(12 days)
Not Found
No
The summary describes a balloon pump apparatus with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No
The device is described as a "balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion." This function is to aid in a procedure, not to directly treat a medical condition or disease.
No
This device is described as a "balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion." Its function is to facilitate a medical procedure, not to diagnose a condition or disease.
No
The device description explicitly states it is a "balloon pump apparatus" and describes its connection to physical components (over-tube, double balloon endoscope, tube kit) and its function of feeding/evacuating air, indicating it is a hardware device with a physical mechanism.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion." This is a mechanical function used during a medical procedure, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic testing.
Therefore, based on the provided information, the Fujifilm Balloon Controller PB-30 is a medical device used for procedural assistance, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDA
Device Description
The Fujifilm Balloon Controller PB-30 is a modified version of the legally marketed Fujifilm Balloon Controller PB-20 in K143556. Just like K143556, the proposed PB-30 is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
PB-30 is connected to the over-tube and double balloon endoscope via a tube kit. PB-30 feeds /evacuates air to the balloon of over-tube and to the balloon at the tip of the endoscope. All of the PB-30's accessories are legally marketed in the US.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
This product is not intended for use for any neonates, infants or children.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Fujifilm conducted the following performance testing of the PB-30 to ensure that the modified device performs equivalently to the predicate PB-20:
EMC and electrical safety of the subject devices were evaluated using the following consensus standards: ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-1-6:2010; and IEC 60601-2-18:2009.
In all cases, the device met the pre-defined acceptance criteria for the test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2015
Fujifilm Medical Systems USA, Inc. Aaron Ge RA Manager, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, New Jersey 07470
Re: K153483
Trade/Device Name: Balloon Controller PB-30 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF, FDA Dated: November 30, 2015 Received: December 3, 2015
Dear Aaron Ge:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/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,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153483
Device Name Balloon Controller PB-30
Indications for Use (Describe)
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
Type of Use (Select one or both, as applicable)
| Commercial and/or Industrial (C&I) Vehicle Registration |
|---|
| Other - This transaction requires a Utah STID |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
Fujifilm's Balloon Controller PB-30
Submitter's Information
FUJIFILM Medical Systems U.S.A., Inc. Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Reqistration Number: 2431293
Contact Person:
Aaron Ge Regulatory Manager, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2636 Ext. 522636 Facsimile: (973) 633-8818 E-Mail age@fujifilm.com
Date Prepared: November 30, 2015
ldentification of the Subject Device:
| Proprietary/Trade Name: | PB-30 |
|---|---|
| Common Name: | Balloon Controller |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Classification Information:
Colonoscope and Accessories (Flexible/Rigid), 21 C.F.R. § 876.1500 Product Code: FDF, FDA
Primary Predicate
Fujifilm Balloon Controller PB-20 (K143556)
Purpose of the Special 510(k) notice.
The PB-30 is a modification to PB-20.
Intended Use
4
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
Technological Characteristics
The Fujifilm Balloon Controller PB-30 is a modified version of the legally marketed Fujifilm Balloon Controller PB-20 in K143556. Just like K143556, the proposed PB-30 is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
PB-30 is connected to the over-tube and double balloon endoscope via a tube kit. PB-30 feeds /evacuates air to the balloon of over-tube and to the balloon at the tip of the endoscope. All of the PB-30's accessories are legally marketed in the US.
Performance Data
Fujifilm conducted the following performance testing of the PB-30 to ensure that the modified device performs equivalently to the predicate PB-20:
EMC and electrical safety of the subject devices were evaluated using the following consensus standards: ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-1-6:2010; and IEC 60601-2-18:2009.
In all cases, the device met the pre-defined acceptance criteria for the test.
Substantial Equivalence
PB-30 has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate PB-20. The minor differences in the modified device's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the PB-30 is as safe and effective as PB-20. Thus, the PB-30 is substantially equivalent to its predicate device.