(43 days)
Not Found
No
The document describes a surgical suture product and its intended use, with no mention of AI or ML technology in the device description, intended use, or any other section.
No
The device is a surgical suture intended for soft tissue approximation and ligation, which are procedures, not therapeutic actions.
No
Explanation: The device is described as suture products intended for general soft tissue approximation and/or ligation, which are therapeutic actions, not diagnostic.
No
The device description clearly indicates the product is a physical suture with attachments, not a software application.
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" and "use in ophthalmic procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "Suture Quick Load® Product" with "Ferrule attachments" to facilitate its use with "suture placement device products." This is a surgical tool used to physically manipulate tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or analysis of biological markers.
Therefore, the LSI SOLUTIONS® Suture Quick Load® Products are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
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 SEW-RIGHT® Quick Load® Unit with PTFE coated, polyester surgical suture is indicated for use in general soft tissue approximation and/or ligation.
The SEW-RIGHT® Quick Load Unit with monofilament polypropylene surgical suture is indicated for use in general soft tissue approximation and/or ligation.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NEW, GAM, GAS, GAW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, ophthalmic
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)
Not Found
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
§ 878.4840 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.
0
| JUN 1 8 2003 | LSI SOLUTIONS, Inc.
510(k) Premarket Notification
LSI SOLUTIONS® Suture Quick Load® Products |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 12. Premarket Notification [510(k)] Summary |
| Submitted By: | LSI SOLUTIONS, Inc.
7796 Victor-Mendon Road
Victor, New York 14564
Phone: (585) 869-6600
Fax: (585) 742-3398
Contact: 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 Polyester
2. SEW-RIGHT® Quick Load® with 2-0 Polyester
3. SEW-RIGHT® DUO™ Quick Load® with 2-0 Polyester
4. SEW-RIGHT® Quick Load® with 2-0 Polypropylene
5. QLU, SRF-5QL™ Suture, Sterile
6. 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:
- No regulation specified. Nearest reference is 21 CFR 878.5000
Nonabsorbable poly(ethylene teraphthalate) surgical suture - No regulation specified. Nearest reference is 21 CFR 878.5000
Nonabsorbable poly(ethylene teraphthalate) surgical suture - No regulation specified. Nearest reference is 21 CFR 878.5000
Nonabsorbable poly(ethylene teraphthalate) surgical suture - 21 CFR 878.5010
Nonabsorbable polypropylene surgical suture - 21 CFR 878.5010
Nonabsorbable polypropylene surgical suture - 21 CFR 878.4493
Absorbable poly(glycolide/L-lactide) surgical suture - 21 CFR 878.4840
Absorbable poly(dioxanone) surgical suture |
1
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 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. | |
| Intended Use: | 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. |
2
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.
3
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
4
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