(29 days)
No
The summary describes a mechanical surgical device for meniscal repair and does not mention any AI or ML components or functionalities.
Yes
The device is described as a surgical instrument intended for soft tissue approximation in meniscal repair procedures, which is a therapeutic intervention.
No
The device is described as a surgical instrument used for soft tissue approximation in meniscal repair procedures, not for diagnosing medical conditions.
No
The device description explicitly states it is a "handheld surgical instrument" and mentions "cartridges preloaded with suture," indicating it is a physical hardware device used in surgery.
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 directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device is a "handheld surgical instrument" used to pass suture through tissue. This is a surgical tool, not a diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The NovoStitch Pro Meniscal Repair System is a surgical device used for repairing meniscal tears.
N/A
Intended Use / Indications for Use
The NovoStitch Pro Mensical Repair System is intended for approximation of soft tissue in meniscal repair procedures.
Product codes
GAT
Device Description
The NovoStitch Pro Meniscal Repair System, size 0 is a new configuration of the predicate device. While the predicate device passes size 2-0 suture, this new configuration passes size 0 braided, nonabsorbable, surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with suture are attached.
The NovoStitch Pro Meniscal Repair System, size 0 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in meniscal repair procedures
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, size 0 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 Meniscal Repair System, size 0 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2018
Ceterix Orthopaedics, Inc. % Mr. Tarhan Kayihan Director of Quality and Regulatory 6500 Kaiser Drive. Suite 120 Fremont, California 94555
Re: K181772
Trade/Device Name: NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 2, 2018 Received: July 3, 2018
Dear Mr. Kayihan:
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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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
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)
K181772
Device Name
NovoStitch Pro Mensical Repair System, CTX-A004 (size 0)
Indications for Use (Describe)
The NovoStitch Pro Mensical Repair System is intended for approximation of soft tissue in meniscal repair procedures.
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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Image /page/3/Picture/0 description: The image shows the text "K181772 P. 1 of 3" on the left side. To the right of the text is an orange graphic and the word "CETERIX" in red, with the word "ORTHOPAEDICS" in orange below it. The image appears to be a logo or header for a document.
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: tkayihan@ceterix.com | |
| Contact Person: | Tarhan Kayihan |
Device Name and Classification
| Trade/Proprietary Name: | NovoStitch® Pro Meniscal Repair System, CTX-A004 (size 0) |
|---|---|
| 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 Pro Meniscal Repair System, CTX-A003 (size 2-0) |
| 510(k) Number: | K180531 |
| Applicant: | Ceterix Orthopaedics |
| Reference Device | |
| Device Name: | Force Fiber® Green Ultra High Molecular Weight |
| Polyethylene Non-Absorbable Surgical Suture | |
| 510(k) Number: | K100506 |
| Applicant: | Teleflex Medical |
Device Description
The NovoStitch Pro Meniscal Repair System, size 0 is a new configuration of the predicate device. While the predicate device passes size 2-0 suture, this new configuration passes size 0 braided, nonabsorbable, surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with suture are attached.
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Image /page/4/Picture/1 description: The image shows the logo for "Ceterix Orthopaedics". The logo consists of an abstract orange shape on the left, followed by the word "CETERIX" in red, and the word "ORTHOPAEDICS" in a smaller, lighter orange font below it. The logo is clean and modern, with a focus on the company name.
Intended Use/Indication for Use
The NovoStitch Pro Meniscal Repair System, size 0 is intended for approximation of soft tissue in meniscal repair procedures.
Technological Characteristics
The NovoStitch Pro Meniscal Repair System, size 0 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, CTX-A004 (size 0) | NovoStitch Pro Meniscal Repair System, CTX-A003 (size2-0) |
|---|---|---|
| 510(k) # | K181772 | K180531 |
| Method of Use | Handheld, manually operated, single procedure arthroscopic suture placement system | Handheld, manually operated, single procedure arthroscopic suture placement system |
| Delivery Instrument | Identical to predicate device, NovoStitch Pro Meniscal Repair System, CTX-A003 (size 2-0) | As described in K180531 |
| Handle Material | ABS/PC blend | ABS/PC blend |
| 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 |
| Suture material | Polyethylene, nonabsorbable surgical suture, size 0, white with green co-braid | Polyethylene, nonabsorbable surgical suture, size 2-0, white with blue co-braid |
| Suture supplier | Teleflex Medical | Teleflex Medical |
| Sterilization | Ethylene oxide | Ethylene oxide |
| Knot tying method | Manually tied knot | Manually tied knot |
Table 3-1. Comparison of technological characteristics to predicate device
Performance Data
Product performance testing for the NovoStitch Pro Meniscal Repair System, size 0 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
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Image /page/5/Picture/1 description: The image shows the logo for "Ceterix Orthopaedics". The logo consists of an abstract graphic on the left, resembling an orange leaf with curved lines. To the right of the graphic is the word "CETERIX" in red, with the word "ORTHOPAEDICS" in a smaller, tan font underneath.
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 Meniscal Repair System, size 0 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.
Conclusion
The NovoStitch Pro Meniscal Repair System, size 0 is substantially equivalent to the predicate device with respect to safety, effectiveness and reliability.