(131 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Clinical applications:
Ultrasound Scanner Pro Focus 2202:
Fetal, Obstetrics, Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Transurethral. Peripheral Vascular, Musculoskeletal.
Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic.
2202 supports the following scanning modes and combinations thereof:
B-mode. M-mode. CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging. Contrast harmonic imaging.
An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications,
The system can guide biopsy- and puncture needles.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Reference |
|---|---|---|---|
| Acoustic Output | Ispta ≤ 720 mW/cm² | The system assures acoustic output stays below pre-amendment upper limits. | N/A (General statement of compliance) |
| MI ≤ 1.9 (Track 3, non-ophthalmic) | The system assures acoustic output stays below pre-amendment upper limits. | N/A (General statement of compliance) | |
| Thermal Index (TI) ≤ 6.0 | Maximum Thermal Index values are 6.0. | N/A (General statement of compliance) | |
| Clinical Measurement Accuracy | Described and accuracies provided in User Guide. | Clinical measurements and calculations are described, and accuracies are provided with the User Guide. | User Guide (assumed to be external document) |
| Safety (Thermal, Mechanical, Electrical) | Compliance with IEC 60601-1. | The scanner 2202 has been tested by a recognized, certified body according to IEC 60601-1. | IEC 60601-1 (stated as met) |
| Acoustic Output Reporting | According to "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 2008" and "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998). | Acoustic Output Reporting is made according to the specified standards (FDA 2008 and AIUM 1998). | FDA 2008, AIUM 1998 (stated as met) |
| Intended Use & Indications for Use | Comparable to predicate devices for all listed clinical applications and modes. | Stated as "Comparable" to predicate devices (ZONARE ZS3, Philips CX50, Toshiba Aplio systems) for all indications, including the new Neonatal Cephalic application. No new indications for use, modes, features, or technologies that require clinical testing are introduced relative to the predicate devices. | Predicate Device Comparison Table (Sections 2, 7 & 8) |
Study Information
The provided document describes a 510(k) Pre-market Notification for an Ultrasound Scanner (Pro Focus 2202) and a specific transducer (N13C5 Type 8862). This submission primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new clinical studies to prove device performance against specific novel acceptance criteria.
Therefore, many of the requested study details (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable (N/A) because the core of this submission is a comparison to established devices and their existing performance and safety profiles.
Here's a breakdown of what can be gleaned:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The submission states: "This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing." This indicates that no new clinical test sets were generated or utilized to prove performance in the traditional sense of a clinical trial for a novel device. The "test set" in this context is implicitly the historical data and established clinical performance of the predicate devices.
-
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):
- N/A. As no new explicit clinical test set was used for this submission, there was no need for a new "ground truth" establishment by experts specifically for this device's performance claims. The substantial equivalence relies on the established ground truth and clinical acceptance of the predicate devices.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No new clinical test set requiring adjudication was performed as part of this substantial equivalence submission.
-
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:
- No. The device is a diagnostic ultrasound system. There is no mention of AI or machine learning components, nor any MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a diagnostic ultrasound system with human-in-the-loop operation. No standalone algorithm performance is reported.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. For this substantial equivalence submission, the "ground truth" for the device's acceptable performance and safety is implicitly tied to the established and accepted clinical performance, safety profiles, and regulatory clearances of the predicate devices. New ground truth for a novel claim was not established as part of this submission.
-
The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no training set in that context.
-
How the ground truth for the training set was established:
- N/A. As above, not an AI/ML device.
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- 6 2014
510(k) Summary:
This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.
Submitters name: B-K Medical Address: Mileparken.34, DK2730 Herlev. Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Gert Nielsen, Regulatory Manager Date prepared: August 23. 2013
Trade name: Ultrasound Scanner Pro Focus 2202 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO. CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) (90 ITX, CFR 892.1570) Diagnostic Ultrasonic Transducer
Identification of predicate, legally marketed device: The predicate device(s) is(are):
- ZONARE Medical Systems Inc .: . ZONARE ZS3 Ultrasound System (K120703) Transducer Model Number: C 10-3
- . Philips Healthcare, Inc .: CX50 Diagnostic Ultrasound System (K111513) Transducer Type: C8-5
- Toshiba America Medical Systems, Inc .: . Diagnostic Ultrasound System (K121422)
- o Aplio 500 TUS-A500 v2.1
- o Aplio 400 TUS-A400 v2.1
- Aplio 300 TUS-A300 v2.1 ୍
Transducer Model Number: PVT-712BT
Device description:
2202 supports the following scanning modes and combinations thereof:
B-mode. M-mode. CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging. Contrast harmonic imaging.
An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications,
The system can guide biopsy- and puncture needles.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Transducers
Transducers are linear and convex phased arrays and mechanical sector. The patient contact materials comply with ISO10993-1
{1}------------------------------------------------
All transducers used together with 2202 are Track 3 transducers.
Acoustic output
The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 m W/cm² and MI ≤ 1.9 (Track 3. non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0
Clinical measurement accuracy.
Clinical measurements and calculations are described and accuracies are provided with the User Guide.
Thermal, mechanical and electrical safety.
The scanner 2202 has been tested by a recognized, certified body according to IEC 60601-1.
Acoustic Output Reporting
The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 2008"
The acoustic output is measured and calculated according to: * Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998).
Intended use.
See comparison below
{2}------------------------------------------------
Technological characteristics compared to the predicate device(s).
The predicate device(s) has the same major technological characteristics as the subject device, see comparison below.
Comparison with the predicate devices mentioned above from:
| Supplier | BK MedicalSystems | ZONAREMedical Systems | Philips | Toshiba | Comparison |
|---|---|---|---|---|---|
| 510K No. | K043524,K100919 | K120703 | K123754 | K121422 | Comparable |
| Intended use | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows: | Diagnostic UltrasoundImaging and fluidflow analysis in thefollowing applications: | Diagnostic UltrasoundImaging and fluidflow analysis in thefollowing applications: | Visualization ofstructures and dynamicprocess with thehuman body usingultrasound and toprovide imageinformation fordiagnosis in thefollowing clinicalapplications: | Comparable |
| Indicationsfor use | AbdominalFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsSmall Parts (organs)Neonatal CephalicAdult CephalicCardiacTransrectalTransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial) | Opthalmic.Fetal/Obstetric.GynecologicalAbdominal (renal,TYN/Pelvic; Intra-operative (abdominal,thoracic, and vascular,Intra-operativeneurological,Pediatric,Small organ (thyroid,breast, testes, etc).Adult Cephalic,Neonatal Cephalic,Trans-rectal,Trans-vaginal,Trans-cranial,Trans-esophageal(non-cardiac andcardiac).Musculoskeletal(conventional &Superficial),3D/4D, CardiacAdult./Pediatrics/Fetal.Echo, Intra-Cardiac.Pelvic,Perpheral vascular,harmonic tissue andcontrast imaging andtissue elasticity, Vetand others | Opthalmic.Intracardiac echo,Intraoperative,Laparoscopic.Fetal, Abdominal,Pediatric.Small organ, AdultCephalic. NeonatalCephalic,Transvaginal,Musculoskeletal,Gynecological,Cardiac Adult,Cardiac Pediatric,Trans-Esophogeal(Cardiac),Peripheral Vessel,Other (Carotid) | abdominal, intra-operative (abdominal).Pediatric,Small organs.Neonatal CephalicAdult CephalicTrans-vaginal,Trans-rectalMusculoskeletal(conventional andsuperficial)Cardiac PediatricCardiac AdultPeripheral VascularTransesophageal | Comparable |
| Transducerspecific | |||||
| 510K No. | K043524 | K120703 | K123754 | K121422 | Comparable |
| Indicationfor use | Neonatal Cephalic | Neonatal Cephalic | Neonatal Cephalic | Neonatal Cephalic | Comparable |
| Frequencyrange | 10-3.8 MHz | 10-3 MHz | 8-5 MHz | 10-3 MHz | Comparable |
Summary of Clinical Tests:
This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound system with these characteristics are well accepted for both predicate and subject devices.
.
{3}------------------------------------------------
K132685
page 4 of 4
Conclusion: The device ProFocus 2202 and the probe N13C5 type 8862 in this application has similar intended uses, and in particular the subject for the submission, the addition of the new application Neonatal Cephalic, is the same.
B-K Medical ApS therefore considers. that 2202 is substantially equivalent to the predicate devices.
· .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2014
B-K Medical ApS % Mr. Gert Nielsen Regulatory Affairs Manager Mileparken 34 Herlev DK-2730 DENMARK
Re: K132685
Trade/Device Name: Ultrasound Scanner Pro Focus 2202 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: December 5, 2013 Received: December 19, 2013
Dear Mr. Nielsen:
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 Ultrasound Scanner Pro Focus 2202, as described in your premarket notification:
Transducer Model Number
N13C5 Type 8862
If your device is classified (see above) into either class II (Special Controls) or class III (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, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
{5}------------------------------------------------
Page 2 - Mr. Gert Nielsen
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/McdicalDevices/Safetv/ReportaProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance 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,
Sm.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (if known): K132685
Device Name: Ultrasound Scanner Pro Focus 2202 Ultrasound Transducer N13C5, Type 8862
Indications For Use:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Clinical applications:
Ultrasound Scanner Pro Focus 2202:
Fetal, Obstetrics, Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Transurethral. Peripheral Vascular, Musculoskeletal.
Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic.
Details on specific Indication for Use forms
Prescription Use (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 In Vitro Diagnostics and Radiological Health (OlR)
Smh.7)
Page 1 of __1
(Division Sign-Off) Division of Radiological Health/OIR 510(k)
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
System: 2202
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 | Mode of Operation | Other | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | Tissue-harmonic imaging | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify 1) | ||
| Ophthalmic | ||||||||||
| Fetal 2) (K0435524) | P | P | P | P | P | P | P | P | ||
| Abdominal (K0435524) | P | P | P | P | P | P | P | P | ||
| Intraoperative (specify)(K0435524) | P | P | P | P | P | P | P | P | ||
| Intraoperative Neurological(K0435524) | P | P | P | P | P | P | P | P | ||
| Pediatric (K0435524) | P | P | P | P | P | P | P | P | ||
| Small Organ (specify)(K0435524) | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | ||
| Adult Cephalic (K070077) | P | P | P | P | P | P | P | P | ||
| Cardiac (K0435524) | P | P | P | P | P | P | P | P | ||
| Transesophageal | ||||||||||
| Transrectal (K0435524) | P | P | P | P | P | P | P | P | ||
| Transvaginal (K0435524) | P | P | P | P | P | P | P | P | ||
| Transurethral (K0435524) | P | P | P | P | P | P | P | P | ||
| Intravascular | ||||||||||
| Peripheral Vascular(K0435524). (K100919 3) | P | P | P | P | P | P | P | P | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional (K0435524) | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal Superficial(K0435524) | P | P | P | P | P | P | P | P | ||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
B+M, B+D, B+C. B+D+C. Additional Comments:_ 1) B mode includes Tissue Harmonic Imaging D is PWD, C is Color Doppler, Fetal is often called Obstetrics 2)
Vector Flow Imaging ਤੇ
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
'
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
{8}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
... ...
| System: | |
|---|---|
| Transducer: |
2202 8862
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined | Amplitude |
| (Track I Only) | (Tracks I & III) | Doppler | (Specify 1) | Doppler | ||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify 2)(K043524) | E | E | E | E | E | E | ||
| Intra-operative (Neuro)(K043524) | E | E | E | E | E | E | ||
| Laparoscopic | ||||||||
| Fetal Imaging | Pediatric(K043524) | E | E | E | E | E | E | |
| (K043524) | ||||||||
| & Other | Small Organ (Specify) | |||||||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
1) Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow Additional Comments: mapping Doppler including Amplitude(power)Doppler)_ 2)Intraoperative: Gall bladder_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
§ 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.