(54 days)
The GastroFlex M™ series of Confocal Miniprobes™ are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The GastroFlex™ M series of Confocal Miniprobes are used as part of the Cellvizio® 100 Series system and the Cellvizio" system, to allow imaging of the internal microstructure of tissues in the gastrointestinal system accessed by an endoscope or endoscopic accessories.
The provided text is a 510(k) Premarket Notification summary for the Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™. It primarily focuses on demonstrating substantial equivalence to a predicate device and modifying the "Indications for Use."
Crucially, the provided document does NOT contain a study with acceptance criteria and reported device performance as requested. The document states that "Verification and validation testing has shown that the GastroFlex M™ Confocal Miniprobes are compatible with endoscopes and endoscopic accessories designed and commonly used for biliary and pancreatic imaging," but it does not present the details of such testing, acceptance criteria, or performance outcomes.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets those criteria, as this information is not present in the provided text.
The document mainly focuses on:
- Device Description: The GastroFlex M™ Confocal Miniprobes are used with the Cellvizio system for imaging internal tissue microstructures in the gastrointestinal system, including biliary and pancreatic ducts. The current submission is for revisions to the Indication for Use, specifically verifying compatibility with specialized endoscopes.
- Comparison to Predicate Device: The subject device is stated to be identical to the previously cleared GastroFlex M™ Confocal Miniprobes (K120208). The change is to the Indications for Use to be consistent with the cleared device and the Boston Scientific SpyGlass Direct Visualization Probe.
- Indications for Use: The GastroFlex M™ series is intended to allow imaging of internal microstructures in the upper gastrointestinal tract, including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
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Section 8. 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: K122042 ·
Applicant Information:
August 29, 2012 Date Prepared:
| Name: | Mauna Kea Technologies |
|---|---|
| Address: | 9 rue d'EnghienF-75010 Paris, France |
Phone: +33 1 48 24 03 45 +33 1 48 24 12 18 Fax:
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 Cellvizio® 100 Series System and the Cellvizio® System with Confocal Miniprobes™ including GastroFlex M™ miniprobes (subject of this submission) are identical in all engineering and design respects to the most recently cleared Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes (K120208). The Boston Scientific SpyGlass Direct Visualization Probe cleared via K050403 and K052194 has been cited as an additional predicate device.
Device Description:
The GastroFlex™ M series of Confocal Miniprobes are used as part of the Cellvizio® 100 Series system and the Cellvizio" system, to allow imaging of the internal microstructure of tissues in the gastrointestinal system accessed by an endoscope or endoscopic accessories.
The GastroFlex M™ Confocal Miniprobes are identical in all engineering and design respects to the previously cleared GastroFlex M™ Confocal Miniprobes (K120208). The reduction in size of these miniprobes was described and cleared in a previous submission (K120208). No change in design is being included in this submission. Revisions to the Indication for Use, pursuant to verification of compatibility with specialized endoscopes and endoscopic accessories, is being requested.
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[K/2 2042
Mauna Kea Technologies
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Indications for Use:
The GastroFlex M™ series of Confocal Miniprobes™ are intended to allow imaging of the internal The Gastluries in " Senes of Ochroun Miniproboo" "Gract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
Comparison to Predicate Device:
No change is being made to the predicate device. The subject device is identical to the previously No change is being made to the procession for use is now consistent with both the previously cleared Geared de (K12020). "The Indialized on the Boston Scientific SpyGlass Direct Visualization Probe cleared via K050403 and K052194.
Verification and validation testing has shown that the GastroFlex M™ Confocal Miniprobes are vembation and validation cooling has copic accessories designed and commonly used for biliary and pancreatic imaging.
Summary:
The GastroFlex 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 the gastrointestinal system. These previously cleared probes have been verified to be compatible with endoscopes and endoscopic accessories designed to be used to access the biliary tree and pancreatic ducts.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 4 2012 .
Mauna Kea Technologies % Daniel and Daniel Consulting Mr. Michael A. Daniel Regulatory Consultant 8 Snowberry Court Orinda, California 94563
Re: K122042
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: Class II Product Code: OWN Dated: August 20, 2012 Received: August 22, 2012
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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
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Page 2 - Mr. Michael Daniel
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 (OS) 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.fdaggv/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
erely yours,
fa
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ional 510(k): Device Labeling Mod
. Traditional 540(K): Device Labeling Modification
Section 7. Indications for Use Statement
510(k) Number (if known): K122042
Device Name: Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™
Indications for Use:
The GastroFlex M™ series of Confocal Miniprobes™ are intended to allow imaging of the internal The Ouction in - conce the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
Prescription Use _ × (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 IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE
Neil R. Ogden for mkm
(Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number. KI22042
Confidential Information
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§ 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.