(29 days)
Not Found
No
The description focuses on mechanical components and procedures, with no mention of AI/ML terms or functionalities.
Yes.
The device is used for endoscopic mucosal resection, which is a therapeutic procedure to remove abnormal tissue in the GI tract.
No
Explanation: The device is intended for endoscopic mucosal resection, which is a therapeutic procedure to remove tissue, not to diagnose a condition.
No
The device description clearly outlines physical components like a ligator kit (handle, loading device, connector tube, barrel, bands, deployment cord) and a snare (handle, finger slide, snare loop). The performance studies also include verification testing of physical attributes and biocompatibility testing, which are not relevant to software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endoscopic mucosal resection in the upper GI tract." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device components (ligator kit, snare) are designed for physical manipulation and removal of tissue within the body during an endoscopic procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples in vitro), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.
Product codes (comma separated list FDA assigned to the subject device)
FDI
Device Description
The SmartBand EMR Device is an endoscopic mucosal resection device that is provided as a kit or a pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack can be used when more bands are needed to complete a procedure. The SmartBand EMR Hexagonal Snare consists of a handle, finger slide and a hexagonal snare loop on the distal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper GI 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)
Verification testing consisting of measurements, visual inspection, ship testing and packaging testing.
Biocompatibility testing in accordance with ISO 10993-4, -5, -10 and -11 and USP38-NF33.
Simulated use testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 7, 2021
Steris Corporation Carroll Martin Regulatory Affairs Director 5976 Heislev Road Mentor, OH 44060
Re: K212860
Trade/Device Name: SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: September 7, 2021 Received: September 8, 2021
Dear Carroll Martin:
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, 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 (reporting of medical
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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.
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212860
Device Name
SmartBand® EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4) SmartBand® EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4) SmartSnare™ EMR Hexagonal Snare (SS-230-1 or packaged with Kit)
Indications for Use (Describe)
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.
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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Image /page/3/Picture/0 description: The image shows the first page of a document with the identifier K212860 and page number 1 of 6. The document features the STERIS logo in a large, bold font. Below the company name is a graphic of several horizontal, curved lines, resembling waves.
510(k) Summary for the SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4) SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4) SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with Kit)
STERIS Corporation 5976 Heisley Road Mentor, OH 44060
Contact: Carroll Martin Regulatory Affairs Director Tel: 440-358-6259 Email: Carroll Martin@steris.com
Submission Date: September 7, 2021
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4)
SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4)
SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with Kit) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Regulation Name: | Endoscopic Electrosurgical Unit and Accessories |
| Common/usual Name: | Ligation Device |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | FDI |
| Review Panel: | Gastroenterology/Urology |
2. Predicate Device
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12) SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12) SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with Kit) All cleared under K190512
3. Device Description
The SmartBand EMR Device is an endoscopic mucosal resection device that is provided as a kit or a pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack can be used when more bands are needed to complete a procedure. The SmartBand EMR Hexagonal Snare consists of a handle, finger slide and a hexagonal snare loop on the distal end.
4. Indications for Use
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.
న్. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
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| Features | SmartBand EMR Device
Predicate Device K190512 | Modified Device | Comparison |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SmartBand® EMR Device is
intended for endoscopic mucosal
resection in the upper GI tract. | The SmartBand® EMR Device is
intended for endoscopic mucosal
resection in the upper GI tract. | Same |
| Device
Components | Ligation Device
5 non-latex bands (4 green and 1
blue)
Trigger cord
Loading Device
Flush Tube
Deployment Handle
Pentax Adaptor | Ligation Device
5 non-latex bands (4 green and 1
black)
Trigger cord
Loading Device
Flush Tube
Deployment Handle
Pentax Adaptor
Universal Connector
Band Lock | Similar. The color
change of one band
and the addition of
the Universal
Connector and
Band Lock do not
affect the intended
use or fundamental
technology of the
device. |
| | Snare
Stainless steel snare loop
Shaft
Finger Slide
Snare Handle Body | Snare
Stainless steel snare loop
Shaft
Finger Rings
Snare Handle Body | Same |
| Materials of
Construction | Snare
Snare loop - stainless steel
(patient contacting)
Sheath - Teflon (patient
contacting)
Core Wire - Nitinol (patient
contacting)
Stainless steel (snare loop) Strain
relief - polyurethane (non-patient
contacting)
Finger slide - ABS (non-patient
contacting)
Snare handle body - ABS (non-
patient contacting)
Ligation Device
Bands - Non-latex synthetic
polyisoprene (patient contacting)
Barrel - Polycarbonate (patient
contacting)
Trigger cord - Liquid crystal
polymer (patient contacting)
Loading device - Stainless steel
(non-patient contacting)
Flush tube - ABS (non-patient
contacting)
Handle - ABS (non-patient
contacting) | Snare
Snare loop - stainless steel
(patient contacting)
Sheath - Teflon (patient
contacting)
Core Wire - Nitinol (patient
contacting)
Stainless steel (snare loop) Strain
relief - polyurethane (non-
patient contacting)
Finger slide - ABS (non-patient
contacting)
Snare handle body - ABS (non-
patient contacting)
Ligation Device
Bands - Non-latex synthetic
polyisoprene (patient contacting)
Barrel - Polycarbonate (patient
contacting)
Trigger cord - Liquid crystal
polymer (patient contacting)
Loading device - Stainless steel
(non-patient contacting)
Flush tube - ABS (non-patient
contacting)
Handle - ABS (non-patient
contacting)
Universal Connector - Silicone
(non-patient contacting)
Band Lock - Polyurethane (non-
patient contacting) | Similar. The
materials of the
Universal
Connector and
Band Lock do not
affect the intended
use or fundamental
technology of the
device. |
| Features | SmartBand EMR Device
Predicate Device K190512 | Modified Device | Comparison |
| # of bands/color | 5 non-latex bands (4 green and 1
blue) | 5 non-latex bands (4 green and 1
black) | Similar. This
change aids the
user in determining
when they are
getting close to
using all of the
bands, as the black
band is the second
to last band in line
on the barrel. The
change in color
does not affect the
intended use or
fundamental
technology of the
device. |
| Barrel
Dimensions | Inside diameter:
10.75mm and 12.0mm
Depth: 7.75mm | Inside diameter
9.4mm, 10.75mm, and12.0mm
Depth 7.75mm (10.75mm and
12.0mm sizes)
Depth 9.5mm (9.4mm size) | Similar. This
change gives the
user more options
based on the size
of the treatment
area. |
| Sterile/Non-
sterile | Sterile (snare) and Non-sterile
(ligation device) | Sterile (snare) and Non-sterile
(ligation device) | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterilization
Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single used; snare is used with
diathermic energy | Single used; snare is used with
diathermic energy | Same |
| Target
Population | Patients undergoing an endoscopic
mucosal resection procedure | Patients undergoing an
endoscopic mucosal resection
procedure | Same |
| Energy
Used/Delivered | Diathermic energy (snare) | Diathermic energy (snare) | Same |
| Method of
Application | Manual | Manual | Same |
| Features | SmartBand EMR Device
Predicate Device K190512 | Modified Device | Comparison |
| Packaging
Change | No band lock | Band lock present to secure
the bands during shipping | Different. The band lock
prevents the bands from
dislodging from the barrel
during shipping. The
additional box is a
convenience for the user.
These changes have no effect
on how the device is used or
its fundamental technology. |
| | No stand-alone box for the
snare | Addition of stand-alone box
for snare | |
| Compatible
endoscopes | Pentax, Fujinon and Olympus | Pentax, Fujinon and Olympus | Same
Similar. The function of the
electrical snare of the
proposed device remains the
same in that it is attached to
the electrical surgical
generator to allow the flow of
electrical energy to the snare
loop for the purpose of
resecting tissue. The use of
the modified device with the
US Endoscopy gi4000
Electrosurgical Generator
does not change the intended
use or fundamental
technology of the modified
device. |
| Compatible
electrical surgical
generators | ERBE VIO 300-D | ERBE VIO 300-D
US Endoscopy gi4000
Electrosurgical Generator | |
| Addition of
universal
connector | Not present. | Present | Different. The universal
connector allows the user to
attach the ligation device
handle directly to the
accessory ports of endoscopes
that do not have a luer
connection on the accessory
port. This change has no
effect on how the device is
used or its fundamental
technology. |
| Expiration
Dating | 12 months | 24 months | Different. The extended shelf
life of the proposed device
provides the user greater
flexibility related to device
use. It has no effect on how
the device is used or its
fundamental technology. |
Table 1. Technological Characteristics Comparison Table
6
7
8
6. Summarv of Non-Clinical Performance Testing
Verification testing consisting of measurements, visual inspection, ship testing and packaging testing.
Biocompatibility testing in accordance with ISO 10993-4, -5, -10 and -11 and USP38-NF33.
Simulated use testing.
7. Conclusion
The minor changes that are the subject of this submission have no impact on the fundamental scientific technology of the device or how it is used. STERIS has determined that the modified device is as safe and effective as the legally marketed predicate device.