TOCO LITE, MODEL TD-01

K013477 · Ventrex, Inc. · HFM · Jan 17, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K013477
• Device Name: TOCO LITE, MODEL TD-01
• Applicant: Ventrex, Inc.
• Product Code: HFM · Obstetrics/Gynecology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2720
• Device Class: Class 2

Intended 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.

Device Story

FeatherLite Toco is an external uterine contraction monitor; functions as an accessory to standard fetal monitors. Device consists of a rectangular thermoplastic body with a flexible polymer sensing nipple and a strain gauge sensor. Operated by clinical staff; secured to patient's abdomen over the uterine fundus using an elastic nylon belt. Receives low-voltage power from the host fetal monitor; detects mechanical uterine activity via the strain gauge; transmits signal to the monitor for display. Provides clinicians with real-time uterine contraction data to assist in labor management and fetal monitoring. Low-profile, lightweight design improves human factors compared to bulkier predicate devices.

Clinical Evidence

Clinical and non-clinical testing performed. Clinical testing demonstrated that data sensed by the FeatherLite Toco was comparable to that measured by the predicate device, even when positioned in sub-optimal locations. No specific statistical metrics (e.g., sensitivity, specificity) provided.

Technological Characteristics

Materials: Thermoplastic body, flexible polymer sensing nipple, elastic nylon belt, vinyl-clad cable. Sensing principle: Strain gauge (Wheatstone bridge). Energy source: Low voltage supplied by host monitor. Form factor: Rectangular, low-profile, domed. Connectivity: Wired (8-foot cable) to fetal monitor. Sterilization: Non-sterile.

Indications for Use

Indicated for pregnant patients requiring evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. Not indicated for home monitoring of pre-term labor.

Regulatory Classification

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.

Predicate Devices

• Agilent Technologies (Hewlett Packard) tocodynamometer model M1355A (K900480)
• GE (Corometrics) tocodynamometer model 2260 (K843385)

Submission Summary (Full Text)

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# 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.

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#### 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 /<br>Corometrics |
| Intended use | Senses uterine activity | Same | Same |
| Indications for use | Used in conjunction with fetal monitors<br>for evaluation of external uterine activity | Same | Same |
| Target patient population | Pregnant patients | Same | Same |
| Design | Sensing nipple attached to strain gauge | Same | Sensing<br>diaphragm<br>attached to strain<br>gauge |
| Materials | Thermal plastics and polymers, vinyl clad<br>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<br>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<br>environment/other devices | MRI and EMI interference not applicable<br>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<br>belts | Replacement<br>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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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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**