(82 days)
The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
This Sutralene Polypropylene Suture is a nonabsorbable, sterile, surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Those dyed blue are dyed with phthalocyaninato(2-) copper in accordance with Title 21 CFR Part 74.3045 and do not exceed 0.5% (w/w) suture. The sutures are uncoated.
Acceptance Criteria and Study for Sutralene Polypropylene Sutures (K070243)
This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of Visionary Medical Supplies' Sutralene Polypropylene Sutures (K070243) to predicate devices, specifically Ethicon PROLENE nonabsorbable polypropylene sutures.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sutralene Polypropylene Sutures are based on meeting the standards outlined in the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures.
| Performance Metric | Acceptance Criteria (USP Standards) | Reported Device Performance (Sutralene Polypropylene Sutures) |
|---|---|---|
| Diameter | Meets USP Monograph standards | Test results showed that Visionary Medical Supplies' devices tested meet USP standards. |
| Tensile Strength | Meets USP Monograph standards | Test results showed that Visionary Medical Supplies' devices tested meet USP standards. |
| Suture-Needle Attachment | Meets USP Monograph standards | Test results showed that Visionary Medical Supplies' devices tested meet USP standards. Additionally, the device is considered technically equivalent to the predicate devices tested. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set during the performance tests. However, the tests were conducted according to methods presented in the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures. USP monographs typically specify the number of samples required for various tests.
The data provenance is not explicitly detailed in terms of country of origin or whether it was retrospective or prospective. However, being a 510(k) submission to the FDA, it is implied that the testing was conducted as part of the regulatory process for market clearance in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for a device like surgical sutures, where "ground truth" is established by adherence to physical and material property standards rather than expert clinical interpretation. The "ground truth" for the test set is the objective, measurable standards set forth in the USP Monograph for nonabsorbable surgical sutures. Therefore, no experts in the sense of clinical reviewers (e.g., radiologists) were explicitly used to establish ground truth for this type of performance testing. The "expertise" lies within the scientific and engineering principles behind the USP standards themselves.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., image analysis by multiple readers). For the physical and mechanical property testing of sutures, such adjudication methods are not relevant. The assessment relies on direct measurement and comparison against predefined objective standards specified in the USP Monograph.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic devices where human readers interpret data (e.g., medical images) and the AI's impact on their performance is being evaluated. Sutralene Polypropylene Sutures are a surgical device, and their performance is evaluated based on material properties, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, the performance tests conducted (diameter, tensile strength, suture-needle attachment) are inherently a "standalone" evaluation of the device's physical properties. These tests assess the material itself (algorithm/device only) against established standards, without direct human-in-the-loop performance measurement.
7. The Type of Ground Truth Used
The ground truth used for evaluating Sutralene Polypropylene Sutures is objective, measurable physical and mechanical standards defined by the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures. This is not "expert consensus" in the clinical sense, nor is it pathology or outcomes data. It is a set of established scientific specifications for the material properties of the device.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to the evaluation of Sutralene Polypropylene Sutures. This device is not an AI/ML algorithm that learns from data. Its performance is inherent in its manufacturing and material composition, which is then verified through direct physical testing against established standards.
9. How the Ground Truth for the Training Set Was Established
As mentioned in point 8, there is no "training set" for this type of device. The "ground truth" for the device's performance (i.e., the USP standards) is established through rigorous scientific research, consensus by pharmaceutical and medical experts, and often a long history of clinical use and safety data that informs the creation of such monographs.
{0}------------------------------------------------
| . | 11 11 140 1111 11 11 11 11 11 11 11 | のです。 人気のただき、このですが、なると、できると、とても | . The state the state of the first the first to the first to the first to the first to the first to the first to the first to the first to the first to the first to the first | そうけるとなるとなるとなるのです。******************************************************************************************************************************************************************************Concert of the may be of the status and the subser work and the see and | and and the comments of the first of the library of the library of | - Cara Marga Alax Parti | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | And I and I and Parties | いくなってきたいというとなるとことでする11 11 11 5 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | Carlos States Market Company of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | with and and a manufacture a province and a minimal contract and a financed a finance the many for any the more the more the more the more the more the more the comments of t | complex comments of the consideration of the consideration of the first and the first and the first and the commend of the first and the commend of the comments of the commen | 11. AN AND STORE AND A A 4. CHE - E + 4. MIL - E + 4. MIL - E - 4. A - 6. A - 6. A - 6. A - 6. A - 6. A - 6. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. 4. | |||||||||||||||||||
| ਟ | C | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 | ਦ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------3 |
6441 Enterprise Lane, Madison, Wisconsin 53719 USA Ph: 608 270-3880 Faz: 608 270-3882 - www.visionarymedicalsupplies.com
510(K) Summary
APR 1 7 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92
The assigned 510(k) number is:
Applicant:
Visionary Medical Supplies, Inc. 6441 Enterprise Lane Madison, WI 53719 Phone: 608-270-3880 Fax: 608-270-3882 Email: mprice@visionarymedicalsupplies.com
Contact Person:
Michael G. Price, President Visionary Medical Supplies, Inc. 6441 Enterprise Lane Madison, WI 53719 Phone: 608-270-3880 Fax: 608-270-3882 Email: mprice@visionarymedicalsupplies.com
Date of 510(k) summary preparation: January 24, 2007
Trade name: Sutralene Polypropylene Sutures
Common name: Suture, nonabsorbable, synthetic, polypropylene
Predicate devices:
The nonabsorbable Sutralene Polypropylene Sutures manufactured for Visionary Medical Supplies are equivalent to Ethicon PROLENE* nonabsorbable polypropylene sutures. The Ethicon PROLENE Nonabsorable polypropylene sutures were approved by PMA N16374. Subsequent to the PMA, polypropylene sutures were down classified and require clearance to market by 510(k),
File: Visionary Medical 510(k) Polypropylene 1-24-2007
{1}------------------------------------------------
1.0 Device description:
This Sutralene Polypropylene Suture is a nonabsorbable, sterile, surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Those dyed blue are dyed with phthalocyaninato(2-) copper in accordance with Title 21 CFR Part 74.3045 and do not exceed 0.5% (w/w) suture. The sutures are uncoated.
2.0 Intended use:
The nonabsorbable Sutralene Polypropylene Suture manufactured for Visionary Medical Supplies is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
3.0 Performance tests to demonstrate substantial equivalency:
To establish the technical equivalency of nonabsorbable sutures manufactured for Visionary Medical Supplies with predicate devices, tests were conducted for diameter, tensile strength, and suture-needle attachment according to methods presented in United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures.
The test results shows that Visionary Medical Supplies' devices tested meet USP standards and are technically equivalent to the predicate devices tested.
4.0 Conclusions
The intended use, technology and materials of the Visionary Medical Supplies Sutralene Polypropylene Suture are the equivalent to the predicate device. No new questions of safety or effectiveness are raised.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Visionary Medical Supplies, Inc. % Quality & Regulatory Associates, LLC Mr. Gary Syring Principal Consultant 800 Lavenger Lane Stoughton, Wisconsin 53711
APR 1 7 2007
Re: K070243
Trade/Device Name: Sutralene Polypropylene Sutures Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable propylene surgical suture Regulatory Class: II Product Code: GAW Dated: March 15, 2007 Received: March 19, 2007
Dear Mr. Syring:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
{3}------------------------------------------------
Page 2 - Mr. Gary Syring
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely you Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Sutralene Polypropylene Sutures
Indications for Use:
The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular,
ophthalmic, and neurological procedures.
Pel Rmz
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number c070243
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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.