(43 days)
For polyester and polypropylene LSI SOLUTIONS® Suture Quick Load® Products: general soft tissue approximation and/or ligation.
For polyglycolic acid (PGA) and polydioxanone (PDS) LSI SOLUTIONS® Suture Quick Load® Products: general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
The LSI SOLUTIONS® Suture Quick Load® Products, like the predicates, are intended for the approximation of soft tissue by passing ligature through said soft tissue. The LSI SOLUTIONS® Suture Quick Load® Products have Ferrule attachments, similar to needle attachments, that facilitate the use of the suture with the LSI SOLUTIONS® SEW-RIGHT® family and PLACE-RIGHT® family of suture placement device products.
This 510(k) premarket notification for the LSI SOLUTIONS® Suture Quick Load® Products does not contain a study demonstrating device performance against acceptance criteria.
Instead, it relies on a substantial equivalence determination to legally marketed predicate devices. This means that LSI SOLUTIONS, Inc. is claiming their device is as safe and effective as existing, approved devices, and therefore does not require new, extensive clinical trials or performance studies to prove its efficacy from scratch.
Here's why the requested information cannot be found in this document:
- Acceptance Criteria & Reported Performance: There are no specific acceptance criteria for performance (e.g., tensile strength thresholds, knot security metrics) described in this document, nor are there reported results of a study designed to measure these. The document focuses on comparing the intended use and technological characteristics of the new device to predicate devices.
- Sample Size, Data Provenance, Experts, Adjudication: These details would typically be part of a formal study report, which is not included here.
- MRMC, Standalone Performance: These refer to types of studies (often for AI/image analysis devices) that are not relevant to a surgical suture product.
- Ground Truth: For a physical medical device like a suture, "ground truth" would be established through a combination of manufacturing specifications, material testing standards, and established clinical performance of similar devices. This document doesn't detail how these were specifically established for this device's premarket notification, beyond asserting its similarity to predicates.
- Training Set Sample Size & Ground Truth (for training): Again, these concepts apply more to machine learning or AI-based devices and are not relevant to a surgical suture.
Summary of what is provided regarding device performance and its path to market:
The document serves as a 510(k) Premarket Notification, which specifically aims to demonstrate substantial equivalence to existing legally marketed predicate devices.
The "study" that proves the device meets acceptance criteria (in the context of a 510(k)) is the comparison to predicate devices, asserting that its technological characteristics and intended use are similar enough that it raises no new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria in the document for the new device. Instead, the general safety and effectiveness of the device are inferred through substantial equivalence to predicate devices. | Not explicitly reported as specific quantitative performance results for the device. The document states that the new products are similar or identical in material, physical properties, indications for use, and technological characteristics to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not Applicable: This document does not describe a "test set" in the context of a performance study with a specific sample size. The substantial equivalence relies on a comparison of device characteristics and intended use to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: "Ground truth" for a surgical suture is typically established through material science testing and clinical experience with equivalent devices, not through expert review of a "test set" as might be done for diagnostic imaging.
- The FDA, through its review process, acts as the ultimate "expert" in determining substantial equivalence based on the provided documentation and existing regulatory standards.
4. Adjudication method for the test set:
- Not Applicable: No test set or adjudication method is described. The FDA's review process itself can be seen as an adjudication on the substantial equivalence claim.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No: This is a surgical suture, not a diagnostic or AI-assisted device. MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No: This is a surgical suture, not an algorithm-based device.
7. The type of ground truth used:
- Predicate Device Equivalence: The "ground truth" for the new device's safety and effectiveness is established by its demonstrated substantial equivalence to legally marketed predicate devices (e.g., Deknatel™ Tevdek® II, Deklene® II, Surgisorb, Mono-Dox). This implies that the predicate devices have already established their safety and effectiveness through their own regulatory pathways and market history.
- The document states: "The LSI SOLUTIONS® Suture Quick Load® Products, like the predicates, are intended for the approximation of soft tissue by passing ligature through said soft tissue." This statement forms the basis of the equivalence argument.
- The regulation classifications (e.g., 21 CFR 878.5000 for nonabsorbable polyester surgical suture) further define the expected performance and safety standards for this product type.
8. The sample size for the training set:
- Not Applicable: This document does not describe a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable: See point 8.
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| JUN 1 8 2003 | LSI SOLUTIONS, Inc.510(k) Premarket NotificationLSI SOLUTIONS® Suture Quick Load® Products |
|---|---|
| 12. Premarket Notification [510(k)] Summary | |
| Submitted By: | LSI SOLUTIONS, Inc.7796 Victor-Mendon RoadVictor, New York 14564Phone: (585) 869-6600Fax: (585) 742-3398Contact: Christopher A. Klaczyk, Regulatory Compliance Manager |
| Common Name: | Surgical Suture |
| Trade Name: | LSI SOLUTIONS® Suture Quick Load® Products |
| Proprietary Name: | 1. SEW-RIGHT® Quick Load® with 0 Polyester2. SEW-RIGHT® Quick Load® with 2-0 Polyester3. SEW-RIGHT® DUO™ Quick Load® with 2-0 Polyester4. SEW-RIGHT® Quick Load® with 2-0 Polypropylene5. QLU, SRF-5QL™ Suture, Sterile6. SEW-RIGHT® Quick Load® with 2-0 STRONGSORB™7. SEW-RIGHT® Quick Load® with 2-0 MONOGLIDE™ |
| Classification: | All products are Class II per the following references:1. No regulation specified. Nearest reference is 21 CFR 878.5000Nonabsorbable poly(ethylene teraphthalate) surgical suture2. No regulation specified. Nearest reference is 21 CFR 878.5000Nonabsorbable poly(ethylene teraphthalate) surgical suture3. No regulation specified. Nearest reference is 21 CFR 878.5000Nonabsorbable poly(ethylene teraphthalate) surgical suture4. 21 CFR 878.5010Nonabsorbable polypropylene surgical suture5. 21 CFR 878.5010Nonabsorbable polypropylene surgical suture6. 21 CFR 878.4493Absorbable poly(glycolide/L-lactide) surgical suture7. 21 CFR 878.4840Absorbable poly(dioxanone) surgical suture |
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LSI SOLUTIONS, Inc. 510(k) Premarket Notification
K03/443 p2/2
| Predicate Device: | 1. Deknatel™ Tevdek® II Surgical Suture (K930738) |
|---|---|
| 2. Deknatel™ Tevdek® II Surgical Suture (K930738) | |
| 3. Deknatel™ Tevdek® II Surgical Suture (K930738) | |
| 4. Deknatel™ Deklene® II Surgical Suture (K930738) | |
| 5. Deknatel™ Deklene® II Surgical Suture (K930738) | |
| 6. Surgisorb Absorbable Suture (K984374) | |
| 7. Mono-Dox Synthetic Absorbable PDS Suture (K013274) | |
| Description: | The LSI SOLUTIONS® Suture Quick Load® Products, like thepredicates, are intended for the approximation of soft tissue bypassing ligature through said soft tissue. The LSI SOLUTIONS®Suture Quick Load® Products have Ferrule attachments, similar toneedle attachments, that facilitate the use of the suture with the LSISOLUTIONS® SEW-RIGHT® family and PLACE-RIGHT® family of sutureplacement device products. |
| Intended Use: | For polyester and polypropylene LSI SOLUTIONS® Suture QuickLoad® Products: general soft tissue approximation and/or ligation. |
| For polyglycolic acid (PGA) and polydioxanone (PDS) LSISOLUTIONS® Suture Quick Load® Products: general soft tissueapproximation and/or ligation, including use in ophthalmicprocedures, but not for use in cardiovascular and neurologicalprocedures. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the feathers. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2003
Mr. Christopher A. Klaczyk Regulatory Compliance Manager LSI Solutions, Inc. 7796 Victor-Mendon Road Victor, New York 14564
Re: K031443 Trade/Device Name: Suture Quick Load® Products Regulation Number: 21 CFR 878.4840 21 CFR 878.4493 21 CFR 878.5000 21 CFR 878.5010 Regulation Name: Suture, surgical, absorbable, polydioxanone Absorbable poly(glycolide/L-lactide) surgical suture Nonabsorbable poly(ethylene terephthalate) surgical suture Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: NEW, GAM, GAS, GAW Dated: May 2, 2003 Received: May 8, 2003
Dear Mr. Klaczyk:
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.
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Page 2 - Mr. Christopher A. Klaczyk
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.
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI SOLUTIONS® Suture Quick Load® Products
7. Statement of Indications For Use
Page 1 1
Ko31443 510(k) Number (if known): LSI SOLUTIONS® Suture Quick Load® Products Device Name:
Indications For Use For Polyester Quick Load® Products:
The SEW-RIGHT® Quick Load® Unit with PTFE coated, polyester surgical suture is indicated for use in general soft tissue approximation and/or ligation.
Indications For Use For Polypropylene Quick Load® Products:
The SEW-RIGHT® Quick Load Unit with monofilament polypropylene surgical suture is indicated for use in general soft tissue approximation and/or ligation.
Indications For Use For Polyglycolic Acid (PGA) Quick Load® Products:
The SEW-RIGHT® Quick Load® Unit with STRONGSORB™ synthetic absorbable 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 procedures.
Indications For Use For Polydioxanone (PDS) Quick Load® Products:
The SEW-RIGHT® Quick Load® Unit with Monoglide™ synthetic absorbable 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 procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
ision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K03/443
(Optional Format 3-10-98)
Section 7 - Page 1 of 1
CONFIDENTIAL
§ 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.