(144 days)
Not Found
Not Found
No
The device description and intended use clearly define a sterile gel for lubrication, with no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device is described as a sterile gel to aid the introduction of catheters and endoscopic instruments, functioning primarily as a lubricant. It does not exert a therapeutic effect itself, but rather facilitates a medical procedure.
No
The device is a sterile gel used for lubrication during medical procedures, specifically to aid in the introduction of catheters and endoscopic instruments. Its description and intended use do not mention any diagnostic function such as detecting, monitoring, or predicting diseases or conditions.
No
The device description clearly states it is a sterile gel contained in a syringe, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the introduction of medical instruments during procedures. This is a physical function, not a diagnostic one.
- Device Description: The description details the composition and physical properties of a lubricant gel. It does not mention any components or functions related to analyzing samples from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
- Performance Studies: The performance studies focus on safety (non-toxic, non-irritating, non-sensitizing), which is relevant for a medical device used in procedures, but not for an IVD.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.
Product codes (comma separated list FDA assigned to the subject device)
FHX
Device Description
Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Results of in vivo and in vitro testing establishes the safety profile of the device as non-toxic, non-irritating and non-sensitizing, which is comparable to the predicate device.
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.
Not Found
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
Ko8199D
DEC 0 5 2008
510(k) Summary
Submitted by Farco-Pharma GmbH Pharmazeutische Präparate Gereonsmühlengasse 1 - 11 Address: 50670 Köln. Germany
Telephone: +49 221 594061
Contact Name: Kornelia Elv-Koort, Regulatory Affairs Dept.
October 1, 2008 Date Submitted:
Lubricano® Sterile Gel - Transurethral Trade Name: Lubricating jelly for transurethral surgical instrument Common Name: Product Code / Regulation: FHX (21 C.F.R. 876.1500)
Description: Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
Intended Use:Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.
Substantial Equivalence:
Lubricano Sterile Gel is similar in intended use and technological characteristics to the predicate lubricating jelly for transurethral surgical instruments. The device is similar with respect to indications for use and physical characteristics to the predicate device in terms of 510(k) substantial equivalency.
Results of in vivo and in vitro testing establishes the safety profile of the device as non-toxic, non-irritating and non-sensitizing, which is comparable to the predicate device.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FARCO-Pharma GmbH % Mr. Seth A. Mailhot Attorney Latham & Watkins LLP 555 Eleventh Street, NW WASHINGTON DC 20004-1304
DEC 0 5 2008
Re: K081990
Trade/Device Name: Lubricano® Sterile Gel Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FHX Dated: November 19, 2008. Received: November 20, 2008
Dear Mr. Mailhot:
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.
2
Page 2
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); 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.
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Arput Mr. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosur
3
Ko81990
Indications for Use
510(k) Number (if known):
Device Name: Lubricano® Sterile Gel - Transurethral
Indications for Use:
Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization particularly for incontinence treatment.
Prescription Use X (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)
4-2
Heidi Lewis
(Division Sign-OH)
1 Division of Reproductive, Abdominal & 1
Radiological Devices
510(k) Number
Page 1 of 1