(29 days)
Not Found
No
The summary describes a mechanical surgical device for suture delivery and does not mention any AI/ML components or functions.
Yes.
The device is intended for approximation of soft tissue in meniscal repair procedures, which directly addresses a health condition (meniscal tears) and aims to restore or improve body function, classifying it as a therapeutic device.
No
This device is a surgical instrument used for soft tissue approximation in meniscal repair procedures, not for diagnosing conditions.
No
The device description explicitly states it is comprised of a handheld surgical instrument and cartridges, indicating it is a hardware device. The performance studies also focus on physical characteristics like strength, reliability, and insertion, further confirming it is not software-only.
Based on the provided information, the NovoStitch Pro Meniscal Repair System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for approximation of soft tissue in meniscal repair procedures." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument that passes suture through tissue. This is a tool for performing a surgical repair, not for analyzing a biological sample.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue samples, etc.) or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NovoStitch Pro is a surgical tool used for repair within the body.
N/A
Intended Use / Indications for Use
The NovoStitch Pro Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Product codes
GAT
Device Description
The NovoStitch Pro Meniscal Repair System is a next generation of the predicate device, the NovoStitch Plus Meniscal Repair System. The NovoStitch Pro Meniscal Repair System passes size 2-0 braided, nonabsorbable, 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
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)
Product performance testing for the NovoStitch Pro Meniscal Repair System was performed in a simulated use environment. Device strength, device reliability, device insertion, suture deployment, device removal, and the ability to reload the device with new suture cartridges to perform additional device insertions, deployments and removals were validated. Bench testing was performed to verify that the device and 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 preloaded handle assembly and up to five additional cartridges. The verification testing included device joint strength and device performance evaluations. Sterilization, packaging and shelf life were either validated or adopted from previous testing where appropriate. In addition, biocompatibility testing for each element of the NovoStitch Pro Mensical Repair System was conducted to demonstrate compliance with ISO 10993-1. The suture implant met all biocompatibility requirements for permanent implants in contact with tissue and/or bone. The patient contact portions of the delivery handle met all requirements for limited duration contact with tissue and/or bone.
Human factors and usability testing was conducted with the NovoStitch Pro. The evaluation was conducted in conformance with the FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices", February 3, 2016. In the study, 15 orthopedic surgeons were trained on the use of the NovoStitch Pro per the Instructions for Use, followed by a quantitative assessment of the human factors and usability processes for six essential tasks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2018
Ceterix Orthopaedics, Inc. % Ms. Debra Cogan Regulatory Affairs Consultant for Ceterix QRAC, LLC 6500 Kaiser Drive, Suite 120 Fremont, California 94555
Re: K180531
Trade/Device Name: NovoStitch Pro 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: February 26, 2018 Received: February 28, 2018
Dear Ms. Cogan:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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, Jennifer R. Stevenson -S3
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
2
Indications for Use
510(k) Number (if known) K180531
Device Name
NovoStitch Pro Meniscal Repair System
Indications for Use (Describe)
The NovoStitch Pro Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Type of Use (Select one or both, as applicable)
| Prescription (Part 21 CFR 201.56 et seq.) Dispensing | Over-The-Counter (Part 21 CFR 201.66 et seq.) Dispensing |
|---|---|
| ---------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for "Ceterix Orthopaedics". The logo consists of an orange square with a white "C" shape inside, followed by the word "CETERIX" in red, and the word "ORTHOPAEDICS" in orange below it. The logo is clean and modern, and the colors are bright and eye-catching.
SECTION 3. 510(K) SUMMARY
Manufacturer and Submitter
| Company Name: | Ceterix Orthopaedics, Inc. | |
|---|---|---|
| Company Address: | 6500 Kaiser Drive | |
| Suite 120 | ||
| Fremont, CA 94555 | ||
| TEL: (650) 316-8660 | ||
| FAX: (650) 618-2779 | ||
| Email: dcogan@ceterix.com | ||
| Contact Person: | Debra Cogan | |
| Date of Preparation: | February 26, 2018 |
Device Name and Classification
| Trade/Proprietary Name: | NovoStitch Pro Meniscal Repair System |
|---|---|
| Common Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Classification Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Regulation Number: | 21 CFR 878.5000 |
| Regulatory Class: | II |
| Product Code: | GAT |
| Panel: | General & Plastic Surgery |
Predicate Device
| Device Name: | NovoStitch Plus Meniscal Repair System |
|---|---|
| 510(k) Number: | K143356 |
| Applicant: | Ceterix Orthopaedics |
Device Description
The NovoStitch Pro Meniscal Repair System is a next generation of the predicate device, the NovoStitch Plus Meniscal Repair System. The NovoStitch Pro Meniscal Repair System passes size 2-0 braided, nonabsorbable, 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.
Intended Use/Indication for Use
The NovoStitch Pro Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
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Image /page/4/Picture/1 description: The image shows the logo for "Ceterix Orthopaedics". The logo consists of an orange square with rounded corners on the left side, with three curved white lines inside. To the right of the square is the word "CETERIX" in red, with the word "ORTHOPAEDICS" in orange underneath.
Performance Data
Product performance testing for the NovoStitch Pro Meniscal Repair System was performed in a simulated use environment. Device strength, device reliability, device insertion, suture deployment, device removal, and the ability to reload the device with new suture cartridges to perform additional device insertions, deployments and removals were validated. Bench testing was performed to verify that the device and 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 preloaded handle assembly and up to five additional cartridges. The verification testing included device joint strength and device performance evaluations. Sterilization, packaging and shelf life were either validated or adopted from previous testing where appropriate. In addition, biocompatibility testing for each element of the NovoStitch Pro Mensical Repair System was conducted to demonstrate compliance with ISO 10993-1. The suture implant met all biocompatibility requirements for permanent implants in contact with tissue and/or bone. The patient contact portions of the delivery handle met all requirements for limited duration contact with tissue and/or bone.
Human factors and usability testing was conducted with the NovoStitch Pro. The evaluation was conducted in conformance with the FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices", February 3, 2016. In the study, 15 orthopedic surgeons were trained on the use of the NovoStitch Pro per the Instructions for Use, followed by a quantitative assessment of the human factors and usability processes for six essential tasks.
Technological Characteristics
The NovoStitch Pro Meniscal Repair System is a handheld, 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.
| Characteristic | NovoStitch Pro Meniscal Repair
System | NovoStitch Plus Meniscal
Repair System |
|---------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| 510(k) # | TBD | K143356 |
| Method Of Use | Handheld, manually operated,
single procedure arthroscopic
suture placement system | Handheld, manually operated,
single procedure arthroscopic
suture placement system |
| Handle Material | ABS/PC blend | Polycarbonate, 10% glass filled |
| Distal end material | Stainless steel | Stainless steel |
| Usability | Single patient use, can deliver
up to six sutures, disposable | Single patient use, can deliver
up to six sutures, disposable |
| Tissue interaction | Tissue retained by upper and
lower jaw | Tissue retained by upper and
lower jaw |
| Needle material | Nitinol | Nitinol |
| Table 3-1.Comparison of technological characteristics to predicate device | ||
|---|---|---|
| -- | --------------------------------------------------------------------------- | -- |
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Image /page/5/Picture/1 description: The image is a logo for "CETERIX ORTHOPAEDICS". The logo consists of a square with rounded corners that is filled with a gradient of orange and red. To the right of the square is the word "CETERIX" in red, with the word "ORTHOPAEDICS" in orange underneath. The logo is clean and modern, and the colors are bright and eye-catching.
| Suture material | Polyethylene, nonabsorbable surgical suture, size 2-0 suture | Polyethylene, nonabsorbable surgical suture, size 2-0 suture |
|---|---|---|
| Sterilization | Ethylene oxide | Ethylene oxide |
| Knot tying method | Manually tied knot | Manually tied knot |
Conclusion
The NovoStitch Pro Meniscal Repair System is substantially equivalent to the predicate device with respect to safety, effectiveness and reliability.