(30 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical function of a hood accessory for endoscopes, with no mention of AI or ML.
No.
The device is used to maintain the field of view during endoscopic procedures, but it does not directly treat a disease or condition. It is an accessory to an endoscope.
No
This device is described as a "hood" used in combination with endoscopes to maintain the field of view during endoscopic procedures. Its purpose is to facilitate the procedure, not to diagnose a condition.
No
The device description clearly indicates it is a physical hood made of material with distinct sections (attaching portion, distal portion, drain portion) and undergoes physical testing (outer diameter, maximum diameter, distance from tip). It is a hardware accessory for endoscopes.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed 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 hood used in combination with endoscopes to maintain the field of view during endoscopic procedures. It is a physical accessory used during a medical procedure on a patient, not a test performed on a sample outside the body.
- Intended Use: The intended use is to assist in endoscopic procedures, which are performed directly on the patient.
- Device Description: The description focuses on the physical components and how it attaches to an endoscope.
- Performance Studies: The performance studies described are related to physical dimensions and compatibility with endoscopes, not diagnostic accuracy or analysis of biological samples.
Therefore, based on the provided information, this device is a medical accessory used in conjunction with an endoscope for procedural assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This hood is 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-106STL. DH-116STL. and DH-096ST are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
The FUJIFILM Hood Models DH-106STL, DH-126STL, and DH-096ST 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
digestive tract
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)
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
- Distance from the tip
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 1, 2023
Fujifilm Healthcare Americas Corporation Chaitrali Kulkarni Sr. Regulatory Affairs Specialist 81 Hartwell Avenue Suite 300 Lexington, Massachusetts 02421
Re: K232314
Trade/Device Name: Hood (DH-106STL, DH-126STL, DH-126STL, DH-096ST) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS, FDF Dated: August 2, 2023 Received: August 2, 2023
Dear Chaitrali Kulkarni:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sivakami Venkatachalam -S
for Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
Indications for Use (Describe)
This hood is 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)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
FUJIFILM Medical Systems U.S.A., Inc.'s FUJIFILM Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST
Date: August 31, 2023
Submitter's Information
FUJIFILM Healthcare Americas Corporation 81 Hartwell ave Lexington, MA 02421
Contact Person:
Chaitrali Kulkarni Sr. Regulatory Affairs Specialist Telephone: (704) 517 4886 E-Mail: chaitrali.kulkarni@fujifilm.c om
Identification of the Proposed Device:
Proprietary/Trade Name: Fujifilm Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST 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-28GR, DH-29CR, DH-30CR (K162749)
4
Intended Use / Indications for Use
The FUJIFILM Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Device Description
FUJIFILM Hood Models DH-106STL. DH-116STL. and DH-096ST are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
The FUJIFILM Hood Models DH-106STL, DH-126STL, and DH-096ST 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 technological characteristics of FIOSTL, DH-116STL, DH-116STL, and DH-096ST with their predicate device DH-29GR, DH-29GR, DH-29GR, DH-29GR, DH-29CR, D 30CR (K162749)
| | Predicate Device model
DH-28GR, DH-29CR, DH-30CR | | | Proposed Device model
DH-106STL, DH-116STL, DH-126STL | | | Proposed Device model
DH-096ST | | FUJIFILM Comments on Predicate Device model |
|--------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: DH-28GR, DH-29CR, DH-30CR devices | | | Image: DH-106STL, DH-116STL, DH-126STL devices | | | Image: DH-096ST device | | |
| | DH-28GR | DH-29CR | DH-30CR | DH-106STL | DH-116STL | DH-126STL | DH-096ST | | |
| Manufacturer | DH-28GR | FUJIFILM corporation | | DH-106STL | FUJIFILM corporation | | FUJIFILM corporation | | Same as Predicate Device model |
| | DH-29CR | | DH-30CR | DH-116STL | | DH-126STL | | | |
| Outer diameter | DH-28GR | 11.8mm | | DH-106STL | 11.6mm | | 11.0mm | | The outer diameter changes slightly due to the shape
change of the resin |
| | DH-29CR | 13.0mm | | DH-116STL | 11.6mm | | | | |
| | DH-30CR | 14.8mm | | DH-126STL | 13.7mm | | | | |
| Maximum
diameter of
attaching
endoscope | DH-28GR | 15.5mm | | DH-106STL | 15.3mm | | 14.2mm | | DH-106STL, DH-116STL, DH-126STL
Since the dimensions of the rubber have been changed in
line with the change in the shape of the resin, the
maximum diameter will change when installed. |
| | DH-29CR | 16.5mm | | DH-116STL | 15.8mm | | | | DH-096ST
Since the size of the rubber is reduced to combine with an
endoscope that is thinner than the existing hood, the
maximum diameter changes when attached. |
| | DH-30CR | 18.4mm | | DH-126STL | 16.8mm | | | | |
| Distance from
the tip | DH-28GR | | | DH-106STL | | | 6.0mm | | In order to increase versatility, the protruding length was
shortened to secure the field of view when the endoscope
is attached. |
| | DH-29CR | 7.0mm | | DH-116STL | 6.0mm | | | | |
| | DH-30CR | | | DH-126STL | | | | | |
| Total length | DH-28GR | | | DH-106STL | | | 16.0mm | | The total length is shortened by changing the Distance
from the tip. |
| | DH-29CR | 17.0mm | | DH-116STL | 16.0mm | | | | |
| | DH-30CR | | | DH-126STL | | | | | |
| Combination
endoscope | DH-28GR | EG-590WR, EG-580RD,
EG-600ZW, EG-760Z,
EC-580RD/M, EC-580RD/L,
EC-740T/M, EC-740T/L | | DH-106STL | EG-760Z, EC-740T/L | | EG-760R | | Appropriate endoscopes are set in combination according
to the shape of the hood. |
| | DH-29CR | EG-760CT, EG-590ZW,
EG-530CT, EC-760P-V/M,
EC-760P-V/L | | DH-116STL | EG-760CT, EG-530CT,
EC-760P-V/L | | | | |
| | DH-30CR | EC-760ZP-V/L, EC-600WL v2,
EC-760R-V/L, EC-530DL,
ES-530WE, EC-600HL,
EC-760Z-V/L, EC-760S-V/L | | DH-126STL | EC-600LS, EC-600WL,
EC-760R-V/L,
EC-760ZP-V/L | | | | |
| How to attach
to the
endoscope | DH-28GR | Align the objective lens of
endoscope with the drain of | | DH-106STL | Attach the hood to the distal
end of the endoscope. | | Align the objective lens of
endoscope with the drain
of the hood and attach the
hood to the distal end of
endoscope by pressing
the hood until it stops. | | Same as Predicate Device model |
| | DH-29CR | the hood and attach the hood
to the distal end of endoscope | | DH-116STL | Align the opening of the
distal portion of the hood | | | | |
| | DH-30CR | by pressing the hood until it
stops. | | DH-126STL | with the instrument channel
outlet of the endoscope and
press the hood until it stops. | | | | |
| Existence of
Sterile | DH-28GR | | | DH-106STL | | | EOG Sterilized | | Same as Predicate Device model |
| | DH-29CR | EOG Sterilized | | DH-116STL | EOG Sterilized | | | | |
| | DH-30CR | | | DH-126STL | | | | | |
| Reuse or not
re-use | DH-28GR | Single Use | | DH-106STL | Single Use | | Single Use | | Same as Predicate Device model |
| | DH-29CR | | DH-30CR | DH-116STL | | DH-126STL | | | |
6
| Intended Use | DH-28GR
DH-29CR
DH-30CR | These hoods are intended to
be used in combination with
compatible endoscopes to
maintain the field of view
during observation of the
digestive tract. | DH-106STL
DH-116STL
DH-126STL | These hoods are intended to
be used in combination with
compatible endoscopes to
maintain the field of view
during observation of the
digestive tract. | These hoods are intended
to be used in combination
with compatible
endoscopes to maintain
the field of view during
observation of the
digestive tract | Same as Predicate Device model |
|-----------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Material | DH-28GR
DH-29CR
DH-30CR | Silicone rubber
Manufacturer: Shin-Etsu
Chemical Co., Ltd. Model:KE-
2090-60-A/B
Polycarbonate resin
Manufacture: Mitsubishi
Engineering-Plastics
Corporation Model: IUPILON
S-2001R 5355 | DH-106STL
DH-116STL
DH-126STL | Silicone rubber
Manufacturer: Shin-Etsu
Chemical Co., Ltd.
Model:KE-2090-60-A/B
Polycarbonate resin
Manufacture: Mitsubishi
Engineering-Plastics
Corporation Model: IUPILON
S-2001R 5355 | Silicone rubber
Manufacturer: Shin-Etsu
Chemical Co., Ltd.
Model:KE-2090-60-A/B
Polycarbonate resin
Manufacture: Mitsubishi
Engineering-Plastics
Corporation Model:
IUPILON S-2001R 5355 | Same as Predicate Device model |
| Transport and
Storage
Environment | DH-28GR
DH-29CR
DH-30CR | Temperature: -20 to +60°C
Humidity: 10 to 95% (No
condensation)
Atmosphere: 70 to 106
kPa(Within range of
atmospheric pressure) | DH-106STL
DH-116STL
DH-126STL | Temperature: -20 to +60°C
Humidity: 10 to 95% (No
condensation)
Atmosphere: 70 to 106
kPa(Within range of
atmospheric pressure) | Temperature: -20 to +60°C
Humidity: 10 to 95% (No
condensation)
Atmosphere: 70 to 106
kPa(Within range of
atmospheric | Same as Predicate Device model |
7
The principle of operation and intended use of the FUJIFILM Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST are identical to that of the predicate device FUJIFILM Hood Model DH-28GR, DH-29CR, DH-30CR (K162749). The modifications done to the subject device include changes in dimensions and applicable endoscopes. The distance from the tip and total length is slightly smaller in the subject device compared to the predicate device. The maximum diameter of attaching endoscope of DH-096ST and DH-126STL is slightly smaller the predicate device.
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
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
- Distance from the tip ●
8
Substantial Equivalence
FUJIFILM Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST have substantially the same intended use and similar indications, technological characteristics, and principles of operation as their predicate device Fujifilm Hood Model DH-28GR, DH-29CR and DH-30CR (K162749) . The minor dimensional differences between the FUJIFILM Hood Models DH-106STL. DH-116STL, DH-126STL, and DH-096ST and their predicate device Fujifilm Hood Model DH-28GR, DH-29CR and DH-30CR (K162749) were made for the purpose of overall product enhancement and general technological advancement, and raise no new issues of safety or effectiveness. Performance data demonstrated that the FUJIFILM Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST have substantial equivalent performance to the predicate device Fujifilm Hood Model DH-28GR, DH-29CR and DH-30CR (K162749) .
Conclusions
The subject devices, Hood Models DH-106STL, DH-126STL, and DH-096ST are substantially equivalent to their predicate device Hood Model DH-28GR, DH-29CR and DH-30CR (K162749) , based on intended use/indications for use and technological characteristics. The differences in the dimensions 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-106STL, DH-116STL, DH-126STL, and DH-096ST are as substantially equivalent as their predicate Fuiifilm Hood Model DH-28GR, DH-29CR and DH-30CR (K162749) .