(225 days)
Not Found
No
The summary describes a mechanical suturing device and its accessories, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on mechanical properties and tissue approximation.
No.
The device is a suturing device, which is used for approximation of soft tissue and prosthetic materials, similar to surgical stitches. While it is used during a medical procedure, its primary function is mechanical closure, not to treat a disease or condition itself.
No
Explanation: The device is described as a suturing device used for the "approximation of soft tissue and prosthetic materials." Its function is to approximate tissue, which is a therapeutic or surgical action, not a diagnostic one. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The device description explicitly mentions physical components like "suturing device," "suture load units," and "knot replacement device," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Approximation of soft tissue and prosthetic materials." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a suturing device and knot replacement device used for physically joining tissues and materials. This is a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
These LSI SOLUTIONS® suture placement products are intended for use in the approximation of soft tissue and prosthetic materials.
Product codes (comma separated list FDA assigned to the subject device)
GAW, GAS, HCF, GCJ
Device Description
LSI SOLUTIONS® Suture Placement Devices, Accessories and Quick Load® products, specifically the RD-180 suturing device and its 2-0 non-absorbable polyester and polypropylene suture load units along with the TK Ti-Knot® knot replacement device and its Titanium Knot® loads, will effectively approximate tissue and prosthetic material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
A "Prosthetic Fixation Study" employed an ex-vivo porcine tissue model to compare LSI cleared suturing products to a Coalescent U-Clip® predicate device and USP standards. Multiple tests were performed covering a variety of different prosthetic material types. All data fell within internal specification requirements, as well as external standard requirements and device performance expectations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A "Prosthetic Fixation Study" employed an ex-vivo porcine tissue model to compare LSI cleared suturing products to a Coalescent U-Clip® predicate device and USP standards. Multiple tests were performed covering a variety of different prosthetic material types. All data fell within internal specification requirements, as well as external standard requirements and device performance expectations.
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.
K981531, K011016, K040232, K031443, K012317
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
§ 878.5010 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.
0
LSI SOLUTIONS® 510(k) Premarket Notification
5. Premarket Notification [510(k)] Summary
| 5. Premarket Notification [510(k)] Summary | ||
|---|---|---|
| Submitted By: | LSI SOLUTIONS®, Inc. | |
| 7796 Victor-Mendon Road | ||
| Victor, New York 14564 |
Phone: (585) 869-6600
Fax: (585) 742-8086 | 1 of 1
OCT 1 3 2010 |
| | Contact: Jude S. Sauer, M.D., President and CEO, or
Peter Spath, Regulatory Director | |
| Date Prepared: | February 22, 2010 | |
| Common Name: | Needle Guide | |
| Trade Name: | LSI SOLUTIONS® Suture Placement Devices and Accessories | |
| Classification
Name: | Manual Surgical Instrument for General Use
Non-absorbable Surgical Sutures
Non-absorbable Surgical Sutures | 21CFR Part 878.4800
21CFR Part 878.5000
21CFR Part 878.5010 |
| Predicate
Devices: | LSI Suture Placement Device and Accessories
LSI Flexible Suture Placement Device and Accessories
LSI "R" Series Placement Device and Accessories
LSI Suture Quick Load® Products
Coalescent Surgical U-Clip® | (K981531)
(K011016)
(K040232)
(K031443)
(K012317) |
| Description: | LSI SOLUTIONS® Suture Placement Devices, Accessories and Quick
Load® products, specifically the RD-180 suturing device and its 2-0 non-
absorbable polyester and polypropylene suture load units along with the
TK Ti-Knot® knot replacement device and its Titanium Knot® loads, will
effectively approximate tissue and prosthetic material. | |
| Intended Use: | These LSI SOLUTIONS® suture placement products are intended for use in
the approximation of soft tissue and prosthetic materials. | |
| Test Data: | A "Prosthetic Fixation Study" employed an ex-vivo porcine tissue model to
compare LSI cleared suturing products to a Coalescent U-Clip® predicate
device and USP standards. Multiple tests were performed covering a variety
of different prosthetic material types. All data fell within internal
specification requirements, as well as external standard requirements and
device performance expectations. | |
| Summary: | Included in this submission are the same devices cleared in previous LSI
SOLUTIONS® 510(k) submissions for the approximation of soft tissue.
Based on the comparison of the Coalescent U-Clip®, analysis of the
historic and recently developed data and our ongoing success with the
same already cleared products, we believe they are substantially
equivalent for the approximation of soft tissue and prosthetic materials. | |
CONFIDENTIAL
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LSI Solutions, Inc. % Mr. Peter Spath Regulatory Director 7796 Victor-Mendon Road Victor, New York 14564
OCT 1 3 2010
Re: K100593
Trade/Device Name: LSI SOLUTIONS®, Inc. Suture Placement Devices and Accessories Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW, GAS, HCF, GCJ Dated: September 24, 2010 Received: September 29, 2010
Dear Mr. Spath:
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. Ilsting 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.
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
2
Page 2 - Mr. Peter Spath
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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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
3
LSI SOLUTIONS® 510(k) Premarket Notification
4. Indications for Use
OCT 13 2010
510(k) Number (if known): K (00593
LSI SOLUTIONS®, Inc. Suture Placement Devices and Accessories Device Name:
Indications for Use: Approximation of soft tissue and prosthetic materials
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
510(k) Numbe
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
LSI Suture Placement Devices 510(k)
Section 4 - Page 1 of 1
CONFIDENTIAL