(208 days)
Not Found
No
The summary describes a confocal laser imaging system and fiber optic probes. There is no mention of AI, ML, or any form of automated image analysis or interpretation that would typically involve these technologies. The focus is on the imaging hardware and its compatibility with endoscopes.
No
The device is described as an imaging system intended to allow imaging of the internal microstructure of tissues, not to provide therapeutic treatment.
Yes
The device is described as "intended to allow imaging of the internal microstructure of tissues" within anatomical tracts like the urinary system, which directly supports the process of diagnosis by providing visual information about the tissue.
No
The device description explicitly states the devices are "identical in design and materials to the bundle and their reprocessing methods," indicating they are physical probes, not software. The intended use also describes a "confocal laser system with fiber optic probes."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allow imaging of the internal microstructure of tissues" within the urinary tract. This is a direct imaging technique performed in vivo (within the living body) using a probe inserted into the anatomical tract.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue biopsies) outside of the body to provide information about a person's health.
- Device Description: The device is a confocal laser system with fiber optic probes used for direct imaging.
- Lack of Mention of Samples: There is no mention of analyzing samples or specimens taken from the patient.
The device is a medical imaging system used for direct visualization of tissue microstructure in situ, which falls under the category of medical devices, but not specifically IVDs.
N/A
Intended Use / Indications for Use
The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
The Uroflex™ B and CystoFlex™ F Confocal Miniprobes can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
Product codes (comma separated list FDA assigned to the subject device)
OWN
Device Description
The subject devices, "Uroflex""B" and "CystoFlex""F" are identical in design and materials to the bundle and their reprocessing methods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Optical Imaging
Anatomical Site
Urinary, including, but not limited to, urethra, bladder, and ureter
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)
Verification and validation testing have shown that the Uroflex™B and CystoFlex™F Confocal Minigrobes are compatible with cystoscopes or endoscopic accessories with operating channels of diameter > 0.91 mm designed and commonly used to image the urinary tract during endoscopic procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K111047, K123676, K043022, K011496, K091962
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
FEB 25 2014
Section 13. Premarket Notification 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.
510(k) Number: K132389
Applicant Information:
| Date Prepared: | February 25, 2014 |
|---|---|
| Name: | Mauna Kea Technologies |
| 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 Confocal |
| Miniprobes™ | |
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/ Regulation: | OWN / 21 CFR 876.1500 |
Predicate Devices:
Classification:
- Regarding the Cellvizio Confocal Imaging System, the Cellvizio 100 Series™ System has been . cleared in K111047.
- Regarding the Imaging System and the Confocal Miniprobes equivalence, the Urollex ""B and
CystoFlex""F Confocal Miniprobes are identical in design and materials to the AQ-Fle . Confocal Miniprobe, most recently cleared through K123676. - Reaarding the compatibility of the access during urological procedures and the visualization . and examination of the urinary tract, the following cystoscopes and ureteroscope:
-
- Flexible CystoNephroscope (K043022 from Stryker)
-
Class II
-
- Cysto-Urethroscope "E-Line" (K011496 from Richard Wolf)
-
- PolyScope Flexible Endoscope (K091962 from Lumenis, Inc.)
Confidential Information
1
Device Description:
The subject devices, "Uroflex""B" and "CystoFlex""F" are identical in design and materials to the bundle and their reprocessing methods.
Indications for Use:
The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
The Uroflex®B and CystoFlex™F Confocal Miniprobes can be used within anatomical tracts, i.e. Urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
| Confocal Miniprobe™ | Endoscope or accessory |
|---|---|
| UroFlex™ B | Cystoscope or ureteroscope with operating channel internal |
| diameter ≥ 1.0mm (3 Fr) | |
| CystoFlex™ F | Flexible Cystoscope with operating channel internal |
| diameter ≥ 1.0mm (3 Fr) |
Comparison to Predicate Devices:
No change is being made to the design and the fundamental technology and operating principle of the previously-cleared AQ-Flex™ 19 Confocal Miniprobe used in this submission as a predicate device (K123676). The Uroflex™B and the CystoFlex!"F are identical to this predicate device, only differing by the length of their fiber bundle (3m for the Uroflex™B and 2m for the CystoFlex™F instead of 4m for the AQ-Flex™ 19) and their reprocessing methods (disinfection instead of sterilization for the CystoFlex™F). The indication for use is being expanded to include visualization of urinary tract during endoscopic procedures.
Verification and validation testing have shown that the Uroflex™B and CystoFlex™F Confocal Minigrobes are compatible with cystoscopes or endoscopic accessories with operating channels of diameter > 0.91 mm designed and commonly used to image the urinary tract during endoscopic procedures.
Summary:
The Uroflex™B and CystoFlex™F 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, such as the AQ-Flex 19 Confocal Miniprobe, and can be used as intended to image the internal microstructure of tissues in the urinary tract during endocsopic procedures. This previously cleared Miniprobe have been verified to be compatible with cystoscopes, cysto-nephroscopes and ureteroscopes, 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 a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
Mauna Kea Technologies % Michael A. Daniel Regulatory Consultant Daniel & Daniel Consulting 8 Snowberry Court Orinda, CA 94563
Re: K132389
Trade/Device Name: Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™ Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OWN Dated: January 17, 2014 Received: January 22, 2014
Dear Michael A. 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.
3
Page 2 - Michael A. Daniel
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 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/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 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.
Herbert P. Lerner -S
for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132389
Device Name
Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™
Indications for Use (Describe)
The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
The Uroflex™ B and CystoFlex™ F Confocal Miniprobes can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
| Confocal Miniprobes™ | Endoscope or accessory |
|---|---|
| UroFlex™ B | Cystoscope or ureteroscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
| CystoFlex™ F | Flexible Cystoscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Herbert 2014.02.
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.