MONOTEX

K140415 · Riverpoint Medical · NBY · Mar 26, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140415
• Device Name: MONOTEX
• Applicant: Riverpoint Medical
• Product Code: NBY · General, Plastic Surgery
• Decision Date: Mar 26, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5035
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

MonoTex PTFE surgical suture; monofilament, nonabsorbable, expanded polytetrafluoroethylene material; attached to medical grade needle or provided without needle. Used by surgeons to secure tissues or create wound closures during surgical procedures. Provided sterile for single-use. Performance meets USP requirements for diameter, tensile strength, and needle attachment strength. Benefits include reliable soft tissue approximation and ligation.

Clinical Evidence

Bench testing only. Performance testing conducted per FDA Special Control Guidance for Surgical Sutures, including mechanical testing per USP standards and biocompatibility testing per ISO 10993-1. Results demonstrate safety and effectiveness equivalent to predicate.

Technological Characteristics

Monofilament, uncoated, synthetic nonabsorbable expanded polytetrafluoroethylene (PTFE) suture. Available in USP sizes 6/0 through 5. Sterile, single-use. Meets USP requirements for diameter, tensile strength, and needle attachment strength.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring cardiovascular, dental, general surgical procedures, or dura mater repair. Contraindicated for microsurgery, ophthalmic procedures, and peripheral neural tissues.

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

• Cytoplast PTFE Suture (K072076)

Submission Summary (Full Text)

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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".

K140415

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## 510(k) Summary

## Submitter Information

| Submitter's Name: | Riverpoint Medical |
|----------------------|----------------------------------------|
| Address: | 825 NE 25th Ave.<br>Portland, OR 97232 |
| Phone Number: | [phone] or 866 445-4923 |
| Fax Number: | [phone] |
| Registration Number: | 3006981798 |
| Contact Person: | Douglas Rowley<br>[phone] |
| Date of Preparation: | February 11th, 2014 |

### Device Name

| Trade Name: | MonoTex |
|----------------------|----------------------------------------------------------------------|
| Common Name: | PTFE Nonabsorbable Surgical Sutures |
| Classification Name: | Suture, surgical, nonabsorbable, expanded<br>Polytetrafluoroethylene |

### Device Classification

| FDA Class: | 2 |
|-------------------------|------------------------------------------------------------------------------|
| Product Classification: | 878.5035: Nonabsorbable expanded polytetrafluoroethelene<br>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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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

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

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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 [phone] or [phone] 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 [phone] or [phone] 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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K140415

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