(92 days)
Not Found
No
The description focuses on the mechanical components and intended use of a rigid endoscopic needle for delivering injectable materials, with no mention of AI or ML capabilities.
No
The device is described as an accessory for endoscopes used for delivery of injectable material, not for treating a disease or condition itself.
No
The device is described as an accessory for endoscopes that allows for the delivery of injectable material into tissues. Its function is to administer substances, not to obtain information for a diagnosis.
No
The device description clearly states it is a physical needle comprised of stainless steel and copolyester, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver injectable material into tissues during an endoscopic procedure. This is a therapeutic or procedural use, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a needle designed for injection, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device is used to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic Possible injectable materials include: tissue bulking agents; sclerosing agents; local procedure. anesthetics; saline; or contrast media.
Product codes
FBK
Device Description
The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The Rigid Endoscopic Needle is comprised of a stainless steel cannula 300 - 500 mm in length with an 18-23 gauge tip (10 - 15 mm in length) and a copolyester Luer lock hub.
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)
Uroplasty conducted biocompatibility and functional testing to support the substantial equivalence of the Uroplasty Rigid Endoscopic Needles to the predicate device. Functional tests to demonstrate forces experienced by the needle during use and to demonstrate mechanical strength.
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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K121337 page 1 of 2
Image /page/0/Picture/1 description: The image shows the word "Uroplasty" next to a circular logo. The logo is black and white and appears to be a stylized representation of a medical device. The text is in a simple, sans-serif font and is also black.
Uroplasty, Inc. 5420 Feltl Road. Minnetonka. MN 55343 USA Main: 952 426 6140 (tel), 952 426 6199 {fax) Toll free: 866 258 2182 (tel), 866 255 4522
510(k) Summary
3 2012 AUG
| Submitter | Uroplasty, Inc.
5420 Feltl Road
Minnetonka, MN 55343
Telephone: (952) 426-6140, Fax: (952) 426-6199
Email: info.usa@uroplasty.com |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | May 2, 2012 |
| Contact | Emily Metcalfe, Regulatory Affairs Specialist
Email: emily.metcalfe@uroplasty.com |
| Trade Name | Uroplasty Rigid Endoscopic Needles |
| Common Name | Endoscopic needles |
| Classification Name | Endoscopes and accessories (21 CFR 876.1500, Product Code FBK) |
| Legally Marketed
(Predicate) Device | Uroplasty Rigid Endoscopic Needles (K091391) |
Device Description
The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The Rigid Endoscopic Needle is comprised of a stainless steel cannula 300 - 500 mm in length with an 18-23 gauge tip (10 - 15 mm in length) and a copolyester Luer lock hub.
Intended Use
The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic Possible injectable materials include: tissue bulking agents; sclerosing agents; local procedure. anesthetics; saline; or contrast media.
Comparison to Predicate Device
The Uroplasty Rigid Endoscopic Needles have the same intended use and same fundamental technology as the predicate device. Both feature a stainless steel needle cannula and tip with a Luer lock hub for attachment to syringes used during endoscopic procedures to deliver injectable materials to patient tissues. The Uroplasty Rigid Endoscopic Needles have a modified needle hub compared to the predicate device.
1
K121337 page 2 of 2
Summary of Non-Clinical and Performance Data
Uroplasty conducted biocompatibility and functional testing to support the substantial equivalence of the Uroplasty Rigid Endoscopic Needles to the predicate device. Functional tests to demonstrate forces experienced by the needle during use and to demonstrate mechanical strength.
Conclusion
The Uroplasty Rigid Endoscopic Needle is substantially equivalent to the previously cleared endoscopic needle by Uroplasty (K091391).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Emily Metcalfe Regulatory Affairs Specialist Uroplasty, Inc. 5420 Feltl Road MINNETONKA MN 55343
AUG 3 2012
Re: K121337
Trade/Device Name: Uroplasty Rigid Endoscopic Needles Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: July 13, 2012 Received: July 16, 2012
Dear Ms. Metcalfe:
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 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
3
Page 2 -
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 n you docute oper.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the 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 Tournal 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K. Fisher, Ph.D.
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
4
Indications for Use Statement
510(k) Number:
KIZI337
New Device Name:
Uroplasty Rigid Endoscopic Needles
Indication for Use:
The Uroplasty Rigid Endoscopic Needles are accessories to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needles may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.
Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sten Bby
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and,
Urological Devices
510(k) Number K121337