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.

AI/ML Overview

Here's an analysis of the provided text regarding the NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0), focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) summary for the NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0). This document is primarily concerned with demonstrating substantial equivalence to a predicate device (NovoStitch Pro Meniscal Repair System, CTX-A003 (size 2-0)) rather than detailing a comprehensive study with specific acceptance criteria in the manner one might find for a novel AI/software device. The device in question is a surgical instrument that deploys sutures.

Therefore, the information you've requested regarding AI/software performance metrics (like sensitivity, specificity, MRMC studies, training set details, ground truth establishment for training, etc.) is not applicable to this submission, as it describes a mechanical surgical device and not a software-based diagnostic or therapeutic aid.

However, I can extract the relevant information concerning the device's acceptance criteria and performance as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of numerical acceptance criteria with corresponding performance values in the way software performance data might be presented (e.g., "sensitivity > X%" and "achieved Y%"). Instead, it describes general categories of testing and the successful outcomes. The acceptance criteria are implied by the nature of the tests conducted and the statements that the device "meet all pre-established acceptance criteria."

Acceptance Criteria Category (Implied)	Reported Device Performance
Device Strength	Testing performed in a simulated use environment; device met all pre-established acceptance criteria.
Device Reliability	Testing performed in a simulated use environment; device "can reliably deliver up to six stitches. This includes the preloaded handle assembly and up to five additional cartridges." Device met all pre-established acceptance criteria.
Device Insertion	Testing performed in a simulated use environment; device performed as expected. Device met all pre-established acceptance criteria.
Suture Deployment	Testing performed in a simulated use environment; device performed as expected. Device met all pre-established acceptance criteria.
Device Removal	Testing performed in a simulated use environment; device performed as expected. Device met all pre-established acceptance criteria.
Ability to Reload with Suture Cartridges	Testing performed in a simulated use environment; device demonstrated the ability to reload with new suture cartridges to perform additional device insertions, deployments, and removals. Device met all pre-established acceptance criteria.
Device Joint Strength	Verification testing included device joint strength evaluation; device met all pre-established acceptance criteria.
Device Performance Evaluations	Verification testing included device performance evaluations; device met all pre-established acceptance criteria.
Sterilization	Validated or adopted from previous testing.
Packaging	Validated or adopted from previous testing.
Shelf Life	Validated or adopted from previous testing.
Biocompatibility (Suture)	"met all biocompatibility requirements for permanent implants in contact with tissue and/or bone" (ISO 10993-1 compliant).
Biocompatibility (Delivery Handle - patient contact portions)	"met all requirements for limited duration contact with tissue and/or bone" (ISO 10993-1 compliant).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test category, nor does it detail data provenance in terms of country of origin or retrospective/prospective studies. It states "Product performance testing for the NovoStitch Pro Meniscal Repair System, size 0 was performed in a simulated use environment." This implies these were bench tests focused on the device's mechanical and functional capabilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the device is a surgical instrument, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device would be its ability to physically perform its intended function (e.g., deploy a suture correctly, maintain strength).

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Adjudication methods are typically for subjective assessments or disagreements in diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size with AI Assistance

This is not applicable. The device is a surgical tool, not an AI-assisted diagnostic or therapeutic system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a mechanical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is based on engineering and functional specifications in a simulated use environment (bench testing) and ISO standard requirements for biocompatibility. For instance, whether the suture was reliably deployed, if the device maintained its strength, and whether material components met biocompatibility standards.

8. The Sample Size for the Training Set

This is not applicable. The device is not a machine learning model, and thus does not have a "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated above.

Summary

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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

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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 DriveSuite 120Fremont, CA 94555TEL: (650) 316-8660FAX: (650) 618-2779Email: 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 WeightPolyethylene Non-Absorbable Surgical Suture
510(k) Number:	K100506
Applicant:	Teleflex Medical

Device Description

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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.

Regulation Number and Section

§ 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.