(87 days)
The Softrans Temp™ IUPC System may be used during the interpartum 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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Softrans Temp™ Intrauterine Pressure Catheter System:
It's important to note right away that the provided 510(k) summary (K991235) is for a predicate device where the main change is the addition of a specific claim in labeling: "intrauterine temperature measured by the device is clinically equivalent to oral temperature and that intrauterine temperature can be used in place of oral temperature measurements in laboring patients."
The document heavily relies on the substantial equivalence to a previously marketed predicate device also named Softrans Temp™ Intrauterine Pressure Catheter System. This means that many of the original performance studies and acceptance criteria from the initial approval of the predicate device are not explicitly detailed in this specific 510(k) summary. The current submission is primarily about demonstrating that the new device (with the added temperature claim) is still substantially equivalent to the existing predicate.
Therefore, some of the requested information (like specific sample sizes, expert qualifications for the original device tests, etc.) is not present in this document because it defaults to the established equivalence of the predicate. The focus here is on the new claim about temperature equivalence.
Acceptance Criteria and Device Performance for K991235
The acceptance criteria for K991235 primarily revolve around the substantial equivalence to the predicate device and the validation of the new labeling claim regarding intrauterine temperature equivalence to oral temperature.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The intended use of the subject device (monitoring uterine contractions, intrauterine temperature, amnioinfusion, amniotic fluid sampling) must be substantially equivalent to the predicate device. | The intended use and application of the subject Softrans Temp™ is substantially equivalent to the predicate Softrans Temp™. |
| Technological Characteristics Equivalence: The physical and technical characteristics (e.g., pressure transducer at tip, thermistor, amnioinfusion port, introducer, reusable cable with rezero/cable check/temperature display) must be substantially equivalent to the predicate device. | The physical and technical comparison confirms substantial equivalence. |
| Biocompatibility: The device materials must be biocompatible (non-irritating, non-cytotoxic, non-sensitizing). | Biocompatibility testing data was submitted with the predicate device notification and found the device to be non-irritating, non-cytotoxic, and non-sensitizing. (This data refers to the predicate, assumed to apply to the current device as it's the same design for these aspects). |
| Sterility & Shelf Life: The single-use catheter must be sterile with a visible expiration date. The reusable cable is non-sterile. | Catheter will be sold as a sterile unit with an expiration date on labeling. Reusable cable is non-sterile. (Assumed to meet established standards). |
| New Labeling Claim Validation (Temperature Equivalence): The intrauterine temperature measured by the device must be clinically equivalent to oral temperature, allowing its use in place of oral temperature measurements in laboring patients. | The document states: "the intended use of the subject Softrans Temp™ now includes the addition of a claim in labeling stating that the intrauterine temperature measured by the device is clinically equivalent to oral temperature and that intrauterine temperature can be used in place of oral temperature measurements in laboring patients." However, the actual study proving this clinical equivalence is not detailed in this summary. It only states that the claim is now included. It implies a study was done to support this, but the details are absent. |
| Meets or Exceeds Manufacturer's Specifications: The product must meet or exceed internal specifications. | Ludlow Technical Products has established its own specifications and the product meets or exceeds those specifications. (General statement, no specific metrics provided). |
Study Details (based on available information):
Due to the nature of this 510(k) being a claim of substantial equivalence to a predicate device, the detailed study information for many aspects is not provided, as it would have been part of the original predicate device submission. The primary new aspect is the temperature equivalence claim.
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Sample size used for the test set and the data provenance:
- Not specified in this document. For the new temperature equivalence claim, a clinical study would have been required to compare intrauterine temperature readings to oral temperature readings. The number of patients, their demographics, country of origin, and whether it was retrospective or prospective data are not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. For the temperature equivalence claim, the "ground truth" would likely be established through standard clinical thermometry (e.g., oral temperature taken with a validated thermometer) and, potentially, expert clinical assessment of patient condition. The number and qualifications of clinicians involved in such a study are not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. For a temperature measurement equivalence study, adjudication methods like those used for image interpretation (2+1, etc.) are generally not relevant. The comparison would be between numerical measurements.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is typically for evaluating diagnostic imaging devices where human readers interpret cases with and without AI assistance. This device is a direct physiological measurement device, not an imaging interpretation tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is standalone in terms of generating the pressure and temperature measurements. The "performance" in this context is the accuracy and equivalence of these measurements. For the temperature claim, the device's measured intrauterine temperature would have been compared directly to an established reference (e.g., oral temperature). The document states the device provides "continuous monitoring and display" of temperature, implying autonomous measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the temperature equivalence claim, the most likely ground truth would be clinical measurements from a recognized standard of care (e.g., oral temperature using a calibrated thermometer), and/or potentially comparison to core body temperature (though oral is specified in their claim).
- For the pressure monitoring capabilities, the ground truth would be based on direct physiological measurement principles and validation against established pressure measurement standards.
-
The sample size for the training set:
- Not applicable/Not specified. This device is hardware-based (catheter with transducers) and likely uses direct physical principles for measurement, rather than a machine learning algorithm that requires a "training set" in the conventional sense. If there were any internal calibrations or algorithms for temperature conversion, those details are not provided.
-
How the ground truth for the training set was established:
- Not applicable/Not specified. As above, a training set is not typically associated with this type of device. The ground truth for functional performance (pressure, temperature accuracy) would be established through engineering validation and, for the clinical equivalence claim, through direct comparative clinical studies against established methods.
Summary of Limitations in Information:
This 510(k) summary is very high-level regarding performance data, as is common for submissions based on substantial equivalence. It confirms that internal specifications are met and biocompatibility was previously established for the predicate. However, it does not provide detailed clinical study data (e.g., sample size, methodology, results) to support the specific new claim that "intrauterine temperature measurements correspond to oral temperature measurements and can be used in place of oral temperature measurements in laboring patients." This information would have been part of supporting documentation provided to the FDA but is not included in the public summary.
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JUL - 8 1999
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Ludlow Technical Products
Two Ludlow Park Drive P.O. Box 297 Chicopee, MA 01021-0297 413-593-6400
510(k) Summary
| Manufacturer | Ludlow Technical ProductsTwo Ludlow Park DriveChicopee, MA 01022Registration Number 9001764 |
|---|---|
| Manufacturing Location | Graphic Controls Corporation1 Carnegie PlazaCherry Hill, NJ 08003Registration Number 2243963 |
| Contract Sterilizer | Isomedix9 Apollo DriveWhippany, NJ 07981Registration Number 2245604 |
| Telephone | (413) 593-6400 |
| Contact Person | Kathleen M. MurphyRegulatory Affairs ManagerPhone: (413)-593-6400Fax: (413) 593-6114 |
| Device Trade Name | Softans Temp™ Intrauterine Pressure CatheterSystem (IUPC 5000 Softrans Temp™ IUPC) |
| Common Name | Intrauterine Pressure Catheter with continuous temperature display |
| Classification Name | Catheter, Intrauterine Pressure Catheter System |
| Regulatory Reference | 85 KXO |
| Predicate Device | Softans Temp™ Intrauterine Pressure Catheter System |
| Description | An intrauterine catheter with a pressure transducer at the tip, a thermistor locatednear the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and anintroducer which is removed after placement. System includes a reusable cable thatcontains a rezero mechanism, cable check and temperature display unit. Anattachment strap is provided. |
| Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of saleis a case of 10 IUPC's. | |
| Cables are packaged in protective wrap and corrugated shippers. | |
| Intended Use | The Softrans Temp™ System is used to obtain direct internal measurements of theintensity, duration, and frequency of uterine contractions during labor and to providecontinuous monitoring and display of patient intrauterine temperature. |
| The catheter rests in the amniotic fluid between the fetus and uterine wall. Duringuterine contractions, the amniotic fluid is compressed; this pressure is transferredthrough the fluid and measured by the pressure transducer located at the tip of thecatheter. The pressure signal is sent to the fetal monitor via the cable. The catheteralso may be used for amniotic fluid sampling. | |
| Intrauterine temperature is sensed by the thermistor located in the catheter. Thereturn signal from the thermistor is sent to the temperature display unit located on thecable. Intrauterine temperature measurements correspond to oral temperaturemeasurements and can be used in place of oral temperature measurements inlaboring patients. | |
| Physical andTechnical Comparison | The intended use and application of the subject Softrans Temp™ described inthis submission is substantially equivalent to the predicate Softrans Temp™ currentlymanufactured and marketed by Graphic Controls Corp (a division of LudlowTechnical Products). |
| In addition, the intended use of the subject Softrans Temp™ now includes theaddition of a claim in labeling stating that the intrauterine temperature measured bythe device is clinically equivalent to oral temperature and that intrauterinetemperature can be used in place of oral temperature measurements in laboringpatients. | |
| PerformanceSummary | FDA has not established special controls or performance standards for thisdevice. Ludlow Technical Products has established its own specifications and theproduct meets or exceeds those specifications. |
| BiocompatibilityTesting | This device was subjected to biocompatibility testing and the data wassubmitted with the predicate device notification. The device was found to be non-irritating, non-cytotoxin and non-sensitizing. |
| Sterility andShelf Life | Softrans Temp™ catheter will be sold as a sterile unit. The reusable cable issupplied non sterile. The expiration date is visible on the labeling for each catheter. |
A LUCO INTERNATIONAL LTD. COMPANY
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Image /page/2/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 1999
Ms. Kathleen M. Murphy Regulatory Affairs Manager Ludlow Technical Products Two Ludlow Park Drive P.O. Box 297 Chicopee, MA 01021-0297
Re: K991235
Softrans Temp™ Intrauterine Pressure Catheter System (IUP 5000, Softrans_Temp™ IUPC) Dated: April 6, 1999 Received: April 12, 1999 Regulatory Class: II 21 CFR §884.2700/Procode: 85 KXO
Dear Ms. Murphy:
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 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). 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 III (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 requirements, 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 requlatory 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K991235
Device Name: Softtrans Temp™ IUPC System
Indications for Use:
The Softrans Temp™ IUPC System may be used during the interpartum 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991235
Prescription Use _X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
§ 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).