(139 days)
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
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.
The provided text is a 510(k) summary for the Dunamis Force DFX Suture. It states that the device is identical to a legally marketed predicate device (Teleflex Force Fiber Polyethylene Non-Absorbable Surgical Sutures, K063778) except for brand name, part number, and "manufactured for" indication on the labeling. As such, the Dunamis Force DFX Suture leverages the testing and established performance of the predicate device.
Given this context, the request for acceptance criteria and a study proving the device meets those criteria, along with details like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not directly applicable to this specific submission. This is because the device's substantial equivalence is established by its identical specifications to a previously cleared product, rather than new, independent performance testing for the Dunamis device itself.
Therefore, the following information is derived from the context of substantial equivalence to the predicate device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on USP for non-absorbable sutures and ISO 10993-1 for biocompatibility) | Reported Device Performance (Leveraged from Predicate K063778) |
|---|---|
| Meets USP requirements for non-absorbable sutures (except for diameter) | Specifications are identical to predicate device, which met these requirements. |
| Biocompatibility in accordance with ISO 10993-1 | Specifications are identical to predicate device, which met these requirements. |
| Stability testing | Specifications are identical to predicate device, which met these requirements. |
| Tensile strength, knot strength, and other relevant mechanical properties as per USP | Specifications are identical to predicate device, which met these requirements. |
| Sterility | Specifications are identical to predicate device, which met these requirements. |
2. Sample size used for the test set and the data provenance
The document states, "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 contract-manufactured product."
Therefore, specific sample sizes and data provenance for the Dunamis device are not provided as its performance is inferred from the predicate device (K063778). The provenance of the predicate device's data would be from its original submission. This would be retrospective for the Dunamis submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as no new performance testing with a 'test set' was conducted for the Dunamis Force DFX Suture to establish a new ground truth. The device demonstrates equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no new performance testing with a 'test set' requiring adjudication was conducted for the Dunamis Force DFX Suture.
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
This information is not applicable. This device is a surgical suture, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate device (K063778) on which the Dunamis device's performance is based, the "ground truth" would be established by standardized laboratory testing methods as specified in the USP for non-absorbable sutures and ISO 10993-1 for biocompatibility. These are objective engineering and biological measurements, not expert consensus or pathology in the typical sense.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device requiring a training set.
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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 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
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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)
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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.
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- 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.
§ 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.