(313 days)
Not Found
No
The summary describes a flexible endoscope with mechanical deflection and a working channel. There is no mention of any software, image processing, or AI/ML terms.
Yes.
The device's intended use explicitly states its ability to "perform various diagnostic and therapeutic procedures" using additional accessories.
Yes
The device is described as allowing medical professionals to "examine the urinary tract" and to "perform various diagnostic and therapeutic procedures," indicating its use in diagnosing conditions.
No
The device description clearly states it is a flexible endoscope with physical components like lengths, a working channel, and a 'Y Port' accessory, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures." This describes a device used directly on or within the body for visualization and intervention.
- Device Description: The description details a "flexible endoscope" with a working channel for irrigation and potentially other accessories. This is a physical instrument used for internal examination.
- Lack of IVD Characteristics: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. The provided information does not mention any such use or analysis of specimens.
Therefore, the MaxiFlex Semi Flex Scopes are a medical device used for direct examination and procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times
Product codes
FGB
Device Description
The Maxi-Flex Semi Flex Scopes™ is flexible endoscope that allows operator-controlled deflection of the distal end or tip of the scope. The devices will be made available in lengths (25 cm and 65 cm), each length with a working channel. With a Maxi-Flex accessory a 'Y Port' the working channel may be utilized as an irrigation channel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals / clinical setting only.
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
Maxi-Flex Semi-Flex Scopes™ (this submission), for reuse has been tested for four (4) EtO sterilization cycles without any degradation from original design specifications. All other core elements of K062725 remain unchanged.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MaxiFlex
Advanced Surgical Devices
for Urology
APR - 4 2012
Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Maxi-Flex Semi-Flex Scopes™
1. Company making the submission:
| Owner Name: | MaxiFlex, LLC |
|---|---|
| Address: | 1516 Thalia Street |
| New Orleans, LA 70130 | |
| Telephone: | 225-978-9237 |
| Fax: | 504-265-8977 |
| Contact: | Gary Ventrella |
| E-mail: | garyventrella@me.com |
| Correspondent/consultant | Harvey Knauss |
| Address: | 1516 Thalia Street |
| New Orleans, LA 70130 | |
| Telephone: | 832-675-9281 |
| Fax: | 713-723-0786 |
| E-mail: | Harvey.knauss@gmail.com |
2. Device Name:
| Trade/Proprietary Name: | Maxi-Flex Semi-Flex Scopes™ |
|---|---|
| Common Name: | Endoscopes and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | FGB |
| Device Class: | Class II |
3. Predicate Devices:
The Maxi-Flex Semi-Flex Scopes™ is substantially equivalent to the Maxi-Flex Semi-Flex Scopes [K062725] and ACMI DUR-8 [K023358].
4. Indications for Use Statement:
The MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times
1516 Thalia Street New Orleans, LA 70130 Phone: (504) 265-8972 Fax: (504) 265-8977 www.MaxiFlexLLC.com
1
Image /page/1/Picture/0 description: The image shows the logo for "MaxiFlex Advanced Surgical Devices for Urology". The logo has a series of black dots in an arc above the word "MaxiFlex". Below the word "MaxiFlex" is the phrase "Advanced Surgical Devices for Urology". To the right of the phrase is a starburst design.
-
- Description of Device:
The Maxi-Flex Semi Flex Scopes™ is flexible endoscope that allows operator-controlled deflection of the distal end or tip of the scope. The devices will be made available in lengths (25 cm and 65 cm), each length with a working channel. With a Maxi-Flex accessory a 'Y Port' the working channel may be utilized as an irrigation channel.
- Description of Device:
-
- Testing:
Maxi-Flex Semi-Flex Scopes™ (this submission), for reuse has been tested for four (4) EtO sterilization cycles without any degradation from original design specifications. All other core elements of K062725 remain unchanged.
- Testing:
-
- Rx or OTC:
The Maxi-Flex Semi-Flex Scopes™ is an Rx prescription device per 21 CFR Subpart D. The indication for use is for clinical setting only.
- Rx or OTC:
-
- Conclusions:
The Maxi-Flex Semi-Flex Scopes™ is substantially equivalent to the predicate devices in the scope of practical application, effectiveness for this application, and ensuring the safety of its patient. This submission ad re-use to K062725.
- Conclusions:
The Maxi-Flex Semi-Flex Scopes™ with four (4) reuse cycles does not raise any new safety or effectiveness issues.
MaxiFlex, LLC
Gary Ventrella
Date: 03/3/12
1516 Thalia Street New Orleans, LA 70130 Phone: (504) 265-8972 Fax: (504) 265-8977 www.MaxiFiexLLC.com
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the symbol. The text is in all capital letters and is relatively small compared to the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Technology Delivery Systems, Inc. % Mr. James Harvey Knauss Contract Consultant Delphi Consulting Group 1516 Thalia Street NEW ORLEANS LA 70130
APR -4 2012
Re: K111480
Trade/Device Name: MaxiFlex - Semi Flex Scopes Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: March 21, 2012 Received: March 26, 2012
Dear Mr. Knauss:
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 for use sunce in the encrease) to 10g.ing and ment 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 1 ou may, therefore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and actited , good manataotaning prace. 00, xx 10, xx 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = addition. Thease noter of 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 your device is elassified (otto as to stime 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 Flease of advised that I Dr 3 555 and of the your device complies with other requirements of the Act that I Dri has made a acterimations administered by other Federal agencies. You must 01 any 1 cocrar studios and regulations, but not limited to: registration and listing Comply will an the Act 3 requirements) rr. 801); medical device reporting (reporting of medical
3
Page 2 -
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K. Fisher
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
Indications for Use Statement
510(k) Number: K111480
Device Name: MaxiFlex - Semi Flex Scopes
Indications for Use:
The MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times
Prescription Use YES (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)
Hales
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, an
Urological Devices
510(k) Number. K111480
Section 4 510(k) Submission Page #
ind for use form.doc Delphi Consulting Group
Houston, TX 77071