(142 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a suture, with no mention of AI or ML.
No
The device is a non-absorbable orthopedic suture used for soft-tissue approximation and ligation, which is a structural component for repair rather than a therapeutic intervention.
No
The device description and intended use clearly state that DYNATAPE suture is for "orthopedic procedural use in soft-tissue approximation, and or ligation". This describes a surgical tool for treatment, not a device designed to identify or diagnose a condition.
No
The device description clearly states it is a physical suture made of materials like Ultra High Molecular Weight Polyethylene, Polyester, and Silicone/NaCl, indicating it is a hardware 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 or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a sterile, non-absorbable orthopedic suture. This is a physical device used for surgical repair, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue approximation, and or ligation, including use with allograft tissue.
Product codes
GAT
Device Description
DYNATAPE™ Suture is a sterile non-absorbable orthopedic suture. DYNATAPE™ Suture has a double sheath and core design, composed of Ultra High Molecular Weight Polyethylene and Polyester, with or without colorants, as well as a Silicone/NaCl core. DYNATAPE™ Suture's outer sheath is braided flat, with rounded tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft-tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic procedural use
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
USP Knot Tensile Strength, in-vitro approximation force over time, and sterility testing have been conducted. Biocompatibility, stability, in-vivo testing of the predicate device were included by reference (K181182). Bacterial endotoxin testing has been completed as part of the HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949), meeting the endotoxin limits.
Key Metrics
Not Found
Predicate Device(s)
K181182 DYNACORD™ Suture
Reference Device(s)
K200949 HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture, K183506 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture, K021434, K041553 FiberWire® (Arthrex)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2021
Medos International SARL % Tatyana Korsunsky Regulatory Affairs Technical Manager DePuy Mitek, a Johnson and Johnson company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K203186
Trade/Device Name: DYNATAPE Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 25, 2020 Received: October 27, 2020
Dear Tatyana 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203186
Device Name DYNATAPETM Suture
Indications for Use (Describe)
DYNATAPE 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
DYNATAPE™ Suture
Date Prepared: February 09, 2021
| Submitter's
Name and
Address | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
On behalf of:
Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Technical Manager
DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Telephone: 508-828-3122
e-mail: tkorsuns@its.jnj.com |
| Name of
Medical Device | Proprietary Name: DYNATAPE™ Suture
Classification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000)
Common Name: Suture |
| Substantial
Equivalence | The DYNATAPE™ Suture is substantially equivalent to:
K181182 DYNACORD™ Suture (MEDOS International SARL) Reference devices: K200949 HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (MEDOS International SARL) K183506 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture (MEDOS International SARL) K021434, K041553 FiberWire® (Arthrex) |
| Device
Classification | DYNATAPETM Suture is classified as: |
| | Polyethylene, suture, nonabsorbable, synthetic, classified as Class II, product code
GAT, regulated under 21 CFR 878.5000. |
| Device
Description | DYNATAPE™ Suture is a sterile non-absorbable orthopedic suture. DYNATAPE™
Suture has a double sheath and core design, composed of Ultra High Molecular
Weight Polyethylene and Polyester, with or without colorants, as well as a
Silicone/NaCl core. DYNATAPE™ Suture's outer sheath is braided flat, with
rounded tips. |
| Technological
Characteristics | The DYNATAPE™ Suture is a surgical suture, that meets USP knot tensile strength
for size 2 non-absorbable sutures. As DYNATAPE™ Suture is flat, it does not follow
USP suture diameter requirements. DYNATAPE™ Suture's outer sheath is braided
flat to allow for a wider contact area with tissue. |
| | When DYNATAPE™ 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 self-tensioning property of DYNATAPE™ Suture is designed to resist laxity and
minimize gap formation in a repair, by maintaining approximation force
(compression) if laxity (looseness) is present. |
| Comparison to
the Predicate
Devices | The DYNATAPE™ Suture, similar to the predicate device DYNACORD®
(K181182), meets USP knot tensile requirements for size 2 suture. Both subject and
predicate device have the same indications, intended use and materials. Both
DYNATAPE™ and DYNACORE™ sutures are laxity resistant, as shown by
approximation force testing.
The sheath of the DYNATAPE™ Suture has been redesigned with a unique braiding
pattern of ticker fibers to create the flattened structure specific to DYNATAPE™ |
| | Suture, differentiating from the predicate device.
DYNATAPE™ Suture is offered as a suture component of the reference predicate
HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949). |
| Indications for
Use | DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue
approximation, and/ or ligation, including use with allograft tissue. |
| Non clinical
Testing | USP Knot Tensile Strength, in-vitro approximation force over time, and sterility
testing have been conducted. Biocompatibility, stability, in-vivo testing of the
predicate device were included by reference (K181182). Bacterial endotoxin testing |
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| has been completed as part of the HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949), meeting 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 DYNATAPE™ Suture has shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act. |