(30 days)
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
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.
The provided text describes a 510(k) submission for endoscopy hoods, which are physical accessories for endoscopes, not an AI/ML-driven medical device. Therefore, the information requested regarding acceptance criteria, study design for AI claims (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details), is not applicable to this submission.
The "device" in question (endoscopy hood) is a physical accessory without any computational or AI/ML components. The "performance data" mentioned refers to physical properties and conformity to standards for medical devices, not the performance of an algorithm.
Summary of Device and Performance Information Available in the Document:
The document concerns the Fujifilm Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST. These are endoscopy hoods intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Acceptance Criteria and Reported Device Performance (as inferred from the document for a physical device):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device maintains field of view during endoscopic procedures when combined with compatible endoscopes. | The intended use is identical to the predicate device. The changes in dimensions and applicable endoscopes do not alter the intended use or fundamental technology. The device maintains the field of view during observation of the digestive tract. |
| Technological Characteristics Equivalence: Similar physical and material properties to the predicate. | - Manufacturer: Same as predicate (FUJIFILM corporation). - Outer Diameter: Slightly different from predicate due to shape changes (e.g., DH-106STL: 11.6mm vs. Predicate DH-28GR: 11.8mm). - Maximum Diameter of Attaching Endoscope: Slightly different from predicate (e.g., DH-106STL: 15.3mm vs. Predicate DH-28GR: 15.5mm). - Distance from the Tip: Shorter than predicate for versatility (e.g., DH-106STL: 6.0mm vs. Predicate DH-29CR: 7.0mm). - Total Length: Shorter than predicate due to tip shortening (e.g., DH-116STL: 16.0mm vs. Predicate DH-29CR: 17.0mm). - Combination Endoscope: Different specific endoscope models, but appropriate combinations set according to hood shape. - How to Attach: Same method as predicate. - Sterilization: EOG Sterilized (same as predicate). - Reuse: Single Use (same as predicate). - Material: Silicone rubber and Polycarbonate resin (same as predicate). - Transport and Storage: Same environment parameters as predicate. |
| Safety and Effectiveness: Changes do not raise new safety or effectiveness issues. | "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)." "The differences in the dimensions between the subject devices and its predicate device raise no new issues of safety or effectiveness." |
| Compliance with Consensus Standards: Adherence to relevant industry standards. | Endoscope specific testing was conducted using ISO 8600-1:2015 and ISO 8600-4:2014. |
| Additional Testing for Physical Properties: Verified dimensional specifications. | Subject devices met performance specifications in additional testing for: - Outer diameter - Maximum diameter of attaching endoscope - Distance from the tip |
Details of Study that Proves the Device Meets Acceptance Criteria:
-
A table of acceptance criteria and the reported device performance: See table above.
-
Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses "test sets" or "training sets" of data. The device is a physical accessory for endoscopes. The "performance data" refers to bench testing and comparison of physical characteristics against predicate devices and consensus standards. No patient data or images were used for evaluation of this device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of expert review of data is irrelevant for a physical endoscopy hood.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
-
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: Not applicable. No "human readers" or "AI assistance" are involved with this device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance relies on engineering specifications, material properties, and physical functionality, verified through bench testing and comparison to a legally marketed predicate device.
-
The sample size for the training set: Not applicable.
-
How the ground truth for the training set was established: Not applicable.
{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)
< | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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 CFR876.1500 | FDS |
| Colonoscope and Accessories (Flexible/Rigid) | 21 CFR876.1500 | 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 modelDH-28GR, DH-29CR, DH-30CR | Proposed Device modelDH-106STL, DH-116STL, DH-126STL | Proposed Device modelDH-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 shapechange of the resin | |||
| DH-29CR | 13.0mm | DH-116STL | 11.6mm | ||||||
| DH-30CR | 14.8mm | DH-126STL | 13.7mm | ||||||
| Maximumdiameter ofattachingendoscope | DH-28GR | 15.5mm | DH-106STL | 15.3mm | 14.2mm | DH-106STL, DH-116STL, DH-126STLSince the dimensions of the rubber have been changed inline with the change in the shape of the resin, themaximum diameter will change when installed. | |||
| DH-29CR | 16.5mm | DH-116STL | 15.8mm | DH-096STSince the size of the rubber is reduced to combine with anendoscope that is thinner than the existing hood, themaximum diameter changes when attached. | |||||
| DH-30CR | 18.4mm | DH-126STL | 16.8mm | ||||||
| Distance fromthe tip | DH-28GR | DH-106STL | 6.0mm | In order to increase versatility, the protruding length wasshortened to secure the field of view when the endoscopeis 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 Distancefrom the tip. | |||||
| DH-29CR | 17.0mm | DH-116STL | 16.0mm | ||||||
| DH-30CR | DH-126STL | ||||||||
| Combinationendoscope | 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 accordingto 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 attachto theendoscope | DH-28GR | Align the objective lens ofendoscope with the drain of | DH-106STL | Attach the hood to the distalend of the endoscope. | Align the objective lens ofendoscope with the drainof the hood and attach thehood to the distal end ofendoscope by pressingthe hood until it stops. | Same as Predicate Device model | |||
| DH-29CR | the hood and attach the hoodto the distal end of endoscope | DH-116STL | Align the opening of thedistal portion of the hood | ||||||
| DH-30CR | by pressing the hood until itstops. | DH-126STL | with the instrument channeloutlet of the endoscope andpress the hood until it stops. | ||||||
| Existence ofSterile | 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 notre-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-28GRDH-29CRDH-30CR | These hoods are intended tobe used in combination withcompatible endoscopes tomaintain the field of viewduring observation of thedigestive tract. | DH-106STLDH-116STLDH-126STL | These hoods are intended tobe used in combination withcompatible endoscopes tomaintain the field of viewduring observation of thedigestive tract. | These hoods are intendedto be used in combinationwith compatibleendoscopes to maintainthe field of view duringobservation of thedigestive tract | Same as Predicate Device model |
|---|---|---|---|---|---|---|
| Material | DH-28GRDH-29CRDH-30CR | Silicone rubberManufacturer: Shin-EtsuChemical Co., Ltd. Model:KE-2090-60-A/BPolycarbonate resinManufacture: MitsubishiEngineering-PlasticsCorporation Model: IUPILONS-2001R 5355 | DH-106STLDH-116STLDH-126STL | Silicone rubberManufacturer: Shin-EtsuChemical Co., Ltd.Model:KE-2090-60-A/BPolycarbonate resinManufacture: MitsubishiEngineering-PlasticsCorporation Model: IUPILONS-2001R 5355 | Silicone rubberManufacturer: Shin-EtsuChemical Co., Ltd.Model:KE-2090-60-A/BPolycarbonate resinManufacture: MitsubishiEngineering-PlasticsCorporation Model:IUPILON S-2001R 5355 | Same as Predicate Device model |
| Transport andStorageEnvironment | DH-28GRDH-29CRDH-30CR | Temperature: -20 to +60°CHumidity: 10 to 95% (Nocondensation)Atmosphere: 70 to 106kPa(Within range ofatmospheric pressure) | DH-106STLDH-116STLDH-126STL | Temperature: -20 to +60°CHumidity: 10 to 95% (Nocondensation)Atmosphere: 70 to 106kPa(Within range ofatmospheric pressure) | Temperature: -20 to +60°CHumidity: 10 to 95% (Nocondensation)Atmosphere: 70 to 106kPa(Within range ofatmospheric | 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) .
§ 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.