 36" length, single armed HC-5 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile.
USP Size 5 (metric 7)
White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 5 (oversized) x 36" length, single armed HS48 needle.
Packaged 1(one) strand per pouch, 12 pouches per box, sterile
Materials:
Co-Braid of UHMWPE and Blue Monofilament Polypropylene Non-absorbable Surgical Sutures meets USP requirements except for diameter.
Polymer/Colorant: Ultra High Molecular Weight Polyethylene (white): None
Polypropylene (blue): [bhthalocyaninato (2-)] copper with a concentration not to exceed 0.5% by weight.
Performance Testing:
Dunamis has established contract manufactured product specifications with Telefical that documents the product configuration and required test methods to assure the device is identical in performance and to all the elements of Teleflex 510(k) K063778. Because the sutures are manufactured to the same specifications as those cleared in K063778, data provided in K063778 may be leveraged to support equivalence, including testing in accordance to the USP for non-absorbable sutures, biocompatibility testing performed in accordance with ISO 10993-1, and stability testing. No additional testing was performed on the contractmanufactured product.
-
- Conclusions: The Dunamis Force DFX Sutures are identical to the predicate Force Fiber sutures cleared in K063778 with respect to indications for use, materials, design, and manufacturing processes. The sutures are contract manufactured for Dunamis by Teleflex to the same product specifications cleared in K063778. Therefore, the Dunamis Force DFX Sutures are substantially equivalent to the Force Fiber sutures cleared in K063778.