(258 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic functionality of an endoscope hood, with no mention of AI/ML or related concepts like image processing or data analysis.
No.
The 'Intended Use' states its purpose is to "maintain the field of view during endoscopic procedures such as mucosal resection," which is a supportive function, not a direct treatment or diagnosis.
No
This device is described as an accessory (hood) for endoscopes, used to maintain the field of view during procedures like mucosal resection. Its function is to facilitate the procedure, not to diagnose a condition or disease.
No
The device description clearly states it is comprised of physical components (attaching portion, distal portion, drain portion) and is intended to be used in combination with physical endoscopes. The performance studies also focus on physical characteristics and biocompatibility.
Based on the provided text, the FUJIFILM Hood Models DH-28GR, DH-29CR, and DH-30CR are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is to "maintain the field of view during endoscopic procedures such as mucosal resection." This describes a physical accessory used during a medical procedure performed on a patient, not a device used to examine specimens from a patient outside the body.
- Device Description: The description details the physical components and how the hood attaches to an endoscope. It focuses on its mechanical function in maintaining the field of view and preventing fluid lodging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The FUJIFILM Hood models described here do not fit this definition.
N/A
Intended Use / Indications for Use
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Product codes (comma separated list FDA assigned to the subject device)
FDS, FDF
Device Description
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endscopic procedures such as mucosal resection.
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are comprised of three main sections: an attaching portion, a distal portion, and a drain portion. The attaching portion is a wider diameter opening which is used to connect the hood to an applicable endoscope; a distal portion is the ending portion of the hood which tapers into narrower diameter opening, the drain slits on the distal portion form drain portion which prevent the fluids lodging on the surface of the endoscope.
The subject devices are used in combination with their respective applicable Fujifilm's endoscopes as shown in the table 7.1. All the applicable endoscopes marketed in USA are cleared under respective 510(k) notices.
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
Not Found
Intended User / Care Setting
Not Found
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)
- Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-7:2008; and ISO 10993-10:2010.
- Sterilization was evaluated according to the following consensus standards: ISO 11135:2014 and ASTM F1980-07:2011.
- Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015; and ISO 8600-4:2014.
- Subject devices met performance specifications in the following additional testing:
- Outer diameter
- Maximum diameter of attaching endoscope
- Inner diameter of distal end
- Inner diameter of attaching portion
- Distance from the tip
- Bench testing data demonstrated that the subject devices have substantially equivalent performance to the predicate.
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.
Fujifilm Hood Model DH-17EN (K143556)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
Fujifilm Medical Systems USA, Inc. Shraddha S. More Specialist. Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470
Re: K162749
Trade/Device Name: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Codes: FDS. FDF Dated: May 2, 2017 Received: May 4, 2017
Dear Shraddha S. More:
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
1
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 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 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.
Charles Viviano -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) K162749
Device Name
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
Indications for Use (Describe)
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201.66) |
|---|---|
| ------------------------------------------------ | ---------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K162749 Page 1 of 5
510(k) SUMMARY
FUJIFILM Medical Systems U.S.A., Inc.'s FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
Date: September 29, 2016
Submitter's Information
FUJIFILM Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293
Contact Person:
Shraddha More Specialist, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2627 Facsimile: (973) 633-8818 E-Mail: smore@fujifilm.com
Identification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR |
|---|---|
| Common Name: | Hood |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Gastroscope and Accessories (Flexible/Rigid) | 21 CFR | |
| 876.1500 | FDS | |
| Colonoscope and Accessories (Flexible/Rigid) | 21 CFR | |
| 876.1500 | FDF |
Predicate Devices
- Fujifilm Hood Model DH-17EN (K143556)
4
Intended Use / Indications for Use
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endscopic procedures such as mucosal resection.
Device Description
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endscopic procedures such as mucosal resection.
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are comprised of three main sections: an attaching portion, a distal portion, and a drain portion. The attaching portion is a wider diameter opening which is used to connect the hood to an applicable endoscope; a distal portion is the ending portion of the hood which tapers into narrower diameter opening, the drain slits on the distal portion form drain portion which prevent the fluids lodging on the surface of the endoscope.
The subject devices are used in combination with their respective applicable Fujifilm's endoscopes as shown in the table 7.1. All the applicable endoscopes marketed in USA are cleared under respective 510(k) notices.
Technological Characteristics
A comparison of the technological characteristics between the subject and predicate devices is provided in the table below.
5
Table 7.1: Comparison of FUJIFILM Hood Models DH-28GR, DH-29CR with their predicate device DH-17EN (K143556)
| | Predicate Device model
DH-17EN (K143556) | Proposed Device
model DH-28GR | Proposed Device
model DH-29CR | Proposed Device
model DH-30CR |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This hood is intended to be
used in combination with the
dedicated Endoscope to
maintain the field of view during
endoscopic procedures. | These hoods are intended to be
used in combination with compatible
endoscopes to maintain the field of
view during endoscopic procedures
such as mucosal resection. | These hoods are intended to be
used in combination with compatible
endoscopes to maintain the field of
view during endoscopic procedures
such as mucosal resection. | These hoods are intended to be used in
combination with compatible endoscopes
to maintain the field of view during
endoscopic procedures such as mucosal
resection. |
| Appearance | Image: DH-17EN | Image: DH-28GR | Image: DH-29CR | Image: DH-30CR |
| Outer diameter | 11.5mm | 11.8mm | 13.0mm | 14.8mm |
| Maximum diameter
of attaching
endoscope | 13.5mm | 15.5mm | 16.5mm | 18.4mm |
| Total length | 8.0mm | 17.0mm | 17.0mm | 17.0mm |
| Distance from the tip | 1.5mm | 7.0mm | 7.0mm | 7.0mm |
| Diameter of
attaching portion | 9.5mm | 10.4 - 11.3 mm | 11.6 - 12.3 mm | 13.4 - 14.2 mm |
| Inner diameter of
distal end | 8.5mm | 8.0mm | 8.0mm | 8.0mm |
| Size and number of
the drain | N/A | Square hole
5.0mmx1.25mm 2piece | Square hole
5.0mmx1.25mm 2piece | Square hole
5.0mmx1.25mm 2piece |
| Sterility | Not sterilized | Sterilized | Sterilized | Sterilized |
| Reuse or not re-use | Single use | Single use | Single use | Single use |
| Applicable
endoscopes | EN-530T and EN-580T
EN-450T5
EC-450BI5 | EG-590WR
EG-580RD [Note]
EC-580RD/M [Note]
EC-580RD/L [Note]
EG-600ZW [Note] | EG-530CT
EG-590ZW | EC-590WM [Note] EC-590ZW/M [Note]
EC-590ZW/L EC-530WM3 [Note]
EC-530WI3 [Note] EC-530WL3 [Note]
EC-530DL ES-530WE
EC-590WM4 [Note] EC-590WI4 [Note]
EC-590WL4 [Note] EC-590ZW3/M [Note]
EC-590ZW3/L [Note] EC-600WM [Note]
EC-600WI [Note] EC-600WL
EC-600WL v2 EC-600HL
EC-600ZW/M [Note] EC-600ZW/L [Note] |
[Note] Not available in USA.
6
The principle of operation and intended use of the FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are identical to that of the predicate device FUJIFILM Hood Model DH-17EN (K143556). The modifications done to the subject device include changes in dimensions, material and sterility status. The subject hoods are slightly longer and larger than the predicate device. Also, subject devices are provided sterilized, while predicate device is supplied non-sterilized.
As detailed in the following sections of the 510(k) notice, these changes do not alter the intended use or fundamental technology of the subject devices neither affects their safety and effectiveness.
Performance Data
Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-7:2008; and ISO 10993-10:2010.
Sterilization was evaluated according to the following consensus standards: ISO 11135:2014 and ASTM F1980-07:2011.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015; and ISO 8600-4:2014.
Subject devices met performance specifications in the following additional testing:
- Outer diameter
- Maximum diameter of attaching endoscope
- Inner diameter of distal end ●
- Inner diameter of attaching portion ●
- Distance from the tip
7
Substantial Equivalence
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR have substantially the same intended use and similar indications, technological characteristics, and principles of operation as their predicate device Fujifilm Hood Model DH-17EN (K143556). The minor dimensional differences between the FUJIFILM Hood Models DH-28GR, DH-29CR and their predicate device Fujifilm Hood Model DH-17EN were made for the purpose of overall product enhancement and general technological advancement, and raise no new issues of safety or effectiveness. The material changes in the subject device do not raise new concerns regarding biocompatibility as discussed in section XVII. Performance data demonstrated that the FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR have substantial equivalent performance to the predicate device Fujifilm Hood Model DH-17EN (K143556). The subject devices are provided sterile to the end users as opposed to the predicate device which is provided non-sterile. The subject devices are successfully validated for the sterilization process as well as residual EO and ECH concentrations, supporting their safety equivalent to the predicate device.
Conclusions
The subject devices, Hood Models DH-28GR, DH-29CR and DH-30CR are substantially equivalent to their predicate device Hood Model DH-17EN (K143556), based on intended use/indications for use and technological characteristics. The differences in the dimensions and material between the subject devices and its predicate device raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject devices have substantially equivalent performance to the predicate. Thus, the subject devices FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are as substantially equivalent as their predicate Fujifilm Hood Model DH-17EN (K143556).