(88 days)
Medline Y-Type TUR/Bladder Irrigation Set is Intended for the infusion of sterile solutions into the bladder to cleanse (evacuate) the contents of the bladder. It is also indicated for use in the bludder to election (prostrate or bladder surgery) as a means of continuous irrigation of the bladder. It is intended to be used with sterile solutions only. Not intended for reuse.
This device is comprised of vinyl tubing with a catheter adapter at one end and "spikes" with protectors at the "Y" shaped end. There are pinch clamps on each of the "Y" shaped ends below the spikes. On the single tubing there is a drip chamber. Directly below the drip chamber is a roller clamp. There is a latex rubber connecting tube, approximately 5-6 inches in length attached to the catheter adapter. This latex rubber tubing is removable.
This document describes a 510(k) premarket notification for a medical device submitted in 1997. It is not a study report that details acceptance criteria and performance data in the way a modern clinical trial or performance evaluation would. Instead, it focuses on demonstrating substantial equivalence to previously marketed predicate devices.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of regulatory submission and regulatory outcome. The provided document does not contain an actual study demonstrating performance against specific acceptance criteria for the Medline Y-Type TUR/Bladder Irrigation Set.
Here's an analysis based on the provided text, indicating where information is present and where it is not:
1. Table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance data (e.g., accuracy, sensitivity, specificity, flow rate, pressure tolerance, etc.) are provided in this regulatory submission. The submission's goal is to establish substantial equivalence based on device description and intended use, not to present performance data from a specific study against predefined criteria.
2. Sample size used for the test set and the data provenance
Not applicable. No "test set" in the context of performance metrics (like accuracy or efficacy) is mentioned or implied. The submission relies on a comparison to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment in the context of performance evaluation is mentioned.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a urological irrigation set, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a urological irrigation set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Acceptance Approach in this 510(k) Submission:
Instead of demonstrating performance against specific acceptance criteria through a study, this 510(k) submission relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" from a regulatory perspective for this submission is that the device is as safe and effective as the predicate devices.
The study that "proves" the device meets this "acceptance criterion" of substantial equivalence is the comparison presented in the document itself.
- Predicate Devices: Vital Concepts, K934382 and Baxter Healthcare's Y-Type TUR/Bladder Irrigation Set (pre-amendment exempt).
- Basis of Substantial Equivalence:
- Similar Materials: "made of smooth vinyl tubing" (implied for both previous and new device).
- Similar Components: "have pinch and roller clamps, spikes with protectors and a catheter adapter."
- Similar Intended Use: Both are "urological irrigation systems" for infusing sterile solutions into the bladder for cleansing or continuous irrigation during transurethral resection.
- Minor Differences: The only noted "significant difference is the length of the latex tubing and the length of the vinyl tubing," which presumably does not alter the fundamental safety or effectiveness of the device.
The FDA's letter (K970946, June 10, 1997) explicitly states: "we have determined the device is substantially equivalent... 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)."
The "study" here is the descriptive comparison provided in the "SUBSTANTIAL EQUIVALENCE" section. There are no performance metrics, sample sizes, expert panels, or statistical analyses akin to what would be found in a modern clinical study report.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS - K970946
May 6, 1997
SUBMITTER INFORMATION: Medline Industries, Inc. One Medline Place Mundelein, IL 60060 1-847-949-3109 Establishment Registration Number: 1417592 Christine Galea, Corporate Regulatory Affairs Associate Contact Person:
REGULATORY INFORMATION
| Device Name: | Y-Type TUR/Bladder Irrigation Set |
|---|---|
| Proprietary: | Medline Y-Type TUR/Bladder Irrigation Set |
| Common: | Urological Irrigation System and/or Tubing Set |
| Panel: | 78 Gastroenterology & Urology |
| Class: | II |
| Procode/Classification: | LJH 78 (Unclassified) |
| Special Controls: | None established |
DEVICE DESCRIPTION:
This device is comprised of vinyl tubing with a catheter adapter at one end and "spikes" with protectors at the "Y" shaped end. There are pinch clamps on each of the "Y" shaped ends below the spikes. On the single tubing there is a drip chamber. Directly below the drip chamber is a roller clamp. There is a latex rubber connecting tube, approximately 5-6 inches in length attached to the catheter adapter. This latex rubber tubing is removable.
INTENDED USE:
A urological irrigation system is intended for the infusion of sterile solutions into the bladder to cleanse or evacuate the contents of the bladder. Medline Y-Type TUR/Bladder Irrigation Set is indicated for use in transurethral resection (prostrate or bladder surgery) as a means of continuous irrigation of the bladder. This product contains natural rubber latex which may cause allergic reactions in some individuals. For use with sterile saline or sterile water only. Do not use with plasma products. Not intended for reuse.
SUBSTANTIAL EQUIVALENCE
Medline Industries, Inc. claims substantial equivalence to Vital Concepts, K934382 and Baxter Healthcare's Y-Type TUR/Bladder Irrigation Set, which is pre-amendment exempt.
Medline Y-Type TUR/Bladder Irrigation set is similar to other Y-Type TUR/Bladder Irrigation sets currently being marketing. They are made of smooth vinyl tubing, have pinch and roller clamps, spikes with protectors and a catheter adapter. The significant difference is the length of the latex tubing and the length of the vinyl tubing.
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Image /page/1/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 10 1997
Ms. Christine Galea Corporate Regulator - Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486 Re: K970946
Medline Y - Type TUR/Bladder Irrigation Set --------Dated: May 29, 1997 Received: May 30, 1997 Regulatory class: unclassified Product code: 78 LJH
公 Dear Ms. Galea:
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 531 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,
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproductive, Abdominal, Ear, Nose and Throath and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1
510(k) Number (if known): K970946
Device Name: Medline Y-Type TUR/Bladder Irrigation Set
Indications For Use:---------
Medline Y-Type TUR/Bladder Irrigation Set is Intended for the infusion of sterile solutions into the bladder to cleanse (evacuate) the contents of the bladder. It is also indicated for use in the bludder to election (prostrate or bladder surgery) as a means of continuous irrigation of the bladder.
It is intended to be used with sterile solutions only. Not intended for reuse.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
Robert D. Sather/
(Division Sign-Off)
(Optional Format 1-2-96)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K970946
Page 3.0
§ 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.