(7 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal (new indication)
Portascan Bladder Scanner; Portascan Probe (3.5 MHz/5.0 MHz Transabdominal & Bladder)
This looks like an FDA 510(k) clearance letter for the Portascan Bladder Scanner, not a study document. It establishes substantial equivalence to a predicate device and gives permission to market the device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It doesn't describe the performance of the device, sample sizes, ground truth establishment, or any comparative effectiveness studies.
The provided text only contains:
- Regulatory Information: Device name, regulation numbers, product codes, and the FDA's determination of substantial equivalence.
- Intended Use: The clinical applications for which the device is cleared, specifically for "Abdominal" imaging (indicated by 'N' for new indication in the first table of the "Diagnostic Ultrasound Indications for Use Form" for the "Portascan System"). The second table identifies the "Portascan Probe" manufactured by Pie Medical with a previous 510(k) number as the system.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report from the 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 4 2003
Mediwatch, plc % Ms. Susan Gill Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709
Re: K033906
Trade Name: Portascan Bladder Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Il Product Code: 90 IYO and ITX Dated: December 16, 2003 Received: December 17, 2003
Dear Ms. Gill:
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 transducer intended for use with the Portascan Bladder Scanner, as described in your premarket notification:
Portascan Probe (3.5 MHz/5.0 MHz Transabdominal & Bladder)
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Gill
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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence 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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David K. Severson
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Diagnostic Ultrasound Indications for Use Form
Portascan System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical application | A | B | M | PWD (D) | Colour Doppler (AD) | Amplitude Doppler (AD) | Colour Velocity Imaging | Combined (specify) | Other (Specify) |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | N | ||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Paediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculoskeletal Conventional | |||||||||
| Musculoskeletal Superficial | |||||||||
| Other (specify) |
N = new indication; P= previously cleared by FDA; E=added under Appendix E
Corril by desim .
Prescription Use (Per 21 CFR 892.1560/70)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number (if known): K033906
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
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Diagnostic Ultrasound Indications for Use Form
System: Portascan Probe (manufactured by Pie Medical 510(k) number K020112).
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinicalapplication | A | B | M | PWD(D) | Mode of Operation | ||||
|---|---|---|---|---|---|---|---|---|---|
| ColourDoppler(AD) | AmplitudeDoppler(AD) | ColourVelocityImaging | Combined(specify) | Other(Specify) | |||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | N | ||||||||
| Intraoperative(specify) | |||||||||
| IntraoperativeNeurological | |||||||||
| Paediatric | |||||||||
| Small Organ(Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| PeripheralVascular | |||||||||
| Laparoscopic | |||||||||
| MusculoskeletalConventional | |||||||||
| MusculoskeletalSuperficial | |||||||||
| Other (specify) |
| 510(k) Number (if known): | |
|---|---|
| Device Name: | |
| Indications For Use: |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033906Bladder Scanner FDA Submission 6th issue, 14 September-2003
§ 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.