(86 days)
Not Found
No
The summary describes a standard, reusable rigid laparoscope for visualization and illumination, with no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML-powered devices.
No.
The device's intended use is solely for illumination and visualization, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "illumination and visualization... in a wide variety of diagnostic and therapeutic laparoscopic and thoracoscopic procedures."
No
The device description explicitly states it is a "reusable and rigid laparoscope," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "solely for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thoracoscopic procedures." This describes a device used during a procedure to see inside the body, not a test performed on a sample taken from the body.
- Device Description: It's described as a "reusable and rigid laparoscope." Laparoscopes are surgical instruments used for visualization during minimally invasive procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), performing tests, or providing diagnostic information based on the analysis of biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for visual access during a procedure.
N/A
Intended Use / Indications for Use
The U.S. Surgical Auto Suture* Laparoscope** device is intended for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thorascopic procedures.
Product codes
GCJ
Device Description
The U.S. Surgical Laparoscope** device is a reusable and rigid laparoscope based on existing laparoscopy technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal structures (via laparoscopic and thorascopic procedures)
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
§ 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.
0
K983293 Auto Suture* Laparoscope** Device
IX. 510(k) Summary of Safety and Effectiveness
United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856
LAVELLI VICTOR CONTACT PERSON: Jamie Vich 430
DATE PREPARED: September 18, 1998
CLASSIFICATION NAME: Endoscope and accessories
COMMON NAME: Laparoscope
Not yet determined PROPRIETARY NAME:
Imagyn MicroLap™ Laparoscope (K965055) PREDICATE DEVICES:
The U.S. Surgical Laparoscope** device is a reusable and DEVICE DESCRIPTION: rigid laparoscope based on existing laparoscopy technology.
The U.S. Surgical Auto Suture* Laparoscope** device is INTENDED USE: intended for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thorascopic procedures.
MATERIALS: All component materials of the laparoscope are comprised of materials which are in accordance with ISO Standard # 10993-1.
1
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other, with 'Public' on the top line, 'Health' on the second line, and 'Service' on the third line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1998
Re:
Mr. Victor M. Clavelli Manager, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
K983293 Trade Name: Auto Suture* Laparoscope** Device Regulatory Class: II Product Code: GCJ Dated: September 18, 1998 Received: September 21, 1998
Dear Mr. Clavelli:
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 (OS) 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.
2
Page 2 - Mr. Victor M. Clavelli
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
3
IV. Indications For Use:
983293 510(k) Number (if known):
Name: Laparoscope
Indications For Use:
The U.S. Surgical Auto Suture* Laparoscope** device has indication solely for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thoracoscopic procedures.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)
pcooll
(Division Sign-Off) Division of General Restorative De 510(k) Number