(88 days)
Not Found
No
The document describes a surgical suture and its material properties and performance testing, with no mention of AI or ML.
No
This device is a surgical suture used for tissue approximation and ligation, which is a supportive role in healing rather than directly delivering therapy or treatment.
No
The device is a surgical suture used for tissue approximation and ligation, which are therapeutic rather than diagnostic applications.
No
The device description clearly states it is a physical surgical suture made of braided UHMWPE, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant." This is a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples, while this device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles. HS SutureTape is a flat braid configuration of the HS Fiber suture.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Riverpoint Medical HS Fiber Sutures meet requirements established by the United States Pharmacopeia. The HS Fiber sutures are tested per USP performance requirements for needle attachment 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. Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers." Rabbit pyrogenicity assessments were also performed on a manufacturing process-validation basis with periodic determinations.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
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.(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 logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Riverpoint Medical Mr. Edwin Anderson Director of Quality and Regulatory 825 NE 25th Avenue Portland, Oregon 97232
Re: K153307
Trade/Device Name: HS SutureTape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable, polyethylene terephthalate surgical suture Regulatory Class: Class II Product Code: GAT Dated: January 13, 2016 Received: January 14, 2016
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 Part 801); medical device reporting (reporting of medical
1
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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153307
Device Name HS SutureTape®
Indications for Use (Describe)
HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 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 word "RIVERPOINT" in large, bold, black letters, with the word "MEDICAL" in smaller letters underneath.
510(k) SUMMARY
Riverpoint Medical HS SutureTape® 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: | November 13th, 2015 |
Device Name
| Trade Name: | HS SutureTape® |
|---|---|
| Common or Usual Names: | Polyblend Suture, Non-absorbable Surgical Sutures |
| Classification Name: | Nonabsorbable poly(ethylene terephthalate) Surgical Suture |
Device Classification
| FDA Class: | II |
|---|---|
| Product Classification: | 878.5000: Suture, nonabsorbable, synthetic, polyethylene |
| Classification Code: | GAT |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office of Device Evaluation |
| Division of Surgical Devices, Plastic and Reconstructive | |
| General Surgery Devices Branch |
Predicate Device
K100006 – Riverpoint Medical HS Fiber (Polyblend)
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Image /page/4/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of the letters RP inside of a green rounded square. 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.
Device Description
The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles. HS SutureTape is a flat braid configuration of the HS Fiber suture.
Intended Use / Indications for Use
HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures.
Performance Data
The Riverpoint Medical HS Fiber Sutures meet requirements established by the United States Pharmacopeia. The HS Fiber sutures are tested per USP performance requirements for needle attachment 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. Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers." Rabbit pyrogenicity assessments were also performed on a manufacturing process-validation basis with periodic determinations.
Substantial Equivalence and Comparison of Technical Characteristics
The HS SutureTape Iine extension is substantially equivalent to the previously cleared HS Fiber Sutures. The HS SutureTape has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the HS SutureTape and the predicate device are sterilized using the same processes, are composed of the same material, and are tested per USP performance requirements for tensile strength, needle and attachment. The minor difference in technical characteristics is limited to the braiding configuration, and the line extension introduces a braiding configuration differing from the originally cleared device. These differences do not raise new questions of safety or effectiveness, therefore the HS SutureTape 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 HS SutureTape line extension is substantially equivalent to the predicate device.