(30 days)
The 500P Transcranial and Vascular Doppler is to be used for the assessment of circulation in the adult cephalic, (intracranial and extracranial) and peripheral vascular vessels. It is to be used in hospitals, clinics and physicians offices by trained medical personnel by prescriptions or doctors orders. It is not to be used for Obstetrics.
The 500P device consists of a battery operated (also can be used with a medical grade AC adapter) Doppler and display unit with a choice of 2 mHz, 4 mHz, 5 mHz or 8 mHz transducers. The 2 mHz probe is a pulsed Doppler, used for insonating the adult intracranial arteries. The 4mHz, 5 mHz or 8 mHz CW probes are used for insonating the peripheral arteries. The system consists of the transducers, system electronics, a memory and a USB interface for an external computer. All of the transducers are connected to the system using quick disconnect connectors. The 500P Transcranial and Vascular Doppler provides the healthcare professional with the state of blood flow in the intracranial and extracranial vascular arteries.
The provided 510(k) submission for the Multigon Model 500P Pocket Transcranial and Vascular Doppler Spectrum Analyzer is primarily a comparative submission seeking substantial equivalence to predicate devices, rather than a submission detailing original clinical or analytical validation studies against pre-defined acceptance criteria.
The submission does not contain specific acceptance criteria or a study designed to prove the device meets these criteria in the traditional sense of a clinical trial or performance study with quantitative results against specified metrics. Instead, it relies on demonstrating substantial equivalence to previously cleared devices.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or quantitative performance metrics are stated in this 510(k) submission. The device's "performance" is demonstrated through a comparison of its specifications and functions to those of predicate devices.
| Feature/Parameter | Acceptance Criteria (Not Explicitly Stated - Implied by Predicate Equivalence) | Reported Device Performance (Model 500P) |
|---|---|---|
| Probes | Equivalent to predicate devices (2mHz PW, 5mHz CW, and additional 4mHz CW, 8mHz CW) | 2 mHz PW, 5 mHz CW, 4 mHz CW, 8 mHz CW |
| Doppler Type | Bi-Directional | Bi-Directional |
| Frequency Ranges | Equivalent to predicate devices (e.g., 1, 2, 5, 10, 20 kHz, 0, 20, 40% offset) | 1, 2, 5, 10, 20 kHz (frequency ranges), 0, 20, 40, 50% (frequency offset) |
| Time/Frequency Calipers | Present and functional | YES |
| Storage of Spectral Data | Equivalent capacity to predicate devices (e.g., 104 seconds) | 2 hours |
| Calculations | Same parameters as predicate devices (Peak, Mean, Pulsatility Index, Resistance Index, Systolic/Diastolic Ratio) | Peak, Mean, Pulsatility Index, Resistance Index, Systolic/Diastolic Ratio |
| Annotation | Equivalent to predicate devices (Date, Vessel I.D., Patient I.D., printed report) | Date, Vessel I.D., Patient I.D., plus printed Patient Report with waveforms |
| Monitoring Mode | Present and functional, equivalent to predicate devices | YES |
| HITS (Emboli Detection) | Present and functional, equivalent to predicate devices | YES |
Note: The "acceptance criteria" here are implied by the claim of substantial equivalence to predicate devices. The "reported device performance" is a listing of the device's features and specifications, which are implicitly claimed to be "as good as" or "equivalent to" the predicate devices in terms of safety and effectiveness. The 500P often meets or exceeds the predicate in terms of features (e.g., more probes, longer data storage, additional report features, monitoring mode, HITS).
2. Sample Size Used for the Test Set and Data Provenance
The submission states: "The Model 500P Transcranial and Vascular Doppler has been subjected to extensive safety, performance testing, and validation before release. Final testing of the 500P included qualitative performance tests designed to ensure that the device met all of its functional specifications."
- Sample Size for Test Set: Not specified. The submission refers to "extensive safety, performance testing, and validation" which were "qualitative performance tests." This suggests a series of engineering tests rather than a clinical study with a patient sample size.
- Data Provenance: Not specified, but likely internal (Multigon Industries, Inc.) testing data. No mention of country of origin for any clinical data or whether it was retrospective or prospective, as no clinical study with patient data appears to have been conducted as part of this submission for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission does not describe a clinical study where ground truth would be established by experts. The "testing" referred to appears to be engineering and functional validation against internal specifications and industry standards, not a diagnostic accuracy study.
4. Adjudication Method for the Test Set
Not applicable. As no clinical study against ground truth established by experts is described, there's no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission. The submission focuses on demonstrating substantial equivalence in specifications and features, not on the improvement of human readers with or without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
Yes, the device's functional performance was evaluated in a "standalone" manner, in that its features and specifications were tested qualitatively. However, this is not in the context of an "algorithm" or AI in the modern sense, but rather the performance of the Doppler system itself. The submission states, "Final testing of the 500P included qualitative performance tests designed to ensure that the device met all of its functional specifications." This implies testing the device on its own to confirm it performs as designed.
7. Type of Ground Truth Used
The "ground truth" for the internal performance and safety testing appears to be based on:
- Engineering specifications and functional requirements: Ensuring the device's components (probes, display, storage, calculations, monitoring, HITS) work as intended according to design.
- Compliance with industry and safety standards: UL 2601-1, AIUM/NEMA UD 2, UD 3, IEC60601-1-2, IEC60601-2-37.
There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient diagnoses) being used for performance testing in this 510(k) submission.
8. Sample Size for the Training Set
Not applicable. This device is a hardware/software system for Transcranial and Vascular Doppler, not a machine learning model that requires a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
In summary: This 510(k) submission is a "traditional" substantial equivalence application for a medical device (a Doppler system). It establishes equivalence by comparing its technical specifications and functionalities to existing, legally marketed predicate devices, rather than through de novo clinical studies with pre-defined quantitative acceptance criteria and ground truth derived from patient data. The "tests" mentioned are qualitative performance tests and compliance with safety standards, not clinical trials.
{0}------------------------------------------------
JUL 2 8 2005
500P 510k Submission
500P Transcranial and Vascular Doppler Multigon Industries, Inc.
SUMMARY
This summary of 510k safety and effectiveness information is being submitted in accordance with 21CFR part 807.92
- Submitters name, address, phone number, contact person and preparation date:
Name: Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 ext. 27 Fax: 914 376 6111 Email: wstern@multigon.com Responsible person: William Stern
Official correspondent:
William Stern Multigon Industries, Inc. I Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 ext. 27 Fax: 914 376 6111 Email: wstern@multigon.com
Date of Preparation: 6/16/05
- Proprietary Name: Model 500P Pocket Transcranial and Vascular Doppler Spectrum Analyzer
Common /Usual Name:
Transcranial and Vascular Doppler
Diagnostic Ultrasound Transducer
Classification Name:
21 CFR892.1550 System, Imaging, Pulsed Doppler, Ultrasonic
21 CFR892.1570 Diagnostic Ultrasound Transducer
{1}------------------------------------------------
500P 510k Submission
Classification Number: 90IYN 9011X
- Substantially Equivalent Devices
Multigon Industries, Inc. believes that the Model 500P Transcranial and Vascular Doppler Spectrum Analyzer and transducers is substantially equivalent to the following cleared devices:
| Trade or Proprietary Name | Manufacturer | S10(k) Number |
|---|---|---|
| Model 500V Transcranialand Vascular Doppler Analyzer | Multigon Industries. | K882755/A |
| Intra-View Transcranial Doppler | Rimed LTD | K974588 |
| Explorer CVS Transcranial Doppler Diagnostic Medical Sys. | K990517 | |
| Nourogard Transcranial Dopplor | Mcdasonics, Inc. | K962796 |
| Transpect Transcranial Doppler | Medasonics, Inc. | K872292 |
| Model TC4040 Pioneer Transcranial Eden EMS-NicoletDoppler | K874684 | |
| Multidon Transcranial Donnler | DWI Flectronische Svs | K930458 |
Comparison of Multigon Model 500P Transcranial and Vascular Doppler Spectrum Analyzer and Transducers with the predicate device Multigon Model 500V Transcranial and Vascular Doppler Spectrum Analyzer.
SPECIFICATION
| Model 500V | Model 500P | |
|---|---|---|
| PROBES: | 2 mHz PW | 2 mHz PW |
| 5 mHz CW | 5 mHz CW | |
| 4 mHz CW | ||
| 8 mHz CW |
The 4 mHz CW probe and 8 mHz CW probe substantial equivalence to predicate devices is claimed by comparison to the Rimed Intraview TCD K974588 and to the DMS CVS System 1990517.
{2}------------------------------------------------
500P Transcranial and 500P 510k Submission Vascular Doppler Multigon Industries, Inc. Bi- Directional DOPPLER TYPE Bi- Directional FREQUENCY RANGES 1,2,5,10,20,40 kHz 1,2,5,10,20 kHz FREQUENCY OFFSET 0,20,40% 0,20,40,50 % TIME AND FREQUENCY YES YES CALIPERS STORAGE OF SPECTRAL 104 seconds 2 hours DATA CALCULATIONS Peak, Mean, Pulsatility Index Same Parameters Resistance Index, Systolic/Diastolic Ratio ANNOTATION Date, Vessel I.D., Patient I.D. Same plus printed Patient Report Report of waveforms
। ર .. _
The printed report with the waveforms is substantially equivalent to that provided by the Explorer CVS device of Diagnostic Medical systems, cleared with k 990517. The printed report is also substantially equivalent to that provided on the Intraview TCD manufantured by Rimed LTD and cleared with K974588.
| MONITORING MODE | NO | YES |
|---|---|---|
| ----------------- | ---- | ----- |
For the Monitoring Mode for the 500P substantial equivalence is claimed by predicate devices as follows and previously cleared in the Pioneer model TC 4040 510k clearers k 874684 manufactured by Eden Medizinische Elektronik GmBH (EME) a subsidiary of Nicolet Biomedical, now called Viasys. Substantial Equivalence is also claimed by a predicate device manufactured by Rimed LTD, the model Intraview, 510 to use of a predicate are rice Mode of the 500P is substantially equivalent in form and function to the above predicated vices.
{3}------------------------------------------------
500D Trenaoranial and Vaocular Doppler Multigon Industries,Inc.
NO
YES
HITS (HIGH INTENSITY TRANSIENT SIGNALS EMBOLI DETECTION)
The HITS (High Intensity Transient Signals) detection has been cleared in the Pioneer (TC4040)
Children and Children to the existent aredicate device manufactured by Eden The HITS (High Intensity Transient Siguals) contines device manufactured by Eden
( S10k number L874684) substantially equivalent prodicate device manufactured by Eden ( 510k number K874684) subsidiary of Nicolet Biometical, page 430 in their 510(k)
Medizinische Elektronik Ombildiry of Nicolet Biometical, page 430 in their 510(k)
Medizinis Medizinische Elektronik (imbl, a subsidiary of Neone Prististan the indication and seving of
submission described as follows: HITs indications in usingsisms in the indicatio submission described as follows (H.I.T.S.) by allowing physicians to customize the indication
High Intensity Transient signals (H.I.T.S.) by allowing physicians to customize High Intensity Transient signing (11:11:11) of and their personal preferences.
The study the study requirements and their personal preferences.
The HITS function is also present in a predicate Multi-Dop system (510k clearance 1930468)
States (1970) The HITS function is also present in a presented on presented on page 477 of the original 510k submission.
The Multigon 500P HITS detection is substantially equivalent in form and function to the HITS detection in the two predicate devices above.
Conclusion: The Model 500P Transcranial and Vascular Doppler are substantially equivalent to
r and the contraction of the consistion, soccifications, Conclusion: The Model 3001 Transcranial and 1 specifications, specifications, performance, safety and effectiveness.
4. DEVICE DESCRIPTION
The 500P device consists of a battery operated (also can be used with a medical grade AC)
Called of the consists of a battery of the collection of the AmHz of 8 mHz or 8 mHz The 500P device consists of a battly operation and of and of anHz of 8 mHz or 8 mHz transducers.
adapter) Doppler and display unit with a choice of 2 mHz of 8 mHz or 8 mHz t adapter) Doppler and display und while in insultation of the adult intracranial arteries. The 2 mHz probe is a pulsed Doppic, used for insonating the peripheral arteries. The The 4mHz , 5 mHz of 8 mirrz , w proves are ace activer, system electronics, a memory Doppler and and a USB interface for an external computer.
All of the transducers are connected to the system using quick disconnect connectors.
The 500P Transcranial and Vascular Doppler provides the healthcare professional with The 500P Transcratial and Vascular Dopped province the state of blood flow in the intracranial and extracranial vascular arteries.
{4}------------------------------------------------
500P 510k Submission
500P Transcranial and Vascular Doppler Multigon Industries, Inc.
5. PERFORMANCE STANDARDS
of I was a more and the been astablished for the 500P Transcranial and Vacanter Doppler No performance standards have been established tot do 3001 * 1225000
under section 514 of the Federal Food and Drug Act. However the 500P Transcranial and
ers and the became under section 514 of the Federal Food and Drag - Vascular Doppler has been designed to meet the following standards:
UL 2601-1 Safety Requirements for Medical Equipment UL 2601-1 Safety Requirements for Medical Equipment
ATUM/NEMA UD 2 Standard for Real Time Dsplay of Thermal and Mechanical Output Indices
Childer Standard For Real Time Depla on Diagnostic Ultrasound Equipment on Diagnostic Ultrasound Equipment
AIUM/NEMA UD 3 Standard for Real Time Display of Thermal and
AIUM/NEMA UD 3 Standard Discount Four and Fouipment AIUM/NEMA OD 3 Standard Ioi resostic Ultrasound Equipment
Mechanical Output Indices on the Rever Mechamedi Claration of Acoustic Power IEC60601-1-2 IEC60601-2-37
6. INDICATIONS FOR USE
The 500P Transcranial and Vascular Doppler is to be used for the assessment of circulation in
t is to be use a the support is to be used for the ral vascular vessels. It is t The 500P Transcranial and Vascular Dopler is to be ascular vessels. It is to be used
the adult cephalic, (intractania) and estacemail) and prophens vessels. It is to be used the adult cephalic, (intracranial and extracramar) and performers and connections offices by prescriptions or doctors orders.
7. CONTRA-INDICATIONS
None known at this time.
8. COMPARISON TO PREDICATE DEVICES
The 500P Transcranial and Vascular Doppler has the same device characteristics as the The 500P Transcranial and Vascular Doppics mas uit the commonality of ultrasound
approved predicate devices listed in item 3 above with the commonslity of ultrasound
ing the approved predicate devices insted in tiem 3 "door of blood flow waveforms.
9. TEST DATA
The Model 500P Transcranial and Vascular Doppler has been subjected to extensive safety, performance testing, and validation before release. Inal testing of the SOOP included writive performance tests designed to ensure that the device met all of its finactional specifications.
Performance tests designed to ensure that the device comples with and performance tests designed to ensure that the device complies with applicable industry and safety standards.
The Model 500P Transcranial and Vascular Doppler device labeling includes instructions for safe and effective use, wernings, cantions and guidance for use. It has therefore shown to be safe and effective.
{5}------------------------------------------------
10. LITERATURE REVIEW
A review of the literature pertaining to the safety of the 500P Transcranial and Vascular Doppler has been conducted and appropriate safeguards have been incorporated in the design of the 500P Transcranial and Vascular Doppler.
11. CONCLUSIONS
The conclusion drawn from these tests is that the 500P Transcranial and Vascular Doppler with transducers is substantially equivalent in safety and efficacy to the predicate devices listed in item 3 above.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2005
Mr. William Stern Official Correspondent Multigon Industries, Inc. One Odell Plaza YONKERS NY 10701
44
Re: K051739
Trade Name: Model 500P Pocket Transcranial and Vascular Doppler Spectrum Analyzer Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN and ITX Dated: June 24, 2005 Received: June 28, 2005
Dear Mr. Stern:
We have reviewed your Section 510(k) premarket 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 transducers intended for use with the Model 500P Pocket Transcranial and Vascular Doppler Spectrum Analyzer, as described in your premarket notification:
Transducer Model Number
2 MHz Model 2MPB 4 MHz Model 4MPB 5 MHz Model 5MPB 8 MHz Model 8MPB
{7}------------------------------------------------
Page 2 - Mr. Stern
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (660 acover) inrols. Existing major regulations affecting your device it may be subject to such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Feactas concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reast be advised that 1 DTC 5 losantly evice complies with other requirements of the Act that I DA has made a determinentisions administered by other Federal agencies. You must or any I catal stutures and regarments, including, but not limited to: registration and listing (21 Comply with an the Hot 8 requirements, 01); good manufacturing practice requirements as set CITY art 607), adomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I ins uctimination of Submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, meruding acoused of the Center's September 30, 1997 "Information for Manufacturers In Appendix Of (cherosou) of the Some stic Ultrasound Systems and Transducers." If the special Secking Marketing Clearantee of Diagnosable 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.
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 I mis letter will unow you to begin manage quivalence 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), please If you desire specific as Compliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of oremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on Jour Corpumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
{8}------------------------------------------------
Page 3 - Mr. Stern
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel R. Lynn
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{9}------------------------------------------------
50()P Transcranial and
。
Vascular Doppler Multigon Industries, Inc.
Indications for Use
510(k) Number (if known):
Model 500P Pocket Transcranial and Vascular Doppler Device Name: Spectrum Analyzer
The 500P Transcranial and Vaseular Doppler is to Indications For Use: The 500r framberainsal of circulation in the be used for che abberanial and extracranial) and peripheral vascular vessels. It is to be used and perfoncral vabource in hospitals, clinics by crained medical persoriptions or doctors and physician not to be used for Obstetrics.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segura
Page 1 of
{10}------------------------------------------------
500P 510K Submission
500P Transcranial and Vascular Doppler Multigon Industries, Inc.
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | - B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | N | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: 2 MHz Transducer Model 2MPB for the Model 500P Transcranial and Vascular Doppler
(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. Seymour
F-3
(Division Sig Division of Reprodu and Radiological Devic 510(k) Nur
{11}------------------------------------------------
500P 510K Submission
5()()P Transcranial and Vascular Doppler Multigon Industries, Inc.
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal-Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||||
| Additional Comments: 4 MHz Transducer Model 4MPB for the | ||||||||||
| Model 500P Transcranial and Vascular | ||||||||||
| Doppler | ||||||||||
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel G. Seymore ,
(Division Sign-Off) and Hadle 510(k) Nu
22
{12}------------------------------------------------
500P Transcranial and Vascular Doppler Multigon Industries, Inc.
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: 5 MHz Transducer Model 5MPB for the Model 500P Transcranial and Vascular Doppler
(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. Lypson
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __
F-3
{13}------------------------------------------------
500P Transcranial and Vascular Doppler Multigon Industries, Inc.
Appendix F .
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||||
| Additional Comments: 8 MHz Transducer Model 8MPB for the Model 500P Transcranial and Vascular Doppler |
(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. Lyman
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K051739 |
E-3
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.