(90 days)
This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.
The provided 510(k) summary for the Koala Intrauterine Pressure Catheter focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria through a specific performance study against defined metrics. Therefore, the information requested for a detailed acceptance criteria study is largely not present in the provided text.
However, based on what is available, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensor Accuracy | Verified in laboratory testing. (Specific numerical criteria or margin of error are not provided.) |
| Mechanical Integrity | Verified in laboratory testing. (Specific criteria are not provided.) |
| Overall Performance | Verified in laboratory testing. (Specific criteria are not provided.) |
| Biocompatibility | Materials used are safe for this application, as shown by biocompatibility testing. (Specific tests or metrics are not provided.) |
| Intended Use Equivalence | Same as predicate devices: intrauterine pressure measurement and monitoring, and amniotic fluid access. (Not a performance metric, but a claim of functional equivalence.) |
| Technological Equivalence | Same basic technological characteristics as predicate devices (e.g., pressure sensor at catheter tip, soft tip, markings, low-cost disposable, port for access, external zeroing). (Not a performance metric, but a claim of design equivalence.) |
Disclaimer: The document states that effectiveness is "the same as the predicate devices." This implies that the performance of the Koala IPC is expected to meet the established performance levels of the legally marketed predicate devices, but these specific levels are not quantified in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "clinical testing" but does not provide details on the number of patients or samples.
- Data Provenance: Not specified, but "clinical testing" generally implies prospective data collected from patients. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified. The document only generically mentions "clinical testing."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study is not indicated or described in the provided text. This device is a measurement catheter, not an imaging interpretation or diagnostic aid system that typically involves human readers. The clinical testing mentioned would likely involve comparing pressure readings against a reference standard or assessing clinical outcomes, rather than human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Yes, in a sense. The document states "The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance." This "laboratory testing" would represent a standalone evaluation of the device's technical specifications and function without direct human interpretation in the loop (beyond operating the equipment). However, it's not an "algorithm" in the typical sense of AI/software.
7. The Type of Ground Truth Used
- The ground truth for sensor accuracy would typically be established against a highly accurate reference pressure measurement system in a laboratory setting.
- For mechanical integrity, ground truth would be against engineering specifications and failure criteria.
- For the "clinical testing" mentioned, the ground truth would likely be physiologic pressure measurements and/or clinical outcomes. Specific details are not provided.
8. The Sample Size for the Training Set
- Not applicable. This device is a medical catheter with a pressure sensor; it is not described as having an AI algorithm that requires a "training set" in the machine learning sense. The "training set" concept is therefore irrelevant to the reported evaluations.
9. How The Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this device.
{0}------------------------------------------------
Section 6.0 510(k) Summary
K974389
Plnz
FEB 1 9 1998
510(k) Summary
| Submitter: | Clinical Innovations, Inc. |
|---|---|
| Name: | Wm. Dean Wallace |
| Address: | 6477 So. Cottonwood St., Murray, UT 84107 |
| Telephone: | (801) 268-8200 |
| Fax: | (801) 266-7373 |
Proprietary Names:
Common/Usual Name: Classification Name:
Koala Intrauterine Pressure Catheter and Koala External Intrauterine Pressure Catheter Intrauterine Pressure Monitor and Accessories Monitor, Pressure, Intrauterine
The legally marketed devices to which equivalence is claimed are the Medex MX 4041 Intrauterine Pressure Catheter, Graphic Controls Life Trace 3000 Intrauterine Pressure Catheter System, and Utah Medical Products Intran Plus IUP Catheter.
Description of the device: An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.
Intended use: This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
The Koala IPC's are substantially equivalent to the predicate devices because: they have the same intended uses, namely, intrauterine pressure measurement and monitoring and amniotic fluid access, and
- they have the same basic technological characteristics as predicate devices, namely, . pressure sensor located at catheter tip,
- soft tip for low risk of perforation. .
- markings for catheter insertion,
- low-cost disposable in order to avoid cross contamination, ●
- . port and lumen with female luer connector for access to amniotic space, and
- external zeroing of pressure. ●
They use the same or similar materials, all of which have been shown to be biocompatible and to function well in the intended application.
The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing. Biocompatibility testing shows that the materials used
{1}------------------------------------------------
in the Koala IPC and the Koala External IPC are safe for this application. Effectiveness is the same as the predicate devices. The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance.
Wm. Dean Wallace
Wm. Dean Wallace, M.D., Ph.D.
11-18-97
Date
K974389
P2092
Wm. Dean Wallace, M.D., Ph.D.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wm. Dean Wallace, M.D., Ph.D. President . Clinical Innovations 6477 S. Cottonwood Street Murray, UT 84107
Re: K974389
FEB 1 9 1998
Koala Intrauterine Pressure Catheters, Models 5000 and 5000E Dated: November 19, 1997 Received: November 21, 1997 Regulatory Class: II 21 CFR 884.2700/Procode: 85 HFN
Dear Dr. Wallace:
We have reviewed your Section 5 for the intent to market the device referenced above and we have there 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 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) 594-4613. 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 of the regulation of the regulation of the regulation "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,
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
11.0 Indications For Use
Device Name: Koala Intrauterine Pressure Catheter and Koala External Intrauterine Pressure Catheter
510(k) Number: K974389
Indications for use: This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Sething
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K 74389 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 884.2700 Intrauterine pressure monitor and accessories.
(a)
Identification. An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).