(322 days)
The N-DO Endoinjector Needles are intended to deliver a variety of legally marketed therapeutic and diagnostic agents into the urethra, prostate and vesical cavities with visualization via a cystoscope.
Not Found
This is a 510(k) premarket notification for a medical device (N-DO Endoinjector Needle). The provided document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. This type of FDA clearance does not typically involve a study with acceptance criteria and device performance in the way a clinical trial for a new drug or a more complex medical device would.
The information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance) is characteristic of a performance study for AI/CADe devices or those requiring more extensive clinical validation. For a 510(k) clearance based on substantial equivalence, especially for a device like an endoinjector needle, the "study" demonstrating equivalence is usually based on bench testing and comparison to existing predicate devices, rather than a clinical trial with human subjects and ground truth established by experts.
Therefore, most of the information you've asked for is not applicable to this specific FDA clearance document.
Here's a breakdown of why and what can be inferred:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable in the traditional sense. This document does not present acceptance criteria for a performance study. Instead, the "acceptance criteria" for 510(k) substantial equivalence revolve around demonstrating that the new device has "the same intended use and the same technological characteristics as the predicate device" or "has different technological characteristics from the predicate device and the information submitted demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness than the predicate device."
- Reported Device Performance: The letter states the device "is substantially equivalent... to legally marketed predicate devices." This implies that its performance, through bench testing or other non-clinical data, was deemed comparable to existing, safe, and effective devices.
2. Sample size used for the test set and the data provenance:
- Not Applicable. There is no "test set" in the context of a clinical performance study described here. The evaluation for substantial equivalence would involve comparing the physical and functional characteristics of the N-DO Endoinjector Needle to predicate devices. This might involve testing a sample of the needles for various parameters (e.g., dimensions, material strength, fluid delivery rates), but these are engineering/bench tests, not clinical performance tests on a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical performance, is not established for this type of 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set or adjudication process is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is an endoinjector needle, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. Ground truth from clinical data is not applicable to this type of device and submission. The "ground truth" for substantial equivalence would be the established safety and effectiveness profile of the predicate device (based on its prior clearance) and the demonstration that the new device meets similar engineering and functional standards.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable.
In summary: The provided FDA letter pertains to a 510(k) clearance for an endoinjector needle, which is a physical medical device. The "study" for such a clearance primarily involves demonstrating substantial equivalence to existing predicate devices through bench testing, materials characterization, and comparison of technological characteristics and intended use. The detailed clinical performance study criteria and data provenance requested in your prompt are not typically relevant or included in such a submission.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2005
Physion®, Inc. c/o Eric J. Nemeth, Esq. Sheffet & Dvorin Attorneys at Law 2509 Park Avenue, Suite 2B SOUTH PLAINFIELD NJ 07080
Re: K043383
K045585
Trade/Device Name: N-DO Endoinjector Needle, Models PH00961109 and -1110; PH00971102 and -1103 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: August 15, 2005 Received: August 22, 2005
Dear Mr. Nemeth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced wowe 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 do not require 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 it your do ree is stable to such additional controls. Existing major regulations affecting your Apple rary, it they of casylone 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 I Dri nas made a drommissions administered by other Federal agencies. You must comply with all the r carrarss and regulating, but not limited to registration and listing (21 CFR Part 807); labeling All CFR Part 801); good nanufacturing practice requirements as set forth in the quality systems (QS) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 5 I 0(k) This letter will anow you to begin manceing of substantial equivalence of your device to a legally premarket notification. The FDA Inding of substantial of 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), pleased If you desire specific advice for your device on our languing numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to prematic notification" (21 CFR Also, please note the regulation chitted, "thisorians on your responsibilities under the Act from the 807.97). You may obtain other general information on yours I
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ K043383 _________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The N-DO Endoinjector Needles are intended to deliver a variety of legally The N-DO Endomjector Novethra, prostate and vesical cavities with visualization via a cystoscope.
Prescription Use X (Part 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 OF NEEDED)
Daind Lee Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.