(27 days)
"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.
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 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).
The provided 510(k) summary for the Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System focuses on demonstrating substantial equivalence to a predicate device through nonclinical testing and comparison of technological characteristics. It explicitly states that clinical studies were NOT required. Therefore, the information requested for acceptance criteria and a study proving the device meets criteria, particularly those related to clinical performance, a test set, ground truth, and expert evaluation, is not present in the given document.
However, I can extract the nonclinical acceptance criteria and the methods used to prove the device meets these criteria.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) summary demonstrating substantial equivalence for an ultrasound system, the "acceptance criteria" are primarily that the new device's performance in specific nonclinical tests (related to safety and efficacy) is comparable to established standards and the predicate device. The "reported device performance" is implicitly that it met these standards and was found to be comparable.
| Acceptance Criteria (Nonclinical Standards/Requirements) | Reported Device Performance (Implicitly Met) |
|---|---|
| Acoustic Output Measurement (in accordance with AIUM/NEMA UD-2 and UD-3) | Compliant; Performance comparable to predicate (ISPTA.3 94 mW/cm2, MI 1.9 (Maximum)) |
| Electrical Safety (IEC 60601-1) | Compliant |
| Electromagnetic Compatibility (IEC/EN 60601-1-2) | Compliant |
| Ultrasound Equipment Safety (IEC 60601-2-37) - includes Thermal Safety Validation | Compliant |
| Biological Safety (ISO 10993-1 Compliant, Selection of Tests) | Compliant |
| Cytotoxicity Study (ISO 10993-5 Compliant, using ISO Elution Method) | Compliant |
| Vaginal Irritation Study (ISO 10993-10 Compliant) | Compliant |
| Maximum Sensitization Study - Extract (ISO 10993-10 Compliant) | Compliant |
| Sample Preparation (ISO 10993-12 Compliant) | Compliant |
| Technological Characteristics (Materials, Display Mode, Measurements, Principle of Operation, Transducer Probe Design, Acoustic Output Limits) | Comparable to predicate device (Laborie Medical Technologies, NuWav Ultrasound System (K081781)) and established safety limits |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission explicitly states, "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, no clinical test set data from actual patients was used. The provenances are the nonclinical test labs that conducted the specified standards testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as no clinical studies requiring expert ground truth were conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies requiring adjudication were conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as no clinical studies, including MRMC studies, were conducted. This device is an ultrasound imaging system, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is an ultrasound imaging system, not an algorithm, and no clinical performance studies were conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical tests:
- Acoustic Output: Measured against established engineering and physics standards (AIUM/NEMA UD-2 and UD-3).
- Electrical Safety, EMC, Ultrasound Equipment Safety: Tested against established safety standards (IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-2-37).
- Biological Safety: Tested against established biocompatibility standards (ISO 10993 series).
- Technological Characteristics: Direct comparison to the specifications of the legally marketed predicate device (Laborie NuWav, K081781).
8. The sample size for the training set
This information is not applicable as no machine learning algorithm requiring a training set is mentioned or implied for this device's 510(k) submission.
9. How the ground truth for the training set was established
This information is not applicable as no machine learning algorithm requiring a training set is mentioned or implied, and thus no training set ground truth was established.
{0}------------------------------------------------
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: (505) 231-6452
(505) 989-3507 Fax:
Email j.kinney@halomedtech.com
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 |
{1}------------------------------------------------
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
{2}------------------------------------------------
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.
- Technological Characteristics
{3}------------------------------------------------
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
| TechnologicalCharacteristics | Subject Device:Halo Medical Technologies,Catalyst™™, MidCRYSTL™, HALO™Ultrasound System | Predicate Device:Laborie Medical Technologies, NuWavUltrasound System (K081781) | |
|---|---|---|---|
| Lens | TPX brand Polymethyle Pentene(PMP) | TPX brand Polymethyle Pentene(PMP) | |
| Materials | Housing | Ertalyte brand PolyetheyleneTerephthalate (PET-P) | Ertalyte brand PolyetheyleneTerephthalate (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-electric material in the transducer anddetect the reflected echo to construct2D images for diagnostic purposes. | Apply high voltage bursts to Piezo-electric material in the transducer anddetect the reflected echo to construct 2Dimages for diagnostic purposes. | |
| Transducer ProbeDesign | Mechanical sector ultrasound imagingprobe that connects directly to hostcomputer via Universal Serial Bus(USB). Host computer forms real-timeultrasonic images of human tissuewithout need for additional electronics,power supplies, or support devices ofany kind. | Mechanical sector ultrasound imagingprobe that connects directly to hostcomputer via Universal Serial Bus (USB).Host computer forms real-time ultrasonicimages of human tissue without need foradditional electronics, power supplies, orsupport devices of any kind. | |
| Acoustic Output Limits:All Applications | ISPTA.3 94 mW/cm2 (Maximum)MI 1.9 (Maximum) | ISPTA.3 94 mW/cm2 (Maximum)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:
{4}------------------------------------------------
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
{5}------------------------------------------------
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.
{6}------------------------------------------------
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.
{7}------------------------------------------------
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{8}------------------------------------------------
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 PRAStaff@fda.hhs.gov
"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."
{9}------------------------------------------------
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(Track 1 only) | Specific(Tracks 1&3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | Note 1 | ||||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative Neurological | ||||||||
| Laparoscopic | ||||||||
| Pediatric(excluding transcranial& neonatal) | ||||||||
| Small Organ (e.g. testicles,lymph nodes, thyroid) | N | Note 2 | ||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| FetalImaging& Other | Trans-rectal | N | ||||||
| & Other | Trans-vaginal | N | ||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-card.) | ||||||||
| Muscular-Skeletal (Conventional) | ||||||||
| Muscular-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Invasive Diagnostic or therapeuticprocedures (e.g. biopsies, punctures,free fluid detection, regionalanesthesia, vascular access) | ||||||||
| Retroperitoneum | ||||||||
| Female reproduction system andfetus (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)
{10}------------------------------------------------
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(Track 1 only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative Neurological | ||||||||
| Laparoscopic | ||||||||
| Pediatric(excluding transcranial& neonatal) | ||||||||
| Small Organ (e.g. testicles,lymph nodes, thyroid) | ||||||||
| Neonatal Cephalic | ||||||||
| FetalImaging& Other | Adult Cephalic | |||||||
| Trans-rectal | N | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-card.) | ||||||||
| Muscular-Skeletal (Conventional) | ||||||||
| Muscular-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Invasive Diagnostic or therapeuticprocedures (e.g. biopsies, punctures,free fluid detection, regionalanesthesia, vascular access) | ||||||||
| Retroperitoneum | ||||||||
| Female reproduction system andfetus (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)
.
{11}------------------------------------------------
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(Track 1 only) | Specific(Tracks 1&3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | Note 1 | ||||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative Neurological | ||||||||
| Laparoscopic | ||||||||
| Pediatric(excluding transcranial& neonatal) | ||||||||
| Small Organ (e.g. testicles,lymph nodes, thyroid) | N | Note 2 | ||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| FetalImaging& Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-card.) | ||||||||
| Muscular-Skeletal (Conventional) | ||||||||
| Muscular-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Invasive Diagnostic or therapeuticprocedures (e.g. biopsies, punctures,free fluid detection, regionalanesthesia, vascular access) | ||||||||
| Retroperitoneum | ||||||||
| Female reproduction system andfetus (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)
{12}------------------------------------------------
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(Track 1 only) | Specific(Tracks 1&3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative Neurological | ||||||||
| Laparoscopic | ||||||||
| Pediatric(excluding transcranial& neonatal) | ||||||||
| Small Organ (e.g. testicles,lymph nodes, thyroid) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| FetalImaging& Other | Trans-rectal | |||||||
| Trans-vaginal | N | |||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-card.) | ||||||||
| Muscular-Skeletal (Conventional) | ||||||||
| Muscular-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Invasive Diagnostic or therapeuticprocedures (e.g. biopsies, punctures,free fluid detection, regionalanesthesia, vascular access) | ||||||||
| Retroperitoneum | ||||||||
| Female reproduction system andfetus (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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§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.