(62 days)
Not Found
No
The device description relies on a physical principle (transit time difference of ultrasonic signals) and does not mention any computational methods indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a flowmeter intended for measurement during surgery, not for treatment or therapy. Its purpose is diagnostic (measurement of blood volume flow), which informs surgical decisions but doesn't directly provide therapy.
Yes
The device is described as estimating "blood volume flow" which is a measurement of a physiological parameter. This measurement provides information that can be used for diagnosis or guidance during surgery.
No
The device description explicitly mentions "two ultrasonic transducers" and a "flat reflector," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device measures blood volume flow during surgery by using ultrasound directly on the blood vessel. It is not analyzing a sample taken from the body.
- Intended Use: The intended use is for "accurate transit time blood volume flow measurements during cardiovascular, vascular and transplantation surgery," which is an in-vivo measurement.
Therefore, this device falls under the category of a medical device used for in-vivo measurement, not an in-vitro diagnostic.
N/A
Intended Use / Indications for Use
The Medi-Stim Butterfly Flowmeter estimates blood volume flow by measuring the transit time difference between an ultrasonic signal propagated through a blood vessel in the downstream direction and one propagated in the upstream direction. It is intended for accurate transit time blood volume flow measurements during cardiovascular, vascular and transplantation surgery.
The same indications for use apply to the Medi-Stim flowmeter as the predicate device: intraoperatively through a venous or arterial wall of an adult or pediatric patient to measure the approximate instantaneous and average blood volume flow through exposed peripheral and/or cardio-thoracic veins or arteries. It is not intended for fetal use.
The device is also indicated for:
- Diagnostic ultrasound imaging or fluid flow analysis of the human body for Intraoperative applications.
- Specific probes are intended for volume flow measurements during cardiovascular, vascular and transplantation surgery.
- ClampOn probes are intended for transit-time volume flow measurements in tubings.
- InLine probes are intended for transit-time volume flow measurements in tubings; not for clinical use.
Product codes
90 ITX, 74 DPT, 74 DPW, 74 DSK
Device Description
The Medi-Stim Butterfly Flowmeter estimates blood volume flow by measuring the transit time difference between an ultrasonic signal propagated through a blood vessel in the downstream direction and one propagated in the upstream direction. The measuring unit consists of two ultrasonic transducers on one side of the vessel aimed at a common point on a flat reflector on the other side of the vessel.
The transit time signal processing is performed by hardware that uses algorithms similar to an ultrasound scanner, and the received ultrasound phase shifts are processed digitally. The flowmeter displays the measurement results with a flow curve and its associated mean flow value. All other measurement results are displayed simultaneously on an active matrix touch screen. The system utilizes a Pentium microprocessor and software developed in C++ running on Windows '95. The probes have a flat front face design. The system can measure mean flow value and flow volume patterns, simulated Doppler sound, pulsatility index, instant Q value, flow integral, and vascular resistance. It supports 1 or 2 channels and has ancillary input. It features automatic flow probe zero line calibration (EEPROM) and a touch screen or keyboard user interface with an active matrix 13" display. Documentation can be printed or stored in a patient database on a hard disk.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic signal / Diagnostic ultrasound imaging
Anatomical Site
Blood vessel (cardiovascular, vascular, transplantation surgery relevant vessels), venous or arterial wall, exposed peripheral and/or cardio-thoracic veins or arteries.
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Intended for use intraoperatively during cardiovascular, vascular and transplantation surgery.
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.)
Probe accuracy: Perivascular: ±10%; Cardiac output: ±15%; Tubings: ±5%
Acoustic Output: MI
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
510(k) - Medi-Stim Butterfly Flowmeter 510(k) Summary
4.9. 510(k) Summary
510(k) Summary
as required by 807.92 (c)
for Medi-Stim Butterfly Flowmeter, BF1000 - BF2004
Prepared June 28th, 1999
| Submitted by: | Medi-Stim A/S |
|---|---|
| Sandakerveien 110 | |
| P.O. Box 35 Grefsen | |
| N-0475 Oslo | |
| Norway | |
| tel. +47 23 05 96 70 (direct), +47 23 05 96 60 (switch board) | |
| fax +47 23 05 96 61 | |
| Contact Person: | Jon H. Hoem, VP International Sales & Marketing |
| Device Trade Name: | Medi-Stim Butterfly Flowmeter |
| Common Name: | Cardiovascular Blood Flowmeter |
| Classification: | Class II |
| Predicate Device: | Transonic Flowmeter |
| Transonic Systems. Inc. | |
| 34 Dutch Mill Road | |
| Ithaca, NY 14850 | |
| K872048 |
Description of Device:
The Medi-Stim Butterfly Flowmeter estimates blood volume flow by measuring the transit time difference between an ultrasonic signal propagated through a blood vessel in the downstream direction and one propagated in the upstream direction. The measuring unit consists of two ultrasonic transducers on one side of the vessel aimed at a common point on a flat reflector on the other side of the vessel.
Intended Use of Device:
:
. 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992
1
It is intended for accurate transit time blood volume flow measurements during cardiovascular, vascular and transplantation surgery.
Substantial Equivalence to Predicate Device:
The intended use of the Transonic Flowmeter is intraoperatively through a venous or arterial wall of an adult or pediatric patient to measure the approximate instantaneous and average blood volume flow through exposed peripheral and/or cardio-thoracic veins or arteries. It is not intended for fetal use. The same indications for use apply to the Medi-Stim flowmeter.
Both the Medi-Stim Butterfly Flowmeter and the Transonic Flowmeter uses the transit time principle to measure volume flow. The main differences between the systems lie in the implementation and presentation of the measurement results. Medi-Stim has utilized a commercial available platform and developed a transit time technology that interfaces with this platform. The transit time signal processing is performed by hardware that uses algorithms similar to an ultrasound scanner, and the received ultrasound phase shifts are processed digitally. The flowmeter displays the measurement results with a flow curve and it's associated mean flow value. All other measurement results are displayed simultaneously on an active matrix touch screen. The predicate utilizes hardware that needs more calibration points and where the signal processing is mainly analog.
There is also a difference with regard to the design of the transit time probes which in the case of Medi-Stim has a flat front face design providing a more stable and reproducible measurement.
However, there is no safety or effectivity issues associated with these differences. The table below summarizes the differences between the Medi-Stim flowmeter and the predicate device.
2
| Medi-Stim Butterfly Flowmeter vs. the predicate device | ||
|---|---|---|
| The Medi-Stim Butterfly Flowmeter | Transonic Flowmeter | |
| 1. Intended use | Cardiovascular, vascular and transplantation surgery | Cardiac surgery, vascular reconstructions and transplanted organs |
| 2. Patient group | Adult and pediatric | Adult and pediatric |
| 3. Flow measurements | ||
| Technology | Transit time | Transit time |
| No. of channels | 1 or 2 | 1 or 2 |
| Measured parameters | Mean flow value and flow volume patterns | Mean flow value + "instantaneous value" |
| Simulated Doppler sound | Yes | No |
| Type of probes | Perivascular, cardiac output and tubing measurements | Perivascular, cardiac output and tubing measurements |
| Perivascular probe design | Flat Front Face Design | Angular Front Face Design |
| Probe sizes | 1.5mm – 35mm | |
| 1/8" – ½" | 6mm, 32mm | |
| 3/8" | ||
| (Whole range of probes added later) | ||
| Probe accuracy | Perivascular: ±10% | |
| Cardiac output: ±15% | ||
| Tubings: ±5% | Perivascular: ±10% | |
| Cardiac output: ±15% | ||
| Tubings: ±5% | ||
| Probe sterilization methods | Ethylene Oxide Gas (ETO), formaldehyde, Steris, J & J Sterrad, or 5% buffered glutaraldehyde | ETO or standard/cold liquid sterilization |
| Probe count limitation | Yes | No |
| Medi-Stim Butterfly Flowmeter vs. the predicate device | ||
| The Medi-Stim Butterfly | ||
| Flowmeter | Transonic Flowmeter | |
| 4. Pressure measurements | ||
| Intended use | Intraoperatively during surgery | None |
| Technology | Commercial available | |
| disposable pressure transducers | N/A | |
| Alarm settings | No | N/A |
| 5. Derived parameters | ||
| Flow parameters | ||
| Pulsatility Index | ||
| Instant Q value | ||
| Flow integral | Yes | |
| Yes | ||
| Yes | No | |
| No | ||
| No | ||
| Vascular resistance | Yes | No |
| Auxiliary input | Yes | No |
| 6. User interface | ||
| Flow probe zero line calibration | Automatic (EEPROM) | Manual |
| Controls | Touch screen or keyboard | Push-button |
| Read-out | Active matrix 13" display | LED display + analog meter |
| Documentation | Patient database (hard disk) or | |
| print-out | None | |
| 7. Technology platform | ||
| Hardware | Pentium microprocessor | |
| Proprietary digital transit time | ||
| front end | Proprietary analog transit time | |
| front end and dedicated | ||
| electronics | ||
| Software | Windows '95 and software | |
| developed in C++ | All algorithms programmed in | |
| hardware | ||
| 8. Acoustic Output | MI Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 |
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Paul M. Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
Edward A. Boyanom
CAPT Daniel G. Schul Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
7
Diagnostic Ultrasound Indications for Use Form
PJ100011 1.5mm Medi-Stim transit-time probe without handle (to be used with BF1000 -- BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | • | |||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PJ100011 1.5mm Medi-Stim transit-time probe without handle (J-reflector)
interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use (Per 21 CFR 801.109)
David A. Gynn
(Division Sign-Off) Division of Reproductive, Abdominal, EN
Radiological Devices
510(k) Number K992305
8
Diagnostic Ultrasound Indications for Use Form
PC100181, PC100182, PC103161, PC103162, PC100141, PC100142, PC100382, PC100122, PC100123, PC100124: 1/8", 3/16", ¼", 3/8" and ½" ClampOn Medi-Stim transit-time probe (to be used with BF1000 - BF2004)
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | N |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PC100181, PC100182, PC103161, PC103162, PC100141, PC100142,
PC100382, PC100383, PC100123, PC100124: 1/8", 3/16", ¼", 3/8" and ½" ClampOn Medi-
Stim transit-time probe; interfaced with a transit-time volume flow measurements in tubings. Placed around tubings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deyice Evaluation (OL
Prescription Use (Per 21 CFR 801.109)
David A. Segner
Reproductive odominal
9
Diagnostic Ultrasound Indications for Use Form
PI100181, PI100141, PI100381, PI100121: 1/8", ¼", 3/8" and ½" InLine Medi-Stim transit-time probe (to be used with BF1000 – BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | N |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Pl100181, Pl100141, Pl100121: 1/8", ¼", 3/8″ and ½" InLine Medi-Stim transit-time probe; interfaced with a transit-time volume flowmeter for volume flow measurements in
tubings. Spliced into tubings - not for clinical use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF IN Concurrence of CDRH, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)
Thrist A. Segerstrom
on of Reproductive, Abdominal, ENT
Radiological Devices
510(k) Number K992305
10
Diagnostic Ultrasound Indications for Use Form
PR100151. PR100181. PR100211. PR100251. PR100301 and PR100351 15mm, 18mm, 21mm, 25mm, 30mm and 35mm Medi-Stim transit-time probe without handle (to be used with BF1000 – BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PR100151, PR100181, PR100251, PR100251, PR100301 and PR100351: 15mm,
18mm, 21mm, 25mm, 30mm and 35mm Medi-Stim transit-time probe without handle; interfaced with a
transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and
transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (6 Prescription Use (Per 21 CFR 801.109)
510(k) Number
David G. Nguyen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
(Division of Reproductive, Abdominal, ENT,
and Radiological Devices
11
Diagnostic Ultrasound Indications for Use Form
PA100271 and PB100271 27mm Medi-Stim transit-time probe without handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100271 and PB100271 27mm Medi-Stim transit-time probe without handle;
510 k
interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David G. Seymann
ision Sign-Off) ivision of Reproductive, Abdominal, El and Radiological I
12
Diagnostic Ultrasound Indications for Use Form
PA100211 and PB100211 21mm Medi-Stim transit-time probe without handle (to be used with BF1000 – BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100211 21mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)
Yamil h. Syam
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D
510(k) Number K99236
13
Diagnostic Ultrasound Indications for Use Form
PA100161 and PB100161 16mm Medi-Stim transit-time probe without handle (to be used with BF1000 – BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100161 and PB100161 16mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
(Please do not write below this line - continge on another page if needed) Concurrence of CDRH, Office of Deyice Evaluation (ODF Prescription Use (Per 21 CFR 801.109)
Thind A. Segerson
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT and Radiological De
510(k) Number
14
Diagnostic Ultrasound Indications for Use Form
PA100122 and PB100122 12mm Medi-Stim transit-time probe with handle (to be used with BF1000 – BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | . | |||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100122 and PB100122 12mm Medi-Stim transit-time probe with handle;
interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| (Division Sign-Off) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
K992305
510(k) Number
15
Diagnostic Ultrasound Indications for Use Form
PA100121 and PB100121 12mm Medi-Stim transit-time probe without handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100121 and PB100121 12mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF Concurrence of CDRH, Office of Device Evalyation (OD Prescription Use (Per 21 CFR 801.109) AN
oductive, Abdominal, El
16
Diagnostic Ultrasound Indications for Use Form
PA100082 and PB100082 8mm Medi-Stim transit-time probe with handle (to be used with BF1000 – BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (specify) | Other | |||||||||||
| (specify) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (specify) | N | |||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100082 and PB100082 8mm Medi-Stim transit-time probe with handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation, (ODE) |
|---|
| --------------------------------------------------------- |
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992305
17
Diagnostic Ultrasound Indications for Use Form
PA100081 and PB100081 8mm Medi-Stim transit-time probe without handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | • | ||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100081 and PB100081 2mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deyice Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Severson
(Division Sign-Off)
Division of Reproductive, Abdominat, ENT,
and Radiological Devices
510(k) Number K992305
18
Diagnostic Ultrasound Indications for Use Form
PA100052 and PB100052 5mm Medi-Stim transit-time probe with handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100052 and PB100052 5mm Medi-Stim transit-time probe with handle;
interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
のお店舗の賃貸マンション (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション (賃貸マンション) (賃貸マンション (賃貸マンション) (賃貸マンション (賃貸マンション) (賃貸マンション (賃貸マンション) (賃貸マンション (賃貸マンション) (賃貸マンション (賃貸マンション) (賃貸マンシ
and the same of the same of the same of the same of the states of the states and
510(k) Number .
vascular and transplantation surgery.
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices |
4
92305
19
Diagnostic Ultrasound Indications for Use Form
PA100051 and PB100051 5mm Medi-Stim transit-time probe without handle (to be used with BF1000 – BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100051 and PB100051 5mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David h. Segerson
(Division Sign-Off) sion Sign-Off)
sion of Reproductive, Abdominal, ENT
Radiological Devices
510(k) Number K992305
20
Diagnostic Ultrasound Indications for Use Form
PA100042 and PB100042 4mm Medi-Stim transit-time probe with handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100042 and PB100042 4mm Medi-Stim transit-time probe with handle;
interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
David A. Sepsion
Y
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
Devices
21
Diagnostic Ultrasound Indications for Use Form
PA100041 and PB100041 4mm Medi-Stim transit-time probe without handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100041 and PB100041 4mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
510(k) Number
and States State Mariel - Books Callery Contral Collect - Society - Society - Society - Society - Society - Society - Society - Society - Society - Society - Society - Societ
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices |
22
Diagnostic Ultrasound Indications for Use Form
PA100032 and PB100032 3mm Medi-Stim transit-time probe with handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100032 and PB100032 3mm Medi-Stim transit-time probe with handle;
interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Office of Device Evaluation (ODE)
David A. Symon
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological De
23
Diagnostic Ultrasound Indications for Use Form
PA100031 and PB100031 3mm Medi-Stim transit-time probe without handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100031 and PB100031 3mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE Prescription Use (Per 21 CFR 801.109)
Yavid A. Segerson
(Division Sign-Off)
(Division Sign-Off),
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
24
Diagnostic Ultrasound Indications for Use Form
PA100022 and PB100022 2mm Medi-Stim transit-time probe with handle (to be used with BF1000 - BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100022 and PB100022 2mm Medi-Stim transit-time probe with handle;
interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular,
vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel A. Seaman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological I
510(k) Number
25
Diagnostic Ultrasound Indications for Use Form
PA100021 and PB100021 2mm Medi-Stim transit-time probe without handle (to be used with BF1000 -- BF2004)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | • | |||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: PA100021 and PB100021 2mm Medi-Stim transit-time probe without handle; interfaced with a transit-time volume flowmeter for volume flow measurements during cardiovascular, vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Seymann
Division of Reproductive, Abdominal, EN and Radiological D
510(k) Number
26
Diagnostic Ultrasound Indications for Use Form
Medi-Stim Butterfly Flowmeter BF1000 Single channel flowmeter BF2000 Dual channel flowmeter BF1001 Single channel flowmeter with AUX/ECG channel BF2001 Dual channel flowmeter with AUX/ECG channel BF1004 Single channel flowmeter with 2 pressure channels and two AUX/ECG channels BF2004 Dual channel flowmeter with 2 pressure channels and two AUX/ECG channels
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | ||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Medi-Stim Butterfly Flowmeter BF1000 - BF2004; transit-time volume flowmeter;
volume flow measurements during cardiovascular, vascular and transplantation surgery.
(PLEASE DO NOT WRITE BELOW THIS YINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH/Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Hamid A. Slammon
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological De
510(k) Number