(116 days)
This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.
The International Medsurg Connections Irrigation Sets.
This is a 510(k) premarket notification for a medical device (Irrigation Sets), not an AI/ML device. Therefore, the questions related to AI/ML performance, ground truth, expert adjudication, and training/test sets are not applicable.
The document describes the device's characteristics and its substantial equivalence to a predicate device based on intended use, configurations, and materials. It also outlines a summary of testing conducted to ensure the materials and components meet certain standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a list of evaluations performed on the "Joined Tubing 5" and 20"" and "Irrigation Sets*". These can be considered the acceptance criteria for material and component properties. The document states that "All materials used in the fabrication... were evaluated for" these characteristics, implying they met specified acceptance levels, although the specific performance values or pass/fail thresholds are not detailed in this summary.
| Acceptance Criteria (Evaluated For) | Device Performance (Implied) |
|---|---|
| For Joined Tubing 5" and 20" | |
| Oxidizable Matter | Evaluated (Implied to meet acceptable range) |
| Acidity and Alkalinity | Evaluated (Implied to meet acceptable range) |
| UV Absorbancy | Evaluated (Implied to meet acceptable range) |
| Metallic ions | Evaluated (Implied to meet acceptable range) |
| Evaporated Residual | Evaluated (Implied to meet acceptable range) |
| Diameter of the end conical fitting | Evaluated (Implied to meet specifications) |
| Length of conical fitting | Evaluated (Implied to meet specifications) |
| Taper of conical fitting | Evaluated (Implied to meet specifications) |
| Separate force of conical fitting | Evaluated (Implied to meet specifications) |
| Tightness of conical fitting | Evaluated (Implied to meet specifications) |
| Force of split the conical fitting | Evaluated (Implied to meet specifications) |
| Diameter of conical aperature | Evaluated (Implied to meet specifications) |
| Depth of conical aperature | Evaluated (Implied to meet specifications) |
| Taper of conical aperature | Evaluated (Implied to meet specifications) |
| Separate force of conical aperature | Evaluated (Implied to meet specifications) |
| Tightness of conical aperature | Evaluated (Implied to meet specifications) |
| Force of split the conical aperature | Evaluated (Implied to meet specifications) |
| Outer diameter of conical fitting on outstanding position | Evaluated (Implied to meet specifications) |
| Angle of conical fitting on outstanding position | Evaluated (Implied to meet specifications) |
| Length of tubing | Evaluated (Implied to meet specifications) |
| Connection Strength | Evaluated (Implied to meet specifications) |
| Integrity | Evaluated (Implied to meet specifications) |
| For Irrigation Sets* | |
| Oxidizable Matter | Evaluated (Implied to meet acceptable range) |
| Acidity and Alkalinity | Evaluated (Implied to meet acceptable range) |
| UV Absorbancy | Evaluated (Implied to meet acceptable range) |
| Metallic ions | Evaluated (Implied to meet acceptable range) |
| Evaporated Residual | Evaluated (Implied to meet acceptable range) |
| Integrity | Evaluated (Implied to meet specifications) |
| Connection between components | Evaluated (Implied to meet specifications) |
| Closure-piecing device | Evaluated (Implied to meet specifications) |
| Tubing | Evaluated (Implied to meet specifications) |
| Drip chamber and drip tubing | Evaluated (Implied to meet specifications) |
| Flow rate of infusion | Evaluated (Implied to meet specifications) |
| Flow regulator | Evaluated (Implied to meet specifications) |
| Self-sealing injection site | Evaluated (Implied to meet specifications) |
| Protective caps | Evaluated (Implied to meet specifications) |
| Symbol | Evaluated (Implied to meet specifications) |
| Packing | Evaluated (Implied to meet specifications) |
| Chemical property | Evaluated (Implied to meet acceptable properties) |
2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the context of AI/ML evaluation. The "testing" refers to material and component evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device, and no "ground truth" for diagnostic or predictive performance is being established.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 an irrigation set, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be engineering specifications and material standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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Ko23808
SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
INTERNATIONAL MEDSURG CONNECTIONS IRRIGATION SETS
| Manufacturer: | International Medsurg Connections, Inc.935 N. Plum Grove Road, Suite FSchaumburg, Illinois 60173-4770 | |
|---|---|---|
| Regulatory Affairs Contact: | Michele VovolkaP.O. Box 848Grayslake, Illinois 60030 | |
| Telephone: | (847) 856-0355 | |
| Date Summary Prepared: | November 5, 2002 | |
| Product Trade Name: | TUR, Arthroscopic, Cystoscopy Irrigation Sets | |
| Common Name: | Irrigation Sets | |
| Classification: | Class II | |
| Predicate Devices: |
Description: The International Medsurg Connections Irrigation Sets.
Intended Use:
This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.
Substantial Equivalence:
The International Medsurg Connections Irrigation Sets are substantially equivalent to the Baxter Healthcare Corporation Irrigation Sets in that they provide the following characteristics:
- Intended use is the same
- Similar configurations
- Similar materials
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Ko23808
Summary of Testing: All materials used in the fabrication of the International Medsurg Connections Irrigation Sets were evaluated for:
| Joined Tubing 5" and 20" | Irrigation Sets* |
|---|---|
| Oxidizable Matter | Oxidizable Matter |
| Acidity and Alkalinity | Acidity and Alkalinity |
| UV Absorbancy | UV Absorbancy |
| Metallic ions | Metallic ions |
| Evaporated Residual | Evaporated Residual |
| Diameter of the end conical fitting | Integrity |
| Length of conical fitting | Connection between components |
| Taper of conical fitting | Closure-piecing device |
| Separate force of conical fitting | Tubing |
| Tightness of conical fitting | Drip chamber and drip tubing |
| Force of split the conical fitting | Flow rate of infusion |
| Diameter of conical aperature | Flow regulator |
| Depth of conical aperature | Self-sealing injection site |
| Taper of conical aperature | Protective caps |
| Separate force of conical aperature | Symbol |
| Tightness of conical aperature | Packing |
| Force of split the conical aperature | Chemical property |
| Outer diameter of conical fitting on | |
| outstanding position | |
| Angle of conical fitting on outstanding | |
| postion | |
| Length of tubing | |
| Connection Strength | |
| Integrity |
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2003
International Medsurg Connection % Ms. Michele H. Vovolka Regulatory Consultant Vantage Consulting International, Ltd. P.O. Box 848 GRAYSLAKE IL 60030
Re: K023808
Trade/Device Name: Irrigation Sets Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJH Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: 87 HRX Dated: February 18, 2003 Received: February 19, 2003
Dear Ms. Vovolka:
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.
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); 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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
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
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
International Medsurg Connections Irrigation Sets Device Name:
Indications For Use:
This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR Over -The-Counter Use Prescription Use (Per 21 CFR 801.109) antil (Division Sign-Qff) (Division Sigh-Off) Division of Dental, Intection Control, Division of Reproductive, Abdominal, and Radiological Devices And General Hospital Devices 510(k) Number 510(k) Númber
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.