(223 days)
No
The summary describes a simple mechanical attachment for an endoscope and does not mention any AI or ML capabilities.
No.
The device (SB Soft Hood) is used to maintain visualization during an endoscopic submucosal dissection procedure, which is a therapeutic procedure, but the device itself does not provide any therapeutic effect. It serves as an accessory to aid in the therapeutic procedure.
No
Explanation: The device is described as a transparent distal attachment for an endoscope used to maintain visualization during endoscopic submucosal dissection procedures, not for diagnosing conditions. Its intended use is for facilitating a surgical procedure by maintaining field of view, not for producing diagnostic information.
No
The device description clearly states that the device is a "transparent distal attachment applied to the tip of an endoscope," indicating it is a physical hardware component.
Based on the provided information, the SB Soft Hood is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with an endoscope during endoscopic submucosal dissection within the gastrointestinal tract. Its purpose is to maintain visualization and suitable depth of field during a surgical procedure performed on the patient.
- Device Description: The description confirms it's a physical attachment for an endoscope used during a procedure. It's a tool used in vivo (within the living body).
- Lack of IVD Characteristics: IVDs are devices intended for use in the examination of specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnostic, monitoring, or compatibility purposes. The SB Soft Hood does not interact with or analyze such specimens.
Therefore, the SB Soft Hood is a medical device used during an endoscopic procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FDS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal 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)
Non-Clinical Testing was performed.
Biocompatibility testing: Tests performed include Cytotoxicity, Sensitization, Acute systemic toxicity, and Irritation reactivity as per ISO standards, and Material-mediated pyrogenicity as per USPC. No biocompatibility concern was raised.
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.
Sterility testing: Evaluated by sterilization validation in accordance with ISO 11135-1:2007 and packaging integrity tests in accordance with ASTM F1929 and 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. Residual EO and ECH and endotoxin were not detected.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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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)
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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™
-
- Submission Sponsor
Sumitomo Bakelite Co., Ltd. Medical Products Business Division 5-8, Higashi-Shinagawa 2-chome, Shinagawa-ku, Tokyo 140-0002, JAPAN
- Submission Sponsor
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 | |
| Olympus Distal Attachment | |||
| (K984358) | Note | ||
| Indications for use | |||
| 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. | a) for use with electrosurgical snares | ||
| for endoscopic mucosal resection | |||
| within the gastrointestinal tract; and | |||
| b) for use in keeping the suitable depth | |||
| of endoscopic field of view | |||
| Design and Materials | |||
| Type | Straight : MD-47950, MD-47960 | ||
| MD-47970 |
Under Cut : MD-47951, MD-47961,
MD-47971 | Straight : MH-462, MH-463, MH-464,
MH-465, MH-466, MH-483,
Oblique : MH-587, MH-588, MH-589,
MH-590, MH-591, MH-592
With rim : MH-593, MH-594, MH-595,
MH-596, MH-597, MH-598
Oblique with rim :
MAJ-289, MAJ-290, MAJ-291
MAJ-292, MAJ-293, MAJ-294
Wide opening oblique with rim :
MAJ-295, MAJ-296, MAJ-297 | Similar
(*1) |
| Shape and
Structure | Straight
Image: [Straight shape]
Under Cut
Image: [Under Cut shape] | Straight
Image: [Straight shape]
Oblique
Image: [Oblique shape]
With rim
Image: [With rim shape]
Oblique with rim
Image: [Oblique with rim shape]
Wide opening oblique with rim
Image: [Wide opening oblique with rim shape] | Similar
(*1) |
| Table 1 Comparison table for technological characteristics | ||
|---|---|---|
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| Table 1 Comparison table for technological characteristics (Cont'd) | |||
|---|---|---|---|
| Predicate Device | |||
| Feature | SB Soft Hood™ | Olympus Distal Attachment (K984358) | Note |
| Maximum | |||
| Outer | |||
| Diameter | Model | ||
| : Maximum | |||
| Outer Diameter | Model | ||
| : Maximum | |||
| Outer Diameter | Similar | ||
| (*2) | |||
| MD-47950 : 13.0 mm | |||
| MD-47951 : 13.0 mm | MH-462, MH-587 : 12.6 mm | ||
| MH-463, MH-588 : 13.5 mm | |||
| MD-47960 : 14.8 mm | |||
| MD-47961 : 14.8 mm | MH-464, MH-589 : 14.8 mm | ||
| MH-465, MH-590 : 16.6 mm | |||
| MD-47970 : 15.9 mm | |||
| MD-47971 : 15.9 mm | MH-466, MH-591 : 17.2 mm | ||
| MH-483, MH-592 : 19.0 mm | |||
| MH-593 : 12.9 mm | |||
| MH-594 : 13.9 mm | |||
| MH-595 : 14.9 mm | |||
| MH-596 : 16.6 mm | |||
| MH-597 : 17.2 mm | |||
| MH-598 : 19.2 mm | |||
| MAJ-289 : 12.8 mm | |||
| MAJ-290 : 13.8 mm | |||
| MAJ-291 : 14.8 mm | |||
| MAJ-292 : 16.6 mm | |||
| MAJ-293 : 17.2 mm | |||
| MAJ-294 : 19.1 mm | |||
| MAJ-295, MAJ-296, MAJ-297: 16.1 mm | |||
| Suitable | |||
| Outer | |||
| Diameter of | |||
| Endoscope | Model | ||
| : Outer Diameter | |||
| of Endoscope | Model | ||
| : Outer Diameter | |||
| of Endoscope | Similar | ||
| MD-47950, MD-47951 : 9.9 – 10.8 mm | MH-462, MH-587, MH-593 : 8.9 – 9.0 mm | ||
| MAJ-289, MAJ-295 | |||
| MD-47960, MD-47961 : 11.7 – 12.3 mm | MH-463, MH-588, MH-594 : 9.2 – 10.3 mm | ||
| MAJ-290, MAJ-296 |
MH-464, MH-589, MH-595 : 10.9 – 11.7 mm
MAJ-291, MAJ-297 | |
| | MD-47970, MD-47971 : 12.8 – 13.2 mm | MAJ-663, MAJ-664 : 11.7 – 12.2 mm
MAJ-666, MAJ-665
MH-466, MH-591, MH-597 :13.2 – 13.6 mm
MH-293 | |
| Length of tip
protrusion
from
Endoscope | Model
: Length of
tip Protrusion | Model
: Length of
tip
Protrusion | Different
(*3) |
| | MD-47950, MD-47951 : 6 mm
MD-47960, MD-47961
MD-47970, MD-47971 | MH-462, MH-463, MH-464 : 12 mm
MH-465, MH-466, MH-483
MH-593, MH-594, MH-595
MH-597, MH-598 | |
| | | MH-587, MH-588, MH-589 : 13 mm
MH-590, MH-591, MH-592
MAJ-289, MAJ-290, MAJ-291 : 14 mm
MAJ-293, MAJ-294
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
Olympus Distal Attachment
(K984358) | Note |
|--------------------------------------|-----------------------|------------------------------------------------------------|-------------------|
| Drainage
Side Hole | Yes | No | Different
(*4) |
| Transparenc
V | Yes | Yes | Similar |
| Number
of
Products
Packaged | 1 device per package. | 1 device per package. | Identical |
| Sterilization
Type | EO sterilized | Non sterilized | Different
(*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
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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™
-
- International and Japanese Gastric Cancer Associations; Takuji Gotoda, Endoscopic resection of early gastric cancer. Gastric Cancer 2007; 10:1-11
-
- ASGE Technology Committee; Joo Ha Hwang, MD, PhD, FASGE, et al. Endoscopic mucosal resection. GASTROINTESTINAL ENDOSCOPY 2015:82:215-226
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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. 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.