(30 days)
No
The 510(k) summary describes a physical surgical suture and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device, RiverLon Suture, is a non-absorbable surgical suture used for approximation and/or ligation of soft tissues. It is used in surgical procedures to close wounds or tie off blood vessels, which is a structural or supportive function rather than a therapeutic one. It does not exert any pharmacological, immunological, or metabolic action.
No
Explanation: The device is a surgical suture, which is used for approximation and/or ligation of soft tissue during surgery. It is not used to diagnose a medical condition.
No
The device description clearly states it is composed of physical materials (Nylon 6 and Nylon 6/6) and is a surgical suture, which is a physical medical device. There is no mention of software as the primary or sole component.
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," which is a surgical procedure performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The information clearly describes a surgical device used for physical repair within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RiverLon Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
Product codes
GAR
Device Description
The Riverpoint Medical RiverLon Nylon Sutures are inert, non-absorbable, sterile surgical sutures composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6/6. RiverLon sutures are available in common sizes and length with or without pre-attached needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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)
The Riverpoint Medical RiverLon Sutures meet requirements established by the United States Pharmacopeia. The RiverLon Sutures are tested per USP performance requirements for needle attachment, diameter, and tensile strength. FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission. Materials used were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100006 – Riverpoint Medical RiverLon (Nylon)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.(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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2015
Riverpoint Medical Mr. Edwin Anderson Director of Quality and Regulatory 825 Northeast 25th Avenue Portland, Oregon 97232
Re: K152795
Trade/Device Name: RiverLon (Nylon) Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: Class II Product Code: GAR Dated: September 24, 2015 Received: September 28, 2015
Dear Mr. Anderson:
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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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
- 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
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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 rounded square with a green border. To the right of the square is the text "RIVERPOINT" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it.
Indications for Use Statement
K152795 510(k) Number (if known):
Device Name: RiverLon (Nylon) Suture
Indications for Use:
RiverLon Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
X Prescription Use (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)
Page _________________________________________________________________________________________________________________________________________________________________________
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Image /page/3/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of a green square with rounded corners, inside of which are the letters "RP" in white. To the right of the square is the text "RIVERPOINT" in bold, black letters, with the word "MEDICAL" in smaller letters underneath.
510(k) SUMMARY
Riverpoint Medical RiverLon Nylon Suture Line Extension
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: | Edwin Anderson |
| (503) 517-8001 | |
| Date of Preparation: | September 24th, 2015 |
Device Name
| Trade Name: | RiverLon (Nylon) Suture |
|---|---|
| Common or Usual Names: | Nylon Suture, Non-absorbable Surgical Sutures |
| Classification Name: | Nonabsorbable Polyamide Surgical Suture |
Device Classification
| FDA Class: | II |
|---|---|
| Product Classification: | 878.5020: Suture, Nonabsorbable, Synthetic, Polyamide |
| Classification Code: | GAR |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office of Device Evaluation |
| Division of Surgical Devices, Plastic and Reconstructive | |
| Surgery Devices Branch Two - Skin/Wound | |
| Dressing/Aesthetic Injectables |
Predicate Device
K100006 – Riverpoint Medical RiverLon (Nylon)
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Image /page/4/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of a green rounded square with the letters "RP" in white inside. To the right of the square is the text "RIVERPOINT" in bold, black letters, with the word "MEDICAL" in smaller letters underneath.
Device Description
The Riverpoint Medical RiverLon Nylon Sutures are inert, non-absorbable, sterile surgical sutures composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6/6. RiverLon sutures are available in common sizes and length with or without pre-attached needles.
Intended Use / Indications for Use
The Riverpoint Medical RiverLon Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures. The Riverpoint Medical RiverLon Nylon Sutures are provided sterile. RiverLon Suture are intended for single use and are not to be resterilized.
Performance Data
The Riverpoint Medical RiverLon Sutures meet requirements established by the United States Pharmacopeia. The RiverLon Sutures are tested per USP performance requirements for needle attachment, diameter, and tensile strength. FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission. Materials used were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices.
Substantial Equivalence and Comparison of Technical Characteristics
The RiverLon Nylon Suture line extension is as safe and effective as the previously cleared RiverLon Nylon Sutures. The RiverLon Suture has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the RiverLon Nylon Suture and the predicate device are sterilized using the same processes, are composed of the same material, and are tested per USP performance requirements for needle attachment, diameter, and tensile strength. The minor difference in technical characteristics is limited to USP size, and the line extension introduces a size outside of the originally cleared range of sizes. These differences do not raise new questions of safety or effectiveness, therefore the RiverLon Nylon Suture line extension is substantially equivalent to the currently marketed predicate device.
Conclusion
The information provided in this Special 510(k) demonstrates that the Riverpoint Medical RiverLon Nylon Suture line extension is substantially equivalent to the predicate device.