(56 days)
The Flex-THOR System is indicated for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.
The Flex-THOR System includes two main components: (1) the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR), and (2) the Camera Control Unit (CCU). The insertion shaft of the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR) has an outer diameter of 2.9 mm and a working length of 675 mm with 8.5 Fr elliptical shaped distal tip (major diameter of 3.2 mm and minor diameter of 2.4 mm). Users can access the 1.2 mm working channel through the Luer ports.
This FDA 510(k) summary for the KARL STORZ Flex-THOR System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness.
Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (electrical safety, EMC, and reprocessing validation) and a comparison of technological characteristics.
Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study that proves the device meets them in the context of clinical performance or diagnostic accuracy.
Here's what can be extracted from the provided text:
Acceptance Criteria and Device Performance (Not applicable for clinical performance/diagnostic accuracy)
As mentioned, there are no specific acceptance criteria for clinical performance or diagnostic accuracy provided in this document. The focus for this 510(k) submission is on demonstrating safety and effectiveness through substantial equivalence, primarily via non-clinical testing.
The document does report performance against safety and reprocessing standards:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| ANSI/AAMI ES:60601-1:2005 | Compliance |
| IEC 60601-1-2:2007 | Compliance |
| AAMI TIR 12:2010 | Compliance |
| ISO 15883-5:2005 | Compliance |
| AAMI TIR 30:2011 | Compliance |
| AAMI/ANSI/ISO 11737-1:2006/ (R)2011 | Compliance |
| ASTM E1837-96:2014 | Compliance |
Study Information (Primarily Non-Clinical)
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Sample size used for the test set and the data provenance (country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. The document discusses non-clinical bench testing for electrical safety, EMC, and reprocessing. These types of tests typically involve devices/prototypes and simulated conditions, not a "test set" of patient data in the sense of clinical performance or diagnostic accuracy.
- Data Provenance: Not specified, but generally, bench testing is performed in a controlled laboratory environment. It is not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of clinical expert consensus is not part of this 510(k) submission for this device. The non-clinical tests rely on established engineering and microbiological methodologies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for expert review of images or data, which is not described here.
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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: No MRMC study was done, as this device (an endoscope) does not involve AI or image interpretation for diagnostic assistance that would require such a study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests:
- Electrical Safety & EMC: Compliance with international standards.
- Reprocessing: Verification based on microbiological testing (reduction of microbial load) and visual inspection against established reprocessing protocols outlined in the standards.
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The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm.
Summary of what the document does provide:
- Clinical Performance Data: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
- Purpose of Non-Clinical Data: The non-clinical data covered electrical safety, electromagnetic compatibility (EMC), and reprocessing validation, all to demonstrate the device is as safe and effective as the predicate device.
- Conclusion: The submission concludes that based on non-clinical performance data and comparison of device characteristics, the Flex-THOR System is substantially equivalent to the predicate device, and the differences do not raise new questions of safety and effectiveness.
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January 18, 2019
KARL STORZ Endoscopy-America, Inc. Nozomi Yagi Sr. Regulatory Affairs Specialist 2151 E. Grand Avenue EI Segundo, California 90245
Re: K183264
Trade/Device Name: Flex-THOR scope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 21, 2018 Received: November 23, 2018
Dear Nozomi Yagi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Long H. Chen Digitally signed by Long H.
Chen-s Date: 2019.01.18 17:48:16 -5 -05'00' for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183264
Device Name Flex-Thor System
Indications for Use (Describe)
The Flex-THOR System is indicated for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K183264
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Submitter: | KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | Nozomi YagiSr. Regulatory Affairs SpecialistPhone: (424) 218-8351Fax: (424) 218-8519 |
| Date ofPreparation: | November 21, 2018 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: Flex-THOR SystemClassification Name: Endoscope and accessories (21 CFR Part876.1500) |
| RegulatoryClass: | II |
| Product Codeand CommonName: | GCJ (Laparoscope, General & Plastic Surgery) |
| GuidanceDocument: | Not Applicable for GCJ product code |
| RecognizedConsensusStandards: | Not Applicable for GCJ product code |
| Predicate andReferenceDevice(s): | Primary Predicate Device: Vibrynt Inc's VISTA Endoscope(K100533)Reference Device: XLTF-VAW Laparo-ThoracoVideoscope (K053382)The above predicate and reference device have not been subjected to anyrecall |
| DeviceDescription: | The Flex-THOR System includes two main components: (1) the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR), and (2) theCamera Control Unit (CCU). The insertion shaft of the Flex-THORScope (Part Number: 11292VS(U)A-THOR) has an outer diameter of2.9 mm and a working length of 675 mm with 8.5 Fr elliptical shaped |
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| distal tip (major diameter of 3.2 mm and minor diameter of 2.4 mm).Users can access the 1.2 mm working channel through the Luer ports. | |||
|---|---|---|---|
| Intended Use: | The Flex-THOR System is intended for visualization purposes duringabdominal and thoracic diagnostic and therapeutic procedures. | ||
| Indications ForUse: | The Flex-THOR System is indicated for use in providing access to,and visualization of, the thoracic and abdominal cavities, to allow forthe performance of various diagnostic and therapeutic surgicalprocedures. | ||
| TechnologicalCharacteristics: | Comparison Table: Subject vs. Primary Predicate Devices | ||
| Subject Device | Primary Predicate Device,K100533 | ||
| Type of Scope | Flexible | Same as the subject device | |
| Distal EndDiameter | 3.2 mm x 2.4 mm | 5.0 mm | |
| Insertion ShaftLength | 675 mm | 530 and 890 mm | |
| Type of Imager | CMOS | Fiber | |
| Direction of View | 0° | 0° | |
| Light Source | Internal LED | External | |
| Cleaning | Yes | Yes | |
| Sterilization | Yes | Yes | |
| Non-ClinicalPerformanceData: | Electrical Safety and Electromagnetic Compatibility SummaryThe electrical safety and EMC data included in the submission is in compliancewith the following FDA recognized standards:• ANSI/AAMI ES:60601-1:2005• IEC 60601-1-2:2007Reprocessing Validation SummaryThe Flex-THOR Scope (Part Number: 11292VS(U)A-THOR) is provided non-sterile and is reusable. The users are required to reprocess it for initial and aftereach use. The subject device contacts intact mucosal membranes so it is a semi-critical device per Spaulding Classification. We performed validation activities forcleaning and sterilization according to the FDA Guidance. The reprocessing datasubmitted is in compliance with the following standards:• AAMI TIR 12:2010• ISO 15883-5:2005• AAMI TIR 30:2011• AAMI/ANSI/ISO 11737-1:2006/ (R)2011• ASTM E1837-96:2014 | ||
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish the substantial equivalence of themodifications. | ||
| Conclusion: | The conclusions drawn from the non-clinical performance data andcomparison of device characteristics demonstrated that the subjectdevice is as safe as and as effective as the predicate device. As such,we concluded that the substantial equivalence of the subject and the |
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| predicate device has been met, and the differences between the |
|---|
| subject and the predicate device do not raise new questions of safety |
| and effectiveness. |
§ 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.