(90 days)
Not Found
No
The 510(k) summary describes a purely mechanical device for positioning a needle within an endoscope. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as an accessory to help position an injection needle within an endoscope, not to directly treat a medical condition. Its function is purely facilitative for another procedure.
No
This device is designed to aid in the physical positioning of an injection needle within an endoscope, not to detect, diagnose, or monitor a disease or condition. It's a positioning tool, not a diagnostic one.
No
The device description explicitly states it consists of a cannula and a cap, 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 is to "help position an injection needle within the center of an endoscope." This describes a device used during a medical procedure to facilitate the delivery of a substance (presumably a medication or other therapeutic agent) via injection.
- Device Description: The description details a physical device (cannula and cap) designed to fit within an endoscope and guide a needle. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples
- Detecting analytes
- Providing diagnostic information
- Using reagents or assays
This device is a surgical accessory or instrument used to aid in a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.
Product codes
FBK
Device Description
Advanced UroScience InnerSheath consists of a cannula and a cap. The cannula is designed to fit easily within an endoscope and to permit easy alignment of an injection needle within to in easily within an endosope and to provide adequate gripping of the cannula and endoscope, and an adequate seal with the injection needle. Advanced UroScience InnerSheath is provided sterile and is intended for single use only.
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)
Biocompatibility and bench testing have demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.
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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 27 2015
Advanced UroScience, Inc. Ms. Karen E. Peterson Vice President of Regulatory, Clinical and Quality Affairs 1290 Hammond Road St. Paul, MN 55110
Re: K002573
Trade/Device Name: Advanced UroScience Innersheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated (Date on orig SE ltr): August 17, 2000 Received (Date on orig SE ltr): August 18, 2000
Dear Ms. Peterson,
This letter corrects our substantially equivalent letter of November 16, 2000.
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
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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 (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 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
EXHIBIT 3
Indications for Use Statement
L 30 25 73 510(k) Number (if known)_
Advanced UroScience InnerSheath Device Name
Indications for Use
Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109
・
OR
Over the Counter Use_
(Optimal Format 1-2-96)
Daniel C. Heggem
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
3
Advanced UroScience, Inc.
EXHIBIT 7 Koo2573
510(k) Summary
Submitter's Name, Address, and Date of Submission
Karen E. Peterson Vice President of Regulatory, Clinical, & QA Advanced UroScience, Inc. 1290 Hammond Road St. Paul, MN 55110
| Phone: | 651-762-2146 |
|---|---|
| Fax: | 651-407-1975 |
August 17, 2000 Submitted:
Device Name
Trade Name: Classification Name:
Advanced UroScience InnerSheath Endoscope and/or Accessories, 21 CFR 876.1500 Cannula .
Common/Usual Name:
Predicate Device
Bard Stabilizing Cannula (K930827)
Indication for Use
Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.
Device Description
Advanced UroScience InnerSheath consists of a cannula and a cap. The cannula is designed to fit easily within an endoscope and to permit easy alignment of an injection needle within to in easily within an endosope and to provide adequate gripping of the cannula and endoscope, and an adequate seal with the injection needle. Advanced UroScience InnerSheath is provided sterile and is intended for single use only.
Technological Characteristics and Performance
The technological characteristics are similar to or equivalent to the predicate device. Biocompatibility and bench testing have demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.