DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100

K040605 · Dymedix, Inc. · BZQ · Apr 26, 2004 · Anesthesiology

Device Facts

• Record ID: K040605
• Device Name: DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
• Applicant: Dymedix, Inc.
• Product Code: BZQ · Anesthesiology
• Decision Date: Apr 26, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

Device Story

Reusable sensors for sleep study monitoring; input consists of physical stretch, compression, or vibration from patient movement. Respiratory effort belt sensor attaches to chest/abdomen; limb movement sensor attaches to limbs. Piezoelectric material (PVDF) converts mechanical motion into small voltage signals. Sensors connect to external sleep study recording equipment for signal amplification and conditioning. Used in clinical settings by physicians/clinicians to interpret recorded signals for sleep study diagnosis. Benefits include non-invasive diagnostic data collection for respiratory and limb movement patterns. No active electronics or software contained within sensors.

Clinical Evidence

Bench testing only. Laboratory data provided to establish performance compared to predicate sensors. Biocompatibility data for patient contact materials provided. Certification of conformance to 21 CFR Part 898 (Performance Standard for Sensor Lead Wires and Patient Cables) included.

Technological Characteristics

Piezoelectric material: polarized Polyvinylidene Fluoride Film (PVDF). Passive device; no active electronics or software. Lead wires comply with 21 CFR Part 898. Reusable form factor with Velcro/cloth attachment. Connectivity: wired interface to external sleep study recording equipment.

Indications for Use

Indicated for patients requiring sleep study recordings to assist in the diagnostic recording of respiratory effort and limb movement. Contraindicated for use as apnea monitoring sensors.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• Respiratory Effort Belt Sensor, Periodic Limb Movement Sensor (K001030)
• Crystal Trace Piezo Respiratory Effort Sensor (K923402)
• PLM Sensor, Model PLM1 (Periodic Limb Movement) (K940014)

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness

# APR 2 6 2004

| Company Name: | DYMEDIX, Inc.<br>3989 Central Ave. NE, Suite 116<br>Minneapolis, MN 55421 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Contact: | Bill Ham, President, COO | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Summary Date: | April 12, 2004 | |
| Trade Name: | Reusable Respiratory Effort Belt Sensor<br>Reusable Limb Movement Sensor | |
| Common Name: | Respiration Effort Sensor, Limb Movement Sensor | |
| Classification Name: | Predicate devices have been found substantially equivalent to<br>21 CFR 868.2375, Breathing Frequency Monitor, Class II, BZQ. | |
| Predicate Device(s): | | |
| | 510(k) Number: | K001030 |
| | Manufacture: | DYMEDIX Inc. |
| | Trade Name: | Respiratory Effort Belt Sensor, Periodic Limb Movement<br>Sensor |
| | 510(k) Number: | K923402 |
| | Manufacture: | Pro-Tech, Inc. |
| | Trade Name: | Crystal Trace Piezo Respiratory Effort Sensor |
| | 510(k) Number: | K940014 |
| | Manufacture: | Pro-Tech, Inc. |
| | Trade Name: | PLM Sensor, Model PLM1 (Periodic Limb Movement) |

#### 1.0 Description of Sensors

The Respiratory Effort Belt Sensor and Limb Movement Sensor are reusable devices. The sensors use a self-generating, piezo material technology. The piezo material generates a small voltage in response to stretch, compression and vibration due to motion. The sensors contain no active electronics or software.

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The Respiratory Effort Belt Sensor attaches to the patient with a Velcro belt and a cloth strap. The Limb Movement Sensor is applied to the patient with a Velcro belt.

The Respiratory Effort Belt Sensor is applied to the upper chest and/or abdomen. Respiration effort results in stretch of the sensor with chest and/or abdomen circumference change indicative of respiration effort. The sensor transfers this change to a small voltage signal which can be recorded.

The Limb Movement Sensor is applied to the arm, hand, leg or foot of the patient. The sensor translates limb movement into a small voltage signal which can be recorded.

The sensors connect to the user's sleep study recording equipment. The sleep study recording equipment amplifies and conditions the sensor signal to the user's preferences. The sleep study recording device provides electrical isolation for the applied sensors.

#### 2.0 Intended Use of Sensors

The sensors arc applied to the patient prior to a sleep study evaluation. The Respiratory Effort Belt Sensor provides a signal that is recorded as respiration effort, chest/abdomen movement. The Limb Movement Sensor provides a signal that is recorded as arm, hand, leg, foot movement. Professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis. The sensors are contraindicated for use as apnea monitoring sensors.

The sensors indication for use is:

The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

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#### 3.0 Technological Characteristics

The sensors consist of a piezo material, polarized Polyvinylidene Fluoride Film (PVDF) sensor assembly. The sensor assembly has lead wires attached. The lead wires comply with 21 CFR Part 898 Performance Standards for Sensor Lead Wires and Patient Cables. The sensor lead wires interface to the user's existing sleep recording device.

#### 4.0 Data Summary

Laboratory data are presented to establish the performance of the Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor in comparison to predicate sensors. Patient contact material biocompatibility is provided.

A Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898 is provided.

#### 5.0 Conclusions

The laboratory data, skin contact material information and certification presented support the conclusion of the safety and effectiveness the Respiratory Effort Belt Sensor and Limb Movement Sensor.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2004

Dymedix, Inc. C/O Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger LN. Stoughton, WI 53589

Re: K040605

Trade/Device Name: Dymedix Reusable Respiratory Effort Belt Sensor, Model 601 Regulation Number: 868.2375 Regulation Name: Respiratory Belt Sensor and Limb Movement Sensor Regulatory Class: II Product Code: BZQ Dated: March 02, 2004 Received: March 08, 2004

Dear Mr. Syring:

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 such 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.

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### Page 2 - Mr. Syring

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 531-542 of the Acti: 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040605

Device Name: Reusable Respiratory Effort Belt Sensor and a Reusable Limb Movement Sensor Indications for Use:

> The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

Prescription Use X Over-The-Counter Usc AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

cotuh

v. General Hospital.

510(k) Number:

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