(244 days)
Not Found
No
The summary describes a mechanical device (an overtube) used with an endoscope. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on physical properties and sterilization, not algorithmic performance.
No
The device facilitates endoscopic procedures by providing an access for repeated insertion and withdrawal of an endoscope, but it does not directly treat or diagnose a disease or condition. It is an accessory to the endoscope.
No
The device, a Flexible Overtube, is described as an accessory to an endoscope, facilitating repeated insertion and withdrawal for tissue or foreign body retrieval and endoscopic procedures. Its function is procedural access, not the diagnosis of a condition.
No
The device description clearly describes a physical, flexible tube used in conjunction with an endoscope, and the performance studies focus on physical properties like tensile strength, insufflation seal, sterilization, and biocompatibility. There is no mention of software components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for tissue or foreign body retrieval and facilitating multiple endoscope insertions during endoscopic procedures. This is a surgical/interventional use, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device used in conjunction with an endoscope to provide access within the body. This aligns with a surgical/interventional tool.
- 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.
- Performance Studies: The performance studies focus on physical properties (insufflation seal, tensile strength, bendability, stiffness), sterilization, residual chemicals, and biocompatibility. These are typical tests for a medical device used within the body, not for an IVD.
In summary, the Flexible Overtube is a medical device used during endoscopic procedures within the patient's body, not a device used to perform diagnostic tests on samples outside the body.
N/A
Intended Use / 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.
Product codes
FED
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™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mucosal membrane in digestive 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)
- insufflation seal testing: 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.
- Sterilization Validation: conducted in accordance with ISO 11135:2014. The Sterilization Validation demonstrated that the Sterility Assurance Level of 10-6 was achieved.
- Residual EO and ECH testing: Residual EO and ECH of the final product did not exceed the allowable limit.
- Endotoxin testing: endotoxin of the final product did not exceed the allowable limit.
- Biocompatibility tests:
- Cytotoxicity (ISO 10993-5: 2009)
- Sensitization (ISO 10993-10:2010)
- Acute systemic toxicity (10993-11:2006)
- Irritation reactivity (ISO 10993-10:2010)
No biocompatibility concern was raised.
- Tensile strength test: The tensile strength of the proposed device is enough for the actual use.
- Simulated use test: The bendability and stiffness of the Flexible Overtube™ were kept during endoscopic treatment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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™
-
- Submission Sponsor
Sumitomo Bakelite Co., Ltd. Healthcare Products Division 5-8, Higashi-Shinagawa 2-chome, Shinagawa-ku, Tokyo 140-0002, JAPAN
- Submission Sponsor
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
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™.
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.
4
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) | ||
| 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. | The disposable overtube is a device | |
| used in conjunction with a flexible | ||
| endoscope for foreign body or tissue | ||
| retrieval, and/or for endoscopic | ||
| procedures requiring multiple | ||
| endoscope intubations. | ||
| Overtube | Single tube system | Two-tube system |
| Design | ||
| of | ||
| distal end of | ||
| the Overtube | The overtube has a soft and | |
| beveled distal end. The distal end | ||
| has a lengthwise slit on short | ||
| side. | Inner tube has a tapered distal end | |
| Outer tube has a soft and tapered | ||
| distal end | ||
| Seal Unit | Detachable | Tethered to the outer tube |
| Mouthpiece | Detachable | Not provided. |
| Length | 205 mm | 250 mm model and 500 mm model |
| Inner | ||
| diameter | 16.0 mm | 16.7 mm (Outer tube) |
| 8.6 mm or 10.2 mm (Inner tube) | ||
| Outer | ||
| diameter | 19.0 mm | 19.5 mm (Outer tube) |
Table 1 Comparison table for technological characteristics
5
| Endoscope
OD range | 9.0 mm to 12.0 mm | 8.6 to 10.0 mm for 8.6 mm ID of
inner tube |
|-----------------------|-------------------|-------------------------------------------------|
| | | 10.0 mm to 11.7 mm for 10.2 mm of
inner 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.
6
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