(140 days)
PDO surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery other than contact with comea and/or sclera. PDO Suture is not intended for use in adult cardiovascular tissue, microsurgery or neural tissue.
PGA 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 or neural tissue.
Fast Absorbing PGA (Trade Name: Vilet Quick): Vilet Quick surgical suture is indicated for use in general soft tissue approximation, including use in ophthalmic procedures, where only short-term wound support is required. Vilet Quick is not intended for use in cardiovascular or neurological procedures.
PGCL: PGCL surgical suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
Riverpoint Medical 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).
Available Suture sizes will be standard according to USP 32 requirements (12/0 through 7, depending on suture type).
The provided document describes the 510(k) summary for Riverpoint Medical's absorbable surgical sutures (PGCL, PGA, Fast Absorbing PGA, PDO). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The document does not provide a table of acceptance criteria with specific numeric targets for metrics (e.g., sensitivity, specificity, accuracy) or reported performance data in those terms. Instead, the acceptance criteria are implicitly and explicitly defined by:
- Substantial Equivalence: The primary "acceptance criterion" is that each variety of Riverpoint Medical absorbable suture must be substantially equivalent to its respective predicate device. This means it performs as safely and effectively as a legally marketed device.
- USP 32 Requirements: The device must meet the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32 (United States Pharmacopeia 32). This is an explicit acceptance criterion.
- Biocompatibility: The materials used must meet known biocompatibility standards (per ISO 10993). This includes specific tests like Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity (Bacterial Reverse Mutation and Chromosomal Aberration, Bone Marrow Micronucleus), Subchronic Toxicity, and Muscle Implantation. The document states that these tests were performed and implies successful completion, thus acting as acceptance criteria.
No standalone performance metrics like sensitivity, specificity, or AUC are reported since this is a medical device (suture) and not an AI/diagnostic algorithm. The performance is assessed against established material and mechanical standards, and against the safety and effectiveness of predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an algorithm. For the physical testing (USP 32 requirements, biocompatibility), the document states that "Testing is performed on each lot of product to verify that USP requirements have been met prior to release." This implies a continuous quality control process rather than a one-time test set. The number of samples per lot for these tests is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data for an AI algorithm. The "data" here are physical and biological test results on the suture materials themselves.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable: This information is not relevant to a medical device like a surgical suture. Ground truth, in this context, refers to established scientific and regulatory standards (USP 32, ISO 10993) and the performance of predicate devices, not expert human assessment of images or clinical cases.
4. Adjudication Method:
- Not Applicable: There is no adjudication method described as there are no human readers or expert panels involved in "adjudicating" the device's performance in the way an AI algorithm's output might be reviewed. Compliance is assessed against predefined standards and testing protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable: An MRMC comparative effectiveness study is designed for diagnostic systems, particularly those involving human interpretation of data (e.g., radiologists reading images) where AI assistance might improve performance. This is a surgical suture, a physical medical device. The "effectiveness" is shown through meeting material science standards and demonstrating substantial equivalence to already approved predicate devices.
7. Type of Ground Truth Used:
- Regulatory Standards and Physical/Biological Testing: The ground truth for this device's acceptance is based on:
- USP 32: United States Pharmacopeia standards for surgical sutures regarding physical properties like diameter, tensile strength, and needle attachment strength.
- ISO 10993: International Organization for Standardization standards for biological evaluation of medical devices (biocompatibility).
- Predicate Device Performance: The established safety and effectiveness profiles of the identified predicate devices (K061037, K972566, K023710, K960653). The new devices are considered safe and effective if they are substantially equivalent to these predicates.
8. Sample Size for the Training Set:
- Not Applicable: This is not an AI/machine learning device. There is no concept of a "training set" for the surgical suture itself. The "training" data, if one were to extend the metaphor loosely, are the historical data, scientific understanding, and manufacturing processes accumulated over time that allow for the creation of materials meeting specific regulatory and performance criteria.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no training set in the AI context, this question is not relevant. The "ground truth" for the device's design and manufacturing is derived from the long-standing scientific and regulatory principles governing medical device development, material science, and prior art represented by predicate devices.
{0}------------------------------------------------
point
K100461 Page 1/3
510(k) Summary
Page 1-23
JUL = 8 2010
Submitter Information
Submitter's Name:
Address:
825 NE 25" Ave. Portland, OR 97232
Riverpoint Medical
Phone Number:
Contact Person:
(503) 517-8001 or 866 445-4923
(503) 517-8002 Fax Number:
Registration Number:
Douglas Rowley (503) 517-8001
February 03, 2010
3006981798
Date of Preparation:
Device Names
Trade Names:
PGCL: PGA: Fast Absorbing PGA:
PDO:
PDM Mono Q Vilet Vilet Quick
| Common Names: | Absorbable Surgical Sutures: PDO, PGA, PGCL |
|---|---|
| Classification Names: | All: General and Plastic Surgery Devices |
Device Classification
FDA Class:
2 (All varieties listed)
Product Classification:
- Polydioxanone (PDO): 1. 878.4840, Absorbable polydioxanone surgical suture 2. Polyglycolic Acid (PGA):
-
- Fast Absorbing Polyglycolic Acid (PGA):
-
- Poly(glycolide-co-caprolactone){PGCL):
878.4493, Absorbable poly(glycolide/l-lactide) surgical suture 878.4493, Absorbable poly(glycolide/l-lactide) surgical suture 878.4493, Absorbable poly(glycolide/l-lactide) surgical suture
510(k) Summary - Absorbable Suture
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a stylized drawing of the letter 'r' in a simple, blocky font. Below the letter, the word 'point' is written in a bold, sans-serif typeface. The letter 'r' has a distinct, almost cartoonish appearance due to its rounded top portion. The overall image has a clean and straightforward design.
K100461 Aa.
Page 1-24
Codes:
-
- Polydioxanone (PDO): NEW
-
- Polyglycolic Acid (PGA): GAM
-
- Fast Absorbing PGA: GAM
-
- Poly(glycolide-co-caprolactone)(PGCL): GAM
Classification Panel: All: Class II (special controls); General and Plastic Surgery
Predicate Devices (applicable 510(k) number listed):
| 1. PDO: | K061037 |
|---|---|
| 2. PGA: | K972566 |
| 3. Fast Absorbing PGA: | K023710 |
| 4. PGCL: | K960653 |
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 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).
Available Suture sizes will be standard according to USP 32 requirements (12/0 through 7, depending on suture type).
Intended Use
PDO: PDO surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery other than contact with comea and/or sclera. PDO Suture is not intended for use in adult cardiovascular tissue, microsurgery or neural tissue.
PGA: PGA 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 or neural tissue.
510(k) Summary - Absorbable Suture
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows a symbol that looks like the letter 'r' with a curved top. Below the symbol, the word 'point' is written in a bold, sans-serif font. The image quality is somewhat degraded, with visible noise and artifacts, particularly around the edges of the symbol and text.
K100461 Age 3/3
Fast Absorbing PGA (Trade Name: Vilet Quick): Vilet Quick surgical suture is indicated for use in general soft tissue approximation, including use in ophthalmic procedures, where only short-term wound. support is required. Vilet Quick is not intended for use in cardiovascular or neurological procedures.
PGCL: PGCL surgical suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
Safety and Effectiveness
Each variety of Riverpoint Medical 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 (per ISO 10993) 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. Biocompatibility testing performed on each variety of absorbable sutures within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity - Bacterial Reverse Mutation and Chromosomal Aberration, Bone Marrow Micronucleus, Subchronic Toxicity (4-week, following subcutaneous implantation), Muscle Implantation (12-week).
Riverpoint Medical 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.
510(k) Summary - Absorbable Suture
{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 or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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
JUL 8 2010
Re: K100461
Trade/Device Name: Polyglycolic Acid (PGA) Absorbable Surgical Suture, PGA Absorbable Surgical Suture (Fast Absorbing), Poly(glycolide co caprolactone) PGCL) Absorbable Surgical Suture, Polydioxanone (PDO) Absorbable Suture
Regulation Number: 21 CFR 878.4493
Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM, NEW Dated: June 7, 2010 Received: July 2, 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.
{4}------------------------------------------------
Page 2 - Mr. Doug Rowley
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 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 tolloffree 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 Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows a symbol that resembles the letter 'p' with a circular loop at the top. Below the symbol, the word 'point' is written in lowercase letters. The symbol and the word are likely related, possibly indicating a specific point or location.
Indications for Use Statement
| 510(k) Number: | Unknown at this time |
|---|---|
| Device Name: | Polyglycolic Acid (PGA) Absorbable Surgical Suture |
| Trade Name: | Vilet |
Indications for Use:
PGA 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 or neural tissue. PGA 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 Krone for MKM
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K100461
Page 1 of 1
510(k) Indications for Use Statement - Absorbable Suture
Page 1-19
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows a drawing of the letter 'P' with the word 'point' written below it. The 'P' is drawn with a thick line and has a circular shape at the top. The word 'point' is written in a simple, sans-serif font. There are some blurry artifacts around the image.
Indications for Use Statement
| 510(k) Number: | Unknown at this time |
|---|---|
| Device Name: | PGA Absorbable Surgical Suture (Fast Absorbing) |
| Trade Name: | Vilet Quick |
Indications for Use:
Vilet Quick surgical suture is indicated for use in general soft tissue approximation, including use in ophthalmic procedures, where only short-term wound support is required. Vilet Quick is not intended for use in cardiovascular or neurological procedures. Vilet Quick suture is provided sterile as a single use device.
Prescription Use ਮੁ (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 MKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100461
Page 1 of 1 510(k) Indications for Use Statement - Absorbable Suture Page 1-20
{7}------------------------------------------------
K100461 RESPONSE
Image /page/7/Picture/1 description: The image shows a stylized drawing of the letter 'p' with the word 'point' written below it. The letter 'p' is drawn with a thick outline, and the circular part of the 'p' is a complete circle. The word 'point' is written in a simple, sans-serif font.
Page 1-21
Indications for Use Statement
| 510(k) Number: | Unknown at this time |
|---|---|
| ---------------- | ---------------------- |
Poly(glycolide co-caprolactone) (PGCL) Absorbable Surgical Suture Device Name:
Trade Name: Mono Q
Indications for Use:
PGCL surgical suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures. PGCL 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 for MXM
(Division Sign-Off)
Division of Surgical, Orthoped and Restorative Devices
510(k) Number K100461
Page 1 of 1
510(k) Indications for Use Statement - Absorbable Suture
{8}------------------------------------------------
K100461 RESPONSE
Image /page/8/Picture/1 description: The image shows a stylized letter "P" above the word "point". The "P" is drawn with a thick line and has a circular top. The word "point" is written in a simple, sans-serif font and is positioned directly below the letter.
Page 1-18
Indications for Use Statement
| 510(k) Number: | Unknown at this time |
|---|---|
| Device Name: | Polydioxanone (PDO) Absorbable Surgical Suture |
| Trade Name: | PDM |
Indications for Use:
PDO surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and/or sclera). PDO Suture is not intended for use in adult cardiovascular tissue, microsurgery or neural tissue. PDO 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 BECOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Device Evaluation (SDE)
David Krane for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100461
510(k) Indications for Use Statement - Absorbable Suture
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.