(139 days)
The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal.
The AQ-Flex 19TM member of the GastroFlex M series.of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal. accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
The subject device, "AQ-Flex 19" is a member of the GastroFlex M family of devices cleared via K122042 and K120208. It is identical in design to the GastroFlex M devices described in K120208. There are no differences in design, materials, or function between the subject AQ-Flex 19 device and the recently cleared GastroFlex M devices. A locking accessory is being added to the package as an aid to secure placement inside a EUS-FNA needle in place of a Stylet. Instructions for Sterilization have also been added.
This document is a 510(k) premarket notification for the "AQ-Flex 19" Confocal Miniprobe, a component of the Cellvizio family of devices. The filing asserts substantial equivalence to previously cleared devices. Therefore, the information provided does not describe a clinical study with acceptance criteria and a detailed performance evaluation of a new or significantly modified device. Instead, it focuses on demonstrating that the new device is functionally identical to existing, cleared devices.
Here's an analysis based on the provided text:
-
Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a device stated to be identical to a previously cleared one, direct acceptance criteria and specific performance metrics for this particular device are not explicitly stated in the provided text. The submission focuses on demonstrating sameness rather than new performance. The text states:- "The subject device, "AQ-Flex 19" is a member of the GastroFlex M family of devices cleared via K122042 and K120208. It is identical in design to the GastroFlex M devices described in K120208. There are no differences in design, materials, or function between the subject AQ-Flex 19 device and the recently cleared GastroFlex M devices."
- "No change is being made to the subject/predicate device. The subject device is identical to the previously cleared device (K120208)."
- "Verification and validation testing has shown that the AQ-Flex 19 Confocal Miniprobes are compatible with endoscopes or endoscopic accessories designed and commonly used in these procedures (such as endoscopic needles)."
Therefore, the "acceptance criteria" implicitly are that the device performs identically to the predicate device, K120208, and remains compatible with intended endoscopic accessories. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided for this filing.
-
Sample size used for the test set and the data provenance:
The document does not describe a specific clinical test set for evaluating a new performance claim. The "verification and validation testing" mentioned is likely engineering and bench testing to demonstrate physical and functional equivalence and compatibility, rather than a clinical study with a patient test set. No information is given regarding data provenance (e.g., country of origin, retrospective/prospective). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set for establishing ground truth is described. -
Adjudication method for the test set:
Not applicable, as no clinical test set requiring adjudication is described. -
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 a confocallaser system and miniprobe for imaging, not an AI or diagnostic software tool that would typically involve human reader performance evaluation. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical imaging system, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical ground truth assessment is described for the new device's performance. The "ground truth" for the submission is the demonstrated functional equivalence to its predicate. -
The sample size for the training set:
Not applicable, as this is not an AI/machine learning device requiring a training set. -
How the ground truth for the training set was established:
Not applicable.
{0}------------------------------------------------
Mauna Kea Technologies
Page ① of ↷
Traditional 510(k)
Section 8.Premarket Notification 510(k) Summary
APR 1 8 2013
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | K123676 |
|---|---|
| ---------------- | --------- |
Applicant Information:
Mauna Kea Technologies Name: Address: 9 rue d'Enghien F-75010 Paris, France
Phone: +33 1 48 24 03 45 Fax: +33 1 48 24 12 18
Contact Person:
Michael A Daniel, Consultant
| Phone Number: | (415) 407-0223 |
|---|---|
| Office: | (925) 254-5228 |
| Facsimile Number: | (925) 254-5187 |
Device Information: ·
| Device Trade Name: | Cellvizio® 100 Series System and Cellvizio® System with ConfocalMiniprobes™ |
|---|---|
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/ Regulation: | OWN / 21 CFR 876.1500 |
| Classification: | Class II |
Predicate Device:
- The AQ-Flex 19 Confocal Miniprobes are identical in all respects to the Confocal Miniprobe . GastroFlex M most recently cleared with Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes, K120208.
- Endoscopic UltraSound Needles : Expect Endoscopic Aspiration Needle (K112198 from Boston . Scientific), EchoTip Ultra Ultrasound Needle System (K083330 from Cook Endoscopy) and EchoTip Ultra High Definition Ultrasound Access Needle (K092359 from Cook Ireland Ltd)
Device Description:
The subject device, "AQ-Flex 19" is a member of the GastroFlex M family of devices cleared via K122042 and K120208. It is identical in design to the GastroFlex M devices described in K120208. There are no differences in design, materials, or function between the subject AQ-Flex 19 device and the recently cleared GastroFlex M devices.
{1}------------------------------------------------
Mauna Kea Technologies
page (2) of (2)
Traditional 510(k)
A locking accessory is being added to the package as an aid to secure placement inside a EUS-FNA needle in place of a Stylet. Instructions for Sterilization have also been added.
Indications for Use:
The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal.
The AQ-Flex 19TM member of the GastroFlex M series of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
Comparison to Predicate Device:
No change is being made to the subject/predicate device. The subject device is identical to the neviously cleared device (K120208). The indication for use is being expanded to include selected needle-based endoscopic procedures.
Verification and validation testing has shown that the AQ-Flex 19 Confocal Miniprobes are compatible with endoscopes or endoscopic accessories designed and commonly used in these procedures (such as endoscopic needles).
Summary:
The AQ-Flex 19 M Confocal Miniprobes, when used as part of the Cellvizio 100 Series and the Cellvizio Systems, have been shown to be substantially equivalent to cleared predicate devices and can be used as intended to image the internal microstructure of tissues in a variety of anatomical locations. These previously cleared probes have been verified to be compatible with endoscopes and endoscopic accessories designed to be used in these applications.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of a stylized eagle or bird-like figure with three overlapping, curved lines representing its wings or body. The text is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2013
Mauna Kea Technologies % Daniel and Daniel Consulting Mr. Michael Daniel 8 Snowberry Court Orinda, California 94563
Re: K123676
Trade/Device Name: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN Dated: April 01, 2013 Received: April 02, 2013
Dear Mr. Daniel:
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
{3}------------------------------------------------
Page 2 - Mr. Michael Daniel
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 go to http://www.fda.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 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/Safetv/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, FOR
Peter Di Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Section 7.Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™
Indications for Use:
The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal.
The AQ-Flex 19TM member of the GastroFlex M series.of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal. accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
Prescription Use X AND/OR Over-The-Counter-Use _
(Part 21 CFR 801 Subpart D) (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
Neil R Oge 2013.04.17
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number K123676
§ 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.