(25 days)
The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic or graspilly son thisue not intended for therapeutic use.
Like the predicate devices, the Acueity ViaDuct Miniscope and Accessories consist of a semi-rigid fiberscope with an irrigating outer sheath or introducer capable of passing a biopsy needle to a soft tissue site for view or, to view and assess/biopsy soft tissue. The Acueity ViaDuct Miniscope and Accessories is also designed with an inner grasping sheath or tube that can be placed within the outer introducer, which together act as forceps capable of grasping soft tissue for biopsy. The combination of these devices allows access to very finite spaces.
The provided 510(k) summary (K040949) for the ViaDuct Miniscope and Accessories does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data. It is a premarket notification for a medical device seeking substantial equivalence to predicate devices, rather than a submission detailing performance against predefined metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify any quantitative acceptance criteria or provide a table of reported device performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or biopsy. The submission focuses on demonstrating substantial equivalence in terms of intended use, principles of operation, anatomical site, safety characteristics, and physical characteristics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document states, "All necessary testing was or will be performed on the ViaDuct Miniscope and Accessories to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." However, it does not detail any specific test sets, sample sizes, or data provenance from studies designed to prove clinical performance. This typically refers to bench testing, biocompatibility, sterilization, and sometimes animal studies, but not necessarily human clinical trials for diagnostic performance in the way AI/ML devices often do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. No clinical test set involving expert ground truth determination is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. As no clinical test set is detailed, no adjudication method 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
- Cannot be provided. This document predates the common practice of extensive AI/ML efficacy studies and does not describe any MRMC studies comparing human readers with and without AI assistance. The device is purely an imaging and biopsy tool, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This device is a manual, physical instrument (fiberscope, biopsy forceps) and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No specific ground truth type is mentioned for a performance study. For a device like this, "ground truth" might refer to the successful retrieval of tissue biopsies or direct visual confirmation of anatomical structures, but this is not detailed in the context of a performance study proving diagnostic accuracy.
8. The sample size for the training set
- Cannot be provided. This refers to a physical device, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Cannot be provided. As there is no training set for an algorithm, this question is not applicable.
Summary of Device and Regulatory Context from the Document:
- Device Name: ViaDuct Miniscope and Accessories
- Device Description: Semi-rigid fiberscope with an irrigating outer sheath/introducer, capable of passing a biopsy needle, and an inner grasping sheath/tube functioning as forceps for soft tissue biopsy.
- Intended Use: For use by a physician for viewing an interior cavity of the human body (via natural opening or incision) and for grasping soft tissue for biopsy. It is for diagnostic purposes only and not therapeutic use.
- Regulatory Pathway: 510(k) Pre-market Notification, seeking substantial equivalence.
- Predicate Devices: Acueity (formerly DOFI Communications, Inc.) Miniaturized Biopsy Scope (K011189) and Acueity ViaDuct Microendoscope and Accessories (K983527).
- Substantial Equivalence Claim: Based on similar intended use, principles of operation, anatomical site for viewing and sampling, safety characteristics, and physical characteristics compared to predicate devices.
- Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls.
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MAY - 7 2004 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
- A. Name, Address, Phone and Fax number of the Applicant
Acueity, Inc. 100 Hamilton Avenue, Suite 140 Palo Alto, CA 94301
Telephone: (650) 473-9910 (650) 473-9306 Fax:
B. Contact Person
Nancy Lincé Regulatory Affairs Consultant
Telephone: (650) 759-6186
- ். Date Prepared
March 2, 2004
D. Device Name
Trade Name: ViaDuct Miniscope and Accessories Classification Name: Endoscope and Accessories and Bioosv Instruments and Non-electric biopsy forceps
Device Description ட்ட
Like the predicate devices, the Acueity ViaDuct Miniscope and Accessories consist of a semi-rigid fiberscope with an irrigating outer sheath or introducer capable of passing a biopsy needle to a soft tissue site for view or, to view and assess/biopsy soft tissue. The Acueity ViaDuct Miniscope and Accessories is also designed with an inner grasping sheath or tube that can be placed within the outer introducer, which together act as forceps capable of grasping soft tissue for biopsy. The combination of these devices allows access to very finite spaces.
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F. Intended Use
The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. - The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.
G. Substantial Equivalence
The Acueity ViaDuct Miniscope and Accessories is substantially equivalent to the Acueity (formerly DOFI Communications, Inc.) Miniaturized Biopsy Scope and the Acueity ViaDuct Microendoscope and Accessories, cleared by the FDA under K011189 and K983527, respectively. The design of the ViaDuct Miniscope and Accessories is similar to the predicate device insofar as intended use, principles or operation, anatomical site for viewing and sampling, safety characteristics and physical characteristics.
Device Testing Results and Conclusion H.
All necessary testing was or will be performed on the ViaDuct Miniscope and Accessories to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Acueity, Inc. c/o Mr. J.A. van Vugt KEMA Quality B.V. P.O. Box 5185 6802 Ed Arnhem Arnhem. Netherlands
Re: K040949
Trade/Device Name: ViaDuct™ Miniscope and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCT Dated: April 27, 2004 Received: April 28, 2004
Dear Mr. van Vugt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 complics 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); 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.
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Page 2 - Mr. J.A. van Vugt
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: ViaDuct™ Miniscope and Accessories
Indications For Use:
The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic or graspilly son thisue not intended for therapeutic use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K040949
Page 1 of 1
§ 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.