(105 days)
The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries.
The Cypris eXact Suture (PDO) is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Cypris eXact 5.1 Suture Placement Device can be used in conjunction with eXact Sutures, which are indicated for use in general soft tissue approximation and/or ligation.
The Cypris eXact Suturing System is comprised of the Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device. The Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device are for use in general soft tissue approximation by surgeons, are single-use, and are provided sterile.
The Cypris eXact Suture is a synthetic, monofilament suture available in three different materials: polypropylene (PP), polydioxanone (PDO), and polytetraflouroethylene (PTFE). The Cypris eXact Suture (PP) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. The Cypris eXact Suture (PTFE) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 2-0 and 3-0. The Cypris eXact Suture (PDO) is an absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. Each 24-inch suture has a stainless-steel BB needle attached to one end of the suture.
Cypris eXact Sutures can be used with the Cypris eXact 5.1 Suture Placement Device, a handheld device used for the placement of a surgical suture.
The FDA 510(k) clearance document for the Cypris eXact Suturing System (K233355) indicates that the device's substantial equivalence to predicate devices is based on non-clinical testing rather than a study involving human-in-the-loop performance or diagnostic accuracy of an AI algorithm. Therefore, many of the requested criteria related to AI/MRMC studies, number of experts, adjudication methods, and training/test set ground truth for AI models are not applicable.
The document primarily focuses on demonstrating that the Cypris eXact Sutures are identical in formulation, processing, sterilization, and geometry to previously cleared sutures and that their performance meets established USP and FDA guidance standards for surgical sutures. The Cypris eXact 5.1 Suture Placement Device is evaluated for its integrity and functionality.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP/FDA Guidance Standards) | Reported Device Performance (Cypris eXact Suture) |
|---|---|
| Suture Diameter meets USP <861> requirements | All suture sizes meet USP <861> requirements |
| Suture Tensile Strength meets USP <881> requirements | All suture sizes meet USP <881> requirements |
| Needle Attachment Strength meets USP <871> requirements | All suture sizes meet USP <871> requirements |
| Biocompatibility (as per ISO 10993-1:2018 for implanted devices with long-term contact) | All evaluated endpoints met (cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, and implantation). |
| Sterile Barrier Integrity (for 5.1 Suture Placement Device) | Demonstrated following 3 years of real-time aging. |
| Functionality (for 5.1 Suture Placement Device) | Demonstrated following 3 years of real-time aging. |
| Shelf-life for Sutures | 5 years |
| Shelf-life for Suture Placement Device | 3 years |
2. Sample Size Used for the Test Set and Data Provenance:
The document doesn't explicitly state "sample sizes for a test set" in the context of an AI-driven study. Instead, it refers to performance testing of the physical sutures and the placement device. The data provenance is not described as medical cases or patient data, but rather as results from laboratory testing performed in accordance with USP and ISO standards. The country of origin of the data is not specified beyond being generated for an FDA submission. The studies were likely prospective in that they were designed and performed to meet regulatory requirements prior to submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is compliance with established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
Not applicable. This is not an AI/diagnostic device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI/diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/diagnostic device. The "standalone" performance relates to the physical and biological characteristics of the suture materials and the mechanical functionality of the placement device as tested in laboratory settings.
7. The Type of Ground Truth Used:
The ground truth used for evaluating the performance of the sutures and placement device are established industry standards and regulatory guidelines:
- USP <861>, <881>, <871> requirements for surgical sutures (diameter, tensile strength, needle attachment strength).
- ISO 10993-1:2018 standards for biological evaluation of medical devices (biocompatibility endpoints).
- FDA's Guidance for Industry and FDA Staff: Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff (issued June 3, 2003).
8. The Sample Size for the Training Set:
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a series of non-clinical, laboratory-based performance and biocompatibility tests.
- Device Tested: Cypris eXact Sutures (PP, PTFE, PDO) and Cypris eXact 5.1 Suture Placement Device.
- Tests Performed:
- Suture Testing: Measurement of suture diameter, tensile strength, and needle attachment strength for various suture sizes and materials. These tests were conducted according to the specific methods outlined in the United States Pharmacopeia (USP) standards (<861>, <881>, <871>).
- Biocompatibility Testing: Evaluation of material interactions with biological systems, including cytotoxicity, sensitization, irritation (for the placement device), acute systemic toxicity, material-mediated pyrogenicity, subacute and subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, and implantation (for the sutures). These tests followed ISO 10993-1:2018 guidelines.
- Shelf-life Testing: Evaluation of sterile barrier integrity and device functionality for the Cypris eXact 5.1 Suture Placement Device after 3 years of real-time aging to establish its shelf-life. The sutures had a separate, longer shelf-life of 5 years.
- Acceptance Criteria Basis: The acceptance criteria for each test were defined by the adherence to the requirements specified in the aforementioned USP standards, ISO 10993-1:2018, and FDA's specific guidance for surgical sutures.
- Conclusion: The tests demonstrated that the Cypris eXact Sutures meet all specified USP requirements and that all materials used are biocompatible. The Cypris eXact Sutures are explicitly stated as being "identical in their final finished form in formulation, processing, sterilization, and geometry to the sutures previously cleared" under the predicate devices (K131224, K160744, K063680). The Cypris eXact 5.1 Suture Placement Device also demonstrated integrity and functionality over its claimed shelf-life. This body of non-clinical evidence provided the basis for the FDA's determination of substantial equivalence.
{0}------------------------------------------------
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.
January 12, 2024
Cypris Medical % Erin Gontang Senior Consultant Ram+ 2251 San Diego Avenue B-257 San Diego, California 92110
Re: K233355
Trade/Device Name: Cypris eXact Suturing System Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW, GAW, NBY, GEJ Dated: September 29, 2023 Received: September 29, 2023
Dear Erin Gontang:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
{2}------------------------------------------------
3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
for Tek Lamichhane Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K233355
Device Name Cypris eXact Suturing System
Indications for Use (Describe)
Cypris eXact Suture PP (Polypropylene)
The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Cypris eXact Suture PTFE (Polytetraflouroethylene)
The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries.
Cypris eXact Suture PDO (Polydioxanone)
The Cypris eXact Suture (PDO) is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Cypris eXact 5.1 Suture Placement Device can be used in conjunction with eXact Sutures, which are indicated for use in general soft tissue approximation and/or ligation.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) SUMMARY
DATE PREPARED
January 12, 2024
MANUFACTURER AND 510(k) OWNER
Cypris Medical, Inc. 4541 N. Ravenswood Ave. #202 Chicago, IL 60640, USA Phone: +1 888-433-5002
OFFICIAL CONTACT
Dan Holton, President & CEO
REPRESENTATIVE/CONSULTANT
Erin A. Gontang, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ 2251 San Diego Ave, Suite B-257 San Diego, CA 92110, USA Phone: +1 412-816-8290 Email: egontang@rqmplus.com akomiyama@rqmplus.com
DEVICE INFORMATION
| Trade/Proprietary Name | Cypris eXact Suturing System |
|---|---|
| Common Name | Suturing System |
| Regulatory Class: | II |
| Regulation Number/Name: | 878.4840 Absorbable polydioxanone surgical suture |
| 878.5010 Nonabsorbable polypropylene surgical suture | |
| 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture | |
| 878.4800 Manual surgical instrument for general use | |
| Product Code: | NEW |
| GAW | |
| NBY | |
| GEJ | |
| Classification Panel | General & Plastic Surgery |
| Premarket Review | Office of Health Technology 4 |
| (Surgical and Infection Control Devices) | |
| Division of Health Technology 4B | |
| (Infection Control and Plastic and Reconstructive Surgery) |
{5}------------------------------------------------
PREDICATE DEVICE IDENTIFICATION
The Cypris eXact Suturing System is substantially equivalent to the following predicates:
| 510(k)Number | Predicate Device Name / Manufacturer | PrimaryPredicate |
|---|---|---|
| K131224 | Sharpoint Polypropylene Surgical Suture, LOOK PolypropyleneSurgical Suture, Quill Polypropylene Knotless Tissue-Closure/ Surgical Specialties Corp. | ✓ |
| K160744 | LOOK PTFE Suture/ Surgical Specialties Corp. | |
| K063680 | Sharpoint PDO (polydioxanone) Sutures/ Surgical Specialties Corp. |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The Cypris eXact Suturing System is comprised of the Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device. The Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device are for use in general soft tissue approximation by surgeons, are single-use, and are provided sterile.
The Cypris eXact Suture is a synthetic, monofilament suture available in three different materials: polypropylene (PP), polydioxanone (PDO), and polytetraflouroethylene (PTFE). The Cypris eXact Suture (PP) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. The Cypris eXact Suture (PTFE) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 2-0 and 3-0. The Cypris eXact Suture (PDO) is an absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. Each 24-inch suture has a stainless-steel BB needle attached to one end of the suture.
Cypris eXact Sutures can be used with the Cypris eXact 5.1 Suture Placement Device, a handheld device used for the placement of a surgical suture.
{6}------------------------------------------------
INDICATIONS FOR USE
Cypris eXact Suture PP (Polypropylene)
The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Cypris eXact Suture PTFE (Polytetraflouroethylene)
The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries.
Cypris eXact Suture PDO (Polydioxanone)
The Cypris eXact Suture (PDQ) is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Cypris eXact 5.1 Suture Placement Device can be used in conjunction with eXact Sutures, which are indicated for use in general soft tissue approximation and/or ligation.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Cypris Medical believes that the Cypris eXact Suturing System is substantially equivalent to the predicate devices based on the information summarized here:
The Cypris eXact Sutures are equivalent to original equipment manufacturer (OEM) sutures currently produced under the Sharpoint (K131224 and K063680) and LOOK (K160744) brands. The Cypris eXact Suturing System sutures are identical in their final finished form in formulation, processing, sterilization, and geometry to the sutures previously cleared in K131224, K063680, and K160744. Given the Cypris eXact Sutures are identical to the predicate device, share the same intended use, and have equivalent technological performance characteristics, the Cypris eXact Sutures are considered substantially equivalent to the predicates.
{7}------------------------------------------------
SUBSTANTIAL EQUIVALENCE
The Cypris eXact Suture - PP (Polypropylene) is substantially equivalent in intended use and fundamental scientific technology as the Sharpoint Polypropylene Surgical Suture, LOOK Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure cleared under K131224 (May 16, 2013). The substantial equivalence table for the comparison of the subject and predicate device is provided below.
| Subject Device | Predicate Device | |
|---|---|---|
| Cypris Medical, Inc. | Surgical Specialties Corp. | |
| Cypris eXact Suture - PP (Polypropylene) | Sharpoint Polypropylene Surgical Suture,LOOK Polypropylene Surgical Suture, QuillPolypropylene Knotless Tissue-Closure | |
| K233355 | K131224 | |
| Indications for Use | The Cypris eXact Suture (PP) is indicated foruse in general soft tissue approximation and/orligation, including use in cardiovascular,ophthalmic and neurological procedures. | Polypropylene suture is indicated for use ingeneral soft tissue approximation and/orligation, including use in cardiovascular,ophthalmic and neurological procedures. |
| Regulation Number | 21 CFR 878.5010 | 21 CFR 878.5010 |
| Regulation Description | Nonabsorbable polypropylene surgical suture | Nonabsorbable polypropylene surgicalsuture |
| Product Code/Name | GAW - Suture, Nonabsorbable, Synthetic,Polypropylene | GAW - Suture, Nonabsorbable, Synthetic,Polypropylene |
| Materials | Polypropylene SutureStainless Steel Needle | Polypropylene SutureStainless Steel Needle |
| Suture Construction | Monofilament | Monofilament |
| Suture Colorant | Phthalocyaninato (2-) Copper | Phthalocyaninato (2-) Copper |
| Suture Size(s) | USP sizes 3-0 and 4-0 | USP sizes 3-0 and 4-0 |
| Suture Diameter | All suture sizes meet USP <861>requirements for nonabsorbable surgicalsutures | All suture sizes meet USP <861>requirements for nonabsorbable surgicalsutures |
| Suture Tensile Strength | All suture sizes meet USP <881>requirements for nonabsorbable surgicalsutures | All suture sizes meet USP <881>requirements for nonabsorbable surgicalsutures |
| Needle AttachmentStrength | All suture sizes meet USP <871>requirements for nonabsorbable surgicalsutures | All suture sizes meet USP <871>requirements for nonabsorbable surgicalsutures |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, AcuteSystemic Toxicity, Material-MediatedPyrogenicity, Subacute and SubchronicToxicity, Chronic Toxicity, Genotoxicity,Carcinogenicity, and Implantation | Cytotoxicity, Sensitization, Irritation, AcuteSystemic Toxicity, Material-MediatedPyrogenicity, Subacute and SubchronicToxicity, Chronic Toxicity, Genotoxicity,Carcinogenicity, and Implantation |
{8}------------------------------------------------
Cypris eXact Suture - PTFE (Polytetraflouroethylene) is substantially equivalent in intended use and fundamental scientific technology as the LOOK PTFE Suture cleared in K160744 (July 13, 2016). The substantial equivalence table for the comparison of the subject and predicate device is provided below.
| Subject Device | Predicate Device | |
|---|---|---|
| Cypris Medical, Inc. | Surgical Specialties Corp. | |
| Cypris eXact Suture - PTFE(Polytetraflouroethylene) | LOOK PTFE Suture | |
| K233355 | K160744 | |
| Indications for Use | The Cypris eXact Suture (PTFE) is indicatedfor use in all types of soft tissueapproximation and/or ligation, includingdental and general surgeries. | PTFE (polytetrafluoroethylene) suture isindicated for use in all types of soft tissueapproximation and/or ligation, includingdental and general surgeries. |
| Regulation Number | 21 CFR 878.5035 | 21 CFR 878.5035 |
| Regulation Description | Nonabsorbable expandedpolytetrafluoroethylene surgical suture | Nonabsorbable expandedpolytetrafluoroethylene surgical suture |
| Product Code/Name | NBY - Suture, Surgical, Nonabsorbable,Expanded, Polytetraflouroethylene | NBY - Suture, Surgical, Nonabsorbable,Expanded, Polytetraflouroethylene |
| Materials | Polytetraflouroethylene SutureStainless Steel Needle | Polytetraflouroethylene SutureStainless Steel Needle |
| Suture Construction | Monofilament | Monofilament |
| Suture Colorant | None | None |
| Suture Size(s) | USP sizes 2-0 and 3-0 | USP sizes 2-0 and 3-0 |
| Suture Diameter | All suture sizes meet USP <861>requirements for nonabsorbable surgicalsutures | All suture sizes meet USP <861>requirements for nonabsorbable surgicalsutures |
| Suture Tensile Strength | All suture sizes meet USP <881>requirements for nonabsorbable surgicalsutures | All suture sizes meet USP <881>requirements for nonabsorbable surgicalsutures |
| Needle AttachmentStrength | All suture sizes meet USP <871>requirements for nonabsorbable surgicalsutures | All suture sizes meet USP <871>requirements for nonabsorbable surgicalsutures |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, AcuteSystemic Toxicity, Material-MediatedPyrogenicity, Subacute and SubchronicToxicity, Chronic Toxicity, Genotoxicity,Carcinogenicity, and Implantation | Cytotoxicity, Sensitization, Irritation, AcuteSystemic Toxicity, Material-MediatedPyrogenicity, Subacute and SubchronicToxicity, Chronic Toxicity, Genotoxicity,Carcinogenicity, and Implantation |
{9}------------------------------------------------
Cypris eXact Suture - PDO (Polydioxanone) is substantially equivalent in intended use and fundamental scientific technology as the Sharpoint PDO (polydioxanone) Sutures cleared in K063680 (May 9, 2007). The substantial equivalence table for the comparison of the subject and predicate device is provided below.
| Subject Device | Predicate Device | |
|---|---|---|
| Cypris Medical, Inc. | Surgical Specialties Corp. | |
| Cypris eXact Suture - PDO (Polydioxanone)K233355 | Sharpoint PDO (polydioxanone) SuturesK063680 | |
| Indications for Use | The Cypris eXact Suture (PDO) is indicated foruse in general soft tissue approximation and/orligation, but not for use in cardiovascular orneurological tissues, microsurgery orophthalmic surgery. | Sharpoint PDO sutures are indicated for usein general soft tissue approximation and/orligation, but not for use in cardiovascular,or neurological tissues, microsurgery orophthalmic surgery. |
| Regulation Number | 21 CFR 878.4840 | 21 CFR 878.4840 |
| Regulation Description | Absorbable polydioxanone surgical suture | Absorbable polydioxanone surgical suture |
| Product Code/Name | NEW - Suture, Surgical, Absorbable,Polydioxanone | NEW - Suture, Surgical, Absorbable,Polydioxanone |
| Materials | Polydioxanone SutureStainless Steel Needle | Polydioxanone SutureStainless Steel Needle |
| Suture Construction | Monofilament | Monofilament |
| Suture Colorant | D&C No.2 | D&C No.2 |
| Suture Size(s) | USP sizes 3-0 and 4-0 | USP sizes 3-0 and 4-0 |
| Suture Diameter | All suture sizes meet USP <861> requirementsfor absorbable surgical sutures | All suture sizes meet USP <861>requirements for absorbablesurgical sutures |
| Suture Tensile Strength | All suture sizes meet USP <881> requirementsfor absorbable surgical sutures | All suture sizes meet USP <881>requirements for absorbablesurgical sutures |
| Needle AttachmentStrength | All suture sizes meet USP <871> requirementsfor absorbable surgical sutures | All suture sizes meet USP <871>requirements for absorbablesurgical sutures |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, AcuteSystemic Toxicity, Material-MediatedPyrogenicity, Subacute and SubchronicToxicity, Chronic Toxicity, Genotoxicity,Carcinogenicity, and Implantation. | Cytotoxicity, Sensitization, Irritation, AcuteSystemic Toxicity, Material-MediatedPyrogenicity, Subacute and SubchronicToxicity, Chronic Toxicity, Genotoxicity,Carcinogenicity, and Implantation. |
SUMMARY OF NON-CLINICAL TESTING
The Cypris eXact Sutures were tested in accordance with the requirements of USP - absorbable and non-absorbable surgical sutures for suture diameter, tensile strength, and needle attachment, and meet the requirements of the Guidance for Industry and FDA Staff: Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff (issued June 3, 2003). The Cypris eXact 5.1 Suture Placement Device was tested to evaluate the integrity of the sterile barrier and the functionality of the device following 3 years of real-time aging. While the shelflife of the Cypris eXact 5.1 Suture Placement Device is 3 years, the Cypris eXact Sutures have a shelf-life of 5 years.
{10}------------------------------------------------
All materials used in the fabrication of the Cypris eXact Sutures were evaluated through biocompatibility testing as outlined in ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part I: Evaluation and Testing for an implanted device with Long Term (> 30 days) contact with tissue. The following biocompatibility endpoints were evaluated for the Cypris eXact Sutures: cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, subacute and subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, and implantation. The Cypris eXact 5.1 Suture Placement Device underwent biocompatibility testing as an external communicating device with limited contact (<24 hours) with tissue. The following biocompatibility endpoints were evaluated for the Cypris eXact 5.1 Suture Placement Device: cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
CONCLUSION
The Cypris eXact Sutures are substantially equivalent to the predicate devices because there are no differences in technological or performance characteristics between them. Biocompatibility data and the results of performance testing also demonstrate the substantial equivalence of the Cypris eXact Sutures to that of the predicate devices. Furthermore, the Cypris eXact Sutures demonstrate conformance with the USP. ISO, and FDA's Guidance for Surgical Sutures. The Cypris eXact Sutures can be used with the Cypris eXact 5.1 Suture Placement Device.
The Cypris eXact Suturing System is considered substantially equivalent to the predicate devices based on the testing performed, same intended use, and identical technological characteristics. The subject device does not raise new issues of safety or performance compared to the predicate devices.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.