SB Soft Hood is intended for use with SB Knife for endoscopic submucosal dissection within the gastrointestinal tract and for use in keeping the suitable depth of endoscopic field of view.
Device Story
SB Soft Hood is a transparent, disposable distal attachment for endoscopes used during endoscopic submucosal dissection (ESD). The device attaches to the endoscope tip to maintain a consistent distance between the tissue and the endoscope, ensuring a clear visual field. It features a drainage side hole to allow the egress of blood and water, which improves visibility during the dissection phase. The device is used by physicians in a clinical setting. It functions by lifting the incised mucosa, facilitating the use of the SB Knife for submucosal dissection. The device is provided EO-sterilized. It benefits the patient by maintaining visualization and protecting tissue during the ESD procedure.
Clinical Evidence
No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, -10, -11; USPC 151), performance testing (visual inspection, durability, detachment), and sterilization validation (ISO 11135-1:2007, ISO 10993-7:2008, USP <85>).
Technological Characteristics
Transparent distal attachment; EO sterilized (ISO 11135-1:2007). Materials evaluated per ISO 10993. Features drainage side hole. Available in straight and undercut types with outer diameters 13.0-15.9 mm. Tip protrusion length 6 mm. Standalone mechanical device.
Indications for Use
Indicated for use with SB Knife for endoscopic submucosal dissection (ESD) within the gastrointestinal tract to maintain endoscopic field of view depth. No specific patient population or contraindications described.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 8, 2018
Sumitomo Bakelite Co., Ltd % Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo Bunkyo-ku, Tokyo 1130033 Japan
Re: K173004 Trade/Device Name: SB Soft Hood™ Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDS Dated: April 23, 2018 Received: April 26, 2018
Dear Izumi Maruo:
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.
{1}------------------------------------------------
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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173004
Device Name SB Soft Hood™
Indications for Use (Describe)
SB Soft Hood is intended for use with SB Knife for endoscopic submucosal dissection within the gastrointestinal tract and for use in keeping the suitable depth of endoscopic field of view.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
| |
|X 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}------------------------------------------------
# UMITOMO BAKELITE CO., LTD.
5-8, HIGASHI-SHINAGAWA 2-CHOME, SHINAGAWA-KU, TOKYO 140-0002, JAPAN PHONE: 81-3-5462-4811 FACSIMILE: 81-3-5462-4894
MEDICAL PRODUCTS BUSINESS DIV.
# 510 (k) Summary for SB Soft Hood™
- 1. Submission Sponsor
Sumitomo Bakelite Co., Ltd. Medical Products Business Division 5-8, Higashi-Shinagawa 2-chome, Shinagawa-ku, Tokyo 140-0002, JAPAN
### 2. Date Prepared
April 23, 2018
### 3. Device Name
Trade/Proprietary Name: SB Soft Hood™ Common/Usual Name: Transparent Cap Classification Name: Endoscope and accessories Classification Regulation: 876.1500 Classification Panel: Gastroenterology - Urology Devices Product Code: FDS Device Class: ll
### 4. Predicate Devices
Olympus Optical Corporation: Olympus Distal Attachment (K984358)
### 5. Device Description
SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is used in endoscopic submucosal dissection (hereinatter ESD) procedures. The subject device is used for maintaining visualization during the dissection phase of the procedure. The subject device is disposable and in a variety of diameters that correspond to different endoscope sizes. Each model of the subject device contains a drainage side hole that allows egress of water and blood.
### 6. Indications for Use
SB Soft Hood™ is intended for use with SB Knife for endoscopic submucosal dissection within the gastrointestinal tract and for use in keeping the suitable depth of endoscopic field of view.
{4}------------------------------------------------
# 7. Models of SB Soft Hood™
SB Soft Hood™ consists of six models as follows:
SB Soft Hood™ - Straight type (MD-47950) SB Soft Hood™ - Undercut type (MD-47951) SB Soft Hood™ - Straight type (MD-47960) SB Soft Hood™ - Undercut type (MD-47961) SB Soft Hood™ - Straight type (MD-47970) SB Soft Hood™ - Undercut type (MD-47971)
Maximum outer diameters for MD-47950 and MD-47951, MD-47960 and MD-47961, and MD47970 and MD47971 are 13.0 mm, 14.8 mm, and 15.9 mm, respectively.
#### Technological Characteristics and Substantial Equivalence Discussion 8.
SB Soft Hood™ is intended for use with SB Knife (K152771) for ESD within the gastrointestinal tract and for use in keeping the suitable depth of endoscopic field of view. The intended use of SB Soft Hood™ is similar to that of the Predicate Device (Olympus Distal Attachment K984358).
Both SB Soft Hood™ and the Predicate Device are attached to the tip of an endoscope in order to keep the distance between the tissue and the endoscope, and securing the endoscopic visual field.
However, the surgical device combined with SB Soft Hood™ is different from the device combined with the Predicate Device. SB Soft Hood™ is intended for use with SB Knife (K152771) which is used for ESD. The Predicate Device is intended for use with electric snare which is used for endoscopic mucosal resection (hereinafter EMR). (For detail about comparison for the use of the Subject and the Predicate Devices, please see following section 8.1.1)
Even though removed tissue area and depth are different between ESD and EMR procedures, both SB Soft Hood™ and the Predicate Device temporarily contact mucosal membrane and lesion of resected submucosal layer in the digestive system.
Based on above, we determined that the indications for use of SB Soft Hood™ is substantially equivalent to that of the Predicate Device.
The comparison table for technological characteristics between the two devices is shown below.
{5}------------------------------------------------
| Table 1 Comparison table for technological characteristics | | | |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Feature | SB Soft Hood™ | Predicate Device<br>Olympus Distal Attachment<br>(K984358) | Note |
| <b>Indications for use</b> | | | |
| Indications<br>for use | SB Soft Hood™ is intended for use<br>with SB Knife for endoscopic<br>submucosal dissection within the<br>gastrointestinal tract and for use in<br>keeping the suitable depth of<br>endoscopic field of view. | a) for use with electrosurgical snares<br>for endoscopic mucosal resection<br>within the gastrointestinal tract; and<br>b) for use in keeping the suitable depth<br>of endoscopic field of view | |
| <b>Design and Materials</b> | | | |
| Type | Straight : MD-47950, MD-47960<br>MD-47970<br><br>Under Cut : MD-47951, MD-47961,<br>MD-47971 | Straight : MH-462, MH-463, MH-464,<br>MH-465, MH-466, MH-483,<br><br>Oblique : MH-587, MH-588, MH-589,<br>MH-590, MH-591, MH-592<br><br>With rim : MH-593, MH-594, MH-595,<br>MH-596, MH-597, MH-598<br><br>Oblique with rim :<br>MAJ-289, MAJ-290, MAJ-291<br>MAJ-292, MAJ-293, MAJ-294<br><br>Wide opening oblique with rim :<br>MAJ-295, MAJ-296, MAJ-297 | Similar<br>(*1) |
| Shape and<br>Structure | Straight<br>Image: [Straight shape]<br><br>Under Cut<br>Image: [Under Cut shape] | Straight<br>Image: [Straight shape]<br><br>Oblique<br>Image: [Oblique shape]<br><br>With rim<br>Image: [With rim shape]<br><br>Oblique with rim<br>Image: [Oblique with rim shape]<br><br>Wide opening oblique with rim<br>Image: [Wide opening oblique with rim shape] | Similar<br>(*1) |
| | Table 1 Comparison table for technological characteristics | |
|--|------------------------------------------------------------|--|
| | | |
{6}------------------------------------------------
| | | Table 1 Comparison table for technological characteristics (Cont'd) | |
|--------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| | | Predicate Device | |
| Feature | SB Soft Hood™ | Olympus Distal Attachment (K984358) | Note |
| Maximum<br>Outer<br>Diameter | Model<br>: Maximum<br>Outer Diameter | Model<br>: Maximum<br>Outer Diameter | Similar<br>(*2) |
| | MD-47950 : 13.0 mm<br>MD-47951 : 13.0 mm | MH-462, MH-587 : 12.6 mm<br>MH-463, MH-588 : 13.5 mm | |
| | MD-47960 : 14.8 mm<br>MD-47961 : 14.8 mm | MH-464, MH-589 : 14.8 mm<br>MH-465, MH-590 : 16.6 mm | |
| | MD-47970 : 15.9 mm<br>MD-47971 : 15.9 mm | MH-466, MH-591 : 17.2 mm<br>MH-483, MH-592 : 19.0 mm | |
| | | MH-593 : 12.9 mm<br>MH-594 : 13.9 mm<br>MH-595 : 14.9 mm<br>MH-596 : 16.6 mm<br>MH-597 : 17.2 mm<br>MH-598 : 19.2 mm | |
| | | MAJ-289 : 12.8 mm<br>MAJ-290 : 13.8 mm<br>MAJ-291 : 14.8 mm<br>MAJ-292 : 16.6 mm<br>MAJ-293 : 17.2 mm<br>MAJ-294 : 19.1 mm<br>MAJ-295, MAJ-296, MAJ-297: 16.1 mm | |
| Suitable<br>Outer<br>Diameter of<br>Endoscope | Model<br>: Outer Diameter<br>of Endoscope | Model<br>: Outer Diameter<br>of Endoscope | Similar |
| | MD-47950, MD-47951 : 9.9 – 10.8 mm | MH-462, MH-587, MH-593 : 8.9 – 9.0 mm<br>MAJ-289, MAJ-295 | |
| | MD-47960, MD-47961 : 11.7 – 12.3 mm | MH-463, MH-588, MH-594 : 9.2 – 10.3 mm<br>MAJ-290, MAJ-296<br><br>MH-464, MH-589, MH-595 : 10.9 – 11.7 mm<br>MAJ-291, MAJ-297 | |
| | MD-47970, MD-47971 : 12.8 – 13.2 mm | MAJ-663, MAJ-664 : 11.7 – 12.2 mm<br>MAJ-666, MAJ-665<br><br>MH-466, MH-591, MH-597 :13.2 – 13.6 mm<br>MH-293 | |
| Length of tip<br>protrusion<br>from<br>Endoscope | Model<br>: Length of<br>tip Protrusion | Model<br>: Length of<br>tip<br>Protrusion | Different<br>(*3) |
| | MD-47950, MD-47951 : 6 mm<br>MD-47960, MD-47961<br>MD-47970, MD-47971 | MH-462, MH-463, MH-464 : 12 mm<br>MH-465, MH-466, MH-483<br>MH-593, MH-594, MH-595<br>MH-597, MH-598 | |
| | | MH-587, MH-588, MH-589 : 13 mm<br>MH-590, MH-591, MH-592<br><br>MAJ-289, MAJ-290, MAJ-291 : 14 mm<br>MAJ-293, MAJ-294<br>MAJ-295, MAJ-296, MAJ-297 | |
| | Table 1 Comparison table for technological characteristics (Cont'd) | |
|--|---------------------------------------------------------------------|--|
| | | |
{7}------------------------------------------------
| | Table 1 Comparison table for technological characteristics (Cont'd) | |
|--|---------------------------------------------------------------------|--|
| | | |
| Feature | SB Soft Hood™ | Predicate Device<br>Olympus Distal Attachment<br>(K984358) | Note |
|--------------------------------------|-----------------------|------------------------------------------------------------|-------------------|
| Drainage<br>Side Hole | Yes | No | Different<br>(*4) |
| Transparenc<br>V | Yes | Yes | Similar |
| Number<br>of<br>Products<br>Packaged | 1 device per package. | 1 device per package. | Identical |
| Sterilization<br>Type | EO sterilized | Non sterilized | Different<br>(*5) |
Note (*1) – (*5): comparisons between SB Soft Hood and the Predicate Device are discussed in Section 8.1.2
# 8.1 Discussion reqarding differences
# 8.1.1 Differences between ESD and EMR
### The ESD procedure using SB Soft Hood™ and the EMR procedure using the Predicate Device
The use of SB Soft Hood™ is different from that of the Predicate Device because combined surgical device and surgical procedure using the combined device are different.
When SB Soft Hood™ attached to an endoscope is used in ESD procedure using SB Knife, SB Soft Hood™ is inserted under the incised mucosa and lifts it (Figure 1). SB Soft Hood™ maintains visualization during the dissection phase of the procedure, for supporting the submucosal dissection by SB Knife.
{8}------------------------------------------------
Image /page/8/Picture/2 description: This image shows a diagram of an endoscope being used to examine the mucosa and submucosa. The endoscope is a long, thin tube with a camera on the end that is inserted into the body to view internal organs. The SB soft hood and SB knife are attached to the end of the endoscope. The SB knife is used to cut tissue, and the SB soft hood is used to protect the tissue from damage.
Figure 1 ESD procedure with the use of SB Soft Hood™
On the other hand, when the Predicate Device attached to an endoscope is used in EMR procedure using the electric snare, it is for use in keeping the suitable depth of endoscopic field of view and for use as suction space of the lesion. Figure 2 is EMR procedure with transparent cap extracted from the review article, "Endoscopic resection of early gastric cancer" provided by The International and Japanese Gastric Cancer Associations (IGCA & JGCA)1.
The review article, "Endoscopic mucosal resection" provided by The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee2 explained about the EMR steps as follows;
"The endoscope is then immediately positioned over the target lesion, and suction is used to retract the mucosa into the cap after which the snare is closed to capture the lesion. The lesion is then resected with standard snare excision technique by using electrocautery."
Image /page/8/Picture/7 description: In the image, a medical illustration depicts a surgical procedure. A black and white image shows a medical instrument being used on a patient. The instrument is inserted into the patient's body through a small incision. The image is likely from a medical textbook or journal.
Figure 2 EMR procedure
{9}------------------------------------------------
# 8.1.2 Differences between SB Soft Hood™ and the Predicate Device for technological characteristics
# (*1) Type, Shape and Structure
SB Soft Hood™ and the Predicate Device are similar in that they have "Joint" which is attached to the endoscope and "Hood" which keeps the endoscopic field of view. SB Soft Hood™ "Straight" type and the Predicate Device "Straight" type are similar in that they are straight at the tip of Hood. SB Soft Hood™ "Under Cut" type and the Predicate Device "Oblique" type are similar in that they are oblique at the tip of Hood.
Image /page/9/Figure/5 description: The image shows a comparison between "SB Soft Hood" and "Predicate Device" with different designs. For "SB Soft Hood", there are two designs: "Straight" and "Under cut". The "Straight" design shows a cylindrical object with labels pointing to "Hood", "Joint", and "Drainage Side Hole". The "Under cut" design is similar but includes an additional label for "Undercut". For "Predicate Device", there are also two designs: "Straight" and "Oblique", both showing a connection between "Hood" and "Joint".
# Figure 3 Schematics of SB Soft Hood™ and the Predicate Device
The rim of the Predicate Device is used for fixing the electrosurgical snare. Because SB Soft Hood™ is not used with the electric snare, it does not have types with the rim.
# (*2) Maximum Outer Diameter
Maximum Outer Diameter is important for insertion into the esophagus, stomach or colon. Maximum Outer Diameter of SB Soft Hood™ is in range of 13.0 - 15.9 mm, and that of the Predicate Device is in range of 12.6 - 19.2 mm. Maximum Outer Diameter of SB Soft Hood™ is within the range of maximum Outer Diameter of the Predicate Device.
{10}------------------------------------------------
# (*3) Lenath of tip protrusion from Endoscope
Length of tip protrusion from the tip of the endoscope for all the six models of SB Soft Hood™ is 6 mm. On the other hand, such length for the Predicate Device is in range of 12-14 mm. There is a difference, but both of devices can achieve their intended use respectively for following reasons;
As shown in Figure 1, SB Soft Hood™ lifts the mucosa. On the other hands, the Predicate Device is used as suction space (See Figure 2). The difference of length of tip protrusion between SB Soft Hood™ and the Predicate Devices is attributed to the different role for each surgical procedure.
# (*4) Drainage Side Hole
SB Soft Hood™ has "Drainage Side Hole", but the Predicate Device does not have it. Water and blood are easily to be accumulated in the Hood during ESD and interfere with the endoscopic field of view. "Drainage side hole" allows egress of water and blood for keeping clear vision. This function is necessary for securing the endoscopic field of view during ESD.
# (*5) Sterilization Type
SB Soft Hood™ is EO sterilized, but the Predicate Device is not sterilized. Therefore, the risk of infection for SB Soft Hood™ is reduced than that for the Predicate Device. The Sterilization Validation was conducted in accordance with ISO 11135-1:2007. The Sterilization Validation demonstrated that the Sterility Assurance Level of 10-6 was achieved. Residual EO and ECH were not detected from the final product. In addition, endotoxin was not detected from the final product.
Furthermore, the material of SB Soft Hood is different from that of the Predicate device.
In order to evaluate any effects of the above differences on substantial equivalence, risk analysis, biocompatibility testing, sterilization validation, and shelf-life testing were conducted. The results of risk analysis and testing did not demonstrate any new concern compared to the Predicate Device. Based on the above consideration, we concluded that SB Soft Hood™ is substantially equivalent to the Predicate Device.
# REFERENCES ESD procedure with the use of SB Soft Hood™
- 1. International and Japanese Gastric Cancer Associations; Takuji Gotoda, Endoscopic resection of early gastric cancer. Gastric Cancer 2007; 10:1-11
- 2. ASGE Technology Committee; Joo Ha Hwang, MD, PhD, FASGE, et al. Endoscopic mucosal resection. GASTROINTESTINAL ENDOSCOPY 2015:82:215-226
{11}------------------------------------------------
### 9. Design
For proper functioning of SB Soft Hood™, proper structure is a key. We identified following risks;
- inadequate length between distal end of the endoscope and the tissue
- poor view for endoscopic field
- disturbance of the endoscope
- interference by SB Soft Hood™ with the movement of SB Knife ●
Those risks were mitigated by proper designing of SB Soft Hood™.
### 10. Non-Clinical Testing
# 10.1 Biocompatibility testing
This testing was conducted because the material of SB Soft Hood™ is different from the Predicate Device.
SB Soft Hood™ directly contacts mucosal membrane and lesion of resected submucosal layer in digestive tract and categorized as Surface devices, Bleached or compromised surface, Contact duration A-limited ≤24 hours.
Accordingly, we performed following biocompatibility tests:
- · Cytotoxicity Standards: ISO 10993-5 Year: 2009
- Sensitization . Standards: ISO 10993-10 Year: 2010
- · Acute systemic toxicity Standards: ISO 10993-11 Year: 2006
- Irritation reactivity . Standards: ISO 10993-10 Year: 2010
- Material-mediated pyrogenicity . Standards: USPC 151 Year: 2005
In the biocompatibility testing reports, no biocompatibility concern was raised.
# 10.2 Performance testing
Visual inspection, durability testing, and detachment testing were performed to verify that the unaged and the aged SB Soft Hood™ remain attachment to an endoscope during actual clinical use. All samples met in-house standard which was determined based on expected worst-case.
# 10.3 Sterility testing
Sterility was evaluated by sterilization validation in accordance with ISO 11135-1:2007 and packaging integrity tests in accordance with ASTM F1929 and
{12}------------------------------------------------
ASTM F88/F88M. Residual EO and ECH testing were performed in accordance with ISO10993-7:2008 and endotoxin testing was performed in accordance with USP<85>. Residual EO and ECH and endotoxin were not detected.
#### 11. Clinical Testing
Clinical testing was not performed for SB Soft Hood™.
#### 12. Conclusion
Based on the above validation and verifications, we concluded that SB Soft Hood™ is substantially equivalent to the Predicate Device.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
