(125 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical suture, with no mention of AI or ML technologies.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a restorative or supportive function rather than a therapeutic one (treating or curing a disease/condition).
No
Explanation: The device, Nexus Suture, is a non-absorbable surgical suture used for approximation and/or ligation of soft tissues. Its intended use and description clearly indicate it is a therapeutic/surgical device, not a diagnostic one.
No
The device description clearly states that Nexus Suture is a physical, nonabsorbable, sterile, surgical suture made of UHMWPE and polypropylene. It is a tangible 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 "approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical suture, a physical material used to hold tissues together.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Nexus Suture does not involve any of these activities.
Therefore, the Nexus Suture is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nexus™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Product codes
GAT
Device Description
Nexus Suture is a nonabsorbable, sterile, surgical suture provided in sizes 2-0, 0 and 2. It is composed of either undyed (white) ultra high molecular weight polyethylene (UHMWPE) or white UHMWPE braided with one or two strands of blue polypropylene to add color. The blue colorant is [phthalocyaninato(2-)] copper with a concentration not to exceed 0.5% by weight. It does not have a coating. Nexus Suture will be provided to the user in a variety of cut lengths without needles or on reels that facilitate suture handling.
Nexus Suture meets all USP requirements for non-absorbable surgical suture, except for oversized diameter.
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
To demonstrate substantial equivalence of the Nexus Suture to the predicate devices, bench top testing was performed. The devices were subject to the following verification tests: biocompatibility, diameter testing and tensile strength testing.
Key Metrics
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2015
Baylis Medical Company Incorporated Ms. Meghal Khakhar Director of Regulatory & Scientific Affairs 2645 Matheson Boulevard East Mississauga, Ontario L4W 5S4 CANADA
Re: K151009
Trade/Device Name: Nexus™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: June 30, 2015 Received: July 6, 2015
Dear Ms. Khakhar:
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
1
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
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Indications for Use
510(k) Number (if known) K151009
Device Name
Nexus™ Suture
Indications for Use (Describe)
Nexus™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic 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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7. 510(k) Summary
Submitter Information
- A. Company Name: Baylis Medical Company Inc.
- B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
- C. Company Phone: (905) 602-4875
- D. Company Facsimile: (905) 602-5671
- E. Contact Person: Meghal Khakhar, Director of Regulatory & Scientific Affairs
- F. Summary Prepared on: 13-Apr-2015
Device Identification
- A. Device Trade Name: Nexus™ Suture
- B. Device Common Name: Suture, nonabsorbable, synthetic, polyethylene
- C. Classification Name: CFR 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture
- D. Product Code: GAT
- E. Device Class: Class II
Identification of Predicate Devices
The predicate devices are provided in Table 7.1.
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Table 7.1: Predicate Devices
| Predicate Device | Manufacturer | 510(k) |
|---|---|---|
| Force Fiber Polyethylene | ||
| Nonabsorbable | ||
| Surgical Suture | Teleflex Medical | K033654 |
| Force Fiber Blue Co-Braid | ||
| Polyethylene Non- | ||
| Absorbable Surgical Suture | Teleflex Medical | K040472 |
Indications for Use
Nexus™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Device Description
Nexus Suture is a nonabsorbable, sterile, surgical suture provided in sizes 2-0, 0 and 2. It is composed of either undyed (white) ultra high molecular weight polyethylene (UHMWPE) or white UHMWPE braided with one or two strands of blue polypropylene to add color. The blue colorant is [phthalocyaninato(2-)] copper with a concentration not to exceed 0.5% by weight. It does not have a coating. Nexus Suture will be provided to the user in a variety of cut lengths without needles or on reels that facilitate suture handling.
Nexus Suture meets all USP requirements for non-absorbable surgical suture, except for oversized diameter.
Comparison to Predicate Devices
Nexus Suture and its predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. The results of verification testing support the substantial equivalence determination to the predicate devices (Table 7.2).
5
| Characteristic | Proposed White Nexus
Suture Compared to
Predicate Teleflex
Medical Suture
(K033654) | Proposed White/Blue
Nexus Suture Compared
to Predicate Teleflex
Medical Suture
(K040472) |
|--------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | Identical | Identical |
| Indications for Use | Identical | Identical |
| Fundamental scientific
technology | Identical | Identical |
| Operating principles | Identical | Identical |
| Mechanism of action | Identical | Identical |
| Technological aspects | Identical | Identical |
| Available Sizes | Similar* | Similar* |
Table 7.2: Comparison of Proposed and Predicate Devices
*The 2-0, 0 and 2 sizes are identical. Additional sizes available in the predicate are not applicable to the subject device.
Performance Testing
To demonstrate substantial equivalence of the Nexus Suture to the predicate devices, bench top testing was performed. The devices were subject to the following verification tests: biocompatibility, diameter testing and tensile strength testing.
Conclusions
Nexus Suture and its predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action.