(168 days)
the Rüsch Catheter
Not Found
No
The device description details a simple mechanical catheter and associated kit components, with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes.
The device facilitates the passage of fluids to or from the urinary tract, which is a therapeutic function for individuals needing assistence with urination or bladder management.
No
The device description indicates it is a "flexible tubular device to pass fluids to or from the urinary tract" and is intended for "catheterization," which is a therapeutic rather than a diagnostic procedure.
No
The device description clearly details physical components such as a catheter, drainage bag, cloths, gauze, tweezers, and other items, indicating it is a kit containing hardware, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pass fluids to or from the urinary tract" and "allow for the catheterization of the individual." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description details a physical device (catheter, drainage bag, accessories) used for collecting urine or introducing fluids into the urinary tract. This is consistent with a medical device used for a procedure, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (like blood, urine, tissue) in vitro.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or treatment based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a tool for a medical procedure involving the urinary tract.
N/A
Intended Use / Indications for Use
The Self Cath is a flexible tubular device to pass fluids to or from the urinary tract. The set is intended to allow for the catheterization of the individual.
Product codes
FCM, KOD
Device Description
The catheter consists of a funnel, a clear tube and a soft, Tiemann tip. The tube has two (2) drainage eyes at the distal end that are opposite and offset. The funnel, at the proximal end, is sized to connect to the drainage baq provided in the kit. For the 'HomeSet', the catheter is packed in an inner plastic bag and a Paper-Film outer pouch. For the 'Travelset', the catheter is packed in the inner plastic bag and is in the sterile paper-film kit tray with the other contents.
The kit comes in two configurations. One is a 'HomeSet' and the other is a 'Travelset'. Each set comes in men's and woman's configurations which differs by the length of the catheter.
The 'HomeSet' consists of:
- (1) 1.5 l drainage catch bag with closure cap
- (3) Dab cloths
- (3) compression gauze
- (1) Tweezers
- (1) Table cloth (to set kit contents on)
- (1) disposal Bag
- (1) cleaning wipe
The 'Travelset' consists of:
- (1) Safety Cath
- (1) 1.5 l drainage catch bag with closure cap
- (2) Dab cloths
- (3) compression gauze
- (1) Table cloth (to set kit contents on)
- (1) Chair Cloth (for under the genital area)
- (1) disposal Baq
- (2) Rubber qloves
- (1) cleaning wipe
Attached to the back of the kit is a bottle of water soluble antiseptic (approx 15 ml).
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
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)
the Rüsch Catheter
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 shows handwritten text that appears to be a code or identifier. The text includes the characters 'K18 3010' followed by '1 of 2'. The handwriting is somewhat stylized, with variations in stroke thickness and letter formation, giving it a casual yet distinct appearance.
Image /page/0/Picture/1 description: The image shows the logo for RUSCH, with the word "RUSCH" in large, bold, black letters. Below the logo, the words "INTERNATIONAL Group Regulatory Affairs" are printed in a smaller font. Underneath that, the text "A Subsidiary of Teleflex Incorporated (USA)" is printed in an even smaller font.
(603) 532-8211 or 6108
510 (k) Summary
Submitter Name, Address, and Date of Submission. 1.
Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
Telephone: (603) 532-7706 Facsimile: (603) 532-8211 E-Mail: jrwhitney@compuserve.com
Contact: Same as above
2. Name of the Device, Common, Proprietary (if Known), and Classification.
Classification Name: Urological Catheter and Accessories
Common Name: Urinary Catheter
Proprietary Name: Self Cath Set
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Self Cath Set is substantially equivalent to the Rüsch Catheter for intermittent catheterization.
4 . Description of the Device.
The catheter consists of a funnel, a clear tube and a soft, Tiemann tip. The tube has two (2) drainage eyes at the distal end that are opposite and offset. The funnel, at the proximal end, is sized to connect to the drainage baq provided in the kit. For the 'HomeSet', the catheter is packed in an inner plastic bag and a Paper-Film outer pouch.
1
For the 'Travelset', the catheter is packed in the inner plastic bag and is in the sterile paper-film kit tray with the other contents.
1983010 20f2
The kit comes in two configurations. One is a 'HomeSet' and the other is a 'Travelset'. Each set comes in men's and woman's configurations which differs by the length of the catheter.
The 'HomeSet' consists of:
- (1) 1.5 l drainage catch bag with closure cap
- (3) Dab cloths
- (3) compression gauze
- (1) Tweezers
- (1) Table cloth (to set kit contents on)
- (1) disposal Bag
- (1) cleaning wipe
The 'Travelset' consists of:
- (1) Safety Cath
- (1) 1.5 l drainage catch bag with closure cap
- (2) Dab cloths
- (3) compression gauze
- (1) Table cloth (to set kit contents on)
- (1) Chair Cloth (for under the genital area)
- (1) disposal Baq
- (2) Rubber qloves
- (1) cleaning wipe
Attached to the back of the kit is a bottle of water soluble antiseptic (approx 15 ml).
5. Intended Use of the Device.
The Self Cath is a flexible tubular device to pass fluids to or from the urinary tract. The set is intended to allow for the catheterization of the individual.
Summary of Technological Characteristics. 6 .
The Self Cath is equivalent in design, use and materials to the predicate products.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Miss Karenann Brozowski Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452
Re: K983010
Self Cath Set/Safety Cath (Urology Drainage Catheter) Regulatory Class: II 21 CFR 876.5130/Procode: 78 FCM, 78 KOD Dated: January 12, 1999 Received: January 13, 1999
Dear Ms. Brozowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were 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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
In addition, we have determined that your device kit contains Povidone Iodine or Benzalkomium Chloride (BZK) which are subject to regulation as drugs.
3
Page 2 - Miss Karenann Brozowski
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director. Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your 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 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Stind. A. Ayerm
CAPT. Daniel G. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Self Cath is a flexible tubular device to pass fluids to or from the urinary tract. The set is intended to allow for the catheterization of the individual.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Ort)
ivision of Reproductive. Abdominal, EN and Radiological D 510(k) Number
ption Use ~✓
Prescription Use_ ~ (Per 21 CFR 801.109) OR
Over-The-Counter Use_