Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on the physical components and basic functionality.

Therapeutic

Yes
The device is indicated for use in performing "therapeutic surgical procedures," which directly refers to treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is used to "allow for the performance of various diagnostic and therapeutic surgical procedures," indicating its involvement in diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components: the Flex-THOR Scope and the Camera Control Unit (CCU).

IVD (In Vitro Diagnostic)

Based on the provided information, the Flex-THOR System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the system is for "providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures." This describes a device used in vivo (within the body) for direct visualization and surgical intervention.
Device Description: The description details a scope with an insertion shaft, working length, and working channel, consistent with an endoscope used for internal examination and procedures.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The Flex-THOR System does not mention any interaction with specimens or analysis of biological samples.

Therefore, the Flex-THOR System is a surgical endoscope, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GCJ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic and abdominal cavities

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)

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.

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.

K100533

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.

K053382

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

Regulation Number and Section

§ 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.

Summary

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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 Avenue
EI Segundo, CA 90245 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nozomi Yagi
Sr. Regulatory Affairs Specialist
Phone: (424) 218-8351
Fax: (424) 218-8519 |
| Date of
Preparation: | November 21, 2018 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: Flex-THOR System
Classification Name: Endoscope and accessories (21 CFR Part
876.1500) |
| Regulatory
Class: | II |
| Product Code
and Common
Name: | GCJ (Laparoscope, General & Plastic Surgery) |
| Guidance
Document: | Not Applicable for GCJ product code |
| Recognized
Consensus
Standards: | Not Applicable for GCJ product code |
| Predicate and
Reference
Device(s): | Primary Predicate Device: Vibrynt Inc's VISTA Endoscope
(K100533)
Reference Device: XLTF-VAW Laparo-Thoraco
Videoscope (K053382)
The above predicate and reference device have not been subjected to any
recall |
| Device
Description: | 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 |

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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 during
abdominal and thoracic diagnostic and therapeutic procedures.
Indications For
Use:	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.
Technological
Characteristics:	Comparison Table: Subject vs. Primary Predicate Devices
	Subject Device	Primary Predicate Device,
K100533
	Type of Scope	Flexible	Same as the subject device
	Distal End
Diameter	3.2 mm x 2.4 mm	5.0 mm
	Insertion Shaft
Length	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-Clinical
Performance
Data:	Electrical Safety and Electromagnetic Compatibility Summary
The electrical safety and EMC data included in the submission is in compliance
with the following FDA recognized standards:
• ANSI/AAMI ES:60601-1:2005
• IEC 60601-1-2:2007
Reprocessing Validation Summary
The 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 after
each use. The subject device contacts intact mucosal membranes so it is a semi-
critical device per Spaulding Classification. We performed validation activities for
cleaning and sterilization according to the FDA Guidance. The reprocessing data
submitted 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
Clinical
Performance
Data:	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.
Conclusion:	The conclusions drawn from the non-clinical performance data and
comparison of device characteristics demonstrated that the subject
device 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.