I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016

K073593 · Deltex Medical Limited · DPT · Jan 29, 2009 · Cardiovascular

Device Facts

• Record ID: K073593
• Device Name: I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
• Applicant: Deltex Medical Limited
• Product Code: DPT · Cardiovascular
• Decision Date: Jan 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

Intended Use

The I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I2 is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.

Device Story

Esophageal probe for measuring blood flow in descending aorta; transmits/receives 4 MHz continuous wave Doppler ultrasound via piezoelectric transducer. Input: reflected ultrasound from red blood cells. Output: blood flow velocity signals sent to CardioQ monitor. Used in clinical settings (ICU, OR) by clinicians. Modified spring design increases flexibility for easier nasal insertion in conscious/sedated patients. Non-pigmented shaft/tip cover. Single-use device. Provides real-time hemodynamic data to assist clinicians in cardiac output and fluid status management, potentially improving patient outcomes through optimized fluid therapy.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence established through comparative bench testing of physical properties (flexibility, dimensions) and ultrasound output characteristics against predicate devices.

Technological Characteristics

Esophageal probe; 4 MHz piezoelectric transducer; 14 FG main shaft diameter; 19 FG distal tip; silicone rubber shaft with internal spring (BS5216 HS3 steel); non-pigmented materials; single-use; sterile; connects to CardioQ monitor via non-reversible connector with ROM for probe identification.

Indications for Use

Indicated for monitoring cardiac output and fluid status in patients 16 years or older. Suitable for oral or nasal esophageal placement in sedated or anesthetized patients; nasal placement required for awake patients.

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 Ltd DP240 Hour Doppler Probe (K052989)
• Deltex Medical CardioQ Probe (K031706)
• Arrow International, Inc, Hemosonic 100 Esophageal Probe (K972798)

Submission Summary (Full Text)

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K0735-93

JAN 2 9 2009

Deltex Medical Limited Terminus Road Chichester United Kingdom, PO19 8TX Tel: [phone] 011 44 1243 532534 Fax:

Image /page/0/Picture/3 description: The image shows the logo for Deltex Medical. The logo consists of a stylized wave-like symbol on the left, followed by the words "DELTEX" and "MEDICAL" stacked vertically. The text is in a simple, sans-serif font and is all capitalized. The logo is black and white.

# 510(k) Summary

as required by 21 CFR 807.92

## Owner's Name

Deltex Medical Ltd Address: Terminus Road Chichester West Sussex PO19 8TX United Kingdom Telephone Number: Fax Number: Contact Person:

001 44 1243 523174 001 44 1243 532534 Lawrence Brookfield Regulatory Affairs Manager

### Date

This Summary was prepared on November 12, 2007

## Classification name:

Extravascular blood flow probe

The FDA has classified: "Extravascular blood flow probe" in 21 CFR 870.2120 as a Class II medical device with Product Code DPT

### Common/Usual Name:

probe, blood-flow, extravascular

### Proprietary Name:

Deltex Medical Ltd I2n Series Doppler Probe where n identifies the variant (S, P and C)

5 510(k) Summary or 510(k) Statement

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# Establishment Registration Number:

The device will be manufactured by:

Deltex Medical Ltd Terminus Road Chichester West Sussex PO19 8TX United Kingdom Establishment Registration Number 9680933

and sterilized by: Sterigenics UK, Ltd Cotes Park Estate Somercotes Derbyshire DE55 4NJ United Kingdom Establishment Registration Number 3002807091

## Substantial Equivalence:

The Deltex Medical Ltd I 2n Series Doppler Probe is substantially equivalent in design, use and materials to the:

Deltex Medical Ltd DP240 Hour Doppler Probe - K052989

and like the DP240 probe is for use with the Deltex Medical CardioQ system . 9051-7005 - K031706

The Deltex Medical Ltd I2n Series Doppler Probe is made of the same materials as the Deltex Medical Ltd DP240 Hour Doppler Probe (K052989). The significant differences are that the tip cover (boot) is made of nonpigmented rather than the white material, that is, the white pigment has been removed from the material formulation; and the pitch of the spring increased to improve flexibility for easy of insertion and comfort.

The Deltex Medical Ltd I₂n Series Doppler Probe is intended for the same use as the DP240 probe was cleared for in K052989: oral or nasal use in anaesthetized or sedated patients :

" ... 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." abstract from K052989 indications for use statement.

5 510(k) Summary or 510(k) Statement·

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However the I₂n Series Doppler Probe has a "spring" which has been modified to reduce resistance to insertion; this makes it particularly suitable for nasal use in conscious and sedated patients.

The Deltex Medical Ltd I₂n Series Doppler Probe is manufactured by the same processes as the Deltex Medical Ltd DP240 Hour Doppler Probe (K052989).

The Deltex Medical Ltd I₂n Series Doppler Probe is sterilized under the same conditions as the Deltex Medical Ltd DP240 Hour Doppler Probe (K052989),

The Deltex Medical Ltd I2n Series Doppler Probe, like the DP240 Hour Doppler Probe, is also substantially equivalent to the other Deltex Medical CardioQ Probe included in K031706 and the Arrow International, Inc, Hemosonic 100 Esophageal Probe, K972798.

| Feature | Deltex Medical<br>'I₂n-series'<br><br>Subject Device | Deltex Medical<br>'DP240'<br><br>Predicate Device #1 | Deltex Medical<br>'CardioQ Probe'<br><br>Predicate Device #2 | Arrow<br>'Hemosonic 100 Esophageal Probe'<br><br>Predicate Device #3 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA 510k number | This Submission | K052989 | K031706 | K972798 |
| product name | I₂n-series | DP240 Probe | CardioQ Probe | Transesophageal Probe |
| common name | I₂n-series Doppler<br>probe | 240 Hour Doppler<br>Probe | Esophageal<br>Doppler Monitor<br>Probe | Trans-esophageal<br>Probe & Sterile<br>Jacket |
| product number | 9070 - 7015<br>9070 - 7016<br>9070 - 7017 | 9070- 7006 | 9050 - 7001 | HSP-02150 &<br>HSS-02150 |
| Device Description | | | | |
| General<br>description | Esophageal probe<br>for measuring<br>blood flow in the<br>descending aorta<br><br>Sterile<br><br>For single use only | same | same | Trans-esophageal<br>probe to provide<br>PWD Doppler and<br>M-mode<br>measurement of<br>aortic blood<br>velocity and aortic<br>diameter,<br>respectively.<br><br>Re-usable<br>(with protective<br>sheath) |
| Overall length | 89 cm (35") | same | 90 cm (35.5") | 61 cm (24") |
| Shaft<br>construction | Spring enclosed in<br>silicone rubber | same | same | same |
| Shaft color | Clear (non-<br>pigmented) shaft | same | White (Pigmented) | Black |
| Feature | Deltex Medical<br>'I₂n-series' | Deltex Medical<br>'DP240' | Deltex Medical<br>'CardioQ Probe' | Arrow<br>'Hemosonic 100<br>Esophageal Probe' |
| | Subject Device | Predicate Device<br>#1 | Predicate Device<br>#2 | Predicate Device<br>#3 |
| Shaft flexibility<br>(N) | 0.095 | 1.57 | 1.60 | 3.43 |
| Main shaft<br>diameter | 14 FG<br>(~4.8 mm) | same | 17 FG<br>(~ 5.5 mm) | 20 FG<br>(~7 mm) |
| Distal tip<br>diameter | 19FG<br>(~6.3 mm) | same | same | 20 FG<br>(~7 mm) |
| Maximum Usage<br>time (hours) | 6, 24 or 72 | Probe life (time-<br>out): single use<br>< 10 days/240<br>hours | Probe life (time-<br>out): single use<br>< 10 days/240<br>hours | indefinite<br>(re-usable probe<br>with single use<br>sheath) |
| Main shaft wall<br>thickness | 0.03" (~0.7mm) | 0.03" (~0.7mm) | 0.04" (~1.0mm) | Not known |
| Marks in the shaft | The probe shaft<br>has three depth<br>markers at 35, 40<br>and 45 cm. | same | Same, but only<br>two depth<br>markers at 35 and<br>40 cm. | 4 depth markers<br>at 25, 30, 35 and<br>40 cm |
| Color of<br>transducer head | "clear"<br>(non-pigmented) | white<br>(pigmented) | white<br>(pigmented) | white |
| Color of the<br>molded connector | "white"<br>(pigmented) | white<br>(pigmented) | white<br>(pigmented) | The connection<br>cable is covered<br>with a black<br>housing |
| Color of the shaft | "clear" (non-<br>pigmented) | same | white (pigmented) | black |
| Connection to the<br>monitor | non-reversible<br>connector with<br>ROM to identify<br>probe type | same | same | Connection cable<br>made of coaxial<br>cables. The cable<br>is symmetrical and<br>each of its ends<br>has the same<br>male connector<br>which locks by a<br>simple click<br>mechanism,<br>without thread or<br>bayonet. Only<br>needs to align the<br>red markers and<br>gently push or pull<br>to plug or unplug<br>the connector<br>to/from its base. |
| Doppler<br>transducer /<br>Central frequency | 4MHz | same | same | 5 MHz |
| Doppler<br>transducer /<br>Global maximum<br>output | 195 mW/cm² | same | same | 121 mW/cm² |
| Doppler<br>transducer /<br>Mechanical index | 0.039 | same | same | 0.089 |
| Feature | Deltex Medical<br>'I₂n-series'<br><br>Subject Device | Deltex Medical<br>'DP240'<br><br>Predicate Device #1 | Deltex Medical<br>'CardioQ Probe'<br><br>Predicate Device #2 | Arrow<br>'Hemosonic 100 Esophageal Probe'<br><br>Predicate Device #3 |
| Spring wire | 0.030" (0.76 mm) diameter to<br>BS5216 HS3, Pre-galvanized | same | same | Not known |
| Spring length | 550mm (+/- 25 mm) | same | same | Not known |
| Spring internal diameter | 1.80/2.00 mm | same | same | Not known |
| Spring external diameter | 3.30/3.50 mm | same | same | Not known |
| Spring pitch | The spring has fewer turns per unit of length (it has a larger pitch than DP 240). | The spring has more turns per unit of length (it has a smaller pitch than I₂n). | as DP 240 | Not known |
| ROM memory | This ROM memory is characteristic for the particular probe. | same | same | Not Applicable |
| Feature | Deltex Medical<br>'I₂n-series'<br>Subject Device | Deltex Medical<br>'DP240'<br>Predicate Device #1 | Deltex Medical<br>'CardioQ Probe'<br>Predicate Device #2 | Arrow<br>Hemosonic 100<br>Esophageal Probe'<br>Predicate Device #3 |
| Mode of operation | Esophageal probe<br>transmits and<br>receives 4 MHz<br>Continuous Wave<br>Doppler (CWD)<br>ultrasound from<br>the probe tip at a<br>fixed angle to the<br>descending aorta,<br>by excitation of a<br>piezo-electric<br>transducer. The<br>ultrasound is<br>reflected by the<br>red blood cells and<br>is received by a<br>separate<br>transducer in the<br>probe tip. Signals<br>are returned via<br>the Patient<br>Interface Cable<br>(PIC) to CardioQ<br>Monitor. This<br>permits to<br>measure blood<br>flow velocities in<br>the descending<br>thoracic aorta. | same | same | The principle of<br>operation is based<br>on the<br>simultaneous,<br>independent, real-<br>time ultrasound<br>measurements of<br>aortic cross-<br>section and blood<br>velocity, to<br>determine the<br>instantaneous<br>descending Aortic<br>Blood Flow<br>("ABF"). The<br>flowmeter uses a<br>transesophageal<br>probe with two<br>ultrasonic<br>transducers<br>inserted into the<br>patient's<br>esophagus, either<br>trans-orally or<br>trans-nasally, and<br>is externally<br>orientable. One<br>transducer is an<br>M-mode<br>echograph at 10<br>MHz which<br>measures the<br>CSA, and other is<br>a pulsed Doppler<br>transducer at 5<br>MHz which<br>measures blood<br>velocity. Aortic<br>Blood Flow is a<br>measurements of<br>Cardiac Output. |
| Compatible<br>Monitor | CardioQ monitor | same | same | HemoSonic 100<br>Monitor |
| Rx Status | Rx | same | same | same |
| Physicians<br>Caution included<br>in labeling | Yes | same | same | same |
| Indications for use | | | | |

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2009

Deltex Medical Ltd. c/o Mr. Lawrence Brookfield Regulatory Affairs Manager Terminus Road Chichester, West Sussex PO19 8TX United Kingdom

Re: K073593

Trade/Device Name: I2n Series Doppler Probe Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II (Two) Product Code: DPT Dated: January 26, 2009 Received: January 28, 2009

### Dear Mr. Brookfield:

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. Iisting 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 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Radiological Health

R. vo Anes

fr

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

Enclosure

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# Indications for Use

510(k) Number (if known): Ko73593

Device Name: I2n Series Doppler Probe Indications for Use:

The I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I₂ is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

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

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. h. hmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number: K073593

Page 1 of 1

(Posted November 13, 2003)

4 Indications for Use Statement

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