HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM

K140899 · Halo Medical Technologies, LLC · IYO · May 5, 2014 · Radiology

Device Facts

• Record ID: K140899
• Device Name: HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
• Applicant: Halo Medical Technologies, LLC
• Product Code: IYO · Radiology
• Decision Date: May 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

"Catalyst" is a diagnostic ultrasound system designed to be used for investigating disorders of the pelvic floor. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. MidCRYSTL and HALO probes allow for ultrasonography of the following: 1) on the surface of the perineum and/or abdomen, 2) endocavity, by inserting the endovaginal probe into the vagina, and 3) endocavity, by inserting the endoanal probe into the anal canal.

Device Story

Portable, single-mode, single-application B-Mode ultrasound imaging system; utilizes mechanical sector ultrasound probes (3.5 MHz to 24.0 MHz). System includes ultrasound generator/receiver, analog-to-digital converter, microcontroller, and USB 2.0 interface. Operator inputs transmit power, image selection, and Time Gain Compensation (TGC) via control panel; system stores settings for recall. Device captures, displays, and records 2D ultrasound images; supports cine function (up to 512 images) and distance/angle measurements. Used in clinical settings for pelvic floor investigation; operated by healthcare professionals. Output viewed on LCD monitor; assists clinicians in visualizing organ, muscle, and tissue structures to inform diagnostic decisions.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. Compliance verified through acoustic output measurement (AIUM/NEMA UD-2/UD-3), electrical/ultrasound safety (IEC 60601-1, IEC 60601-2-37), EMC (IEC/EN 60601-1-2), and biocompatibility (ISO 10993-1, -5, -10, -12).

Technological Characteristics

Mechanical sector ultrasound system; 3.5-24.0 MHz probes. Materials: TPX (Polymethyl Pentene) lens, Ertalyte (PET-P) housing. Energy: Piezo-electric transducer. Connectivity: USB 2.0 to host computer. Display: 2D, 256 gray shades. Features: Digital dynamic receive focusing, cine storage (512 images), distance/angle measurement. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993.

Indications for Use

Indicated for diagnostic ultrasound imaging of the pelvic floor, including perineal/abdominal surface, endovaginal, and endoanal applications for investigation of pelvic floor disorders.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Laborie NuWav (AKA "AquaVU360) (K081781)

Reference Devices

• K951976
• K070907

Submission Summary (Full Text)

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K140899
Page 1 of 6

Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

### 1) Submitter Information and Preparation Date

Halo Medical Technologies, LLC

1805 Foulk Road, Suite G

Wilmington, DE 19810

Jennifer L. Kinney

Vice President of Marketing and Regulatory Affairs

Telephone: [phone]

[phone] Fax:

Email [e-mail]

Prepared: March 6, 2014

## 2) Device Name, Common Name, and Classification Name

### Proprietary Name

Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

### Common/Usual Name

Diagnostic Ultrasound System and Accessories

### Classification Names

| | CFR Number | Product Code |
|---------------------------------------|------------|--------------|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

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Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

### 3) Identification of the Predicate Device

The Laborie NuWav (AKA "AquaVU360) (K081781) is a comparable and substantially equivalent device. The Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System Transducer Probes are produced by the same OEM manufacturer, and the system has the same technological characteristics, safety and effectiveness features, design features, and comparable intended uses and basic operating modes.

### 4) Subject Device Description

The Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System is a self contained portable, single-mode, and singleapplication ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording.

User-customized parameter settings for the MidCRYSTL™ Endoanal, HALO™ Endovaginal and HALO™ Surface Ultrasound Probes may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.

More detailed explanations of these functions and controls are included in the User Manuals, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials have been used in accordance to their intended use and are described below for each individual transducer. The transducers were previously cleared for use on other Systems (K951976 and

510(k) Summary of Safety and Effectiveness

Page 2 of 6

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Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

referenced in K070907).

The Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System is a B-Mode ultrasound scanner which provides high resolution, high penetration performance. Probes are supported in frequencies from 3.5 MHz to 24.0 MHz. The probes are indicated expressly for endoanal, endovaginal, and/or abdominal/transperineal (surface) application.

The Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System provides various measuring functions. It can measure distances and calculate angles. Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device(s), Laborie NuWAV (K081781).

### 5) Intended Use

"Catalyst" is a diagnostic ultrasound system designed to be used for investigating disorders of the pelvic floor. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. MidCRYSTL and HALO probes allow for ultrasonography of the following: 1) on the surface of the perineum and/or abdomen, 2) endocavity, by inserting the endovaginal probe into the vagina, and 3) endocavity, by inserting the endoanal probe into the anal canal.

6) Technological Characteristics

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Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

This device has the same technological characteristics (i.e., materials, image display, energy source, design, and acoustic output limits) as the predicate device.

# 6.a.) Technological Comparison Summary of Subject and Predicate Devices

| Technological<br>Characteristics | Subject Device:<br>Halo Medical Technologies,<br>Catalyst™™, MidCRYSTL™, HALO™<br>Ultrasound System | Predicate Device:<br>Laborie Medical Technologies, NuWav<br>Ultrasound System (K081781) | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Lens | TPX brand Polymethyle Pentene(PMP) | TPX brand Polymethyle Pentene(PMP) |
| Materials | Housing | Ertalyte brand Polyetheylene<br>Terephthalate (PET-P) | Ertalyte brand Polyetheylene<br>Terephthalate (PET-P) |
| | Display Mode | 2-D, LCD monitor (256 gray shades) | 2-D, LCD monitor (256 gray shades) |
| Measurements | | Distance (mm), Angle (%) | Distance (mm), Angle (%) |
| Principle of Operation | | Apply high voltage bursts to Piezo-<br>electric material in the transducer and<br>detect the reflected echo to construct<br>2D images for diagnostic purposes. | Apply high voltage bursts to Piezo-<br>electric material in the transducer and<br>detect the reflected echo to construct 2D<br>images for diagnostic purposes. |
| Transducer Probe<br>Design | | Mechanical sector ultrasound imaging<br>probe that connects directly to host<br>computer via Universal Serial Bus<br>(USB). Host computer forms real-time<br>ultrasonic images of human tissue<br>without need for additional electronics,<br>power supplies, or support devices of<br>any kind. | Mechanical sector ultrasound imaging<br>probe that connects directly to host<br>computer via Universal Serial Bus (USB).<br>Host computer forms real-time ultrasonic<br>images of human tissue without need for<br>additional electronics, power supplies, or<br>support devices of any kind. |
| Acoustic Output Limits:<br>All Applications | | ISPTA.3 94 mW/cm2 (Maximum)<br>MI 1.9 (Maximum) | ISPTA.3 94 mW/cm2 (Maximum)<br>MI 1.9 (Maximum) |

## 6.b.1.) Summary of Nonclinical Tests and Standards Used

Substantial equivalency to the predicate device has been demonstrated through the following nonclinical tests and standards referenced in this 510(k) submission:

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Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

- Acoustic Output Measurement, conducted in accordance with the . AIUM/NEMA UD-2 and UD-3 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- Product Safety and EMC Requirements for Medical Equipment: .
- Electrical Safety, IEC 60601-1 o
- Electromagnet Compatibility, IEC/EN 60601-1-2 o
- o Ultrasound Equipment Safety, IEC 60601-2-37
- Includes Thermal Safety Validation .
- Biological Safety .
- o ISO 10993-1 Compliant, Selection of Tests
- o ISO 10993-5 Compliant, Cytotoxicity Study using ISO Elution Method
- o ISO 10993-10 Compliant, ISO Vaginal Irritation Study and ISO Maximum Sensitization Study - Extract
- o ISO 10993-12 Compliant, Sample Preparation

### 6.b.2.) Summary of Clinical Tests

The subject of this premarket submission, the Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System, did not require clinical studies to support substantial equivalence.

### 6.b.3.) Conclusions

Halo Medical Technologies considers the Catalyst™, MidCRYSTL™, HALO™ Ultrasound System to be as safe and effective as the predicate device(s). The performance of the subject device is substantially equivalent to the predicate device(s).

Intended uses and other key features are consistent with traditional clinical

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K140899
Page 6 of 6

Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with medical device industry standards. The device conforms to applicable medical device

safety standards and compliance is verified through independent evaluation. Diagnostic ultrasound has accumulated a long history of safe and effective performance.

Therefore, it is the opinion of Halo Medical Technologies that the Catalyst™, MidCRYSTL™, HALO™ Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 5, 2014

HALO Medical Technologies, LLC % Mr. Mark Job Responsible Third Party Official 1394 25th Street NW BUFFALO MN 55313

Re: K140899

Trade/Device Name: Halo Medical Technologies Catalyst™, MidCRYSTI,"", HALO"* Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: April 7, 2014 Received: April 8. 2014

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the Halo Medical Technologies Catalyst™, HALO™ Ultrasound System, as described in your premarket notification:

Transducer Model Number

ER/12 MHz/ES 12MHz

GP 3.5 MHz/AB 3.5 MHz. EC 7.5 MHz/EB 7.5 MHz

If your device is classified (see above) into either class II (Special Controls) or class !!! (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2-Mr. Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

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

Sincerely yours,


for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

### Indications for Use

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

### 510{k) Number (if known)

### K140899

#### Device Name

Halo Medical Technologies, Catalys1™, MidCRYSTL™, HALO™ Ultrasound System

#### Indications for Use (Describe)

"Catalyst" is a diagnostic ultrasound system designed to be used for investigating disorders of the pelvic floor. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. MidCRYSTL and HALO probes allow for ultrasonography of the following: 1) on the surface of the perineum and/or abdomen, 2) endocavity, by inserting the endovaginal probe into the vagina, and 3) endocavity, by inserting the endoanal probe into the anal canal.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.7).

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

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

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

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

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

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### Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

### Diagnostic Ultrasound Indications for Use Form

#### Halo Medical Technologies, Catalyst™ Ultrasound System System:

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

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|--------------------|---------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks 1&3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | | | | | | Note 1 |
| | Intra-Operative (Specify) | | | | | | | |
| | Intra-Operative Neurological | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric<br>(excluding transcranial<br>& neonatal) | | | | | | | |
| | Small Organ (e.g. testicles,<br>lymph nodes, thyroid) | N | | | | | | Note 2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Trans-rectal | N | | | | | | |
| & Other | Trans-vaginal | N | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-card.) | | | | | | | |
| | Muscular-Skeletal (Conventional) | | | | | | | |
| | Muscular-Skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Invasive Diagnostic or therapeutic<br>procedures (e.g. biopsies, punctures,<br>free fluid detection, regional<br>anesthesia, vascular access) | | | | | | | |
| | Retroperitoneum | | | | | | | |
| | Female reproduction system and<br>fetus (transcutaneous) | | | | | | | |
| | Superficial structures & pathologies | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N=New Indication

Note 1: Abdominal, Solid Organs, Aneurysms, Bladder
Note 2: Small Organ, Testes, Prostale

图 Prescriptive Use (Part 21 CFR 80) Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Concurrence of CDRH. Office of in Viro Diagnostic Devices (OTVD)

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### Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

### Diagnostic Ultrasound Indications for Use Form

#### Transducer: ER/12 MHz/ES 12MHz Mechanical Sector Probe

#### Intended Use: Diagoostic ultrasound imaging or Nuid Now analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|--------------------------|--------------------|---------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-Operative (Specify) | | | | | | | |
| | Intra-Operative Neurological | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric<br>(excluding transcranial<br>& neonatal) | | | | | | | |
| | Small Organ (e.g. testicles,<br>lymph nodes, thyroid) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-card.) | | | | | | | |
| | Muscular-Skeletal (Conventional) | | | | | | | |
| | Muscular-Skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Invasive Diagnostic or therapeutic<br>procedures (e.g. biopsies, punctures,<br>free fluid detection, regional<br>anesthesia, vascular access) | | | | | | | |
| | Retroperitoneum | | | | | | | |
| | Female reproduction system and<br>fetus (transcutaneous) | | | | | | | |
| | Superficial structures & pathologies | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N=New Indication

图 Prescriptive Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

.

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### Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

### Diagnostic Ultrasound Indications for Use Form

#### Transducer: GP 3.5 MHz / AB 3.5 MHz Mechanical Sector Probe

#### Intended Use: Diagnostic ultrasound imaging or Nuld flow analysis of the homan body as follows:

| Clinical Application | | | Mode of Operation | | | | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|--------------------------|--------------------|---------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks 1&3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | | | | | | Note 1 |
| | Intra-Operative (Specify) | | | | | | | |
| | Intra-Operative Neurological | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric<br>(excluding transcranial<br>& neonatal) | | | | | | | |
| | Small Organ (e.g. testicles,<br>lymph nodes, thyroid) | N | | | | | | Note 2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-card.) | | | | | | | |
| | Muscular-Skeletal (Conventional) | | | | | | | |
| | Muscular-Skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Invasive Diagnostic or therapeutic<br>procedures (e.g. biopsies, punctures,<br>free fluid detection, regional<br>anesthesia, vascular access) | | | | | | | |
| | Retroperitoneum | | | | | | | |
| | Female reproduction system and<br>fetus (transcutaneous) | | | | | | | |
| | Superficial structures & pathologies | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N=New Indication

Note I : Abdominal, Solid Organs, Aneurysms, Bladder

Note 2: Small Organ, Testes, Prostate

图 Prescriptive Use (Part 2) CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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### Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System

### Diagnostic Ultrasound Indications for Use Form

#### Transducer: EC 7.5 MHz / EB 7.5 MHz Mechanical Sector Probe

#### Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|--------------------------|--------------------|---------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks 1&3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-Operative (Specify) | | | | | | | |
| | Intra-Operative Neurological | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric<br>(excluding transcranial<br>& neonatal) | | | | | | | |
| | Small Organ (e.g. testicles,<br>lymph nodes, thyroid) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-card.) | | | | | | | |
| | Muscular-Skeletal (Conventional) | | | | | | | |
| | Muscular-Skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Invasive Diagnostic or therapeutic<br>procedures (e.g. biopsies, punctures,<br>free fluid detection, regional<br>anesthesia, vascular access) | | | | | | | |
| | Retroperitoneum | | | | | | | |
| | Female reproduction system and<br>fetus (transcutaneous) | | | | | | | |
| | Superficial structures & pathologies | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N¤New Indication

🇿 Prescriptive Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITT: BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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