(70 days)
The Advanced UroScience Injection needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
The Advanced UroScience Injection Needle consists of a stainless steel needle attached to a plastic luer lock hub. Needle length ranges up to 200 cm to accommodate the length of the endoscope channel and gauge ranges from 14 to 25. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the needle, is designed to accommodate a standard syringe. The Advanced UroScience Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of collagen during cystoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures. The Advanced UroScience Injection Needle is provided sterile and is intended for single use only.
The provided text details a 510(k) summary for the Advanced UroScience Injection Needle. This type of submission is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve studies that define and meet specific acceptance criteria in the same way a new device with novel technology would.
Therefore, many of the requested elements for acceptance criteria and study design are not applicable to this type of regulatory submission. The primary "study" involved is a comparison to a predicate device to establish substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness. The specific criteria are thus a qualitative comparison rather than quantitative performance metrics.
- Reported Device Performance: The document does not report specific quantitative performance data for the Advanced UroScience Injection Needle. Instead, it describes its design and intended use, asserting its similarity to predicate devices.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device | "The Advanced UroScience Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure." (Same as predicate devices implicitly, as determined by FDA's substantial equivalence finding) |
| Technological Characteristics: Similar to predicate devices (materials, design, function) | "The Advanced UroScience Injection Needle consists of a stainless steel needle attached to a plastic luer lock hub. Needle length ranges up to 200 cm... gauge ranges from 14 to 25." "consists of a stainless steel needle and luer lock connector hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue." (Asserted to be similar to predicate devices K843719 and K960519) |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This document is a 510(k) summary, not a report of a performance study with a test set of data. The "test" for a 510(k) is the comparison to the predicate device based on design, materials, manufacturing methods, and indications for use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No such "test set" or ground truth establishment by experts for performance evaluation is described in this 510(k) summary. The "ground truth" here is the regulatory acceptance of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. There is no described "test set" and thus no adjudication method mentioned. The decision on substantial equivalence is made by the FDA reviewer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is not relevant to a 510(k) submission for this device. An MRMC study would typically be for diagnostic imaging devices or algorithms where human reader performance is being evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical instrument (an injection needle), not an algorithm or software. Therefore, the concept of "standalone performance" in this context is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" in a 510(k) submission like this is primarily regulatory precedent and engineering principles. The device is deemed safe and effective because it is substantially equivalent to devices already on the market (the predicate devices K843719 and K960519) that have a history of safe and effective use. There's no specific clinical outcomes or pathology data for this device within this submission that establishes a "ground truth" of its performance.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" for this type of device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, this question is not relevant.
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OCT 2 6 1998
| 16. 510(k) SUMMARY | K 982890 | Pg 1 of 3 |
|---|---|---|
| General Information | ||
| Date Prepared | August 14, 1998 | |
| Classification | Class II | |
| Trade Name | Advanced UroScience Injection Needle | |
| Common Name | Endoscopic Needle | |
| Submitter | Advanced UroScience1290 Hammond RoadSt. Paul, MN 55110651-653-8512 | |
| Contact | Karen E. PetersonVice President of Regulatory, Clinical, and Quality Affairs | |
| Predicate Device | Single Wall Introducer Needle,Ocean Medical Products (K843719)Martech Endoscopic Injection Needle,Martech Medical Products, Inc (K960519) |
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K982896 Pg 2 of 3
Device Description
The Advanced UroScience Injection Needle consists of a stainless steel needle attached to a plastic luer lock hub. Needle length ranges up to 200 cm to accommodate the length of the endoscope channel and gauge ranges from 14 to 25. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the needle, is designed to accommodate a standard syringe.
The Advanced UroScience Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of collagen during cystoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures.
The Advanced UroScience Injection Needle is provided sterile and is intended for single use only.
Indication
The Advanced UroScience Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
Technological Characteristics
The Advanced UroScience Injection Needle consists of a stainless steel needle and luer lock connector hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue. Multiple needle lengths are available to accommodate the length of the endoscope channel.
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Summary
In summary Advanced UroScience believes the above listed predicate devices and the Advanced UroScience Injection Needle are substantially equivalent based on design, materials, methods of fabrication and indications for use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1998
Ms. Karen E. Peterson Vice President of Regulatory, Clinical, and Quality Affairs Advanced UroScience, Inc. 1290 Hammond Road Saint Paul, Minnesota 55110
Re: K982890
Advanced UroScience Injection Needle Dated: August 14, 1998 Received: August 17, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FBK
Dear Ms. Peterson:
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 requirements, as set forth in the Quality System Regulation (QS) 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.
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) 594-4613. 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/odrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K982890 510(k) Number (if known)
Advanced UroScience Injection Needle Device Name
Indications for Use
The Advanced UroScience Injection needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
(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 __
(Optimal Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| Labels | Values |
|---|---|
| 510(k) Number | K982890 |
§ 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.