(215 days)
Not Found
No
The description focuses on the mechanical design and function of the catheter for fluid drainage, with no mention of AI or ML capabilities.
Yes
The device, a urinary catheter, is used for continuous drainage of fluid to and from the urethra and bladder, which is a therapeutic function aimed at managing a physiological condition.
No
The device is a urinary catheter designed for continuous fluid drainage, which is a therapeutic function, not diagnostic.
No
The device description clearly describes a physical catheter with mechanical components (expandable/retractable wings, bellows) and mentions non-clinical performance testing related to physical properties (flow rate, leaflet integrity, pullout). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Hakki Urinary Catheter Function: The Hakki Urinary Catheter is a medical device used for the physical drainage of fluid from the bladder. It is inserted into the body and its function is mechanical, not analytical or diagnostic based on analyzing a sample.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. Its function is purely related to fluid management within the body.
Therefore, based on the provided description, the Hakki Urinary Catheter is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. It must be connected to a standard urinary collector.
Product codes (comma separated list FDA assigned to the subject device)
EZL, GBM
Device Description
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra and is an improved version of the straight urinary catheter. The Hakki catheter has built-in expandable/retractable Malecot type wings permitting holding capabilities less than that of a Foley catheter, but allows greater holding power than a straight catheter. By design the Hakki catheter has the ability to maximize drainage of a bladder, due to the location of its drainage opening at the natural drainage point within the bladder. The Hakki catheter is activated by expanding and contracting the catheter through the built-in patented bellows, which open and close the wing tip. The newly designed Hakki urinary catheter functions in the same manner as a straight or Foley catheter and is inserted through the urethra into the bladder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
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)
Non-clinical device performance testing such as flow rate, expanded leaflet integrity, & response to pullout were evaluated. Testing was performed in accordance to Food and Drug Administration guidance's and recognized international standard ASTM F 623-99 (Reapproved 2006). Results of these tests showed substantial equivalence with international standard ASTM F 623-99 (Reapproved 2006).
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.
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
§ 876.5130 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
Hakki Medical Technologies, Inc.
3851 6200 Avenue North, Suite A. Pinellas Park, Flori
FEB - 7 - 2011
HiO1900
510(k) Summary
Submitted By:
Hakki Medical Technologies, Inc. 3851 62nd Avenue North Pinellas Park, Florida 33781
Contact Persons:
Joseph Del Vecchio (VP) Cell (727) 403-2299 Fax (727) 393-2145
Andrew Endahl (Plant Manager) Cell (407) 493-6806 Fax (727) 393-2145
Date of Preparation:
14 September, 2010
Device:
Proprietary name - Hakki Urinary Catheter Common name - Urinary catheter or Foley catheter Classification name - Urological catheter (21 CFR 876.5130) Product Class - Class II Product Code - EZL
Predicate Devices:
The Hakki Urinary Catheter is substantially equivalent with respect to the following predicate devices: the Bard Malecot and Pezzer drains device (510(k) No. K070879) in terms of design, and the Bardex® I.C. Latex Foley Catheter (510(k) No. K040658) in intended use.
Intended use:
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. It must be connected to a standard urinary collector.
1
K101900
2
Device Description:
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra and is an improved version of the straight urinary catheter. The Hakki catheter has built-in expandable/retractable Malecot type wings permitting holding capabilities less than that of a Foley catheter, but allows greater holding power than a straight catheter. By design the Hakki catheter has the ability to maximize drainage of a bladder, due to the location of its drainage opening at the natural drainage point within the bladder. The Hakki catheter is activated by expanding and contracting the catheter through the built-in patented bellows, which open and close the wing tip. The newly designed Hakki urinary catheter functions in the same manner as a straight or Foley catheter and is inserted through the urethra into the bladder.
Substantial Equivalence: .
The Hakki Urinary Catheter is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Non-clinical device performance testing such as flow rate, expanded leaflet integrity, & response to pullout were evaluated. Testing was performed in accordance to Food and Drug Administration guidance's and recognized international standard ASTM F 623-99 (Reapproved 2006). Results of these tests showed substantial equivalence with international standard ASTM F 623-99 (Reapproved 2006).
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Andrew Endahl Plant Manager Hakki Medical Technologies, Inc. 3851 62nd Avenue, North. Suite A PINELLAS PARK FL 33781
FEB - 7 201
Re: K101900
Trade/Device Name: Hakki Urinary Catheter Regulation Number: 21 CFR 8876,5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: January 5, 2011 Received: January 6, 2011
Dear Mr. Endahl:
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 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
3
Page 2
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/Centers0ffices/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 triom the (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default:htm.
Sincerely yours,
Sticker Lemur ind
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (k) Number (if known)
Device Name: Hakki Urinary Catheter
Indications for Use:
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. It must be connected to a standard urinary collector.
Prescription Use: X
and/or
Over-the Counter Use:_
(Part 21 CFR 801)
(21 CFR 807)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
roductive, Gastro-R (k) Numbe