(349 days)
Not Found
No
The summary describes a standard drainage catheter and does not mention any AI or ML components or functionalities.
No.
The device is used for drainage of fluid from the urinary tract and does not claim to treat or cure any condition.
No
The device is described as a "drainage catheter" used for "continuous drainage of fluid" and "intermittent catheterization," which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a physical catheter made of silicone elastomer, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Device Function: The LotusCatheter is a drainage catheter used to physically remove fluid from the body (bladder, nephrostomy tract). It is an invasive device inserted into the body.
- Lack of Specimen Examination: The description does not mention the device being used to examine any specimens in vitro (outside the body) to provide diagnostic information. Its purpose is purely for drainage.
Therefore, the LotusCatheter falls under the category of a general medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.
Product codes
GBM, FEW
Device Description
The Lotus No Balloon Catheter is a sterile, single patient use drainage catheter made of silicone elastomer. The catheter is used to pass fluids to and from the urinary tract, suprapubically or through the nephrostomy tract. The catheter is supplied in French sizes ranging from 8Fr to 26Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, urethra, bladder, nephrostomy tract
Indicated Patient Age Range
5 years of age or older.
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
The Lotus No Balloon Catheter lacks the balloon retention mechanism present in Foley catheters, therefore some testing was not applicable or was modified to meet the standard set forth in ASTM F623-99:2013; testing of the Lotus No Balloon Catheter was conducted in accordance with modified performance requirements of its predicate device, the Hakki Urinary Catheter (K101900):
- Components Testing
- Flow Rate ●
- Dimensions ●
- Expanded Wings Integrity
- Expanded Wings Response to Pullout ●
- Strength of the Catheter ●
The Lotus No Balloon Catheter passed biocompatibility testing per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2010, ISO 10993-11:2017, ISO 10993-6:2016. Testing data and results are included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 21, 2020
Hakki Medical Technologies, Inc. Shereen Hakky Director of Operations 10333 Seminole Boulevard, Suite #8 Largo, FL 33778
K191512 Re:
Trade/Device Name: LotusCatheter (Lotus No Balloon Catheter) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM, FEW Dated: June 4, 2019 Received: June 7, 2019
Dear Shereen Hakky:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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
1
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva U. Pandya -S
Purva Pandya Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
LotusCatheter (Lotus No Balloon Catheter)
Indications for Use (Describe)
The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.
Type of Use (Select one or both, as applicable)
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ❏ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: June 4, 2019 Date: Hakki Medical Technologies, Inc. Submitter: Address: 10333 Seminole Boulevard, Suite #8, Largo, Florida 33778 Shereen Hakky Contact Person: Director of Operations Hakki Medical Technologies, Inc. Telephone: +1-727-415-7448 Email: Shereen@LotusCatheter.com LotusCatheter (Lotus No Balloon Catheter) Device Name: 876.5130 Regulation Number: Urological Catheter and Accessories Regulation Name: GBM, FEW Product Code: Class II Device Class: Gastroenterology/Urology Review Panel: The Lotus No Balloon Catheter is a sterile, single patient use Device Description: drainage catheter made of silicone elastomer. The catheter is used to pass fluids to and from the urinary tract, suprapubically or through the nephrostomy tract. The catheter is supplied in French sizes ranging from 8Fr to 26Fr. The Lotus No Balloon Catheter is used for continuous Intended Use: drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The Lotus No Balloon Catheter is to be used in patients 5 years of age or older. K101900- Latex Hakki Urinary Catheter Predicate Device(s): K070879- Latex Bard Malecot and Pezzer Drains The Lotus No Balloon Catheter described in this 510(k) is the Substantial Equivalence: silicone version of its predicate device, the latex Hakki Urinary Catheter (K101900). The Lotus No Balloon Catheter has
4
similar technological and performance characteristics as the Latex Bard Malecot and Pezzer Drains Device (K070879). The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 12 of this submission. Our testing shows these differences have no substantial affect on safety or effectiveness.
The Lotus No Balloon Catheter lacks the balloon retention mechanism present in Foley catheters, therefore some testing was not applicable or was modified to meet the standard set forth in ASTM F623-99:2013; testing of the Lotus No Balloon Catheter was conducted in accordance with modified performance requirements of its predicate device, the Hakki Urinary Catheter (K101900):
- Components Testing
- Flow Rate ●
- Dimensions ●
- Expanded Wings Integrity
- Expanded Wings Response to Pullout ●
- Strength of the Catheter ●
The Lotus No Balloon Catheter passed biocompatibility testing per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2010, ISO 10993-11:2017, ISO 10993-6:2016. Testing data and results are included in this submission.