(90 days)
Not Found
No
The summary describes a physical accessory for endoscopes and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device description states that the product "enables the passage of additional endoscopic instruments to enhance the effectiveness of diagnostic and therapeutic interventions."
No
The device is described as an "Endoscopic External Accessory Channel" that "enables the passage of additional endoscopic instruments to enhance the effectiveness of diagnostic and therapeutic interventions." While it facilitates diagnostic interventions, its own function is not to diagnose. It's a tool for procedures that might include diagnosis, but not a diagnostic device itself.
No
The device description explicitly states it is a "sterile conduit" and an "external accessory channel," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "supplemental conduit that attaches to an endoscope to enable improved access during endoscopic procedures." This describes a device used during a medical procedure to facilitate the delivery of instruments, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description reinforces this by calling it a "sterile conduit" that "enables the passage of additional endoscopic instruments." This is a tool for procedural assistance.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The LSI Endoscopic External Accessory Channel and Accessories Product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access during endoscopic procedures.
Product codes
ODC
Device Description
The LSI Endoscopic External Accessory Channel and Accessories Product is a sterile conduit that can be safely attached to common endoscopes. This Endoscopic External Accessory Channel enables the passage of additional endoscopic instruments to enhance the effectiveness of diagnostic and therapeutic interventions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, with three abstract shapes that could be interpreted as heads or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
LSI Solutions, Inc. Mr. Christopher A. Klaezyk Regulatory Compliance Manager 7796 Victor-Mendon Road Victor, NY 14564
JUL 2 7 2015
Re: K024301 Trade/Device Name: LSI Endoscope External Accessory Channel Device and Accessories Product Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated (Date on orig SE ltr): December 20, 2002 Received (Date on orig SE ltr): December 24, 2002
Dear Mr. Klaezyk,
This letter corrects our substantially equivalent letter of March 24, 2003.
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. 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
1
Page 2 -
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact 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. 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.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
024301 MAR 24 2003
LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI Endoscopic External Accessory Channel and Accessories Product
11. 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 Contact: Christopher A. Klaczyk, Regulatory Compliance Manager Common Name: Endoscope and/or accessories LSI Endoscopic External Accessory Channel and Accessories Product Trade Name: Endoscope and accessories (per 21 CFR §876.1500) Classification Name: LSI SOLUTIONS Flexible Suture Placement Device and Accessories Predicate Device: Product (K011016) The LSI Endoscopic External Accessory Channel and Accessories Description: Product is a sterile conduit that can be safely attached to common endoscopes. This Endoscopic External Accessory Channel enables the of additional endoscopic instruments to enhance the passage effectiveness of diagnostic and therapeutic interventions. The LSI Endoscopic External Accessory Channel and Accessories Intended Use: Product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access during endoscopic procedures.
Section 11 - Page 1 of 1
CONFIDENTIAL
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LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI Endoscopic External Accessory Channel and Accessories Product
7. Statement of Indications For Use
Page _ l __ of l________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: LSI Endoscopic External Accessory Channel and Accessories Product
Indications For Use:
--.
The LSI Endoscopic External Accessory Channel and Accessories Product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access during endoscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amit be Siyann
and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 3-10-98)
Section 7 - Page 1 of 1
CONFIDENTIAL