Who is the manufacturer of C-PTFETM Surgical Suture?

Cp Medical, Inc. filed the 510(k) submission for C-PTFETM Surgical Suture (K173922).

What is the FDA product code for C-PTFETM Surgical Suture?

NBY. It is classified under 21 CFR 878.5035 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for C-PTFETM Surgical Suture?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like C-PTFETM Surgical Suture?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

C-PTFETM Surgical Suture

K173922 · Cp Medical, Inc. · NBY · Mar 26, 2018 · General, Plastic Surgery

Device Facts

Record ID	K173922
Device Name	C-PTFETM Surgical Suture
Applicant	Cp Medical, Inc.
Product Code	NBY · General, Plastic Surgery
Decision Date	Mar 26, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5035
Device Class	Class 2
Attributes	Therapeutic

Intended Use

CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.

Device Story

C-PTFE™ Surgical Suture is a sterile, nonabsorbable, monofilament polytetrafluoroethylene (PTFE) suture; provided with or without needles. Used in clinical settings by healthcare professionals for soft tissue approximation and ligation. Sutures are supplied in figure-8 or racetrack configurations within Tyvek/film pouches. Device is single-use and disposable. Sterilized via ethylene oxide (EO). No electrical, software, or mechanical components. Clinical benefit derived from providing secure tissue approximation during surgical procedures.

Clinical Evidence

Bench testing only. No clinical data or animal studies were conducted. Performance supported by comparative bench testing against predicate device, including USP-40-NF35:2017 standards for tensile strength, diameter, and needle attachment, and biocompatibility testing per ISO 10993.

Technological Characteristics

Material: Monofilament Polytetrafluoroethylene (PTFE). Form factor: Suture with/without needles, figure-8 or racetrack configuration. Sterilization: Ethylene Oxide (EO) per EN ISO-11135:2014. Biocompatibility: Per ISO 10993. No electrical components, software, or active energy sources.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including dental surgical procedures. Contraindicated for microsurgery, ophthalmic procedures, or peripheral neural tissue.

Regulatory Classification

Identification

Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).

Special Controls

*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.

Predicate Devices

MonoTex (K140415)

Related Devices

K192088 — GOLNIT Non-aborbable PTFE Surgical Suture · Antarma, LLC Dba Golnit Sutures · Sep 4, 2019
K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture · Demetech Corporation · Oct 11, 2018
K140415 — MONOTEX · Riverpoint Medical · Mar 26, 2014
K170842 — WEGO-PTFE · Foosin Medical Supplies Inc., Ltd. · Jul 31, 2017
K072076 — CYTOPLAST PTFE SUTURE · Osteogenics Biomedical, Inc. · Oct 31, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 26, 2018 CP Medical Inc. Mr. John Hartigan Director QA/RA 1775 Corporate Dr. Suite 150 Norcross, Georgia 30093 Re: K173922 Trade/Device Name: C-PTFFE™ Surgical Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: December 21, 2017 Received: December 26, 2017 Dear Mr. Hartigan: 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, 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); {1}------------------------------------------------ #### Page 2 - John Hartigan 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 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. Jennifer R. Stevenson -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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173922 Device Name C-PTFETM Surgical Suture #### Indications for Use (Describe) The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue. Type of Use (Select one or both, as applicable) | <div> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12"></rect> <line stroke="black" x1="0" x2="12" y1="0" y2="12"></line> <line stroke="black" x1="0" x2="12" y1="12" y2="0"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {3}------------------------------------------------ ## 1. 510(k) Summary In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the C-PTFE® Surgical Suture is provided below. | Date Summary Prepared | December 14, 2017 | |-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer/Distribu tor/ Sponsor | CP Medical Inc. 1775 Corporate Drive, Ste. 150 Norcross, GA 30093 | | 510(k) Contact | CP Medical John Hartigan 1775 Corporate Drive Norcross, GA 30093 470-273-6005 (phone) hartiganj@cpmedical.com (email) | | Trade Name | C-PTFETM Surgical Suture | | Common Name | Surgical Suture, Nonabsorbable | | Code -Name - Classification | NBY – Surgical Suture Class II: 21 CFR §878.5035 | | Predicate Devices | MonoTex K140415 This predicate has not been subject to a design-related recall (FDA's TPLC website,. no filings from 2000 to date 2017) | | Device Description | Device Description: The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014 | | Intended Use | CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C- | | PTFE™ sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue. | | | Non-Clinical Performance Testing | The CP Medical nonabsorbable C-PTFE™ Surgical Suture was tested recognized standard 6-393: USP-40-NF35:2017, Nonabsorbable Surgical Suture, 6-394: USP-40-NF35:2017, <881>, Tensile Strength, 6-395: USP-40-NF35:2017 <861>, Diameter, 6-396 USP-40-NF35:2017 <871>, Sutures – Needle Attachment. | | Substantial Equivalence Summary (Conclusion) | Based on the technological; characteristics and non-clinical performance testing the CP Medical C-PTFE™ Surgical Suture was shown to be substantially equivalent to the predicate device, the MonoTex K140415. | {4}------------------------------------------------ {5}------------------------------------------------ Additionally, a comparison between the CP Medical C-PTFETM Surgical Suture and the predicate device is summarized below: | Feature | CP Medical C-PTFETM Surgical Suture | MonoTex K140415 | Substantially Equivalent | |--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Device Classification | Class II: 21 CFR §878.5035 | Class II: 21 CFR §878.5035 | Yes | | Product Code | NBY – Suture Surgical | NBY – Suture Surgical | Yes | | Device Common Name as Cleared by FDA | Suture, Surgical Nonabsorbable, Polytetraflouroethylene | Suture, Surgical Nonabsorbable, Polytetraflouroethylene | Yes | | Indications for use | CP Medical nonabsorbable C- PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue. | Riverpoint MonoTex surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of dura matter. Riverpoint MonoTex sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue | Yes | | Patient Population | Single use only | Single use only | Yes | | Environment of Use | Point of procedure – clinical settings. | Point of procedure – clinical settings. | Yes | | Feature | CP Medical C-PTFE™ Surgical Suture | MonoTex K140415 | Substantially Equivalent | | Device Description | CP Medical C-PTFE™ Surgical Suture are sterile, nonabsorbable, monofilament sutures available with or without needles, The sutures are delivered in a figure 8 or racetrack configuration, which is contained within a Tyvek/film package. The sutures are sterilized by EO. | Riverpoint PTFE MonoTex Surgical Suture are sterile, nonabsorbable, monofilament sutures available with or without needles, The sutures are delivered in a figure 8 or racetrack configuration, which is contained within a Tyvek/film package. The sutures are sterilized by EO. | Yes | | Principles of Operation | CP Medical C-PTFE™ Surgical Suture are for use in clinical settings and carry a prescription. The sutures are removed for device packing following aseptic protocols. | Riverpoint PTFE MonoTex Surgical Suture are for use in clinical settings and carry a prescription. The sutures are removed for device packing following aseptic protocols. | Yes | | Sizes | Various diameters based on USP (unless stated on labeling), various lengths. | Various diameters based on USP (unless stated on labeling), various lengths. | Yes | | Needles | Available with or without standard needles attached. | Available with or without standard needles attached. | Yes | | Colors available | White/Undyed | White/Undyed | Yes | | Feature | CP Medical C-PTFE™ Surgical Suture | MonoTex K140415 | Substantially Equivalent | | Non-Clinical Testing Summary | The CP Medical nonabsorbable C-PTFE™ Surgical Suture was tested per recognized standard: 6-393: USP-40- NF35:2017, Nonabsorbable Surgical Suture, 6-394: USP-40- NF35:2017, <881>, Tensile Strength. 6-395: USP-40- NF35:2017 <861>, Diameter 6-396 USP-40- NF35:2017 <871>, Sutures – Needle Attachment. | Riverpoint PTFE MonoTex are tested per USP <861>, <871> and <881>. | Yes – Test report 17-033 confirmed equivalency. | | Sterile | Yes | Yes | Yes | | Sterilization method | EO | EO | Yes | | Biocompatible materials | Per ISO 10993 | Per ISO 10993 | Yes | | Instructions for Use | Yes | Yes | Yes | | Materials | Monofilament Polytetraflouroethylene | Monofilament Polytetraflouroethylene | Yes | | RX | Yes | Yes | Yes | {6}------------------------------------------------ {7}------------------------------------------------ # PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. {8}------------------------------------------------ ### Biocompatibility testing The biocompatibility evaluation for CP Medical C-PTFE™ was conducted in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk management Process," as recognized by FDA. The battery of testing included the following tests: - . Muscle Implantation Study in Rabbits - 4 weeks - . Maximization Sensitization - . Bacterial Reverse Mutation - Systemic Toxicity in Mice - USP Pyrogen Study . - Cytotoxicity - Intracutaneous . - Chemical Characterization ● The C-PTFE™ device is considered a >30 implantable device #### Electrical safety and electromagnetic compatibility (EMC) There are no electrical components in the C-PTFE™. No Electrical safety information is required for the safe functioning of this device. #### Software Verification and Validation Testing There is no software in the C-PTFE™ and the C-PTFE™ sutures requires no software to function. This section does not apply to this device. #### Mechanical and acoustical testing This section does not apply to this device. {9}------------------------------------------------ ### Animal study This section does not apply to this device. ### Clinical Studies This section does not apply to this device. ### Summary Based on the comparative testing between post sterile, aged, C-PTFE™ and MonoTex (predicate) currently in interstate commerce, the C-PTFE™ was found to have a safety and effectiveness profile that is similar to the predicate device. ## Conclusions The non-clinical data support the safety of the device and the sterilization validation demonstrate that the C-PTFE™ device should perform as intended in the specific use conditions. Based on the technological characteristics and non-clinical performance testing, the CP Medical C-PTFE™ Surgical Suture performs comparably the predicate device, MonoTex K140415, which is currently marketed for the same intended use.