(208 days)
The Softrans® Temp UPC & System may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.
An intrauterine catheter with a pressure transducer at the tip, a thermistor located near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.
This 510(k) summary describes a medical device, the Softrans® Plus Intrauterine Pressure Catheter System (IUP 5000 Softrans® Plus IUPC), which is intended to monitor intrauterine pressure and temperature during labor, and to facilitate amnioinfusion or amniotic fluid sampling.
Here's an analysis of the provided information, structured according to your request:
Acceptance Criteria and Reported Device Performance
The provided document states: "FDA has not established special controls or performance standards for this device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications."
This indicates that external, regulatory acceptance criteria were not predefined by the FDA for this specific device at the time of submission. Instead, the manufacturer, Graphic Controls, developed its own internal specifications. The document does not explicitly list these internal specifications. Therefore, a table of acceptance criteria and reported performance cannot be fully constructed from the provided text.
However, based on the description of the device's functionality and the comparison to predicate devices, the implied performance criteria would be:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intrauterine Pressure Measurement: | "Both systems measure uterine pressure by means of a pressure transducer located at the tip of an intrauterine catheter." (Substantial equivalence to predicate) |
| - Accuracy of pressure readings | "product meets or exceeds those specifications" (Manufacturer's internal specifications) |
| - Reliability and consistency of pressure readings | "product meets or exceeds those specifications" (Manufacturer's internal specifications) |
| Intrauterine Temperature Measurement: | "Softrans® Plus has a temperature sensing mechanism near the catheter tip and a temperature display unit on the cable." (New feature, substantially equivalent to predicate thermometer technology.) |
| - Accuracy of temperature readings | "The temperature sensing and display features of Softrans® Plus are substantially equivalent in technology and functionality to Welch Allyn (DIATEK) SureTemp Thermometer." |
| - Reliability and consistency of temperature readings | "product meets or exceeds those specifications" (Manufacturer's internal specifications) |
| Amnioinfusion/Sampling Functionality: | "a port for amnioinfusion and amniotic fluid sampling" (Design feature) |
| - Efficacy of fluid delivery/sampling capability | "product meets or exceeds those specifications" (Manufacturer's internal specifications) |
| Biocompatibility: | "The device was found to be non-irritating, non-cytotoxin and non-sensitizing." |
| Sterility: | "Softran® Plus catheter will be sold as a sterile unit." |
| Shelf Life: | "The expiration date is visible on the labeling for each catheter." |
| Substantial Equivalence (Overall comparison to predicate): | The FDA determined the device is "substantially equivalent" to predicate devices. |
Study Details
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance statistics.
Here's how the other requested study information applies:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The 510(k) summary does not mention any specific clinical study sample sizes or patient data related to the performance of the device's pressure or temperature measurement functions. The primary "test set" for this submission appears to be comparisons of the device's design, technology, and functionality to predicate devices and established standards, rather than direct patient outcome data from a large cohort.
- For biocompatibility, it states: "Biocompatibility This device was subjected to biocompatibility testing and the data was submitted with the predicate device notification." This implies a previous study with the predicate, but details are not provided here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable in the context of this 510(k) summary, as it does not describe a clinical study requiring expert ground truth establishment for a test set. Substantial equivalence relies on comparing the new device's technical characteristics and intended use to a predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical study with expert adjudication is described in the provided document.
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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 medical monitoring instrument (catheter system), not an AI-assisted diagnostic tool involving human readers/interpreters.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its measurement capabilities, which would be validated through engineering tests and comparison to predicate devices, not algorithm-only performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the biocompatibility aspect, the ground truth was derived from specific biocompatibility tests (e.g., irritation, cytotoxicity, sensitization) following established standards.
- For the functional performance of pressure and temperature measurement, the ground truth would typically be established by calibrated reference instruments or established measurement standards, against which the device's readings are compared. The document implies these internal tests were conducted as it states "the product meets or exceeds those specifications," but it doesn't detail them.
- For substantial equivalence, the "ground truth" is the performance and safety profile of the legally marketed predicate device (Softrans® IUPC System and Welch Allyn (DIATEK) SureTemp Thermometer).
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The sample size for the training set:
- Not applicable within this 510(k) summary, as it describes a hardware medical device and not a machine learning model that would require a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device's submission.
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189 Van Rensse der Street PO Box 1274 Buffalo, New York 14240-1274 USA 716 853-7500
Customer Relations: 800 669-1009 Fax: 800-347-2421
K974730
102
510(k) Summary
Graphic Controls
Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240 Registration Number 1317188
Graphic Controls Corporation 1 Camegie Plaza Cherry Hill, NJ 08003 Registration Number 2243963
Isomedix 9 Apollo Drive Whippany, NJ 07981 Registration Number 2245604
(716) 853-7500
Kathleen H. Selover Regulatory Affairs Specialist PHONE (716) 853-7500, ext. 7630 FAX (716) 847-7531 E-Mail: kathleen.selover@graphic-controls.com
Softrans® Plus Intrauterine Pressure Catheter System (IUP 5000 Softrans® Plus IUPC)
Intrauterine Pressure Catheter with continuous temperature display
Catheter, Intrauterine and Introducer
85 KXO
Softrans® Intrauterine Pressure Catheter System
SureTemp Thermometer WelchAllyn(DIATEK) System.
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JUL 1 4 1998
Contract Sterilizer
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Manufacturer
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Device Trade Name
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Predicate Device
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An intrauterine catheter with a pressure transducer at the tip, a thermistor Description located near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.
Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.
Cables are packaged in protective wrap and corrugated shippers.
The Softrans® Plus System is used to obtain direct internal measurements of Intended Use the intensity, duration, and frequency of uterine contractions during labor and to provide continuous monitoring and display of patient intrauterine temperature.
The catheter rests in the amniotic fluid between the fetus and uterine wall. During uterine contractions, the amniotic fluid is compressed; this pressure is transferred through the fluid and measured by the pressure transducer located at the tip of the catheter. The pressure signal is sent to the fetal monitor via the cable. The catheter also may be used for amnioinfusion of fluid into the uterus to enhance amniotic fluid volume, or for amniotic fluid sampling.
Intrauterine temperature is sensed by a thermistor located in the catheter. The return signal from the thermistor is sent to the temperature display unit located on the cable.
The intended use and application of Softrans® Plus IUPC System described Physical and Technical in this submission is substantially equivalent to Softrans® IUPC System currently manufactured and marketed by Graphic Controls. Both systems Comparison measure uterine pressure by means of a pressure transducer located at the tip of an intrauterine catheter. The patient contacting surfaces and materials of the predicate and Softrans® Plus are identical.
In addition, Softrans® Plus has a temperature sensing mechanism near the catheter tip and a temperature display unit on the cable. The temperature sensing and display features of Softrans® Plus are substantially equivalent in technology and functionality to Welch Allyn (DIATEK) SureTemp Thermometer.
Performance FDA has not established special controls or performance standards for this Summary device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications.
Biocompatibility This device was subjected to biocompatibility testing and the data was Testing submitted with the predicate device notification. The device was found to be non-irritating, non-cytotoxin and non-sensitizing.
- Sterility Softran® Plus catheter will be sold as a sterile unit. The reusable cable is and supplied non sterile. The expiration date is visible on the labeling for each Shelf Life catheter.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its head turned to the left, and three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the seal.
JUL 1 4 1998
Ms. Kathleen H. Selover Regulatory Affairs Specialist Graphic Controls Corporation 189 Van Renssalaer Street P.O. Box 1274 Buffalo, NY 14240-1274
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K974730 Softrans® Temp IUPC System Dated: April 15, 1998 Received: April 16, 1998 Regulatory Class: II 21 CFR 884.2700/Procode: 85 KXO
Dear Ms. Selover:
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, narket 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 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 vito 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 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/cdrl/dsmaldsmamain.html".
Sincerely yours.
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
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Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Softrans® Temp UPC & System may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Presecription Use (Per 21CFR 801.109)
OR Over-the-CounterUse _
Dand J. Ael for 44
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974230
§ 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).