(405 days)
Not Found
No
The description focuses on the physical characteristics and operational principles of a Doppler ultrasound probe, with no mention of AI or ML technologies.
No.
The device is used for monitoring cardiac output and fluid status, which is a diagnostic function, not a therapeutic one. It measures blood flow, it does not treat or cure a condition.
Yes
The device is used for "monitoring of cardiac output and fluid status" by "measuring blood flow velocities in the descending thoracic aorta," which provides information to diagnose and manage patient conditions.
No
The device description details a physical esophageal probe with specific dimensions, materials, and a Doppler transducer, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The I2 probe is an in vivo device. It is inserted into the esophagus of a patient to directly measure blood flow in the descending aorta using ultrasound. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for monitoring cardiac output and fluid status within the patient's body.
Therefore, the I2 probe falls under the category of a medical device used for physiological monitoring in vivo, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DPT
Device Description
Esophageal probe for measuring blood flow in the descending aorta. Sterile. For single use only. Overall length 89 cm (35"). Shaft construction: Spring enclosed in silicone rubber. Shaft color: Clear (non-pigmented) shaft. Shaft flexibility: 0.095 N. Main shaft diameter: 14 FG (~4.8 mm). Distal tip diameter: 19FG (~6.3 mm). Maximum Usage time (hours): 6, 24 or 72. Main shaft wall thickness: 0.03" (~0.7mm). Marks in the shaft: The probe shaft has three depth markers at 35, 40 and 45 cm. Color of transducer head: "clear" (non-pigmented). Color of the molded connector: "white" (pigmented). Color of the shaft: "clear" (non-pigmented). Connection to the monitor: non-reversible connector with ROM to identify probe type. Doppler transducer / Central frequency: 4MHz. Doppler transducer / Global maximum output: 195 mW/cm². Doppler transducer / Mechanical index: 0.039. Spring wire: 0.030" (0.76 mm) diameter to BS5216 HS3, Pre-galvanized. Spring length: 550mm (+/- 25 mm). Spring internal diameter: 1.80/2.00 mm. Spring external diameter: 3.30/3.50 mm. Spring pitch: The spring has fewer turns per unit of length (it has a larger pitch than DP 240). ROM memory: This ROM memory is characteristic for the particular probe. Mode of operation: Esophageal probe transmits and receives 4 MHz Continuous Wave Doppler (CWD) ultrasound 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. Signals are returned via the Patient Interface Cable (PIC) to CardioQ Monitor. This permits to measure blood flow velocities in the descending thoracic aorta. Compatible Monitor: CardioQ monitor. Rx Status: Rx. Physicians Caution included in labeling: Yes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
esophagus, descending aorta
Indicated Patient Age Range
16 years of age or older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2120 Extravascular blood flow probe.
(a)
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.(b)
Classification. Class II (performance standards).
0
K0735-93
JAN 2 9 2009
Deltex Medical Limited Terminus Road Chichester United Kingdom, PO19 8TX Tel: 011 44 1243 523174 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
1
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·
2/6
2
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
'I₂n-series'
Subject Device | Deltex Medical
'DP240'
Predicate Device #1 | Deltex Medical
'CardioQ Probe'
Predicate Device #2 | Arrow
'Hemosonic 100 Esophageal Probe'
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
probe | 240 Hour Doppler
Probe | Esophageal
Doppler Monitor
Probe | Trans-esophageal
Probe & Sterile
Jacket |
| product number | 9070 - 7015
9070 - 7016
9070 - 7017 | 9070- 7006 | 9050 - 7001 | HSP-02150 &
HSS-02150 |
| Device Description | | | | |
| General
description | Esophageal probe
for measuring
blood flow in the
descending aorta
Sterile
For single use only | same | same | Trans-esophageal
probe to provide
PWD Doppler and
M-mode
measurement of
aortic blood
velocity and aortic
diameter,
respectively.
Re-usable
(with protective
sheath) |
| Overall length | 89 cm (35") | same | 90 cm (35.5") | 61 cm (24") |
| Shaft
construction | Spring enclosed in
silicone rubber | same | same | same |
| Shaft color | Clear (non-
pigmented) shaft | same | White (Pigmented) | Black |
| Feature | Deltex Medical
'I₂n-series' | Deltex Medical
'DP240' | Deltex Medical
'CardioQ Probe' | Arrow
'Hemosonic 100
Esophageal Probe' |
| | Subject Device | Predicate Device
#1 | Predicate Device
#2 | Predicate Device
#3 |
| Shaft flexibility
(N) | 0.095 | 1.57 | 1.60 | 3.43 |
| Main shaft
diameter | 14 FG
(4.8 mm) | same | 17 FG 5.5 mm) | 20 FG
(
(~7 mm) |
| Distal tip
diameter | 19FG
(~6.3 mm) | same | same | 20 FG
(~7 mm) |
| Maximum Usage
time (hours) | 6, 24 or 72 | Probe life (time-
out): single use