(256 days)
No
The 510(k) summary describes a physical surgical suture and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a surgical suture used for tissue approximation and ligation, which is a supportive device rather than a therapeutic device that treats or cures a disease.
No
The device, HS Fiber sutures, is a surgical implant used for tissue approximation and ligation, not for diagnosing conditions.
No
The device description clearly states it is a physical surgical suture made of braided UHMWPE, which is a hardware 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, which is an implantable material used to close wounds or hold tissues together during surgery. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Riverpoint Medical HS Fiber sutures are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues 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, surqical 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.
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 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 10993-1:2018 – 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."
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.
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.
0
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January 05, 2024
Riverpoint Medical Paul Vagts Sr. Regulatory Associate III 825 NE 25th Ave Portland, Oregon 97232
Re: K231163
Trade/Device Name: HS Fiber Sutures Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: November 15, 2023 Received: November 15, 2023
Dear Paul Vagts:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
| Sincerely, | |
|---|---|
| Tek N. Lamichhane -S | Digitally signed by Tek N. Lamichhane -S |
| Date: 2024.01.05 22:48:06 -05'00' | |
| Tek N. Lamichhane, Ph.D. | |
| Assistant Director | |
| DHT4B: Division of Infection Control | |
| and Plastic and Reconstructive Surgery Devices | |
| OHT4: Office of Surgical | |
| and Infection Control Devices | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health |
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
HS Fiber Sutures
Indications for Use (Describe)
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K231163 HS Fiber® Suture
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: | Paul Vagts |
| (503) 517-8001 | |
| Date of Preparation: | 05Jan2024 |
| Device Name | |
| Trade Name: | HS Fiber® Suture |
| 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 |
| Predicate Device | K190817 – HS Fiber Suture |
| Reference Device |
K222500 – AIR OPTIX® COLORS
4
Device Description
The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surqical 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.
Intended Use / Indications for Use
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic surgeries.
Substantial Equivalence and Comparison of Technical Characteristics
The HS Fiber suture line extension is substantially equivalent to the previously cleared HS Fiber Sutures and Suture Tapes. The HS Fiber suture line extension has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device, HS Fiber suture cleared per K190817. Both the HS Fiber suture line extension and the predicate device are sterilized using the same processes, are composed of the same material (UHMWPE), and are tested per USP performance requirements for length, tensile strength and needle attachment.
| Device | HS Fiber Suture
(Proposed Device, K231163) | HS Fiber Suture
(Predicate Device, K190817) | Comparison |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use /
Indications for Use | HS Fiber sutures are indicated for
use in general soft tissue
approximation and/or ligation,
including use in cardiovascular
surgery, and the use of allograft
tissues for orthopedic procedures. | HS Fiber sutures are indicated for
use in general soft tissue
approximation and/or ligation,
including use in cardiovascular
surgery, and the use of allograft
tissues for orthopedic procedures. | Identical |
| Material | UHMWPE | UHMWPE | Identical |
| Regulation Number | 878.5000 | 878.5000 | Identical |
| Regulatory Class | II | II | Identical |
| Prescription or
OTC | Prescription | Prescription | Identical |
| Product Code | GAT | GAT | Identical |
| Color Additive
Regulation | 21CFR74 and 21CFR73 | 21CFR74 and 21CFR73 | Identical |
| Braid Shape | Round Braid, Flat Braid | Round Braid, Flat Braid | Identical |
| Braid Size | 6/0 through 7; 1mm-5mm width | 6/0 through 7; 1mm-5mm width | Identical |
| Needles | 300 or 400 Stainless Steel | 300 or 400 Stainless Steel | Identical |
| Packaging | Tyvek/Poly Pouch | Tyvek/Poly Pouch | Identical |
| Biocompatibility | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 | Identical |
| Sterilization | EtO Sterilization | EtO Sterilization | Identical |
5
The minor difference between the devices is limited to the color additive. While this color additive is new to HS Fiber, it has a long history of use with contact lenses as demonstrated by reference device cleared per K222500. This difference does not raise new questions of safety or effectiveness; therefore, the HS Fiber suture line extension is substantially equivalent to the currently marketed predicate device.
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 10993-1:2018 – 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."
Conclusion
The information provided in this Traditional 510(k) demonstrates that the HS Fiber suture (K231163) is substantially equivalent to the predicate device (K190817 – HS Fiber Suture).