(75 days)
Not Found
No
The summary describes a mechanical suture placement device and does not mention any AI/ML terms or functionalities.
No
The device is described as assisting in the approximation of soft tissue for surgical wounds, which is a surgical tool rather than a device for treating a condition or disease.
No
The device is described as a "Suture Placement device" intended for "approximation of soft tissue" and "approximation of surgical wounds by passing ligature through soft tissue." These functions are therapeutic or surgical, not diagnostic.
No
The device description explicitly mentions "device and accessories" and describes a function of "passing ligature through soft tissue," which strongly indicates a physical, hardware-based device for surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "in the approximation of soft tissue" and "for the approximation of surgical wounds by passing ligature through soft tissue." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description reinforces its use in a surgical context for tissue approximation.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The LSI Suture Placement device and accessories are intended for use in the approximation of soft tissue.
Product codes
GCJ
Device Description
The LSI Suture Placement device and accessories are intended for the approximation of surgical wounds by passing ligature through 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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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LSI SOLUTIONS 510(k) Premarket Notification LSI Suture Placement Device and Accessories
JUL 1 3 1998
Premarket Notification [510(k)] Summary
| LSI SOLUTIONS | |
|---|---|
| 2144 Brighton-Henrietta Town Line Road | |
| Rochester, New York 14623 | |
| Phone: | 716-427-7979 |
| Fax: | 716-427-7482 |
| Contact: | Jude. S. Sauer, M.D., President and CEO or |
| Nicholas Reitter IV, Director of Regulatory Compliance | |
| April 28, 1998 | |
| Common Name: | Needle Guide |
| Trade Name: | The trademark name has not yet been determined. |
| Classification Name: | Manual Surgical Instrument for General Use (per 21 CFR, |
| §878.4800) and an accessory to an endoscope (per 21 CFR | |
| §876.1500). | |
| Predicate Device: | AUTO SUTURE* Suture Closure** device and accessories |
| (K954853) | |
| Description: | The LSI Suture Placement device and accessories intended for |
| the approximation of surgical wounds by passing ligature | |
| through soft tissue. | |
| Intended Use: | The LSI Suture Placement device and accessories are intended |
| for use in the approximation of soft tissue. |
1
LSI SOLUTIONS 510(k) Premarket Notification LSI Suture Placement Device and Accessories
Comparison
Summary of how the device and accessories of this application compare to the predicate device. Both the subject device and accessories and the predicate device and accessories use the same technology.
| Function | The LSI SOLUTIONS Suture
Placement device and accessories
deliver suture materials to the
site of application. | The AUTO SUTURE* Suture
Closure** device and accessories
deliver suture materials to the site
of application. |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication | The LSI SOLUTIONS Suture
Placement device and accessories
approximate soft tissue. | The AUTO SUTURE* Suture
Closure** device and accessories
approximate soft tissue. |
| Materials | The LSI SOLUTIONS Suture
Placement device and accessories
use biocompatible materials. | The AUTO SUTURE* Suture
Closure** device and accessories
use biocompatible materials. |
| Sterilization | The LSI SOLUTIONS Suture
Placement device and accessories
are sterilized with ethylene oxide
(EtO) such that a minimum
lethality of 10-6 (a MSI of 6) is
achieved. | The AUTO SUTURE* Suture
Closure** device and accessories
are sterilized with ethylene oxide
(EtO) such that a minimum
lethality of 10-6 (a MSI of 6) is
achieved. |
| Packaging | The LSI SOLUTIONS Suture
Placement device and accessories
are disposable devices that are
packaged in a thermoformed
blister with a TYVEK™ cover. | The AUTO SUTURE* Suture
Closure** device and accessories
are disposable devices that are
packaged in a thermoformed
blister with a TYVEK™ cover. |
Summary
The LSI SOLUTIONS Suture Placement device and accessories are substantially equivalent to the AUTO SUTURE* Suture Closure** device and accessories (K954853). Both devices have the same design, function, and indicated use.
Description
The LSI Suture Placement device and accessories are intended for the approximation of soft tissue.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with the head facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.111 13 1998
Jude S. Sauer, M.D. President LSI Solutions 2144 Brighton-Henrietta Town Line Road Rochester, New York 14623
Re: K981531 Trade Name: Suture Placement Device and Accessories Regulatory Class: II Product Code: GCJ Dated: April 28, 1998 Received: April 29, 1998
Dear Dr. Sauer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Jude S. Sauer, M.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510 (k) NUMBER (IF KNOWN) : K981531
SUTURE PLACEMENT DEVICE AND ACCESSORIES DEVICE NAME:
INDICATIONS FOR USE:
The LSI Suture Placement device and accessories are intended for use in the approximation of soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON -ANOTHER - PAGE - --IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K98153/