(91 days)
No
The summary describes a physical suture device and its material composition and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a non-absorbable orthopedic suture used for soft-tissue approximation and ligation. While used in orthopedic procedures, it is a tool for surgery, not a device that directly treats or prevents disease or modifies body function for therapeutic purposes, like drug delivery or rehabilitation.
No
This device is a surgical suture used for approximation and ligation of soft tissues, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical suture made of specific materials, indicating it is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "sterile non-absorbable orthopedic suture." This is a physical implant used during surgery.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™ Suture has a double sheath and core design, and contains Ultra High Molecular Weight Polyethylene, Polyester and a Silicone/NaCl core.
When DYNACORD™ Suture is placed in an aqueous environment, the salt particles within the silicone core elute out, leaving behind a micro-porous structure within the silicone core. These small voids are consequently filled with surrounding fluid as the core hydrates, resulting in a radial expansion of the suture. If laxity is present, this radial expansion of the braid causes an axial shortening of the total suture length. The DYNACORD™ Suture is designed to resist laxity and minimize gap formation, by maintaining approximation force (compression).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing included: USP Diameter (DYNACORD™ is oversized), USP Knot Tensile Strength, USP Needle Attachment, in-vitro approximation force over time, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility, sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
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.
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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 2, 2018
Medos International SARL DePuy Mitek, a Johnson and Johnson company % Ms. Tatyana Korsunsky Regulatory Affairs Technical Manager 325 Paramount Drive Raynham, Massachusetts 02767
Re: K181182
Trade/Device Name: DYNACORD™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 3, 2018 Received: July 5, 2018
Dear Ms. Korsunsky:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Krause -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name DYNACORD™ Suture
Indications for Use (Describe)
DYNACORD suture is indicated for orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue.
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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510(k) SUMMARY
DYNACORD™ Suture
Date Prepared: June 27, 2018
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Technical Manager
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3122
e-mail: tkorsuns@its.jnj.com |
| Name of
Medical Device | Proprietary Name: DYNACORD™ Suture
Classification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000)
Common Name: Suture |
| Substantial
Equivalence | The DYNACORD™ Suture is substantially equivalent to:
K021434, K041553 FiberWire® (Arthrex)
Reference devices:
K173859 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture (MEDOS International)K040004 ORTHOCORD® Suture (DePuy Mitek) |
| Device
Classification | DYNACORD™ Suture is classified as:
Polyethylene, suture, nonabsorbable, synthetic, classified as Class II, product code GAT, regulated under 21 CFR 878.5000. |
| Device
Description | DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™
Suture has a double sheath and core design, and contains Ultra High Molecular
Weight Polyethylene, Polyester and a Silicone/NaCl core. |
| Technological
Characteristics | The DYNACORD™ Suture is a surgical suture, that meets USP except for oversized
diameter. |
| | When DYNACORD™ Suture is placed in an aqueous environment, the salt particles
within the silicone core elute out, leaving behind a micro-porous structure within the
silicone core. These small voids are consequently filled with surrounding fluid as the
core hydrates, resulting in a radial expansion of the suture. If laxity is present, this
radial expansion of the braid causes an axial shortening of the total suture length.
The DYNACORD™ Suture is designed to resist laxity and minimize gap formation,
by maintaining approximation force (compression). |
| Comparison to
the Predicate
Devices | The DYNACORD™ Suture, similar to the predicate device FiberWire® (Arthrex,
K021434, K041553), meets USP requirements for size 2 suture, except for oversized
diameter. Both subject and predicate device have the same intended use of soft
tissue approximation. Both sutures contain UHMWPE and Polyester. FiberWire®
(Arthrex) contains Silicone coating. DYNACORD™ Suture contains Silicone/NaCl
core. |
| | The silicone/NaCl core is the main technological difference between the
DYNACORD™ Suture and FiberWire® (Arthrex) Suture. |
| | The DYNACORD™ Suture is identical to the suture component of the reference
predicate HEALIX ADVANCE™ Anchors with DYNACORD™ Suture (K173859). |
| | The needles provided with DYNACORD™ Suture are also used with reference
predicate device ORTHOCORD®(K040004). |
| Indications for
Use | DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissue
approximation, and/or ligation, including use with allograft tissue. |
| Non clinical
Testing | Performance testing included: USP Diameter (DYNACORD™ is oversized), USP
Knot Tensile Strength, USP Needle Attachment, in-vitro approximation force over
time, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility,
sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterial
endotoxin testing has been completed and results have demonstrated that the
proposed devices meet the endotoxin limits. |
| Safety and
Performance | Results of non-clinical testing have demonstrated that the proposed devices are
suitable for their intended use. Based on similarities in the indications for use,
technological characteristics, and performance in comparison to the predicate
device, the proposed DYNACORD™ Suture has shown to be substantially
equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. |
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