(29 days)
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.
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 SmartSnare EMR Hexagonal Snare consists of a handle, finger slide and a hexagonal snare loop on the distal end.
This document is a 510(k) summary for the STERIS SmartBand EMR Kit. It is a submission to the FDA regarding a modified device and argues for its substantial equivalence to a legally marketed predicate device. As such, it does not contain a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.
Instead, this document focuses on demonstrating that the modified device is as safe and effective as the predicate device by showing that the changes made do not affect the fundamental scientific technology or how it is used. The "acceptance criteria" here refer to the regulatory standard of substantial equivalence, and "performance" refers to non-clinical testing performed to support this claim.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as numerical thresholds for clinical performance but rather are inferred from the requirements for demonstrating substantial equivalence to a predicate device. The "performance" reported is related to non-clinical testing to ensure safety and functionality of the modified components.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Non-Clinical) |
|---|---|
| Maintain Intended Use | Intended use is "Same" |
| Maintain Device Functionality | No negative impact from changes in device components (band color, universal connector, band lock, additional barrel diameter) |
| Materials of Construction are biocompatible and safe | Similar materials; new materials for Universal Connector and Band Lock do not affect intended use or fundamental technology. Biocompatibility testing performed per ISO 10993-4, -5, -10 and -11 and USP38-NF33. |
| Sterilization efficacy maintained | Sterilization method (Ethylene Oxide) and Assurance Level (10-6) are "Same". |
| Single use and energy compatibility maintained | Single use and diathermic energy use are "Same". Compatible with new electrosurgical generator (US Endoscopy gi4000) with no change to intended use or fundamental technology. |
| Manual application maintained | Manual application is "Same". |
| Packaging changes do not affect device performance | Band lock prevents band dislodgement during shipping; additional box for snare is a convenience. No effect on device use or fundamental technology. |
| Shelf life change maintained device integrity | Extended shelf life (24 months vs 12 months) provides greater flexibility with no effect on device use or fundamental technology. |
| Overall safety and effectiveness as predicate device | "Modified device is as safe and effective as the legally marketed predicate device." |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable in the context of a clinical performance study. The non-clinical testing would have involved specific numbers of devices or components for each test (e.g., specific number of devices for biocompatibility, simulated use, ship testing), but these numbers are not detailed in the summary.
- Data provenance: Not explicitly stated as country of origin, but it's internal testing conducted by STERIS Corporation. The nature of the tests (biocompatibility, simulated use) suggests laboratory or engineering testing. It is retrospective in the sense that the justification is made after the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. "Ground truth" in this context would likely refer to established engineering standards, regulatory guidelines (e.g., ISO for biocompatibility), and internal quality control specifications, rather than expert clinical consensus on patient data.
4. Adjudication method for the test set
Not applicable. This is a technical submission, not a clinical study requiring adjudication of diagnoses or outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical accessory for endoscopic mucosal resection, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI-related effectiveness was assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing would be established engineering specifications, material standards (e.g., for biocompatibility), and performance benchmarks derived from the predicate device's known characteristics. For example, the ground truth for biocompatibility is meeting the requirements of ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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
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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
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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
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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 DevicePredicate Device K190512 | Modified Device | Comparison |
|---|---|---|---|
| Intended Use | The SmartBand® EMR Device isintended for endoscopic mucosalresection in the upper GI tract. | The SmartBand® EMR Device isintended for endoscopic mucosalresection in the upper GI tract. | Same |
| DeviceComponents | Ligation Device5 non-latex bands (4 green and 1blue)Trigger cordLoading DeviceFlush TubeDeployment HandlePentax Adaptor | Ligation Device5 non-latex bands (4 green and 1black)Trigger cordLoading DeviceFlush TubeDeployment HandlePentax AdaptorUniversal ConnectorBand Lock | Similar. The colorchange of one bandand the addition ofthe UniversalConnector andBand Lock do notaffect the intendeduse or fundamentaltechnology of thedevice. |
| SnareStainless steel snare loopShaftFinger SlideSnare Handle Body | SnareStainless steel snare loopShaftFinger RingsSnare Handle Body | Same | |
| Materials ofConstruction | SnareSnare loop - stainless steel(patient contacting)Sheath - Teflon (patientcontacting)Core Wire - Nitinol (patientcontacting)Stainless steel (snare loop) Strainrelief - polyurethane (non-patientcontacting)Finger slide - ABS (non-patientcontacting)Snare handle body - ABS (non-patient contacting)Ligation DeviceBands - Non-latex syntheticpolyisoprene (patient contacting)Barrel - Polycarbonate (patientcontacting)Trigger cord - Liquid crystalpolymer (patient contacting)Loading device - Stainless steel(non-patient contacting)Flush tube - ABS (non-patientcontacting)Handle - ABS (non-patientcontacting) | SnareSnare loop - stainless steel(patient contacting)Sheath - Teflon (patientcontacting)Core Wire - Nitinol (patientcontacting)Stainless steel (snare loop) Strainrelief - polyurethane (non-patient contacting)Finger slide - ABS (non-patientcontacting)Snare handle body - ABS (non-patient contacting)Ligation DeviceBands - Non-latex syntheticpolyisoprene (patient contacting)Barrel - Polycarbonate (patientcontacting)Trigger cord - Liquid crystalpolymer (patient contacting)Loading device - Stainless steel(non-patient contacting)Flush tube - ABS (non-patientcontacting)Handle - ABS (non-patientcontacting)Universal Connector - Silicone(non-patient contacting)Band Lock - Polyurethane (non-patient contacting) | Similar. Thematerials of theUniversalConnector andBand Lock do notaffect the intendeduse or fundamentaltechnology of thedevice. |
| Features | SmartBand EMR DevicePredicate Device K190512 | Modified Device | Comparison |
| # of bands/color | 5 non-latex bands (4 green and 1blue) | 5 non-latex bands (4 green and 1black) | Similar. Thischange aids theuser in determiningwhen they aregetting close tousing all of thebands, as the blackband is the secondto last band in lineon the barrel. Thechange in colordoes not affect theintended use orfundamentaltechnology of thedevice. |
| BarrelDimensions | Inside diameter:10.75mm and 12.0mmDepth: 7.75mm | Inside diameter9.4mm, 10.75mm, and12.0mmDepth 7.75mm (10.75mm and12.0mm sizes)Depth 9.5mm (9.4mm size) | Similar. Thischange gives theuser more optionsbased on the sizeof the treatmentarea. |
| Sterile/Non-sterile | Sterile (snare) and Non-sterile(ligation device) | Sterile (snare) and Non-sterile(ligation device) | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
| SterilizationAssurance Level | 10-6 | 10-6 | Same |
| Usage | Single used; snare is used withdiathermic energy | Single used; snare is used withdiathermic energy | Same |
| TargetPopulation | Patients undergoing an endoscopicmucosal resection procedure | Patients undergoing anendoscopic mucosal resectionprocedure | Same |
| EnergyUsed/Delivered | Diathermic energy (snare) | Diathermic energy (snare) | Same |
| Method ofApplication | Manual | Manual | Same |
| Features | SmartBand EMR DevicePredicate Device K190512 | Modified Device | Comparison |
| PackagingChange | No band lock | Band lock present to securethe bands during shipping | Different. The band lockprevents the bands fromdislodging from the barrelduring shipping. Theadditional box is aconvenience for the user.These changes have no effecton how the device is used orits fundamental technology. |
| No stand-alone box for thesnare | Addition of stand-alone boxfor snare | ||
| Compatibleendoscopes | Pentax, Fujinon and Olympus | Pentax, Fujinon and Olympus | SameSimilar. The function of theelectrical snare of theproposed device remains thesame in that it is attached tothe electrical surgicalgenerator to allow the flow ofelectrical energy to the snareloop for the purpose ofresecting tissue. The use ofthe modified device with theUS Endoscopy gi4000Electrosurgical Generatordoes not change the intendeduse or fundamentaltechnology of the modifieddevice. |
| Compatibleelectrical surgicalgenerators | ERBE VIO 300-D | ERBE VIO 300-DUS Endoscopy gi4000Electrosurgical Generator | |
| Addition ofuniversalconnector | Not present. | Present | Different. The universalconnector allows the user toattach the ligation devicehandle directly to theaccessory ports of endoscopesthat do not have a luerconnection on the accessoryport. This change has noeffect on how the device isused or its fundamentaltechnology. |
| ExpirationDating | 12 months | 24 months | Different. The extended shelflife of the proposed deviceprovides the user greaterflexibility related to deviceuse. It has no effect on howthe device is used or itsfundamental technology. |
Table 1. Technological Characteristics Comparison Table
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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.
§ 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).