(115 days)
The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld batteryoperated device. The PadScan HD2 Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
The PadScan HD2 Bladder Scanner manufactured by Caresono Technology provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. It is a handheld bladder scanner, the main unit and the probe are all-in-one.
It features:
- · Expert operating mode and Easy operating mode
- · Non-invasive, comfortable, correct, reliable, fast and simple operation
- SD card storage
- Voice recording function
- Urine volume setting and alarm setting
- Multi-language selection
- · Injection molded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels)
- Power supply with built-in battery.
The provided document is a 510(k) summary for the Caresono Technology Co., Ltd. PadScan HD2 Bladder Scanner. It details the device's indications for use, its comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (PadScan HD2 Bladder Scanner) |
|---|---|
| Bladder volume range: 0-999ml | Bladder volume range: 0-999ml |
| Accuracy: ±15%, ±15ml | Accuracy: ±15%, ±15ml |
Study Proving Acceptance Criteria:
The document states: "The PadScan HD2 Bladder Scanner had been tested volume accuracy per the FDA Guidance document 'Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. All the test results comply with the pre-set acceptability criterion, which is the same as predicate device."
Additional Information:
Since this is a 510(k) summary focused on establishing substantial equivalence through non-clinical testing, it primarily details engineering and performance benchmarks against an existing predicate device rather than comprehensive clinical study data. Many of the requested details related to human reader studies, ground truth establishment, and sample sizes for clinical trials are not typically found in this type of submission for a device like a bladder scanner, which primarily relies on established physical principles and performance accuracy.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document for volume accuracy testing. The testing mentioned is "Bench Testing."
- Data Provenance: Not specified, but given it's bench testing, it's likely conducted in a controlled lab environment by the manufacturer in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified. The volume accuracy testing described is mechanical or phantom-based bench testing, not reliant on expert interpretation of clinical data in the same way an AI diagnostic algorithm might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/not specified. This term typically refers to the resolution of discrepancies among human readers in clinical studies, which is not described for this bench testing.
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:
- No, an MRMC comparative effectiveness study is not mentioned. This type of study would be more relevant for an AI-powered diagnostic imaging interpretation tool, not a bladder volume measurement device based on pulsed-echo ultrasound. The device calculates bladder volume non-invasively, not assisting human readers in interpreting complex images to improve diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance testing for volume accuracy described (
10.3 Performance-Bench Testing) appears to be a standalone evaluation of the device's ability to measure volume against a known standard. The device "projects ultrasound energy...to calculate bladder Volume noninvasively," implying an algorithmic calculation of volume based on the ultrasound data, without human interpretation of the final volume number.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the volume accuracy testing, the ground truth would likely be a precisely measured phantom or known volume of fluid, as typically used in bench testing for such devices. The document does not explicitly state the specific ground truth, but refers to "pre-set acceptability criterion."
8. The sample size for the training set:
- Not applicable/not specified. The document does not describe an AI or machine learning component that would require a distinct training set in the context of diagnostic performance testing. The device is described as a "B-mode pulsed-echo ultrasound device" that calculates volume, implying traditional signal processing and measurement algorithms rather than machine learning models that are "trained."
9. How the ground truth for the training set was established:
- Not applicable/not specified, as no training set for an AI/ML algorithm is described.
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Caresono Technology Co., Ltd. % Mr. Long Yang, COO Shenzhen Hlongmed Biotech Company R15-08, East Building, Yihai Plaza, Chuangye Road Nanshan District Shenzhen, Guangdong 518054 CHINA
Re: K153581
Trade/Device Name: Bladder Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: March 15, 2016 Received: March 25, 2016
Dear Mr. Yang:
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.
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 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
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forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Michael D. O'Hara
For
Robert Ochs, Ph.D. 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
510(k) Number (if known)
Device Name
Bladder Scanner
Indications for Use (Describe)
The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld batteryoperated device. The PadScan HD2 Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Diagnostic Ultrasound Indications for Use Form
System: PadScan HD2 Bladder Scanner
Transducer: N3
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other*(Specify) | ||||||
|---|---|---|---|---|---|---|---|---|
| General (Track1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other(Bladder) | N | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N=new indication; P= previously cleared by FDA; E=added under this appendix
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Image /page/4/Picture/1 description: The image shows the word "Caresono" in orange color. The font is sans-serif and the letters are closely spaced. The word is horizontally oriented and appears to be a logo or brand name.
510(k) Summary
(as required by 807.92(c))
The assigned 510(K) number is: Date of Summary:
1. Submitter information
Manufacturer Name: Caresono Technology Co., Ltd. Address: 4th Floor, No.11 Building Initiating Zone Instruments and Meters Industry Base, Near Port Industry Zone, Dandong, Liaoning, CHINA 118009 Contact Person and Title: Yuzhong Ma / Management Representative Tel: 0086-415-6123779 Fax: 0086-415-6123769 Email: myz6178456@163.com
2. Contact person
2.1 Primary Contact Person
Long Yang (COO) Shenzhen Hlongmed Biotech Company R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China Tel: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
Yuzhong Ma (Management Representative) Caresono Technology Co., Ltd. 4th Floor, No.11 Building Initiating Zone Instruments and Meters Industry Base, Near Port Industry Zone, Dandong, Liaoning, CHINA 118009 Tel: 0086-415-6123779
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Image /page/5/Picture/0 description: The image shows the word "Caresono" in orange font. The font is sans-serif and the letters are evenly spaced. The background is white. The word is likely a brand name or company name.
3. Device Information
| Trade/Device Name | Bladder Scanner |
|---|---|
| Model | PadScan HD2 |
| Common Name | Diagnostic Ultrasound System with Accessories |
| Classification Name | Ultrasonic Pulsed Echo Imaging System(IYO)/Diagnostic Ultrasound Transducer(ITX) |
| Regulatory Class | Class II |
| Classification regulation | 21CFR 892.1560 / 21CFR 892.1570 |
| Review Panel | Radiology |
| Regulation Medical Specialty | Radiology |
| Product Code | IYO/ITX |
4. Predicate Device
| 510(k) number | K131227 |
|---|---|
| Device name | PadScan HD series Bladder Scanner |
| Sponsor | Caresono Technology Co., Ltd |
| Product Code | IYO/ITX |
5. Intended Use
The Bladder Scanner (model: PadScan HD2) projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
6. Indications for Use
The Bladder Scanner (model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The PadScan HD2 Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
7. Device Description
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Image /page/6/Picture/0 description: The image shows the word "Caresono" in orange color. The font is bold and sans-serif. The background is white.
The PadScan HD2 Bladder Scanner manufactured by Caresono Technology provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. It is a handheld bladder scanner, the main unit and the probe are all-in-one.
It features:
- · Expert operating mode and Easy operating mode
- · Non-invasive, comfortable, correct, reliable, fast and simple operation
- SD card storage
- Voice recording function
- Urine volume setting and alarm setting
- Multi-language selection
- · Injection molded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels)
- Power supply with built-in battery.
8. Contraindications
Do not use the PadScan HD2 Bladder Scanner on following cases:
- a) Fetal use or pregnant patients.
- b) Patients with ascites.
- c) Patients with open or damaged skin.
- d) Wounds in the suprapubic region
9. Comparison to Predicate Device
Caresono Technology Co., Ltd believes the PadScan HD2 Bladder Scanner described in this submission is substantially equivalent to the predicate device as follows:
PadScan HD series Bladder Scanner (K131227)
The ultrasound power transmitted from the device is not user adjustable, and PadScan HD2 Bladder Scanner is Track 1 System and meets the FDA's pre-amendment acoustic output limits, So as the predicate devices are. Although there are some differences such as resonant frequency, power source and size of display screen, appearance, there is no significant differences in technological characteristics that affecting the safety and efficiently. These are evaluated by safety test and acoustic output test.
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Image /page/7/Picture/0 description: The image features the word "Caresono" in a bold, sans-serif font. The text is rendered in a vibrant orange color, which makes it stand out against the white background. The overall impression is clean and modern, with a focus on the brand name.
| Items | Proposed Device | Predicate Device-K131227 |
|---|---|---|
| Trade Name | Bladder Scanner | PadScan HD series Bladder Scanner |
| Model | PadScan HD 2 | PadScan HD 5, PadScan HD 3 |
| 510k submitter | Caresono Technology Co., Ltd. | Caresono Technology Co., Ltd. |
| 510(K) Number | ------------- | K131227 |
| ClassificationsName & Citations | 21 CFR 892.1560 Ultrasonic PulsedEcho Imaging System(Product code: IYO)21 CFR 892.1570 DiagnosticUltrasonic Transducer(Product code: ITX) | 21 CFR 892.1560 Ultrasonic PulsedEcho Imaging System(Product code: IYO)21 CFR 892.1570 DiagnosticUltrasonic Transducer(Product code: ITX) |
| Intended Use | The Bladder Scanner (model:PadScan HD2) projects ultrasoundenergy through the lower abdomen ofthe patient to obtain images of thebladder which is used to calculatebladder volume noninvasively. ThePadScan HD2 Bladder Scanner isintended to be used only by qualifiedmedical professionals. | The PadScan HD series BladderScanner projects ultrasound energythrough the lower abdomen of thepatient to obtain images of thebladder which is used to calculatebladder volume noninvasively. ThePadScan HD series Bladder Scanneris intended to be used only byqualified medical professionals. |
| Indications forUse | The Bladder Scanner (model:PadScan HD2) is B-modepulsed-echo ultrasound device. Itintended as a handheldbattery-operated device. The PadScanHD2 Bladder Scanner projectsultrasound energy through the lowerabdomen of the patient to obtainimages of the bladder which is used tocalculate bladder Volumenoninvasively. The PadScan HD2Bladder Scanner is intended to be | The PadScan HD series BladderScanner is B-mode pulsed-echoultrasound device. It intended as aportable battery-operated device.The PadScan HD series BladderScanner projects ultrasound energythrough the lower abdomen of thepatient to obtain images of thebladder which is used to calculatebladder volume noninvasively. ThePadScan HD series Bladder Scanneris intended to be used only by |
| used only by qualified medical professionals. | qualified medical professionals. | |
| Contraindications | Do not use the PadScan HD2 Bladder Scanner on following cases:a) Fetal use or pregnant patientsb) Patients with ascitesc) Patients with open or damaged skin.d) Wounds in the suprapubic region | Do not use the PadScan HD series Bladder Scanner on following cases:a) Fetal use or pregnant patientsb) Patients with ascitesc)Patients with open or damaged skind) Wounds in the suprapubic region |
| Modes of operation | B mode | B mode |
| System Characteristics | a) handheld, the main unit and the probe are all-in-oneb) LCD Displayc) Power source: Battery | a) Portableb) LCD Displayc) Thermal Printerd) Power source: Battery or AD-DC adapter |
| Display | PadScan HD2: 2.5" TFT-LCD | PadScan HD5: 8" TFT-LCDPadScan HD3: 7" TFT-LCD |
| Controls for Change of acoustic output during scan | No | No |
| Transducer Type | Mechanical Sector Probe | Mechanical Sector Probe |
| Measurement localization | Abdomen | Abdomen |
| Transducer Resonant Frequency | 3.5 MHz | 2.5 MHz |
| Number of elements | 1 | 1 |
| Sector Angle | 120 degree | 120 degrees |
| No. of Scan Planes | 1 | 12 |
| FDA Limits | Track 1 | Track 1 |
| Product Safety | AAMI / ANSI | IEC 60601-1:2005 +CORR.1(2006) |
| Certification | ES60601-1:2005/(R)2012 AndA1:2012,, C1:2009/(R)2012 AndA2:2010/(R)2012IEC 60601-2-37:2007 | +CORR.2(2007)IEC 60601-2-37:2007 |
| EMC Compliance | IEC 60601-1-2:2007 | IEC 60601-1-2:2007 |
| PatientContactingMaterial | PC(Skin Contact) | Plastic, PE (Skin Contact) |
| Range | Bladder volume range: 0-999mlAccuracy: ±15%, ±15ml | Bladder volume range: 0-999mlAccuracy: ±15%, ±15ml |
| Classification ofprotection againstelectric shock | Class II equipmentType B equipment | Class II equipmentType B equipment |
| Real-timescanning | Yes (Pre-scan) | Yes (Pre-scan) |
| PC Data Upload | Using SD card | Using USB flash disk |
| Power | Battery Charger:input: 100-240Va.c., 50/60HzOutput: 8.4Vd.cBattery: Li-ion rechargeable | AC/DC Adapter:Input: AC100-240V, 50/60Hz,Output: DC14V±0.5VBattery: Li-ion rechargeable |
Table 6-1 Comparison to the predicate
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Image /page/8/Picture/0 description: The image shows the word "Caresono" in a bold, sans-serif font. The color of the text is a vibrant orange. The word appears to be a logo or brand name, presented in a clean and modern style.
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Image /page/9/Picture/0 description: The image shows the word "Caresono" in orange font. The word is written in all lowercase letters and is underlined with a thin black line. The font is sans-serif and the letters are closely spaced together.
Caresono Technology Co., Ltd. believes that the PadScan HD2 Bladder Scanner is substantially equivalent to the PadScan HD2 series Bladder Scanner of Caresono Technology Co., Ltd.
10. Non-clinical Testing Summary
10.1 Safety
Electrical, mechanical, environmental safety and performance data demonstrates that the device is in compliance with ES 60601-1:2005 and IEC 60601-2-37:2007.
10.2 EMC
Electromagnetic Compatibility data demonstrates that the device is in compliance with IEC 60601-1-2:2007.
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10.3 Performance-Bench Testing
-
The PadScan HD2 Bladder Scanner had been tested as Track 1 device per the FDA Guidance document "Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2:2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
-
The PadScan HD2 Bladder Scanner had been tested volume accuracy per the FDA Guidance document "Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. All the test results comply with the pre-set acceptability criterion, which is the same as predicate device.
10.4 Biocompatibility
The biocompatibility testing conducted in according with standard Biocompatibility ISO 10993-5:2009 and ISO 10993-10:2010.
11. Substantial Equivalence Conclusion
The PadScan HD2 Bladder Scanner was evaluated with safety (ES 60601-1:2005 and 60601-2-37:2007), EMC (IEC 60601-1-2:2007), Biocompatibility (ISO IEC 10993-5:2009, ISO10993-10:2010), Acoustic Output (NEMA UD2:2004) and volume accuracy. The conclusions drawn from testing of the PadScan HD2 Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate device.
§ 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.