(90 days)
Not Found
No
The summary describes a purely mechanical and electrical device (strain gauge sensor) with no mention of AI/ML terms, data processing, or performance metrics typically associated with AI/ML algorithms.
No.
The "Intended Use" states that the device is for "evaluation of external uterine activity," indicating a diagnostic rather than therapeutic purpose.
No
The device is a tocodynamometer, which measures uterine activity. While this information can be used in diagnosis, the device itself is a measurement tool and does not inherently provide a diagnosis or diagnostic interpretation. Its purpose is to evaluate external uterine activity during antepartum and intrapartum periods.
No
The device description explicitly details physical components such as a rectangular base, domed sensor body, nipple-like appendage, belt, strain gauge sensor, and cable, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- FeatherLite Toco Function: The FeatherLite Toco is a tocodynamometer. It measures external uterine activity by sensing pressure on the surface of the abdomen. It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly states it's for evaluating external uterine activity during antepartum and intrapartum periods in conjunction with fetal monitors. This is a physical measurement, not an in vitro test.
Therefore, based on the provided information, the FeatherLite Toco is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FeatherLite Toco tocodynamometer is intended 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. Caution: The FeatherLife Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients. It is held in place on the surface of the abdomen using the attached elastic belt.
The product is supplied non-sterile and is intended for single use or limited reuse following appropriate cleaning per hospital protocol.
Product codes (comma separated list FDA assigned to the subject device)
85HFM
Device Description
The FeatherLite Toco is a tocodynamometer (toco) intended for use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. The FeatherLite Toco is not intended for home monitoring of pre-term labor. It is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single or limited reuse.
The FeatherLite Toco is generally rectangular in shape with a domed sensor body and nipple-like appendage. It includes a belt to hold it on the patient. The device is lower profile and significantly lighter than standard tocos.
The rectangular base and dome sensor body are molded from thermoplastic. The sensing nipple is formed from a flexible polymer. The sensor is a strain gauge. The cable is a jacketed array of four individually insulated wires. The belt is an elastic nylon webbing.
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 uterus
Indicated Patient Age Range
Not Found
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)
The FeatherLite Toco performance was tested under both non-clinical and clinical conditions to determine substantial equivalence to the predicate devices. The data sensed by the FeatherLite Toco in clinical testing was also quite comparable to that measured by the predicate device despite being positioned in a sub-optimal location.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a date, "JAN 17 2002". The month is January, the day is the 17th, and the year is 2002. The text is in a bold, sans-serif font. The text is black against a white background.
Image /page/0/Picture/1 description: The image shows the text "K013477 page 1 of 3" written in black ink on a white background. The text appears to be handwritten. The text "K013477" is on the first line, and the text "page 1 of 3" is on the second line.
Section E 510 (k) Summary
Applicant Information
Submitter's Name: Address:
Telephone/Fax Numbers: Contact Person: Date Summary Prepared:
Robert Guthrie 3007 Bunsen Avenue, Suite K, Ventura, California 93003 805-658-2984 x 100 or x 109 / 805-658-6720 Robert Guthrie or Doug Divine October 11, 2001
Device Information
Trade Name of Device: Common Name: Classification Name:
Toco Lite Tocodynamometer (Toco) or Toco transducer External Uterine Contraction Monitor and Accessories (per 21 CFR section 884.2720/Procode: 85HFM)
Predicate Device Information
Predicate Device/s To Which Equivalence is Claimed: Agilent Technologies (Hewlett Packard) tocodynamometer model M1355A
GE (Corometrics) tocodynamometer model 2260
Device General Description and Intended Use
The FeatherLite Toco is a tocodynamometer (toco) intended for use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. The FeatherLite Toco is not intended for home monitoring of pre-term labor. It is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single or limited reuse.
Image /page/0/Picture/15 description: The image is a circular logo or seal. The text "PN 20704" is at the top of the circle, and "EN45001" and "ISO 9001" are at the bottom. In the center of the circle is an inverted triangle with a horizontal line above it.
1
Device Specific Description
K013477
page 2 of 3
The FeatherLite Toco is generally rectangular in shape with a domed sensor body and nipple-like appendage. It includes a belt to hold it on the patient. The device is lower profile and significantly lighter than standard tocos.
The rectangular base and dome sensor body are molded from thermoplastic. The sensing nipple is formed from a flexible polymer. The sensor is a strain gauge. The cable is a jacketed array of four individually insulated wires. The belt is an elastic nylon webbing.
Technological Characteristics vs. Predicate Devices
Differences From Predicate Devices (Predicate device Agilent/Hewlett Packard M1355A tocodynamometer - 510 (k) most likely as an accessory to an Agilent/HP fetal monitor. Product is described in K900480: Predicate device Corometrics 2260 tocodynamometer - 510 (k) most likely as an accessory to a Corometrics fetal monitor. Product is described in K843385.
Performance Characteristics for Determination of Substantial Equivalence
The FeatherLite Toco performance was tested under both non-clinical and clinical conditions to determine substantial equivalence to the predicate devices.
| New Device | Predicate Devices | ||
|---|---|---|---|
| Topic | FeatherLite Toco | Agilent / HP | GE / |
| Corometrics | |||
| Intended use | Senses uterine activity | Same | Same |
| Indications for use | Used in conjunction with fetal monitors | ||
| for evaluation of external uterine activity | Same | Same | |
| Target patient population | Pregnant patients | Same | Same |
| Design | Sensing nipple attached to strain gauge | Same | Sensing |
| diaphragm | |||
| attached to strain | |||
| gauge | |||
| Materials | Thermal plastics and polymers, vinyl clad | ||
| cable, wheat stone bridge sensor | Same | Same | |
| Performance | Please see "Performance" in section I | Same | Same |
| Sterility | Non-sterile | Same | Same |
Summary Comparison vs. Predicate Devices
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page 3 of 3 K013477
| Biocompatibility | Materials in direct skin contact USPC VI | Unknown | Unknown |
|---|---|---|---|
| Patient Safety | Please see "Safety" in section I | Unknown | Unknown |
| Anatomical sites | Surface of abdomen over fundal area of | ||
| uterus | Same | Same | |
| Human factors | Very low profile, small, light weight | Bulky, heavy | Bulky, heavy |
| Energy used | Low voltage supplied by monitor | Same | Same |
| Compatibility with | |||
| environment/other devices | MRI and EMI interference not applicable | ||
| due to indications for use | Same | Same | |
| Standards met | None established | Same | Same |
| Patient attachment | Elastic belt | Same | Same |
| Cable Length | 8 feet | 8 feet | 8 feet |
| Accessories | Replacement belts, monitor adaptors | Replacement | |
| belts | Replacement | ||
| belts |
Performance Conclusions
The clinical and non-clinical testing supports the substantial equivalence of the FeatherLite Toco to the predicate devices. All devices employ the same theory of operation and basic design elements. The performance specifications are comparable. The data sensed by the FeatherLite Toco in clinical testing was also quite comparable to that measured by the predicate device despite being positioned in a sub-optimal location.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird with three curved lines representing wings or feathers, and two wavy lines below, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Robert Guthrie General Manager Ventrex, Inc. 3007 Bunsen Avenue, Unit K VENTURA CA 93003-7633
Re: K013477
Trade/Device Name: Featherlite Toco Regulation Number: 21 CFR 884.2720 Regulation Name: External uterine contraction monitor and accessories
Regulatory Class: II Product Code: 85 HFM Dated: October 16, 2001 Received: October 19, 2001
Dear Mr. Guthrie:
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 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.
4
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section D Statement of Indications for Use
Applicant: Ventrex, inc.
510(k) Number: K013477
Device Name: FeatherLite Toco model TD-01
INDICATIONS FOR USE
The FeatherLite Toco tocodynamometer is intended 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. Caution: The FeatherLife Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients. It is held in place on the surface of the abdomen using the attached elastic belt.
The product is supplied non-sterile and is intended for single use or limited reuse following appropriate cleaning per hospital protocol.
biglon
(Division Sign-Off)
Division of Reproductive, Abdominat,
and Radiological Devices K013477
510(k) Number.
Prescription Use