MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004

K992305 · Medi-Stim A/S · ITX · Sep 8, 1999 · Radiology

Device Facts

• Record ID: K992305
• Device Name: MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
• Applicant: Medi-Stim A/S
• Product Code: ITX · Radiology
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

It is intended for accurate transit time blood volume flow measurements during cardiovascular, vascular and transplantation surgery.

Device Story

Medi-Stim Butterfly Flowmeter estimates blood volume flow using transit time ultrasonic technology; measures time difference between upstream and downstream ultrasonic signals propagated through blood vessels. System uses two ultrasonic transducers aimed at a common reflector on the opposite side of the vessel. Operated intraoperatively by surgeons/clinicians in OR settings. Device features touch screen/keyboard interface; displays flow curves, mean flow values, and derived parameters (pulsatility index, vascular resistance). Includes auxiliary inputs for pressure and ECG. Provides real-time hemodynamic data to assist clinical decision-making during vascular reconstructions and organ transplants. Benefits include stable, reproducible measurements via flat-front probe design and automated zero-line calibration.

Clinical Evidence

Bench testing only. No clinical data presented. Performance validated through comparison of probe accuracy (perivascular ±10%, cardiac output ±15%, tubings ±5%) and acoustic output measurements.

Technological Characteristics

Transit time ultrasonic flowmeter. Hardware: Pentium microprocessor, proprietary digital transit time front end. Probes: Perivascular, cardiac output, and tubing types with flat-front face design. Connectivity: Touch screen/keyboard, auxiliary inputs for pressure/ECG. Sterilization: ETO, formaldehyde, Steris, Sterrad, or glutaraldehyde. Software: C++ based, Windows '95 platform.

Indications for Use

Indicated for adult and pediatric patients undergoing cardiovascular, vascular, or transplantation surgery for intraoperative blood volume flow measurement.

Regulatory Classification

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.

Predicate Devices

• Transonic Flowmeter (K872048)

Submission Summary (Full Text)

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510(k) - Medi-Stim Butterfly Flowmeter 510(k) Summary

K992305

#### 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. [phone] (direct), [phone] (switch board) |
| | fax [phone] |
| 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

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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.

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| 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<br>1/8" – ½" | 6mm, 32mm<br>3/8"<br>(Whole range of probes added later) |
| Probe accuracy | Perivascular: ±10%<br>Cardiac output: ±15%<br>Tubings: ±5% | Perivascular: ±10%<br>Cardiac output: ±15%<br>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<br>Flowmeter | Transonic Flowmeter |
| 4. Pressure measurements | | |
| Intended use | Intraoperatively during surgery | None |
| Technology | Commercial available<br>disposable pressure transducers | N/A |
| Alarm settings | No | N/A |
| 5. Derived parameters | | |
| Flow parameters<br>Pulsatility Index<br>Instant Q value<br>Flow integral | Yes<br>Yes<br>Yes | No<br>No<br>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<br>print-out | None |
| 7. Technology platform | | |
| Hardware | Pentium microprocessor<br>Proprietary digital transit time<br>front end | Proprietary analog transit time<br>front end and dedicated<br>electronics |
| Software | Windows '95 and software<br>developed in C++ | All algorithms programmed in<br>hardware |
| 8. Acoustic Output | MI < 0,022<br>Ispta < 0,189 mW/cm²<br>Isppa < 0,0462 W/cm²<br>Isata < 0,0833 | MI < 0,033<br>Ispta < 0,53 mW/cm²<br>Isppa < 0,028 W/cm²<br>Isata N/A |
| | Isata below pre-<br>amendment level ? Yes | Isata below pre-<br>amendment level ? Yes |

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Table 16. The Medi-Stim Butterfly Flowmeter vs. the predicate device

:

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other, with a flowing, ribbon-like design connecting them.

SEP 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jon H. Hoem, VP International Sales & Marketing Medi-Stim AS P.O. Box 35 Grefsen, N-0409 Sandakervein 110, N-0475 Oslo NORWAY

Re: K992305

Medi-Stim Butterfly Flowmeter: Models BF1000 BF2000 BF1001 BF2001 BF1004 BF2004 and BF2004 Regulatory Class: II 21 CFR 892.1570/ Procode: 90 ITX, Diagnostic Ultrasound Transducer 21 CFR 870.2100/ Procode: 74 DPT. Cardiovascular Blood Flow-meter 21 CFR 870.2120/ Procode: 74 DPW, Extravascular Blood Flow Probe 21 CFR 870.1110/ Procode: 74 DSK, Blood P0ressure Computer Dated: July 2, 1999 Received: July 8, 1999

Dear Mr. Hoem:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducer intended for use with the Medi-Stim Butterfly Flowmeters, models: 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, and the BF2004 Dual channel flowmeter with 2 pressure channels and two AUX/ECG channels, as described in your premarket notification:

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#### Transducer Model Numbers

| PJ100011 1.5mm | PB100041 4mm | PB100082 8mm | PA100271 27mm |
|-------------------------------------------|------------------------------------------|---------------|---------------|
| PA100021 2mm | PA100042 4mm | PA100121 12mm | PB100271 27mm |
| PB100021 2mm | PB100042 4mm | PB100121 12mm | PR100151 15mm |
| PA100022 2mm | PA100051 5mm | PA100122 12mm | PR100181 18mm |
| PB100022 2mm | PB100051 5mm | PB100122 12mm | PR100211 21mm |
| PA100031 3mm | PA100052 5mm | PA100161 16mm | PR100251 25mm |
| PB100031 3mm | PA100052 5mm | PB100161 16mm | PR100301 30mm |
| PA100032 3mm | PA100081 8mm | PA100211 21mm | PR100351 35mm |
| PB100032 3mm | PB100081 8mm | PB100211 21mm | |
| PA100041 4mm | PA100082 8mm | | |
| PI100181 InLine probe, 1/8" | PC100141 ClampOn probe, 1/4", 1/32" wall | | |
| PI100141 InLine probe, 1/4" | PC100142 ClampOn probe, 1/4", 1/16" wall | | |
| PI100381 InLine probe, 3/8" | PC100382 ClampOn probe, 3/8", 1/16" wall | | |
| PI100121 InLine probe, 1/2" | PC100383 ClampOn probe, 3/8", 3/32" wall | | |
| PC100181 ClampOn probe, 1/8", 1/32" wall | PC100122 ClampOn probe, 1/2", 1/16" wall | | |
| PC100182 ClampOn probe, 1/8", 1/16" wall | PC100123 ClampOn probe, 1/2", 3/32" wall | | |
| PC103161 ClampOn probe, 3/16", 1/32" wall | PC100124 ClampOn probe, 1/2", 1/8" wall | | |
| PC103162 ClamnOn probe 3/16" 1/16" wall | | | |

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

{6}------------------------------------------------

Page -3- Mr. Hoem

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone].

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

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### 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | • | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | N |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | N | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | N |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | N |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | N | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | . | | | | | |
| Intraoperative (specify) | | | | | | | | | | N |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | N | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | N | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>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) |
|---------------------------------------------------------|
|-------------------------------------------------------…