(127 days)
No
The device description focuses on a pneumatic pressure-sensing mechanism and does not mention any computational analysis, algorithms, or learning processes. The performance studies are based on predicate comparison and hardware testing, not AI/ML model validation.
No
The device is described as a diagnostic tool used to evaluate uterine activity and detect contractions, and it does not provide any therapeutic intervention.
Yes
Explanation: The device is described as "intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity." Evaluation for medical conditions is a diagnostic function.
No
The device description explicitly details hardware components, including a transducer pressure-sensing device, a guard-ring, an elastic membrane, an air channel, and a pressure transducer within a reusable cable. The performance studies also include hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Koala TOCO and Koala IUP/TOCO Reusable Cable are used to monitor external uterine activity and intrauterine pressure during pregnancy and labor. This is a physical measurement of physiological processes within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly states evaluation of "relative external uterine activity" and "intrauterine pressure monitoring." These are direct measurements, not diagnostic tests performed on samples.
- Device Description: The description details a pressure-sensing device that detects changes in the abdomen and measures air volume and pressure. This aligns with a physical monitoring device, not an IVD.
Therefore, the Koala TOCO and Koala IUP/TOCO Reusable Cable are considered medical devices used for monitoring physiological parameters, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.
The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.
The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.
Product codes
HFM, HFN
Device Description
The Koala TOCO is a single-use tocodynamometer that is a transducer pressuresensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.
The Koala TOCO device is a pneumatic tocodynamometer that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.
The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surface of abdomen over fundal area of the uterus
Indicated Patient Age Range
Pregnant patients, especially during labor
Intended User / Care Setting
Clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing performed to support the performance and safety claims for the Koala TOCO and the Koala IUP/TOCO Reusable Cable includes, but is not limited to, the following:
- Predicate comparison testing.
- Simulated use testing.
- Hardware testing.
- Electrical performance testing.
- Biocompatibility testing according to ISO 10993-1.
- Intrauterine pressure catheter (IUPC) compatibility testing
The evidence resulting from the non-clinical testing supports the substantial equivalence of the proposed and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2720 External uterine contraction monitor and accessories.
(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).
0
MAY 2 9 2014
510(K) SUMMARY FOR THE CLINICAL INNOVATIONS, LLC Koala TOCO and Koala IUP/TOCO Reusable Cable
(per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)
1. SUBMITTER/510(K) HOLDER
Clinical Innovations, LLC 747 West 4170 South Murray, UT 84123 Phone: 1-801-268-8200 Internet: www.clinicalinnovations.com Establishment Registration No: 1722684
Contact: Tom Haueter Contact's Phone: 1-801-268-8200 Contact's Fax: 1-801-263-7373 Contact's Email: T.Haueter@clinicalinnovations.com
2. DEVICE NAME
| Proprietary Name: | Koala TOCO and Koala IUP/TOCO Reusable Cable |
|---|---|
| Common/Usual Name: | Tocodynamometer and cable |
| Classification Name: | external uterine contraction monitor and accessories |
| Classification Panel: | Obstetrics/Gynecology |
| Device Class: | Class II |
| Classification Number: | 21 CFR 884.2720 |
| Product Code: | HFM, HFN |
3. PREDICATE DEVICE
The following device is a legally marketed device to which equivalence is being claimed:
- . FeatherLite™ Tocodynamometer (Ventrex, Inc., K013477)
4. DEVICE DESCRIPTION
The Koala TOCO is a single-use tocodynamometer that is a transducer pressuresensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.
The Koala TOCO device is a pneumatic tocodynamometer that comprises a guardring with a thin elastic membrane stretched across a shallow depression in the center
1
of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.
The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.
INDICATIONS FOR USE / INTENDED USE 5.
The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.
The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.
The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6. DEVICE
A summary comparison of the technological characteristics, including design and materials, is provided in the table below:
| Parameter | Koala TOCO and Koala IUP/TOCO
Reusable Cable
(Clinical Innovations) | FeatherLite™ Tocodynamometer
(Ventrex Inc.) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K140163 | K013477 |
| Indications for Use | For use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. | For use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. It should only be used in a clinical setting. |
| Target Patient Population | Pregnant patients, especially during labor | Pregnant patients, especially during labor |
Clinical Innovations, LLC
2
| Parameter | Koala TOCO and Koala IUP/TOCO
Reusable Cable
(Clinical Innovations) | FeatherLite™ Tocodynamometer
(Ventrex Inc.) |
|-------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Water environment use | No | No |
| Anatomical sites | Surface of abdomen over fundal area of
the uterus | Surface of abdomen over fundal area of
the uterus |
| Size | Body diameter: 7.0cm
Body thickness: 0.8cm | Body diameter (sensing dome): 3.6cm
Body thickness: .10cm
Sensing dome thickness: .79cm |
| Weight (with cable) | 0.35 Ibs (159 g) | 0.11 lbs (51g) |
| Material | Housing material: thermoplastic
polyurethane
Cable: Thermoplastic polyurethane | Housing material: thermoplastic
Sensing nipple: flexible polymer
Cable: vinyl clad |
| Technology | Sensing diaphragm connected to a
pressure transducer centrally located in a
circular (guard ring) body | Sensing nipple attached to a strain gauge |
| Sensor | Wheatstone resistive bridge sensor | Wheatstone resistive bridge sensor |
| Location of electronics | Housed in the reusable cable | Housed in the TOCO device |
| Serviceable | No | No |
| Patient attachment | Elastics belt included.
Compatible with standard elastic belts. | Elastic belt included.
Compatible with standard elastic belts. |
| Cable length | 10 feet | 8 feet |
| Single Use/Disposable | Yes | Yes |
| Biocompatible | Yes | Yes |
| Sterile | Non-sterile | Non-sterile |
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Non-clinical testing performed to support the performance and safety claims for the Koala TOCO and the Koala IUP/TOCO Reusable Cable includes, but is not limited to, the following:
- Predicate comparison testing .
- Simulated use testing .
- Hardware testing .
- Electrical performance testing .
- Biocompatibility testing according to ISO 10993-1 .
- . Intrauterine pressure catheter (IUPC) compatibility testing
The evidence resulting from the non-clinical testing supports the substantial equivalence of the proposed and predicate devices.
3
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Not Applicable.
9. SUMMARY OF OTHER INFORMATION
This submission included proposed product labeling and packaging specifications.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The indications for use, principles of operation, and technological characteristics of the proposed Koala TOCO with the Koala IUP/TOCO Reusable Cable are substantially equivalent to the predicate device FeatherLite™ Tocodynamometer (subject of K013477). Differences between the proposed and predicate device are limited to minor differences in visual appearance, weight, sensing technology, and transducer location. These differences are minor and do not impact the safety and effectiveness of the device.
The safety, performance, and effectiveness of the Koala TOCO for its intended use are demonstrated by non-clinical testing. Based on the evidence provided, Clinical Innovations believes that the proposed Koala TOCO and Koala IUP/TOCO Reusable Cable are substantially equivalent to the predicate.
4
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2014
Clinical Innovations, LLC % JoAnne L. Bronikowski Consultant Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, MA 01752
Re: K140163
Trade/Device Name: Koala TOCO and Koala IUP/TOCO Reusable Cable Regulation Number: 21 CFR§ 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: II Product Code: HFM, HFN Dated: April 29, 2014 Received: April 30, 2014
Dear JoAnne L. Bronikowski,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - JoAnne L. Bronikowski
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on fast page.
510(k) Number (if known) K140163
Device Name
Koala TOCO and Koala IUP/TOCO Reusable Cable
Indications for Use (Describe)
The single-use disposable, non-sterile Koala TOCO is in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.
The Kosla TUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.
The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
: : FOR FDA USE ONLY :: 、人民和人民族、据明确的人才和用品。
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
2014
FORM FDA 3881 (1/14)