(90 days)
Not Found
No
The summary describes a surgical suture and its physical properties and testing, with no mention of AI or ML.
No.
The device is a surgical suture used for tissue approximation and ligation, which is a supportive function during a medical procedure, not a direct treatment or therapy.
No
Explanation: The device is a surgical suture used for general soft tissue approximation and/ligation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical surgical suture made of Polytetraflouroethylene, provided with or without needles, and sterilized via EO. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation, including dental surgical procedures." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical suture," which is a physical material used to close wounds or hold tissues together during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
NBY
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue approximation and/or ligation, including dental surgical procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Point of procedure – clinical settings. Medical professionals.
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
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, , Tensile Strength, 6-395: USP-40-NF35:2017 , Diameter, 6-396 USP-40-NF35:2017 , Sutures – Needle Attachment.
Key Metrics
Not Found
Predicate Device(s)
MonoTex K140415
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
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).(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.
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);
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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,
, Tensile Strength, 6-395: USP-40-NF35:2017 ,
Diameter, 6-396 USP-40-NF35:2017 , 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. |
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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, ,
Tensile Strength. 6-395: USP-40-
NF35:2017 ,
Diameter 6-396 USP-40-
NF35:2017 ,
Sutures – Needle
Attachment. | Riverpoint PTFE
MonoTex are tested
per USP ,
and . | 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 |
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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.