Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

Device Description

Flexible Overtube™ provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Prior to inserting an endoscope into a patient, the user passes the endoscope through Flexible Overtube™. Flexible Overtube™ is placed after the endoscope is inserted into the patient. The endoscope can be inserted and withdrawn through properly placed Flexible Overtube™.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Crucially, the provided text describes a 510(k) submission for a medical device (Flexible Overtube™) seeking substantial equivalence to a predicate device. This type of submission generally does not involve clinical studies with human subjects to prove a device meets specific performance criteria in the way a de novo or PMA submission would. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through technological comparison, material biocompatibility testing, and functional bench testing.

Therefore, many of the typical questions for AI/diagnostic device performance studies (like sample sizes for test sets, expert ground truth, MRMC studies, etc.) are not applicable to this document. The focus here is on the "acceptance criteria" for establishing substantial equivalence, which are different from those for proving a diagnostic algorithm's accuracy.

The "study" here refers to the testing and comparisons done to support the claim of substantial equivalence.

Understanding the Context: 510(k) Premarket Notification

This submission (K182520) is a 510(k) Traditional Premarket Submission. The FDA review process for 510(k)s focuses on demonstrating substantial equivalence to a predicate device. This means the new device is:

Intended for the same use as a predicate device.
Has the same technological characteristics as the predicate device, OR
Has different technological characteristics, but the information submitted by the applicant demonstrates that the device is as safe and effective as a legally marketed predicate device, and does not raise different questions of safety and effectiveness.

This is different from proving absolute performance against a set of clinical criteria for a diagnostic/AI device.

Analysis of the Provided Information:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" in this context are not quantitative performance metrics for a diagnostic algorithm, but rather the criteria for demonstrating substantial equivalence to the predicate device. The "reported device performance" is mainly shown through qualitative comparisons and results of bench tests.

Acceptance Criterion (for Substantial Equivalence)	Reported Device "Performance" (Evidence from the Submission)
Similar Indications for Use	Met: Flexible Overtube™ is used "for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations." This is stated to be "identical to that of the Predicate device (Disposable Overtube K040836)."
Similar Principles of Operation	Met: Both devices facilitate repeated insertion/withdrawal of an endoscope. The predicate device also uses a similar principle to reduce mucosal pinching (albeit with a two-tube system vs. single tube for the subject device).
Technological Characteristics - Overtube Design	Met (with justification): Subject device uses a single tube with a soft, beveled distal end and lengthwise slit to reduce mucosal pinching. Predicate uses a two-tube system (inner/outer) with a tapered distal end for similar purpose. Justification: "both the proposed and the predicate devices provides an access for repeated insertion and withdrawal of an endoscope with reduced potential for mucosal pinching."
Technological Characteristics - Seal Unit	Met (with justification): Subject device has a detachable seal unit. Insufflation seal testing showed internal pressure >4.0 kPa, which "is much more than the average of stomach pressure during insufflation." (No direct comparison to predicate seal performance provided, but the functionality appears to be similar and adequate).
Technological Characteristics - Mouthpiece	Met (with justification): Subject device includes a detachable mouthpiece. Justification: "It is recommended that a minimum 60FR bite block be used with the predicate device. Therefore, the use of the Flexible Overtube™ with the Mouthpiece is not different from the use of the predicate device."
Technological Characteristics - Length	Met (with justification): Subject device is 205 mm. Justification: This length is "within the range" (20-25 cm) recommended by ASGE for protection. The predicate has 250 mm and 500 mm models, with the 250 mm model also in range.
Technological Characteristics - Diameter	Met (with comparison): Inner diameter: Subject - 16.0 mm. Predicate - 16.7 mm (Outer), 8.6 mm or 10.2 mm (Inner). Outer diameter: Subject - 19.0 mm. Predicate - 19.5 mm (Outer tube). Endoscope OD range: Subject - 9.0-12.0 mm. Predicate - 8.6-10.0 mm (for 8.6mm ID inner tube), 10.0-11.7 mm (for 10.2mm ID inner tube). The differences are noted but not presented as raising new questions of safety/effectiveness, implying clinical equivalence in use.
Technological Characteristics - Sterility	Improved (advantage for subject device): Subject device is EO sterilized (Sterility Assurance Level 10-6 achieved, residual EO/ECH/endotoxin within limits). Predicate device is non-sterile. This is considered a positive difference, not a new QSE.
Biocompatibility	Met: Contact with mucosal membrane (Surface device, Mucosal, Contact A-limited). Tests performed: Cytotoxicity, Sensitization, Acute systemic toxicity, Irritation reactivity. "No biocompatibility concern was raised."
Mechanical Performance	Met: Tensile strength test conducted, showed "enough for actual use." Simulated use test showed "bendability and stiffness... were kept during endoscopic treatment."

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set for diagnostic performance. The "test set" here would refer to the physical devices used for bench testing (tensile strength, simulated use, insufflation seal, biocompatibility). The number of samples tested is not specified in the provided summary, but device submissions typically outline these in detailed test reports.
Data Provenance: Not applicable. This is not clinical data from patients. The data comes from in vitro (bench) testing of the device itself and its materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" to establish for a diagnostic decision in this context. The testing is physical and chemical verification of device characteristics and safety.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human adjudication of results is mentioned or would typically be required for this type of physical/material testing.

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

No. An MRMC study is not relevant for this device. This is a physical medical device (an overtube for endoscopy), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this device, "ground truth" refers to established engineering standards, material safety standards (e.g., ISO, AAMI), and the functional requirements for an overtube. For example, the ground truth for biocompatibility is whether the materials elicit an adverse biological response when tested against ISO 10993 standards.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

9. How the ground truth for the training set was established

Not applicable. (See point 8).

In summary, the provided document details a 510(k) submission for a physical medical device (Flexible Overtube™). The "acceptance criteria" and "proof" relate to demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, confirmed by various bench tests (e.g., biocompatibility testing, tensile strength, seal testing). It does not involve clinical studies with human subjects or the evaluation of an AI algorithm's diagnostic performance.

Summary

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May 15, 2019

Sumitomo Bakelite Co., Ltd % Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo Bunkyo-ku, 1130033 Tokyo, Japan

Re: K182520

Trade/Device Name: Flexible Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FED Dated: April 10, 2019 Received: April 12, 2019

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. 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.

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

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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 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,

for Shani Haugen Acting Assistant Division 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) K182520

Device Name Flexible Overtube

Indications for Use (Describe)

Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

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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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

HEALTHCARE PRODUCTS DIV.

510 (k) Summary for Flexible Overtube™

1. Submission Sponsor
  Sumitomo Bakelite Co., Ltd. Healthcare Products Division 5-8, Higashi-Shinagawa 2-chome, Shinagawa-ku, Tokyo 140-0002, JAPAN

2. Date Prepared

September 5, 2018

3. Device Name

Trade/Proprietary Name: Flexible Overtube™ Common/Usual Name: Endoscopic access overtube Classification Name: Endoscope and accessories Classification Regulation: 876.1500 Classification Panel: Gastroenterology - Urology Devices Product Code: FED Device Class: ll

4. Predicate Devices

US Endoscopy: Disposable Overtube (K040836)

5. Device Description

6. Indications for Use

Flexible Overtube™ is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

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Technological Characteristics and Substantial Equivalence Discussion 7.

Flexible Overtube™ is used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. The intended use of the subject device is identical to that of the Predicate device (Disposable Overtube K040836).

Prior to inserting an endoscope into a patient, the user passes the endoscope through Flexible Overtube™. Flexible Overtube™ is placed after the endoscope is inserted into the patient. The endoscope can be inserted and withdrawn through properly placed Flexible Overtube™.

The predicate device has the same principles of operation.

The comparison table for technological characteristics between the two devices is shown below.

Feature:	Flexible Overtube™	Predicate Device
		Disposable Overtube (K040836)
Indicationsfor use	Flexible Overtube™ is a deviceused in conjunction with a flexibleendoscope for tissue or foreignbody retrieval, and/or forendoscopic procedures requiringmultiple endoscope intubations.	The disposable overtube is a deviceused in conjunction with a flexibleendoscope for foreign body or tissueretrieval, and/or for endoscopicprocedures requiring multipleendoscope intubations.
Overtube	Single tube system	Two-tube system
Designofdistal end ofthe Overtube	The overtube has a soft andbeveled distal end. The distal endhas a lengthwise slit on shortside.	Inner tube has a tapered distal endOuter tube has a soft and tapereddistal end
Seal Unit	Detachable	Tethered to the outer tube
Mouthpiece	Detachable	Not provided.
Length	205 mm	250 mm model and 500 mm model
Innerdiameter	16.0 mm	16.7 mm (Outer tube)8.6 mm or 10.2 mm (Inner tube)
Outerdiameter	19.0 mm	19.5 mm (Outer tube)

Table 1 Comparison table for technological characteristics

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EndoscopeOD range	9.0 mm to 12.0 mm	8.6 to 10.0 mm for 8.6 mm ID ofinner tube
		10.0 mm to 11.7 mm for 10.2 mm ofinner tube
Sterility	Sterile	Non-sterile

There are some differences between the predicate and the subject devices as shown in the following:

A. Design of the Overtube:
Flexible Overtube™ uses single tube system. The Flexible Overtube™ has a soft and beveled distal end. The distal end has a lengthwise wide slit on short side. The shape of the distal end reduces the potential for mucosal pinching. On the other hand, the Disposable Overtube (K040836) uses a two-tube system. The tapered distal end of the inner tube fits with the endoscope and the system reduces the potential for mucosal pinching by withdrawing both the inner tube and the endoscope simultaneously from the patient. Therefore, both the proposed and the predicate devices provides an access for repeated insertion and withdrawal of an endoscope with reduced potential for mucosal pinching.
B. Seal Unit
The insufflation seal testing was conducted. The internal pressure of the proposed device's overtube with the seal unit was more than 4.0 kPa. The internal pressure is much more than the average of stomach pressure during insufflation.
C. Mouthpiece
It is recommended that a minimum 60FR bite block be used with the predicate device. Therefore, the use of the Flexible Overtube™ with the Mouthpiece is not different from the use of the predicate device.
D. Length
An overtube needs to be 20 to 25 cm in length if the overtube is intended to protect the cricopharyngeal area or the airway. (The American Society for Gastrointestinal Endoscopy (ASGE) Technology, 2009). The length of the Flexible Overtube™ is 205 mm and within the range. The predicate device includes models of 250 mm in length and 500 mm in length. The model of 250 mm in length is also within the range.
E. Sterility
The Flexible Overtube™ is EO sterilized, but the predicate device is not sterilized. Therefore, the risk of infection for the Flexible Overtube ™ is reduced than that for the predicate device. The Sterilization Validation was conducted in accordance with ISO 11135:2014. The Sterilization Validation demonstrated that the Sterility Assurance Level of 10-6 was achieved.

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Sumitomo-Bakelite Co., Ltd. Traditional 510(k) Premarket Submission September 5, 2018 Flexible Overtube™

Residual EO and ECH of the final product did not exceed the allowable limit. In addition, endotoxin of the final product did not exceed the allowable limit.

F. Materials
The materials of the patient-contacting parts for the Flexible Overtube™ are different from those for the predicate device.

The Flexible Overtube™ directly contacts mucosal membrane in digestive tract and categorized as Surface devices, Mucosal membrane, Contact duration A-limited ≤24 hours .

Accordingly, we performed following biocompatibility tests;

Cytotoxicity (ISO 10993-5: 2009) ●
Sensitization (ISO 10993-10:2010)
Acute systemic toxicity (10993-11:2006)
Irritation reactivity (ISO 10993-10:2010)

In the biocompatibility testing reports, no biocompatibility concern was raised.

In addition to evaluations above, tensile strength test and simulated use test were conducted. Those testing showed that the tensile strength of the proposed device is enough for the actual use and the bendability and stiffness of the Flexible Overtube™ were kept during endoscopic treatment.

Conclusion 8.

Based on the considerations above, we concluded that the Flexible Overtube™ is substantially equivalent to the Disposable Overtube (K040836).

REFERENCE

ASGE Technology Committee; William M. Tierney, MD, Committee Chair, et al. Overtube use in gastrointestinal endoscopy. GASTROINTESTINAL ENDOSCOPY 2009; Vol 70: 828-834

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.