(89 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of surgical sutures, with no mention of AI or ML.
No
The device is a surgical suture used for tissue approximation and ligation, which are mechanical functions to support healing, not therapeutic in the sense of treating a disease or condition with therapy.
No
Explanation: This device is a surgical suture used for tissue approximation and ligation, which are therapeutic functions. It does not perform any diagnostic function such as detecting, monitoring, or predicting diseases.
No
The device description clearly states that the device is a physical surgical suture made of braided strands of PGLA, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description clearly states that Vilet and Vilet Quick sutures are "medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury." This is a description of a device used on the body during a procedure, not for testing specimens outside the body.
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation" and "superficial soft tissue approximation of the skin and mucosa." These are surgical applications, not diagnostic tests.
- Lack of IVD Language: There is no mention of analyzing specimens, diagnostic information, or any of the typical language associated with IVD devices.
Therefore, Vilet and Vilet Quick surgical sutures are classified as surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Vilet: Vilet (PGLA) surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in gorient son thissue cardiovascular and neurological tissues.
Vilet suture is provided sterile as a single use device.
Vilet Quick: Vilet Quick (fast absorbing PGLA) surgical suture is indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophth short cardiovascular or neurological procedures.
Vilet Quick suture is provided sterile as a single use device.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
Riverpoint Medical PGLA absorbable surgical sutures (Vilet and Vilet Quick) are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. Vilet and Vilet Quick sutures are multifilament, and are composed of braided strands of Polyglycolic-Lactic Acid (PGLA) coated with Poly(glycolide-co-L-lactide) and Calcium Stearate attached to a standard min suture needle as annlinghle (cutuse ann Stearate 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 32 requirements (8/0 through 3, depending on suture type).
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 (Vilet), Superficial soft tissue approximation of the skin and mucosa (Vilet Quick)
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 synthetic absorbable sulture, biocompatibility testing in accordance to ISO 10993-1, and in-vitro as well as in-vivo resorption testing has been performed to further ensure substantial equivalence with the predicate devices listed. All testing performed has demonstrated that Riverpoint's Vilet and Vilet Quick PGLA sutures meet current performance requirements for synthelic absorbable braided surgical sutures unless otherwise labeled, 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.
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.
0
K120556 P. 1 of 3
MAY 2 3 2012
K120556 Response 05.2012
| RIVERPOINT
| MEDICAL |
|---|
| ----------------------- |
510(k) Summary
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| ------------------- | -------------------- |
Address:
825 NE 25th Ave. Portland, OR 97232
(503) 517-8001 or 866 445-4923
Phone Number:
Fax Number: (503) 517-8002
Registration Number: 3006981798
Contact Person: Douglas Rowley (503) 517-8001
Date of Preparation: February 14, 2012
Device Names
| Trade Names: | PGLA:
Fast Absorbing PGLA: | Vilet
Vilet Quick |
|-----------------------|-------------------------------------|----------------------|
| Common Names: | Absorbable Surgical Sutures: PGLA | |
| Classification Names: | General and Plastic Surgery Devices | |
Device Classification
| FDA Class: | 2 |
|---|---|
| Product Classification: |
- Vilet:
- Vilet Quick: | 878.4493, Absorbable poly(glycolide/l-lactide) surgical suture
878.4493, Absorbable poly(glycolide/l-lactide) surgical suture |
| Codes: | |
| 1. Vilet: | GAM |
| 2. Vilet Quick: | GAM |
| Classification Panel: | All: Class II (special controls); General and Plastic Surgery |
1
Image /page/1/Picture/1 description: The image shows the words "RIVERPOINT MEDICAL" in a bold, sans-serif font. The word "RIVERPOINT" is on the top line, and the word "MEDICAL" is on the bottom line. The letters are all capitalized and black. The image appears to be a logo or heading.
Predicate Devices (applicable 510(k) number listed):
-
- Ethicon® Vicryl® KO22269
- Ethicon® Vicryl Rapide®: 2. K033746
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 PGLA absorbable surgical sutures (Vilet and Vilet Quick) are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. Vilet and Vilet Quick sutures are multifilament, and are composed of braided strands of Polyglycolic-Lactic Acid (PGLA) coated with Poly(glycolide-co-L-lactide) and Calcium Stearate attached to a standard min
suture needle as annlinghle (cutuse ann Stearate 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 32 requirements (8/0 through 3, depending on suture type).
Intended Uses
Vilet: Vilet (PGLA) surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in gorient son thissue cardiovascular and neurological tissues.
Vilet suture is provided sterile as a single use device.
Vilet Quick: Vilet Quick (fast absorbing PGLA) surgical suture is indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophth short cardiovascular or neurological procedures.
Vilet Quick suture is provided sterile as a single use device.
Safety and Effectiveness
Each variety of absorbable suture has been designed and manufactured to be substantially equivalent to the predicate devices listed for safety and effectiveness. Materials used were selected broend 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 Vilet and Vilet Quick PGLA absorbable sutures have been designed to meet the requirements for diameter, tensile strength, and needle attechment strength
2
Image /page/2/Picture/2 description: The image shows the words RIVERPOINT and MEDICAL stacked on top of each other. The text is in a bold, sans-serif font. The word RIVERPOINT is on the top line, and the word MEDICAL is on the bottom line. The text is black and the background is white.
as specified within USP 32 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 Riverpoint Vilet and Vilet Quick PGLA sutures within this submission have substantially equivalent technological characteristics as the predicate devices listed. As with the predicate devices, Riverpoint Vilet and Vilet Quick PGLA sutures are braided. A coated, synthetic absorbable surgical sutures. Riverpoint Vilet and Vilet and Vilet Quick PGLA sultures are provided sterile for one-time use only, and meet USP requirements unless stated otherwise within labeling.
Performance Data
Per FDA's Special Control Guidance Document: Surgical Sutures, performance testing, including mechanical testing in accordance to USP for synthetic absorbable sulture, biocompatibility testing in accordance to ISO 10993-1, and in-vitro as well as in-vivo resorption testing has been performed to further ensure substantial equivalence with the predicate devices listed. All testing performed has demonstrated that Riverpoint's Vilet and Vilet Quick PGLA sutures meet current performance requirements for synthelic absorbable braided surgical sutures unless otherwise labeled, 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 suture products are substantially equivalent to the predicate devices listed according to the requirements of the Federal Food, Drug, and Cosmetic
Act Act.
3
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 stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 3 2012
Riverpointe Medical % Mr. Doug Rowley 825 NE 25th Avenue Portland, Oregon 97232
Re: K120556 Trade/Device Name: Vilet Vilet Quick Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: May 10 , 2012 Received: May 16, 2012
Dear Mr. Doug 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
4
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 (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,
Mark N. Melkerson
Director
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number: | Unknown at this time |
|---|---|
| Device Name: | Polyglycolic-Lactic Acid (PGLA) Absorbable Surgical Suture |
| Trade Name: | Vilet |
Indications for Use:
PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
PGLA 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)
(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120556
Page 1 of 1 510(k) Indications for Use Statement - PGLA Suture
6
Indications for Use Statement
| 510(k) Number: | Unknown at this time |
|---|---|
| Device Name: | Fast Absorbing Polyglycolic-Lactic Acid (PGLA Quick) Absorbable Surgical Suture |
| Trade Name: | Vilet Quick |
Indications for Use:
Page 1 of 1
Fast absorbing PGLA surgical suture is indicated for use in superficial soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. PGLA Quick 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 (
Evaluation (ODE)
Kariel Kune for MXM
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120556
510(k) Indications for Use Statement - PGLA Quick Suture