(36 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical suture, with no mention of AI or ML.
No
The device is a surgical suture used to secure tissues or create wound closures, which is an aid in treatment, but not a therapeutic device in itself.
No.
The device is a surgical suture used for tissue approximation and ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical surgical suture made of PTFE material, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- MonoTex PTFE Suture Function: The description clearly states that MonoTex PTFE surgical sutures are used to "secure tissues together or create wound closures during a surgical procedure or after an injury." This is a device used within the body for a surgical purpose.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition.
The intended use and device description clearly indicate that this is a surgical device used for tissue approximation and ligation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
MonoTex PTFE surgical suture is indicated for use In general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. MonoTex PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues.MonoTex PTFE suture is provided sterile as a single use device.
Product codes (comma separated list FDA assigned to the subject device)
NBY
Device Description
MonoTex Polytetrafluoroethylene (PTFE) nonabsorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. MonoTex PTFE sutures are monofilament, and are composed of expanded polytetrafluoroethylene material attached to a standard medical grade suture needle as applicable (sutures can be provided without needles as well). Available Suture sizes will be standard according to USP requirements (6/0 through 5).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular, dental, dura mater
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)
Per FDA's Special Control Guidance Document: Surgical Sutures, performance testing, including mechanical testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed to further ensure substantial equivalence with the predicate devices listed. All testing performed has demonstrated that MonoTex PTFE sutures are as safe and effective as the predicate, will meet current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and that they are substantially equivalent to the applicable predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072076 (Cytoplast PTFE Suture, Osteogenics Biomedical, Inc.)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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mar 2 6 2014
Image /page/0/Picture/1 description: The image shows the logo for Riverpoint Medical. The logo consists of the letters "RP" in a square on the left, and the words "RIVERPOINT MEDICAL" on the right. The word "MEDICAL" is smaller and located below the word "RIVERPOINT".
Pg. 1 of 3
510(k) Summary
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| Address: | 825 NE 25th Ave. |
| Portland, OR 97232 | |
| Phone Number: | (503) 517-8001 or 866 445-4923 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Douglas Rowley |
| (503) 517-8001 | |
| Date of Preparation: | February 11th, 2014 |
Device Name
| Trade Name: | MonoTex |
|---|---|
| Common Name: | PTFE Nonabsorbable Surgical Sutures |
| Classification Name: | Suture, surgical, nonabsorbable, expanded |
| Polytetrafluoroethylene |
Device Classification
| FDA Class: | 2 |
|---|---|
| Product Classification: | 878.5035: Nonabsorbable expanded polytetrafluoroethelene |
| surgical suture | |
| Code: | NBY |
| Classification Panel: | Class II (special controls); General and Plastic Surgery |
Predicate Devices (applicable 510(k) number ilsted):
K072076 (Cytoplast PTFE Suture, Osteogenics Biomedical, Inc.)
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Image /page/1/Picture/0 description: The image shows the logo for Riverpoint Medical. The logo consists of the letters RP inside of a rounded square on the left. To the right of the square is the word "RIVERPOINT" in all caps, with the word "MEDICAL" underneath it in a smaller font.
Special Controls
FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission.
Device Description
MonoTex Polytetrafluoroethylene (PTFE) nonabsorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. MonoTex PTFE sutures are monofilament, and are composed of expanded polytetrafluoroethylene material attached to a standard medical grade suture needle as applicable (sutures can be provided without needles as well). Available Suture sizes will be standard according to USP requirements (6/0 through 5).
Intended Uses
Riverpoint MonoTex PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. MonoTex PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. MonoTex PTFE suture is provided sterile as a single use device.
Substantial Equivalence
MonoTex PTFE nonabsorbable sutures have been designed and manufactured to be substantially equivalent to the prodicate device listed for safety and effectiveness. Materials used were selected based on known biocompatibility and established histories of use in the medical device industry for implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed. MonoTex PTFE sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified per USP unless stated otherwise on labeling. Testing is performed on each lot of product to verify that requirements have been met prior to release.
Technological Characteristics
The MonoTex PTFE sutures within this submission have substantially equivalent technological characteristics as the predicate device listed. As with the predicate device, MonoTex PTFE sutures are monofilament, uncoated, synthetic nonabsorbable surgical sutures. MonoTex PTFE sutures are provided sterile for one-time use only, and meet USP requirements unless stated otherwise within labeling.
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Image /page/2/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of the letters RP inside of a square. To the right of the square is the word "RIVERPOINT" in all capital letters, with the word "MEDICAL" underneath it.
Performance Data
Per FDA's Special Control Guidance Document: Surgical Sutures, performance testing, including mechanical testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed to further ensure substantial equivalence with the predicate devices listed. All testing performed has demonstrated that MonoTex PTFE sutures are as safe and effective as the predicate, will meet current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and that they are substantially equivalent to the applicable predicate devices.
Conclusion
Based on the information provided within this 510(k) submission, Riverpoint Medical concludes that the proposed MonoTex PTFE sutures are substantially equivalent to the predicate devices listed according to the requirements of the Federal Food, Drug, and Cosmetic Act.
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Public Ficalth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2014
Riverpoint Medical Mr. Douglas Rowley 825 Northeast 25" Avenue Portland, Oregon 97232
Re: K140415
Trade/Device Name: MONOTEX PTFE Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetrafluorocthylenc surgical suture Regulatory Class: Class II Product Code: NBY Dated: February 11, 2014 Received: February 18, 2014
Dear Mr. Rowley:
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 practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. 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, Paris 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 or any reading the Act 's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Douglas Rowley
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for
Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/1 description: The image shows the logo for Riverpoint Medical. The logo consists of the letters "RP" inside of a rounded square on the left. To the right of the square is the word "RIVERPOINT" in all capital letters, with the word "MEDICAL" in smaller letters underneath.
Indications for Use Statement
| 510(k) Number: | Unknown at this time |
|---|---|
| Device Name: | Nonabsorbable expanded polytetrafluoroethylene (PTFE) surgical suture |
| Trade Name: | MonoTex |
Indications for Use:
MonoTex PTFE surgical suture is indicated for use In general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. MonoTex PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues.
MonoTex PTFE suture is provided sterile as a single use device.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR -
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter L. Hudson -S 2014.03.20 09:36:18 -04'00'
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510(k) Indications for Use Statement - PTFE Suture