DP240 240 HOUR DOPPLER PROBE

K052989 · Deltex Medical · DPT · Mar 8, 2006 · Cardiovascular

Device Facts

• Record ID: K052989
• Device Name: DP240 240 HOUR DOPPLER PROBE
• Applicant: Deltex Medical
• Product Code: DPT · Cardiovascular
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

Intended Use

When used in conjunction with the CardioQ cardiac output and fluid status monitoring system, the DP240 is designed to provide clinicians with real-time information about left-ventricular blood flow. The DP240 is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The DP240 can be placed into the esophagus via oral or nasal insertion in adults.

Device Story

DP240 is an esophageal Doppler probe for real-time left-ventricular blood flow monitoring. Device inputs: 4 MHz continuous wave ultrasonic carrier signal transmitted from probe tip; reflected ultrasound received from red blood cells. Operation: piezo-electric transducer excitation; probe inserted orally or nasally into esophagus (35-45 cm depth) to insonate descending thoracic aorta. Output: blood flow data processed by CardioQ monitoring system. Used in clinical settings (OR/ICU) by clinicians. Benefits: provides continuous hemodynamic data to assist in fluid status and cardiac output management. Single-use, sterile, flexible probe.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Esophageal Doppler probe; 4 MHz continuous wave ultrasound; piezo-electric transducer; medical grade silicone rubber outer insulating cover; 14 French shaft diameter; single-use; sterile; intended for use with existing CardioQ monitoring system.

Indications for Use

Indicated for adult patients under general anesthesia or sedation in intensive care units requiring real-time monitoring of left-ventricular blood flow via esophageal Doppler ultrasound.

Regulatory Classification

Identification

An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

Predicate Devices

• Deltex Medical CardioQ Probe (K031706)
• Arrow International Hemosonic 100 Esophageal Probe (K972798)

Submission Summary (Full Text)

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2006 MAR B

K052989

# DP240 240 HOUR DOPPLER PROBE

# Appendix 2A

# 510(k) SUMMARY

## (1) Submitter's information

| Name: | Deltex Medical Limited |
|----------------------------------------------------------------------------------------------|------------------------|
| Address: | Terminus Road |
| Chichester | |
| West Sussex | |
| PO19 8TX | |
| U.K. | |
| Official Correspondent: Lawrence Brookfield - Quality Assurance & Regulatory Affairs Manager | |
| Telephone: | 011 44 1243 523174 |
| Fax: | 011 44 1243 532534 |

Date prepared: 18 October, 2005

## (2) Device Identification

| Proprietary name: | 240 Hour Doppler Probe |
|----------------------|--------------------------------|
| Common/usual name: | DP240 |
| Classification name: | Extravascular blood flow probe |

## (3) Identification of predicate devices

The DP240 is substantially equivalent to the following previously cleared devices:

Deltex Medical CardioQ Probe as described in 510(k) No. K031706.

Arrow International Hemosonic 100 Esophageal Probe as described in 510(k) No. K972798

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#### (4) Device Description and Intended Use

When used in conjunction with the Cardiac output and fluid status monitoring system (K031706), the DP240 is designed to provide clinicians with real-time information about leftventricular function by measuring blood flow in the descending thoracic aorta. The probe is designed to operate in a clinical setting in which patients are under general anesthesia or sedated in the intensive care unit.

The DP240 transmits a 4 MHz continuous wave ultrasonic 'carrier' signal from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip.

The DP240 is placed orally or nasally and inserted into the esophagus to a depth of 35 – 45 cm, (approx. 14" - 18") for insonation of the descending thoracic aorta at the 6" thoracic vertebra (approximately). The shaft and tip of the DP240 is the only component in contact with the patient and is manufactured with an outer insulating cover of medical grade silicone rubber. The probe is flexible and has a shaft diameter of 14 French (~4.8 mm, approx. 0.18"). The probe is supplied sterile and is for single-use only in adults.

052989

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR & 2006

Mr. Lawrence Brookfield Quality Assurance & Regulatory Affairs Manager Deltex Medical Limited Terminus Road Chichester PO19 8TX U. K.

Re: K052989

Trade Name: DP240 240 Hour Doppler Probe Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II (two) Product Code: DPT Dated: January 30, 2006 Received: February 2, 2006

Dear Mr. Brookfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & no re review 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 10 use stated in the encreate) to regioned date of the Medical Device Amendments, or to eonimered pror to rills) 2011-03-12, 11:24 provisions of the Federal Food, Drug, de noos mat have e sour a sequire approval of a premarket approval application (PMA). and oosmetie for ( 100) for 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. Lawrence Brookfield

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be actived that it at 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. 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 promated notification "Thesults 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/industry/support/index.html.

Sincerely yours,

Bfimmermanfor

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 052989

# 510(k) Number (if known): - Unknown - not yet-assigned by FDA.

## Device Name:

DP240, 240 Hour Doppler Probe

## Indications For Use:

When used in conjunction with the CardioQ cardiac output and fluid status monitoring system, the DP240 is designed to provide clinicians with real-time information about left-ventricular blood flow. The DP240 is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The DP240 can be placed into the esophagus via oral or nasal insertion in adults.

Prescription Use ✓ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blymmuma
on Sign-Off

sion of Cardiovascula MCBS 3 : U(K) Number

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Appendix 3B