(210 days)
The ContiDrain™ Catheter is indicated for continuous urine drainage.
The ContiDrain™ Catheter is an indwelling urinary catheter with the same indication for use and function as a conventional Foley catheter. Like a Foley catheter, the ContiDrain™ Catheter is indicated for continuous urine drainage. Both devices use a tubular catheter to pass urine from the bladder through the urethra and meatus into a urinary drainage bag. Both devices also have a mechanism for retention in the bladder. The ContiDrain™ Catheter has two design features that are different from the conventional Foley catheter. The ContiDrain™ Catheter incorporates two design features found in conventional ureteral stents. These features involve the methods of urine flow and of retention in the bladder.
This submission for the ContiDrain™ Catheter outlines a device intended for continuous urine drainage, comparable to a conventional Foley catheter but with modifications for urine flow and bladder retention. The provided information details a feasibility study rather than a comprehensive comparative effectiveness study or a standalone algorithm performance study.
Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
The provided document describes a "Feasibility Study" rather than explicitly defined acceptance criteria with numerical targets. However, the study aimed to evaluate specific aspects of the device's performance. Based on the "Clinical Evaluation" section, we can infer the following:
| Acceptance Criteria (Inferred from Study Goals) | Reported Device Performance (from Clinical Evaluation) |
|---|---|
| Healthcare Professional Insertion | "healthcare professional can insert" - Satisfactory |
| Healthcare Professional Removal | "healthcare professional can remove" - Satisfactory |
| Catheter Retention in Bladder | "catheter will remain in place" - Adequate |
| Patient Acceptance | "generally favorable acceptance from the patients" |
| Urine Drainage | "found to be good" (in one patient) |
Note: The "acceptance criteria" are inferred from the study's stated goals and reported outcomes. Specific numerical benchmarks for "satisfactory," "adequate," or "good" are not provided in this document.
Detailed Study Information:
2. Sample size used for the test set and the data provenance:
- Sample Size: 9 adult male patients.
- Data Provenance: Clinical study conducted across three Institutional Review Board (IRB)-approved centers. The country of origin is not explicitly stated, but given the FDA clearance and submission to a U.S. regulatory body, it is likely the U.S. This was a prospective feasibility study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three investigators (who were presumably healthcare professionals involved in the study sites).
- Qualifications: Not explicitly stated, but given their role as "investigators" in a clinical study involving catheter insertion and removal, it's reasonable to assume they were clinicians (e.g., urologists, nurses, or other medical professionals) experienced in urological procedures. Specific years of experience or board certifications are not provided.
4. Adjudication method for the test set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical evaluation. The "investigators" at each of the three centers likely assessed the outcomes individually or as part of their standard clinical practice, and their reports were aggregated. There is no mention of an independent review panel or a system for resolving discrepancies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The study described is a feasibility study focused on the device's basic function (insertion, removal, retention, initial drainage, and patient acceptance) in a small cohort of patients. It did not compare the ContiDrain™ Catheter's performance against a predicate device or a control group involving multiple readers assessing cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The ContiDrain™ Catheter is a physical medical device (a catheter), not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not relevant.
7. The type of ground truth used:
- The "ground truth" for the feasibility study was primarily clinical observation and professional judgment by the healthcare professionals (investigators) involved in the study.
- Retention: Assessed by investigators.
- Insertion/Removal: Reported by healthcare professionals as "satisfactory."
- Patient Acceptance: Reported based on patient feedback to the professionals.
- Urine Drainage: Directly observed in one patient as "good."
- This is closest to "expert consensus" or "clinical assessment" by the treating/evaluating professionals. It is not based on pathology, imaging, or long-term outcomes data described in this summary.
8. The sample size for the training set:
- Not applicable. This device is not an AI/algorithm that requires a training set. The "bench testing" mentioned involved physical methods and fixtures derived from ASTM standards, which are not related to data-driven training.
9. How the ground truth for the training set was established:
- Not applicable. As stated in point 8, there is no training set for this type of medical device.
{0}------------------------------------------------
K964757 Questions and Responses
June 19, 1997
K964757 1-11
510(k) Summary
SUBMITTER:
ContiMed. Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344 612-829-4057
JUN 2 5 1997
DATE SUMMARY PREPARED: 06-19-97
| TRADE NAME: | ContiDrain™ Catheter & Accessories |
|---|---|
| COMMON NAME: | Urological catheter |
SUBSTANTIALLY EQUIVALENT TO: The ContiDrain™ Catheter is substantially equivalent to the Folev catheter indications for use. The ContiDrain™ Catheter is substantially equivalent to the technological characteristics for retention to the Bard Figure Four Ureteral Stent and pigtail ureteral stents (K861478). The ContiDrain™ Catheter employs the same type of open-sided flow channels as are found in the Tower peripheral stent. The ContiDrain™ Catheter is substantially equivalent to the materials of the Bard Polyurethane (Flexible tip) Ureteral Catheters (K950300).
DESCRIPTION OF THE DEVICE: The ContiDrain™ Catheter is an indwelling urinary catheter with the same indication for use and function as a conventional Foley catheter. Like a Foley catheter, the ContiDrain™ Catheter is indicated for continuous urine drainage. Both devices use a tubular catheter to pass urine from the bladder through the urethra and meatus into a urinary drainage bag. Both devices also have a mechanism for retention in the bladder. The ContiDrain™ Catheter has two design features that are different from the conventional Foley catheter. The ContiDrain™ Catheter incorporates two design features found in conventional ureteral stents. These features involve the methods of urine flow and of retention in the bladder.
INDICATIONS FOR USE: The ContiDrain™ Catheter is indicated for continuous urine drainage.
SUPPORTING INFORMATION:
BENCH TESTING: Flow and retention bench testing that has been conducted according to (modified) methods and fixtures described in the Foley and stent (draft) ASTM methods.
CLINICAL EVALUATION: The ContiDrain™ Catheter Feasibility Study protocol has been cleared as a non-significant risk clinical study by the FDA and by three IRB-centers with three investigators. The feasibility study, lasting less than 15 minutes per patient, evaluated how well the healthcare professional can insert and remove the 16 Fr catheter and if the catheter will remain in place during the evaluation period. Nine adult male patients in three centers presenting with either an indwelling Foley catheter or at the urodynamic lab for routine evaluation were enrolled. Data from these centers indicate that retention is adequate when the catheter is properly secured. Furthermore, the healthcare professionals have reported satisfactory insertion and removal, with generally favorable acceptance from the patients. Urine drainage was evaluated in one patient and found to be good.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1997
Claude Tihon, Ph.D. President ContiMed, Inc. 7680 Golden Triangle Drive Eden Prairie, Minnesota 55344 Re: K964757
ContiDrain™ Catheter . . . . . Dated: April 18, 1997 Received: April 21, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 EZL
Dear Dr. Tihon:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements conceming 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 53 I through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/dsmamain.html".
Sincerely yours,
William Yin, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproducti Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known) 1464757
Device Name: ContiDrain™ Catheter by ContiMed, Inc
Indications for Use:
The ContiDrain™ Catheter is indicated for continuous urine drainage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
OR
Over - The-Counter Use
(Oprtional Format 1-2-96)
Robert R. Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K9641257
8
§ 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.