HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
Device Facts
| Record ID | K100006 |
|---|---|
| Device Name | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED |
| Applicant | Riverpoint Medical |
| Product Code | GAT · General, Plastic Surgery |
| Decision Date | May 10, 2010 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 878.5000 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
RiverBond, RiverSilk, RiverPro, and RiverLon non-absorbable sutures are intended to be used for soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures. HS Fiber non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
Device Story
Non-absorbable surgical sutures (Polyblend, Polyester, Silk, Polypropylene, Nylon) used to secure tissues or close wounds. Operated by surgeons in clinical settings. Sutures provided with or without needles. Device functions by physical approximation/ligation of soft tissue. Benefits include secure wound closure and tissue support. Performance verified against USP 32 standards for diameter, tensile strength, and needle attachment strength.
Clinical Evidence
Bench testing only. No clinical data provided. Compliance with USP 32 requirements for diameter, tensile strength, and needle attachment strength verified per lot.
Technological Characteristics
Non-absorbable sutures: Polyblend (polyethylene terephthalate), Polyester (polyethylene terephthalate), Silk, Polypropylene, Nylon (polyamide). Sizes 12/0 to 7 per USP 32. Sterile, single-use. Mechanical fixation principle.
Indications for Use
Indicated for general soft tissue approximation and/or ligation in patients requiring cardiovascular, ophthalmic, or neurosurgical procedures; HS Fiber also indicated for orthopedic allograft tissue procedures. Provided sterile for single use.
Regulatory Classification
Identification
Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
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
- Teleflex Force Fiber (K063778)
- Genzyme Biosurgery (K021019)
- Sherwood-Davis & Geck (K982853)
- US Surgical (K050947)
- CP Medical (K001173)
Submission Summary (Full Text)
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## 510(k) Summary
### Submitter Information
MAY 1 0 2010
| Submitter's Name: | Riverpoint Medical |
|----------------------|----------------------------------------|
| Address: | 825 NE 25th Ave.<br>Portland, OR 97232 |
| Phone Number: | (503) 517-8001 or 866 445-4923 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Douglas Rowley<br>(503) 517-8001 |
| Date of Preparation: | December 23rd, 2009 |
### Device Name
| Trade Name: | HS Fiber (Polyblend); RiverBond (Polyester); RiverSilk<br>(Silk); RiverPro (Polypropylene); RiverLon (Nylon) |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Common Name: | Non-absorbable Surgical Sutures: Polyblend, Polyester,<br>Silk Polypropylene, Nylon |
| Classification Name: | All: General and Plastic Surgery Device |
### Device Classification
| FDA Class: | 2 (All varieties) |
|-------------------------|----------------------------------------------------------------------|
| Product Classification: | |
| 1. Polyblend: | 878.5000, Nonabsorbable poly(ethylene terephthalate) surgical suture |
| 2. Polyester: | 878.5000, Nonabsorbable poly(ethylene terephthalate) surgical suture |
| 3. Silk: | 878.5030, Natural Nonabsorbable silk surgical suture |
| 4. Polypropylene: | 878.5010, Nonabsorbable polypropylene surgical suture |
| 5. Nylon: | 878.5020, Nonabsorbable polyamide surgical suture |
510(k) Summary – Non-Absorbable Suture
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#### Code:
- 1. Polyblend Suture: GAT 2. Polyester Suture: GAS
- 3. Silk Suture: GAP
- GAW 4. Polypropylene Suture:
- 5. Nylon Suture: GAR
Classification Panel:
All: Class II (special controls); General and Plastic Surgery
### Predicate Devices (applicable 510(k) number listed)
- 1. Polyblend Suture: Teleflex® Force Fiber® (K063778)
- 2. Polyester Suture: Genzyme Biosurgery® (K021019)
- Silk Suture: Sherwood-Davis & Geck® (K982853) 3.
- US Surgical® (K050947) ধ : Polypropylene Suture:
- 5. Nylon Suture: CP Medical® (K001173)
### 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
Riverpoint Medical non-absorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. They are composed of the applicable suture material and a standard medical grade suture needle as applicable (sutures can be provided without needles as well). See table below for additional information about each applicable suture material included in this submission.
Available Suture sizes will be standard according to USP 32 requirements (12/0 through 7, depending on suture type).
#### Intended Use
RiverBond, RiverSilk, RiverPro, and RiverLon non-absorbable sutures are intended to be used for soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
HS Fiber non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
#### 510(k) Summary - Non-Absorbable Suture
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#### Safety and Effectiveness
Each variety of Riverpoint Medical non-absorbable sutures has been designed and manufactured to be substantially equivalent to the predicate devices 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.
Riverpoint Medical non-absorbable sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32. Testing is performed on each lot of product to verify that USP requirements have been met prior to release.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Riverpoint Medical % Mr. Doug Rowley RA/QA Manager 825 NE 25" Avenue Portland, Oregon 97232
MAY 1 0 2010
Re: K100006
Trade/Device Name: Polyester Non-absorbable Surgical Suture, Polyblend Non-absorbable Surgical Suture, Silk Non-absorbable Surgical Suture, Polypropylene Surgical Suture, Nylon Non-absorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GAS, GAP, GAW, GAR Dated: April 1, 2010 Received: April 16, 2010
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 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
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Page 2 - Mr. Doug Rowley
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
urs,
for
alkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use Statement
510(k) Number:
Unknown at this time
K100006
Polyester Non-absorbable Surgical Suture Device Name:
Trade Name:
RiverBond
Indications for Use:
RiverBond surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. RiverBond 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)
Daniel Kronefu MXM
(Division Sign Off)
Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K100006
Page 1 of 1
510(k) Indications for Use Statement - Nonabsorbable Suture
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Image /page/6/Picture/0 description: The image shows a logo for a company called "riverpoint". The logo consists of two stylized "p" letters, one in black and one in white. The word "riverpoint" is written in a sans-serif font below the two letters, with "river" in black and "point" in white.
### Indications for Use Statement
| 510(k) Number: | K100006 |
|----------------|------------------------------------------|
| Device Name: | Polyblend Non-absorbable Surgical Suture |
| Trade Name: | HS Fiber |
Indications for Use:
Hs Fiber surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
HS Fiber 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)
Daniel Keane by MXM
(Division Sign Off)
Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100006
Page 1 of 1
510(k) Indications for Use Statement - Nonabsorbable Suture
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Image /page/7/Picture/0 description: The image shows a stylized letter 'p' above the word 'point'. The 'p' is drawn with a thick line, forming a loop at the top and a straight vertical line extending downwards. The word 'point' is written in a simple, sans-serif font, positioned directly below the vertical line of the 'p'.
## Indications for Use Statement
Unknown at this time 510(k) Number:
K 100006
Device Name:
Silk Non-absorbable Surgical Suture
Trade Name:
RiverSilk
Indications for Use:
RiverSilk surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. RiverSilk 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)
Daniel Krane for MXM
(Division Sign Off)
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100006
Page 1 of 1
510(k) Indications for Use Statement - Nonabsorbable Suture
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Image /page/8/Picture/0 description: The image shows a logo with the letters 'rp' stacked on top of each other. The letters are stylized and have a textured appearance. Below the letters, the word 'riverpoint' is written in a lowercase font. The logo appears to be for a company or organization named Riverpoint.
# Indications for Use Statement
| 510(k) Number: | Unknown at this time K100006 |
|----------------|----------------------------------------------|
| Device Name: | Polypropylene Non-absorbable Surgical Suture |
| Trade Name: | RiverPro |
Indications for Use:
RiverPro surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures. RiverPro 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)
Daniel Krone for MXM
(Division Sign-Off)
(Division S Division of Surgical, Orthopedic, and Restorative Device
510(k) Number_`K100006
Page 1 of 1
510(k) Indications for Use Statement – Nonabsorbable Suture
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Image /page/9/Picture/0 description: The image shows a logo with the letter 'p' in a stylized font. The letter is duplicated, with one version solid and the other appearing as a dotted outline. Below the letter, the word 'everpoint' is written in a small, sans-serif font.
# Indications for Use Statement
a con un con
| 510(k) Number: | K100006 |
|----------------|------------------------------------------------------|
| | Unknown at this time |
| Device Name: | Nylon Non-absorbable Surgical Suture |
| Trade Name: | RiverLon (monofilament) and RiverLon Braid (braided) |
Indications for Use:
RiverLon and RiverLon Braid surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
RiverPro 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)
David Kromka
(Division Sigr Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100006
Page 1 of 1 510(k) Indications for Use Statement - Nonabsorbable Suture
