Deltex Medical KDP72 Doppler Probe

K142932 · Deltex Medical Limited · DPT · Jan 22, 2015 · Cardiovascular

Device Facts

• Record ID: K142932
• Device Name: Deltex Medical KDP72 Doppler Probe
• Applicant: Deltex Medical Limited
• Product Code: DPT · Cardiovascular
• Decision Date: Jan 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ for Monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger, 50cm (20") to 170cm (67") in height.

Device Story

KDP72 Doppler Probe is an oral extravascular blood flow probe used with CardioQ-EDM/CardioQ-EDM+ systems. Device consists of a spring-reinforced silicone shaft with an ultrasonic transmitting/receiving tip. Used in clinical settings (e.g., OR) by clinicians to monitor cardiac output and fluid status in anesthetized pediatric patients. The probe transmits ultrasonic signals to measure blood flow; the monitor processes these signals to provide hemodynamic data. Output assists clinicians in fluid management and hemodynamic optimization, potentially improving patient outcomes during anesthesia. The KDP72 features a shorter length, increased depth markings, and an open-coil spring design compared to previous models to enhance flexibility for pediatric anatomy.

Clinical Evidence

Bench testing only. Performance data provided in accordance with FDA guidance 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'. Comparative flexibility testing conducted against predicate devices.

Technological Characteristics

Extravascular blood flow probe; spring-reinforced silicone shaft; ultrasonic transducer tip. Biocompatibility per ISO 10993-5, -7, -10. Electrical safety per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Sterilization via ISO 11135-1. Packaging per ISO 11607-1/2. Single-patient use.

Indications for Use

Indicated for monitoring cardiac output and fluid status in anesthetized pediatric patients 15 years of age or younger, with heights between 50cm and 170cm, via oral esophageal placement.

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 I2n Series Doppler Probe (K073593)
• Deltex Medical Ltd DP240 Doppler Probe (K052989)
• Sometic Dynemo 3000 (K972798)

Reference Devices

• CardioQ-EDM (K111542)
• CardioQ-EDM+ (K132139)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 22, 2015

Deltex Medical Limited % Neil Armstrong RA Advisor To Deltex Medical Meddiquest Limited Quest Science, Orton Malborne Peterborough, PE2 5XS GB

Re: K142932

> Trade/Device Name: Deltex Medical KDP72 Doppler Probe Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II Product Code: DPT Dated: October 10, 2014 Received: October 14, 2014

Dear Neil Armstrong,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Melissa A. Torres -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

Device Name KDP72, 72 Hour Doppler Probe

Indications for Use (Describe)

The probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ for Monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger, 50cm (20") to 170cm (67") in height.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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#### Contains Nonbinding Recommendations Appendix G

## Appendix G: Example Diagnostic Ultrasound Indications For Use Format

CardioQ-EDM and CardioQ-EDM+ cardiac output and fluid status monitor System: KDP72 , 72 Hour Doppler Probe Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows;

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | N | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

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Image /page/4/Picture/1 description: The image shows the logo for "Deltex medical". The word "Deltex" is in a large, bold, blue font. Below "Deltex" is the word "medical" in a smaller, light gray font. The logo is simple and clean, with a focus on the company name.

Deltex Medical Limited Terminus Road Chichester United Kingdom, PO19 8TX 011 44 1243 774837 Tel: Fax: [phone]

## 510(k) Summary

as required by 21 CFR 807.92(c)

#### Submitter and Owner:

This Premarket Notification, 510(k), is submitted by: Graham Lowe Marketing and Operations Director For and on behalf of the Owner: Deltex Medical Ltd Terminus Road Chichester West Sussex PO19 8TX United Kingdom Tel: [phone] Fax: [phone]

#### Date

This Summary was prepared on September 22, 2014

## 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

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K142932 page 2 of 4

#### Proprietary Name:

Deltex Medical Ltd KDP72 Doppler Probe

#### Establishment Reqistration 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

## Establishment Registration Number 3002807091

United Kingdom

### Substantial Equivalence:

The Deltex Medical Ltd KDP72 Doppler Probe is substantially equivalent in design, use and materials to the:

Deltex Medical Ltd I2n Series Doppler Probe - K073593 Deltex Medical Ltd DP240 Doppler Probe - K052989 and the Sometic Dynemo 3000 - K972798, now Arrow Hemosonic probe

Like the Inn Series Probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ systems, K111542 and K132139 respectively.

The Deltex Medical Ltd KDP72 Pediatric Doppler Probe is designed to be a shorter version of the current legally marketed Dp240 product with more depth markings. It has an open-coil spring, as used on the 12 series products instead of the closed coil used on the Dp240, to increase flexibility.

The Sometic Dynemo 3000 K972798 has been superseded by the Arrow Hemosonic probe (still K972798) which is indicated for pediatric use for patients above 15kg. The Deltex Medical Ltd KDP72 will be shorter and more flexible enabling it to be indicated for patients above 3kg.

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K142932 page 3 of 4

#### Description:

The Deltex Medical Ltd KDP72 Pediatric Doppler Probe is an oral extravascular blood flow probe designed to work with the CardioQ-EDM and CardioQ-EDM+ Systems (K111542 and K132139 respectively). It consists of a shaft, which is a spring reinforced silicone tube, with an electrical connector on the machine end and an ultrasonic transmitting and receiving tip on the patient end. The tip is fully covered and sealed to the shaft with a silicone rubber boot and by wires running through the shaft to the connector. Visual product identification is provided at the machine end and the device is provided single packed sterile for single patient use.

Standard ultrasonic diagnostic extravascular blood flow probes have been successfully used with pediatric patients; however the KDP72 has been specially designed for pediatric patients with a shorter length, more depth markings and an open coil spring to increase the flexibility.

#### Intended Use:

The probe is for use with Deltex Medical CardioQ-EDM and CardioQ-EDM+ for monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger.

#### Performance Data

The performance data recommended in "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", issued on September 9, 2008, has been included.

Additionally a flexibility test has been conducted on the subject and predicate devices which demonstrates the comparative flexibility.

#### Conclusion

Based on the information above, Deltex Medical Ltd concludes that the Deltex Medical Ltd KDP72 Doppler Probe in substantially equivalent to:

- the Deltex Medical Ltd I2 Series and Dp240 Doppler Probes (K073593 and . K052989), and
- the Arrow International, Inc, Hemosonic 100 Esophageal Probe (K972798 . Sometic Dynemo 3000).

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| Feature | Deltex Medical<br>'KDP72' | Deltex Medical<br>'I₂n-series' | Deltex Medical<br>'DP240' | Arrow<br>'Hemosonic 100 Esophageal Probe' |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| | Subject Device | Predicate Device<br>#1 | Predicate Device<br>#2 | Predicate Device<br>#3 |
| FDA 510k number | This Submission | K073593 | K052989 | K972798 |
| product name | KDP72 | I₂n-series | DP240 Probe | Transesophageal<br>Probe |
| common name | 72 Hour Pediatric<br>Doppler probe | I₂n-series Doppler<br>probe | 240 Hour Doppler<br>Probe | Trans-esophageal<br>Probe & Sterile<br>Jacket |
| product number | 9081-7002 | 9090 - 7015<br>9090 - 7016<br>9090 - 7017 | 9070- 7006 | HSP - 02150 &<br>HSS-02150 |
| Device Description | | | | |
| Sterilization | Sterilized in<br>accordance with<br>ISO11135-1<br>(version of<br>standard current<br>at time of<br>submission) | Sterilized in<br>accordance with<br>ISO11135-1<br>(version of<br>standard current<br>at time of<br>submission) | Sterilized in<br>accordance with<br>ISO11135-1<br>(version of<br>standard current<br>at time of<br>submission) | Unknown |
| Shelf Life | ISO11607-1<br>(version of<br>standard current<br>at time of<br>submission) | ISO11607-1<br>(version of<br>standard current<br>at time of<br>submission) | ISO11607-1<br>(version of<br>standard current<br>at time of<br>submission) | Unknown |
| Biocompatibility | Tested in<br>accordance with<br>ISO 10993-5, ISO<br>10993-10, ISO<br>10993-7 (version<br>of standard<br>current at time of<br>submission) | Tested in<br>accordance with<br>ISO 10993-5, ISO<br>10993-10, ISO<br>10993-7 (version<br>of standard<br>current at time of<br>submission) | Tested in<br>accordance with<br>ISO 10993-5, ISO<br>10993-10, ISO<br>10993-7 (version<br>of standard<br>current at time of<br>submission) | Unknown |
| EMC and<br>Electrical Safety | IEC60601-1,<br>IEC60601-1-2,<br>IEC606001-2-37<br>(version of<br>standard current<br>at time of<br>submission) | IEC60601-1,<br>IEC60601-1-2,<br>IEC606001-2-37<br>(version of<br>standard current<br>at time of<br>submission) | IEC60601-1,<br>IEC60601-1-2,<br>IEC606001-2-37<br>(version of<br>standard current<br>at time of<br>submission) | Unknown |
| Packaging | ISO 11607-1, ISO<br>11607-2 (version<br>of standard<br>current at time of<br>submission) | ISO 11607-1, ISO<br>11607-2 (version<br>of standard<br>current at time of<br>submission) | ISO 11607-1, ISO<br>11607-2 (version<br>of standard<br>current at time of<br>submission) | Unknown |

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