(239 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No.
This device is for surgical repair by approximating soft tissue with sutures, which is a restorative procedure rather than a therapeutic one that treats disease or provides rehabilitation.
No
Explanation: The device is described as a surgical system intended for soft tissue approximation in meniscal repair procedures, focusing on delivering sutures. It is a tool used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a handheld surgical instrument with cartridges and suture, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "approximation of soft tissue in meniscal repair procedures." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "handheld surgical instrument" that passes suture through tissue. This is a surgical tool used during a procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The NovoStitch Plus Meniscal Repair System is a surgical device used during a procedure, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The NovoStitch Plus Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Product codes
GAT
Device Description
The NovoStitch Plus Meniscal Repair System passes size 2-0 braided, non-absorbable, polyethylene surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with polyethylene suture are attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Meniscus
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
Product performance testing for NovoStitch Plus Meniscal Repair System was performed in a simulated use environment and device strength and reliability, device insertion, suture deployment, device removal and ability to reload the device with a new suture cartridge and perform additional device insertions, deployments and removals was validated. Bench testing was performed to verify that the implantable suture meet all pre-established acceptance criteria. The verification testing has demonstrated that the device can reliably deliver up to six stitches. This includes the cartridge provided with the handle assembly and up to five additional cartridges. The verification testing included device joint strength, delivery device, suture tensile strength and suture diameter. Suture tensile strength and suture diameter testing was performed per USP requirements for non-absorbable surgical suture. Sterilization, packaging and shelf life were validated. In addition to these performance tests, full biocompatibility testing was conducted to demonstrate compliance with requirements for biocompatibility of permanent implants in contact with tissue and/or bone in accordance with ISO 10993-1.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
Ceterix Orthopaedics Incorporated Mr. Scott King Senior Director, Regulatory Affairs, Quality Assurance and Compliance 959 Hamilton Avenue Menlo Park. California 94025
Re: K143356
Trade/Device Name: NovoStitch Plus Meniscal Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: June 12, 2015 Received: June 15, 2015
Dear Mr. King:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/ResourcesforYou/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.
For
Sincerelv vours.
Joshua C. Nipper -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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Indications for Use
510(k) Number (if known)
Device Name
NovoStitch Plus Meniscal Repair System
Indications for Use (Describe)
The NovoStitch Plus Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for "CETERIX ORTHOPAEDICS". The logo consists of an orange square with a white curved line inside, followed by the word "CETERIX" in red. Below the word "CETERIX" is the word "ORTHOPAEDICS" in a smaller, lighter orange font.
510(k) Summary
Ceterix Orthopaedics
NovoStitch Plus Meniscal Repair System
| ADMINISTRATIVE INFORMATION | |
|---|---|
| 510(k) Number: | K143356 |
| 510(k) Owner: | Ceterix Orthopaedics, Inc. |
| 959 Hamilton Avenue | |
| Menlo Park, CA 94025 | |
| Telephone (650) 316-8660 | |
| Fax (650) 323-2209 | |
| Contact Person: | Scott King |
| 959 Hamilton Avenue | |
| Menlo Park, CA 94025 | |
| sking@ceterix.com | |
| Telephone (650) 316-8660 | |
| Fax (650) 323-2209 | |
| DATE PREPARED | July 14, 2015 |
| DEVICE NAME | |
| Trade/Proprietary Name: | |
| Common Name: | |
| Classification Names: | |
| Classification Regulation: | NovoStitch Plus Meniscal Repair System |
| Suture, Nonabsorbable, Synthetic, Polyethylene | |
| Suture, Nonabsorbable, Synthetic, Polyethylene | |
| 21CFR 878.5000 | |
| Device Class: | |
| Panel: | |
| Product Code: | |
| PREDICATE DEVICES | Class II |
| General & Plastic Surgery | |
| GAT | |
| Delivery Device Predicate | |
| Suture Implant Predicate | Cayenne CrossFix II® Meniscal Repair Device (K121413) |
| Teleflex Force Fiber® Polyethylene Non-Absorbable Surgical Suture (K063778) | |
DEVICE DESCRIPTION
The NovoStitch Plus Meniscal Repair System passes size 2-0 braided, non-absorbable, polyethylene surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with polyethylene suture are attached.
INDICATIONS FOR USE
The NovoStitch Plus Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
PERFORMANCE DATA
Product performance testing for NovoStitch Plus Meniscal Repair System was performed in a simulated use environment and device strength and reliability, device insertion, suture deployment, device removal and ability to reload the device with a new suture cartridge and perform additional device insertions, deployments and removals was validated. Bench testing was performed to verify that the implantable suture
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Image /page/4/Picture/0 description: The image shows the logo for "Ceterix Orthopaedics". The logo consists of a stylized letter "C" in orange on the left, followed by the word "CETERIX" in red. Below "CETERIX" is the word "ORTHOPAEDICS" in a lighter shade of orange. The logo is simple and modern, with a focus on the company name.
meet all pre-established acceptance criteria. The verification testing has demonstrated that the device can reliably deliver up to six stitches. This includes the cartridge provided with the handle assembly and up to five additional cartridges. The verification testing included device joint strength, delivery device, suture tensile strength and suture diameter. Suture tensile strength and suture diameter testing was performed per USP requirements for non-absorbable surgical suture. Sterilization, packaging and shelf life were validated. In addition to these performance tests, full biocompatibility testing was conducted to demonstrate compliance with requirements for biocompatibility of permanent implants in contact with tissue and/or bone in accordance with ISO 10993-1.
TECHNOLOGICAL CHARACTERISTICS
- The NovoStitch Plus Meniscal Repair System is a hand-held, disposable surgical instrument coupled with an implantable suture for the approximation of soft tissue in meniscal repair procedures. The system is comprised of a delivery handle and a suture cartridge, both of which are provided sterile.
- . Comparison of technological characteristics to the delivery device predicate device
| Characteristic | NovoStitch Plus Meniscal Repair System | CrossFix II Meniscal Repair Device |
|---|---|---|
| Method of use | Handheld, manually operated, single procedure, arthroscopic suture placement system | Handheld, manually operated, single procedure, arthroscopic suture placement system |
| Handle material | Polymer delivery handle | Polymer delivery handle |
| Distal end material | Stainless steel distal end | Stainless steel distal end |
| Tissue interaction | Tissue retained by upper and lower jaws | Tissue pierced with two hypotubes |
| Needle characteristics | Flexible, nitinol needle | Flexible, nitinol needle |
| Suture material | Polyethylene, nonabsorbable surgical suture. | Polyethylene, nonabsorbable surgical suture. |
| Sterilization | Sterile, ethylene oxide | Sterile, ethylene oxide |
| Knot tying method | Manually tied knot | Pre-tied knot plus additional manual throws |
- . The subject device has the same knot tying method as the suture implant predicate Force Fiber® Polyethylene Nonabsorbable Surgical Suture
- The suture used in the NovoStitch Plus Meniscal repair system is the same suture as the predicate suture cleared under K063778 and the same suture used in the predicate delivery device cleared under K121413
EQUIVALENCE TO MARKETED PRODUCT
The NovoStitch Plus Meniscal Repair Device has demonstrated equivalence to the unmodified predicate devices in the following areas:
- Has the same intended use for approximation of soft tissues in meniscal repair procedures
- Has equivalent technological characteristics
- Has equivalent labeling .
- . Has demonstrated equivalent usability with respect to handle deployment force
- Has demonstrated product reliability and biocompatibility
In conclusion, the NovoStitch Plus Meniscal Repair System described in this submission is substantially equivalent to the predicate devices with respect to safety, effectiveness and reliability.