(28 days)
No
The summary describes a mechanical suturing device and explicitly states that AI, DNN, or ML are not mentioned.
No
Explanation: This device is for approximating soft tissue, which is a structural function, not a therapeutic one (i.e., it doesn't treat, cure, or prevent disease).
No
The device description states its purpose is for "approximation or ligation of soft tissue by passing ligature through said soft tissue," which is a treatment or surgical function, not a diagnostic one.
No
The device description explicitly states it is a "Suturing Device and Accessories Product," which implies a physical hardware component for passing ligature through soft tissue.
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 the device description states it's for "approximation or ligation of soft tissue by passing ligature through said soft tissue." This describes a surgical or procedural device used directly on the patient's body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health. The provided information does not mention any interaction with specimens or diagnostic testing.
- Anatomical Site: The anatomical site is "soft tissue," which is a part of the living body, not a specimen being tested.
Therefore, this device falls under the category of a surgical or procedural device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Approximation of soft tissue
Product codes
GAT, HCF
Device Description
The LSI "R" Series Suturing Device and Accessories Product, like the predicate, is intended for the approximation or ligation of soft tissue by passing ligature through said soft tissue.
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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
MAR - 1 2004
LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI "R" Series Suture Placement Device and Accessories Product
11. Premarket Notification [510(k)] Summary
LSI SOLUTIONS, Inc. Submitted By: 7796 Victor-Mendon Road Victor, New York 14564 Phone: (585) 869-6600 Fax: (585) 742-3398 Contact: Christopher A. Klaczyk, Regulatory Compliance Manager
Needle Guide; Manual surgical instrument for general use Common Name:
LSI "R" Series Suture Placement Device and Accessories Product Trade Name:
21 CFR 878.4800; Manual Surgical Instrument for General Use Classification:
Predicate Device: LSI Suture Placement Device and Accessories (K981531)
The LSI "R" Series Suturing Device and Accessories Product, like Description: the predicate, is intended for the approximation or ligation of soft tissue by passing ligature through said soft tissue.
- Approximation of soft tissue. Intended Use:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Mr. Christopher A. Klaczyk Regulatory Compliance Manager LSI Solutions, Inc. 7796 Victor-Mendon Road Victor, New York 14564
Re: K040232
Ro-N232
Trade/Device Name: LSI "R" Series Suturing Device and Accessories Product Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, HCF Dated: January 28, 2004 Received: February 2, 2004
Dear Mr. Klaczyk:
We have reviewed your Scction 510(k) premarket notification of intent to market the device we have reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases of the enactment date of the Medical Device Amendments, or to conniner of they 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees mat have not require approval of a premarket approval application (PMA). and Cosmetic (110) that the device, subject to the general controls provisions of the Act. The r ou may, arovisions 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 (sec 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 may be builted to been 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 1 least be device a determination that your device complies with other requirements of the Act that I Dr has Internations and regulations administered by other Federal agencies. You must or car) x 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 Cr R Part 677, aberting (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Christopher A. Klaczyk
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam 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
3
LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI "R" Series Suture Placement Device and Accessories Product
Statement of Indications For Use 7.
Page 1_ of 1
510(k) Number (if known): K040232
LSI "R" Scries Suturing Device and Accessories Product Device Name:
Approximation of soft tissue Indications For Use:
X Over-The Counter Use Prescription Use AND/OR (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040232
Section 7 - Page 1 of 1
CONFIDENTIAL