(405 days)
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.
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 (N) 0.095. 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.
The provided document is a 510(k) Summary for the Deltex Medical Ltd I2n Series Doppler Probe. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with specific acceptance criteria and performance data for the subject device.
Therefore, many of the requested elements regarding acceptance criteria, study design, and performance metrics are not explicitly stated within this 510(k) summary. The document focuses on comparing the design and materials of the new I2n Series probe to existing predicate devices (DP240 Hour Doppler Probe, CardioQ Probe, and Hemosonic 100 Esophageal Probe). The "study" mentioned is implicitly a comparison of physical and operational specifications to demonstrate equivalence, rather than a clinical performance study with defined acceptance criteria.
Specific answers to your questions based on the provided text:
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Table of acceptance criteria and the reported device performance:
The document does not explicitly present acceptance criteria or reported device performance in the format of a clinical performance study with quantitative results against predefined thresholds. Instead, it provides a comparative table outlining the features of the subject device (I2n-series) against three predicate devices. The "performance" demonstrated is through feature-by-feature comparison, indicating that the new device is either identical or has minor, non-significant differences from the predicates, particularly highlighting the improved shaft flexibility.Implicit Comparison Table (derived from the document's comparative table):
| Feature | Acceptance Criteria (based on Predicate) | Deltex Medical 'I₂n-series' Performance (reported) |
|---|---|---|
| Overall length | ~89-90 cm (from predicates) | 89 cm (35") - Same as DP240 |
| Shaft construction | Spring enclosed in silicone rubber | Same |
| Shaft color | Clear (non-pigmented) or White (pigmented) | Clear (non-pigmented) shaft - Difference from CardioQ, but functionally equivalent or improved by removing pigment. |
| Shaft flexibility (N) | E.g., < 1.6 N (from DP240/CardioQ) | 0.095 N - Significantly improved (lower resistance). This is a key difference highlighted as an improvement for easier insertion. |
| Main shaft diameter | ~4.8 mm or ~5.5 mm (from predicates) | 14 FG (~4.8 mm) - Same as DP240. |
| Distal tip diameter | ~6.3 mm or ~7 mm (from predicates) | 19FG (~6.3 mm) - Same as DP240 and CardioQ. |
| Maximum Usage time | Single use; < 10 days/240 hours | 6, 24 or 72 hours (Single use) - Consistent with predicates DP240/CardioQ in 'single use' and 'time-out' concept. |
| Main shaft wall thickness | ~0.7 mm or ~1.0 mm (from predicates) | 0.03" (~0.7mm) - Same as DP240. |
| Depth markers | Markers at various lengths (e.g., 35, 40, 45 cm) | Three depth markers at 35, 40 and 45 cm. - Similar to predicates, with more markers than CardioQ. |
| Transducer head color | "clear" (non-pigmented) or "white" (pigmented) | "clear" (non-pigmented) - Difference from predicates, but functionally equivalent or improved. |
| Molded connector color | "white" (pigmented) | "white" (pigmented) - Same as Deltex predicates. |
| Spring pitch | More turns per unit length (smaller pitch) | Fewer turns per unit of length (larger pitch than DP240). - This is a key difference contributing to improved flexibility (0.095N vs 1.57N). |
| Doppler frequency | 4 MHz or 5 MHz (from predicates) | 4 MHz - Same as Deltex predicates. |
| Doppler output | < 195 mW/cm² (from predicates) | 195 mW/cm² - Same as Deltex predicates. |
| Mechanical index | < 0.089 (from predicates) | 0.039 - Same as Deltex predicates. |
| Compatible Monitor | CardioQ monitor (for Deltex devices) | CardioQ monitor - Same as Deltex predicates. |
| Indication for Use | Oral/nasal insertion, anesthetized/sedated patients | Oral or nasal use in anaesthetized or sedated patients; nasal use in conscious and sedated patients. - Expanded indication due to flexibility improvement. |
The "acceptance criteria" here are essentially "substantially equivalent to" or "demonstrates an equivalent or improved characteristic compared to" the predicate devices for each feature. The study demonstrates this equivalence through a detailed comparison of specifications and materials.
2. Sample size used for the test set and the data provenance:
No specific "test set" with a defined sample size (e.g., number of patients or cases) is described in the context of a clinical performance study. The data provenance is from internal testing and comparison against the specifications of existing devices, manufactured by Deltex Medical Ltd, located in the United Kingdom. This is a comparison of device specifications and changes rather than a clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set requiring expert ground truth establishment is described. The assessment is based on engineering specifications and comparison with predicate devices. -
Adjudication method for the test set:
Not applicable, as no clinical test set requiring adjudication is described. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an extravascular blood flow probe, not an AI-assisted diagnostic imaging device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. -
The type of ground truth used:
The "ground truth" implicitly used for demonstrating substantial equivalence is the established performance and safety profile of the predicate devices based on their 510(k) clearances and recognized standards for material, manufacturing, and performance characteristics. For instance, the stated flexibility (0.095 N) is a directly measured characteristic of the new device which is then compared against the measured flexibility of the predicate. -
The sample size for the training set:
Not applicable, as there is no machine learning or AI component requiring a training set. -
How the ground truth for the training set was established:
Not applicable.
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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
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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·
2/6
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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'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 Dopplerprobe | 240 Hour DopplerProbe | EsophagealDoppler MonitorProbe | Trans-esophagealProbe & SterileJacket |
| product number | 9070 - 70159070 - 70169070 - 7017 | 9070- 7006 | 9050 - 7001 | HSP-02150 &HSS-02150 |
| Device Description | ||||
| Generaldescription | Esophageal probefor measuringblood flow in thedescending aortaSterileFor single use only | same | same | Trans-esophagealprobe to providePWD Doppler andM-modemeasurement ofaortic bloodvelocity and aorticdiameter,respectively.Re-usable(with protectivesheath) |
| Overall length | 89 cm (35") | same | 90 cm (35.5") | 61 cm (24") |
| Shaftconstruction | Spring enclosed insilicone 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 100Esophageal Probe' |
| Subject Device | Predicate Device#1 | Predicate Device#2 | Predicate Device#3 | |
| Shaft flexibility(N) | 0.095 | 1.57 | 1.60 | 3.43 |
| Main shaftdiameter | 14 FG(~4.8 mm) | same | 17 FG(~ 5.5 mm) | 20 FG(~7 mm) |
| Distal tipdiameter | 19FG(~6.3 mm) | same | same | 20 FG(~7 mm) |
| Maximum Usagetime (hours) | 6, 24 or 72 | Probe life (time-out): single use< 10 days/240hours | Probe life (time-out): single use< 10 days/240hours | indefinite(re-usable probewith single usesheath) |
| Main shaft wallthickness | 0.03" (~0.7mm) | 0.03" (~0.7mm) | 0.04" (~1.0mm) | Not known |
| Marks in the shaft | The probe shafthas three depthmarkers at 35, 40and 45 cm. | same | Same, but onlytwo depthmarkers at 35 and40 cm. | 4 depth markersat 25, 30, 35 and40 cm |
| Color oftransducer head | "clear"(non-pigmented) | white(pigmented) | white(pigmented) | white |
| Color of themolded connector | "white"(pigmented) | white(pigmented) | white(pigmented) | The connectioncable is coveredwith a blackhousing |
| Color of the shaft | "clear" (non-pigmented) | same | white (pigmented) | black |
| Connection to themonitor | non-reversibleconnector withROM to identifyprobe type | same | same | Connection cablemade of coaxialcables. The cableis symmetrical andeach of its endshas the samemale connectorwhich locks by asimple clickmechanism,without thread orbayonet. Onlyneeds to align thered markers andgently push or pullto plug or unplugthe connectorto/from its base. |
| Dopplertransducer /Central frequency | 4MHz | same | same | 5 MHz |
| Dopplertransducer /Global maximumoutput | 195 mW/cm² | same | same | 121 mW/cm² |
| Dopplertransducer /Mechanical index | 0.039 | same | same | 0.089 |
| 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 |
| Spring wire | 0.030" (0.76 mm) diameter toBS5216 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'I₂n-series'Subject Device | Deltex Medical'DP240'Predicate Device #1 | Deltex Medical'CardioQ Probe'Predicate Device #2 | ArrowHemosonic 100Esophageal Probe'Predicate Device #3 |
| Mode of operation | Esophageal probetransmits andreceives 4 MHzContinuous WaveDoppler (CWD)ultrasound fromthe probe tip at afixed angle to thedescending aorta,by excitation of apiezo-electrictransducer. Theultrasound isreflected by thered blood cells andis received by aseparatetransducer in theprobe tip. Signalsare returned viathe PatientInterface Cable(PIC) to CardioQMonitor. Thispermits tomeasure bloodflow velocities inthe descendingthoracic aorta. | same | same | The principle ofoperation is basedon thesimultaneous,independent, real-time ultrasoundmeasurements ofaortic cross-section and bloodvelocity, todetermine theinstantaneousdescending AorticBlood Flow("ABF"). Theflowmeter uses atransesophagealprobe with twoultrasonictransducersinserted into thepatient'sesophagus, eithertrans-orally ortrans-nasally, andis externallyorientable. Onetransducer is anM-modeechograph at 10MHz whichmeasures theCSA, and other isa pulsed Dopplertransducer at 5MHz whichmeasures bloodvelocity. AorticBlood Flow is ameasurements ofCardiac Output. |
| CompatibleMonitor | CardioQ monitor | same | same | HemoSonic 100Monitor |
| Rx Status | Rx | same | same | same |
| PhysiciansCaution includedin 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
Page 23
§ 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).