(201 days)
These catheters are for use on patients requiring gastrointestinal manometry testing. The Esophageal Pressure Catheter Model number GIM-6000E is for use with esophageal motility studies. The Ano-Rectal Pressure Catheter Model number GIM-6000A is for use in ano-rectal pressure studies.
Gastrointestinal pressure catheters with pressure-sensing membrane cavities along the length of the catheter and a port for balloon inflation for the Anorectal model. This product is non-sterile, single patient use catheter. The system includes reusable cables with reusable pressure transducers.
This appears to be a 510(k) premarket notification summary for the Latitude GI Pressure Catheters, not a comprehensive clinical study report. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert adjudication will likely not be present. However, I will extract what can be found and explicitly state what is not provided.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it implicitly states that "Effectiveness is the same as the predicate devices." and that "The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance."
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Effectiveness | Equivalent to predicate devices | "Effectiveness is the same as the predicate devices." |
| Sensor Accuracy | Verified through lab testing | "verified the performance in terms of sensor accuracy" |
| Mechanical Integrity | Verified through lab testing | "verified the performance in terms of... mechanical integrity" |
| Overall Performance | Verified through lab testing | "verified the performance in terms of... overall performance" |
| Biocompatibility | Safe for intended application | "Biocompatibility testing shows that the materials used in the Latitude Pressure Catheters are safe for this application." |
Observation: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific numerical performance targets.
2. Sample Size Used for the Test Set and Data Provenance
The document states "laboratory testing" was conducted, but it does not provide any details on:
- The sample size used for any test set (e.g., number of catheters, number of measurements).
- Data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The "laboratory testing" would typically involve technical experts, but their number and qualifications are not mentioned. Since this is a physical device, ground truth wouldn't typically be established by human experts in the same way as with an imaging AI model.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of "laboratory testing" for a physical medical device, human adjudication a medical sense (like 2+1 reading) is not applicable. The testing would be against established calibration standards or engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this summary. This type of study is typically used for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a physical pressure catheter, not an AI system that assists human interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
Yes, the "laboratory testing" implicitly represents a standalone performance evaluation of the device. The device itself (the catheter and its associated pressure transducers) is the "algorithm" in this context, and its performance was "verified" in a lab setting, meaning without real-time human clinical intervention beyond operating the test equipment. However, it's crucial to understand this isn't an AI "algorithm" in the modern sense.
7. Type of Ground Truth Used
For the laboratory testing, the ground truth would have been established by:
- Engineering Standards / Calibration Reference: For sensor accuracy, the device's readings would be compared against a known, highly accurate pressure reference source.
- Mechanical Specifications: For mechanical integrity, the device would be subjected to tests (e.g., tensile strength, fatigue, material composition) to ensure it meets predetermined engineering specifications for physical properties and durability.
- Biocompatibility Standards: For biocompatibility, tests would be conducted according to ISO or other relevant standards, comparing cellular responses or material characteristics against established safety profiles.
8. Sample Size for the Training Set
This concept is not applicable as this is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the same reason as above.
Summary of what's provided for acceptance criteria and study:
The document serves as a 510(k) summary demonstrating substantial equivalence. It states that laboratory testing was performed to verify sensor accuracy, mechanical integrity, and overall performance, and that biocompatibility testing was done. The overarching acceptance criterion is that the device's performance (effectiveness and safety) is "the same as the predicate devices." No quantitative performance metrics, specific study designs, sample sizes, or details about the ground truth establishment for these specific tests are provided beyond a general statement of verification.
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Latitude GI Pressure Catheters Clinical Innovations, Inc. - Oct. 7, 2002
Section 6.0 510(k) Summary
510(k) Summary
| Submitter: | Clinical Innovations, Inc. |
|---|---|
| Name: | Wm. Dean Wallace |
| Address: | 747 West 4170 South, Murray, UT 84123 |
| Telephone: | (801) 268-8200 |
| Fax: | (801) 266-7373 |
| Proprietary Names: | Latitude Esophageal Motility Study Pressure Cather |
| Proprietary Names: | Latitude Esophageal Motility Study Pressure Catheter andLatitude Ano-Rectal Pressure Catheter |
|---|---|
| Common/Usual Name: | Gastrointestinal Pressure Catheter |
| Classification Name: | System, Gastrointestinal Motility (Electrical) |
The legally marketed devices to which equivalence is claimed are the Konigsberg Esophageal Solid State Catheter and the Medtronic Zinetics AMS Anorectal Catheter.
Description of the device: Gastrointestinal pressure catheters with pressure-sensing membrane cavities along the length of the catheter and a port for balloon inflation for the Anorectal model. This product is non-sterile, single patient use catheter. The system includes reusable cables with reusable pressure transducers.
Intended use: This catheter is for use on patients requiring esophageal and ano-rectal pressure monitoring.
The Latitude Pressure Catheters are substantially equivalent to the predicate devices because:
- . they have the same intended uses, namely, esophageal and ano-rectal pressure measurement, and
- they have the same basic technological characteristics as predicate devices, namely, pressure sensors located along the length of the catheter,
- . markings for catheter insertion,
- port and lumen for Anorectal balloon inflation, 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 testing. Biocompatibility testing shows that the materials used in the Latitude Pressure Catheters are safe for this application. Effectiveness is the same as the
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K022023
PAGE 2 OF 2
Latitude GI Pressure Catheters Clinical Innovations, Inc. - Oct. 7, 2002
predicate devices. The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance.
Wm A. Wallace
Wm. Dean Wallace, M.D., Ph.D.
10-7-02
Date
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight.
JAN 0 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wm. Dean Wallace. M.D., Ph.D. President Clinical Innovations 747 West 4170 South MURRAY UTAH 84123
Re: K022023
Trade/Device Name: Latitude Esophageal Pressure Catheter (Model #GIM-6000E) and Latitude Ano-Rectal Pressure Catheter (Model # GIM-6000A) Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: Class II Product Code: 78 KLA Dated: October 7, 2002 Received: October 9, 2002
Dear Dr. Wallace:
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 such 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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Page 2
This letter will allow you to begin marketing your device as described in your Section 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 (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" (21CFR Part 807.97) you may obtain. 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,
Harriet M. Dyson
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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Indications For Use 10.0
Device Name: Latitude Esophageal Pressure Catheter (Model number GIM-6000E) and Latitude Ano-Rectal Pressure Catheter (Model number GIM-6000A)
510(k) Number: K022023
Indications for use: These catheters are for use on patients requiring gastrointestinal manometry testing. The Esophageal Pressure Catheter Model number GIM-6000E is for use with esophageal motility studies. The Ano-Rectal Pressure Catheter Model number GIM-6000A is for use in ano-rectal pressure studies.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seggern
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K 022023 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).