(129 days)
Not Found
No
The summary describes a physical medical device (catheter kit) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device's intended use is to drain urine, which is a diagnostic or convenience function rather than a treatment for a disease or condition.
No
The device is described as a catheterization kit intended to drain urine, not to diagnose a condition. It facilitates a bodily function (urination) rather than providing information about a disease or condition.
No
The device description clearly states it is a "single-use, disposable, pre-lubricated catheter contained in a sterile collection bag," which are physical hardware components.
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 used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The Apogee Closed System Intermittent Catheterization Kit is used to drain urine from the bladder. It is a device that interacts directly with the body to perform a physical function (draining). It does not analyze or test the urine itself.
- Intended Use: The intended use is to "drain urine from the patient's bladder into a collection bag." This is a therapeutic or management function, not a diagnostic one.
Therefore, the device falls under the category of a medical device used for patient care, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Apogee Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.
Product codes
KOD
Device Description
The Apogee Closed System Intermittent Catheterization Kit is a single-use, disposable, pre-lubricated catheter contained in a sterile collection bag. The Closed System Intermittent Catheter is intended to be user to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag of the Closed System Intermittent Catheterization Kit. The Closed System Intermittent Catheterization Kit is designed with a collection bag and introducer which provide the mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter, thereby, reducing possibility of contamination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
JAN - 9 2004
510(k) SUMMARY
K632710 Assigned 510(k) # is _________________________________________________________________________________________________________________________________________________________
Sponsor's Name and Address and Contact Person:
Apogee Medical, Inc. 90 Weathers Street Youngsville, NC 27596
Contact Person: Diane N. Peper, RA/QA Telephone: (919) 570-9605 Facsimile: (919) 570-9611 email address: dpeper@apogeemed.com
Date Summary Prepared: August 22, 2003
Device Name and Classification:
Common Name: Urological Catheter Classification Name: Gastrology and Urology Product Code: KOD
Manufacturer:
Apogee Medical, Inc. 90 Weathers Street Youngsville, NC 27596
Name of Predicate Device(s):
K003873 Mentor Self-Cath Closed System Hollister InCare Pre-Lubricated Intermittent Catheters K013483
Device Description:
The Apogee Closed System Intermittent Catheterization Kit is a single-use, disposable, pre-lubricated catheter contained in a sterile collection bag. The Closed System Intermittent Catheter is intended to be user to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag of the Closed System Intermittent Catheterization Kit. The Closed System Intermittent Catheterization Kit is designed with a collection bag and introducer which provide the mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter, thereby, reducing possibility of contamination.
Statement of Intended Use
The Apogee Closed System Intermittent Catheterization Kit is intended to brain urine from the patient's bladder into a collection bag.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or lines, possibly representing people or services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2004
Ms. Diane N. Peper Regulatory Affairs/Quality Assurance Manager Apogee Medical, Inc. 90 Weathers Street YOUNGSVILLE NC 27596
Re: K032710
Trade/Device Name: Closed System Intermittent Catheterization Kit Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Il Product Code: 78 KOD Dated: October 20, 2003 Received: November 7, 2003
Dear Ms. Peper:
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 dos based or 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 r ou may , and is 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 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 I'DA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that + Drederal statutes and regulations administered by other Federal agencies. You must or any I educal 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notheation. The PDA inding vices in the 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 If you desire specific article to your do to be of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promote the regulation entitled, "Misbranding Other of Compliance at (501) 57 + 185 (21CFR Part 807.97) you may obtain. Other general by relection on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Section: http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Page 1 of 1
510(k) Number (if known): Ko327 | O
Device Name: Closed System Intermittent Catheterization Kit
Indications For Use:
The Apogee Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.
(PLEASE DO NOT WRITE BELOW THIS INE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dianne Brogdon
(Optional Format 3-10-98)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)