(107 days)
Not Found
No
The device description and performance studies focus on the physical components and functionality of tubing for air/water delivery during endoscopy, with no mention of AI or ML.
No
The device is described as tubing to supply air/CO2 and water during endoscopic procedures, and its function is to facilitate the operation of an endoscope, not to directly treat a medical condition.
No
The device's intended use is to supply air/CO2 and water during gastrointestinal endoscopic procedures, which is a functional role for the procedure itself, not for diagnosing a condition.
No
The device description clearly states it is "tubing" and describes physical components and bench testing related to flow, integrity, and compatibility with hardware (endoscopes and water bottles). There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to supply air/CO2 and water during gastrointestinal endoscopic procedures. This is a procedural aid, not a test performed in vitro (outside the body) on biological specimens to diagnose a condition.
- Device Description: The description focuses on its function in connecting sources to an endoscope for irrigation. It doesn't mention analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic results
- Using reagents or assays
The device is clearly intended for use as a medical device to facilitate an endoscopic procedure, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Vacutore® Air/Water Bottle Tubing (Model GAR025, GAR076) is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The Vacutore® Air/Water Bottle Tubing is intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile. The Vacutore® Air/Water Bottle Tubing is manufactured for use in conjunction with sterile water bottle, and together with Olympus 160 and Pentax 90 series endoscopes. The air/water bottle tubing is individually packed in sealed package, sold as a sterile device. The air/water bottle tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and or clinics
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)
Smartdata performed bench testing to support substantial equivalence. The following testing were performed on Smartdata samples from initial production lots, including sterilization: Assembling Integrity, Endoscope Compatibility, Compatibility with Bottle, Two-Way Valve Integrity, Flow Clamp Test, Water Flow Test, Back Flow Performance Test.
Sterilization: The subject device has been sterilized in a validated EO sterilization cycle with a Sterility Assurance Level (SAL) of 106. EO residuals are below maximum levels defined in ANSI/AAMI/ISO 10993-7:2008.
Shelf Life: A three (3) year expiration date is based on design and material equivalence to predicate devices and existing sterile barrier data. Tests conducted by Sanitation Environment Technology Institute, Soochow University include accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test, and sterility test. Performance tests after accelerated aging imply the device maintains sterile barrier and performance for at least three years.
Biocompatibility: Conducted in accordance with FDA guideline "Use of International Standard ISO 10993-1." Tests included Acute Systemic Toxicity Test, In Vitro Cytotoxicity, Skin sensitization, and Irritation. The device is classified as a surface device with mucosal membrane contact for a limited duration (not more than 24 hours), and test results show it is biocompatible.
Barrier Integrity and Simulated Use Testing: Test results imply that the air/water valve in the endoscope provides sufficient back-backflow prevention to the Vacutore® Air/Water Bottle Tubing and verifies 24-hour multi-patient use.
Clinical Testing: Not necessary due to similar devices on market with proven safety and efficacy, no direct patient contact, and supportive non-clinical testing.
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.
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.
Not Found
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
§ 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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September 6, 2019
Smartdata Suzhou Co., Ltd % Anna Reifschneider Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155-3708
Re: K191366
Trade/Device Name: Vacutore Air/Water Bottle Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: August 23, 2019 Received: August 26, 2019
Dear Anna Reifschneider:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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
Martha W. Betz, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K191366
Device Name
Vacutore® Air/Water Bottle Tubing
Indications for Use (Describe)
The Vacutore® Air/Water Bottle Tubing (Model GAR025, GAR076) is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
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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K191336 Page 1 of 5
510(k) Premarket Notification: Traditional Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd. CONFIDENTIAL
510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
Cindy Ye
General Manager +86 512 6598 3722
+852 6393 5184
1. Submission Sponsor
| Submitter's Name: | Smartdata Suzhou Co., Ltd |
|---|---|
| Submitter's Address: | 4f, Block 7, 198#, Jinshan Rd |
| New District | |
| Suzhou, Jiangsu 215011 | |
| CHINA | |
| Establishment Registration No.: | 3008058134 |
2. Sponsor Contact
| Contact Person: | |
|---|---|
| ----------------- | -- |
Telephone:
Email:
3. Date Prepared
15th Mar 2019
4. Device Identification
Trade Device Name: Common Device Name: Classification Name: Regulation Number: Classification
Vacutore® Air/Water Bottle Tubing Air/Water Tubing for Endoscope OCX - Endoscopic Irrigation/Suction System 876.1500 2
5. Predicate Device Identification
Predicate Device 510(k) No .: Predicate Device Trade Name: Predicate Device Product Code: K093665 Endo SmartCap™ FAJ
6. Device Description:
The Vacutore® Air/Water Bottle Tubing is intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile. Table 1 shows the components included in the application.
4
| Table 1 – Components included in the application | ||||
|---|---|---|---|---|
| Components | Qty | Classification Name | Regulation | |
| Number | Classification | |||
| Vacutore® Air/Water Bottle | ||||
| Tubing | ||||
| (GAR025) | 1 | OCX - Endoscopic | ||
| Irrigation/Suction | ||||
| System | 876.1500 | 2 | ||
| Vacutore® Air/Water Bottle | ||||
| Tubing | ||||
| (GAR072) | 1 | OCX - Endoscopic | ||
| Irrigation/Suction | ||||
| System | 876.1500 | 2 | ||
| Vacutore® Air/Water Bottle | ||||
| Tubing | ||||
| (GAR076) | 1 | OCX - Endoscopic | ||
| Irrigation/Suction | ||||
| System | 876.1500 | 2 |
The Vacutore® Air/Water Bottle Tubing is manufactured for use in conjunction with sterile water bottle, and together with Olympus 160 and Pentax 90 series endoscopes. The air/water bottle tubing is individually packed in sealed package, sold as a sterile device. The air/water bottle tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.
According to the Medical Device Recalls database in FDA website, no product recall was found for the predicate device. According to the FDA MAUDE database, safety issues on fluid leakage and backflow were identified. In the performance test, the leakage test are conducted for verification.
There were no prior submissions for the Vacutore® Air/Water Bottle Tubing.
7. Intended Use:
The Vacutore® Air/Water Bottle Tubing (Model GAR025, GAR072 & GAR076) is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
8. Technological Characteristics
Table 2 summaries the Vacutore® Air/Water Bottle Tubing technological characteristics as compared to the predicate device from Endo SmartCap™.
Table 2 Summary of design, features and principles of operation between the Vacutore® Air/Water Bottle Tubing (GAR025, GAR076) technological characteristics as compared to the predicate devices.
| Specification | Predicate Device | Proposed Device | Substantial
Equivalence |
|---------------|------------------|--------------------------------------|----------------------------|
| Device name | Endo SmartCap™ | Vacutore® Air/Water Bottle
Tubing | N/A |
| K number | K093665 | --- | N/A |
| Manufacturer | Medivators, Inc. | Smartdata Suzhou Co., Ltd | N/A |
| Product code | FAJ | OCX | N/A |
5
| Classification | 2 | 2 | Identical |
|---|---|---|---|
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation | |||
| Name | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Compatibility | Pentax GI Endoscope | GAR025: Olympus 160 series | |
| endoscope | |||
| GAR072 & GAR076: Pentax 90 | |||
| series endoscope | Substantial | ||
| Equivalent | |||
| Indications | |||
| for Use | ENDO SMARTCAP™ Tubing is | ||
| intended to be used with an air | |||
| or CO2 source and/ or pump | |||
| along with a sterile water source | |||
| to supply air or CO2 and sterile | |||
| water to an gastrointestinal | |||
| endoscope during endoscopic | |||
| procedures | The Vacutore® Air/Water Bottle | ||
| Tubing (Model GAR025, GAR072 | |||
| & GAR076) is to connect an | |||
| air/CO2 source, a sterile water | |||
| source (water bottle), and an | |||
| endoscope to supply air/CO2 and | |||
| water during gastrointestinal | |||
| endoscopic procedures. It is a | |||
| 24-hour multi-patient use device. | Substantial | ||
| Equivalent | |||
| Environment of | |||
| Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Material | Methyl methacrylate | ||
| acrylonitrile-butadiene-styrene | |||
| copolymer, Polycarbonate, | |||
| Polyethylene, Polyvinyl | |||
| Chloride, Thermoplastic | |||
| Elastomer, Nitrile Butadiene | |||
| Rubber | Thermoplastic polyurethanes, | ||
| Polyvinyl Chloride, Silicone, | |||
| Polyoxymethylene, | |||
| Polycarbonate, stainless steel | |||
| 304, Acrylonitrile Butadiene | |||
| Styrene | Substantial | ||
| Equivalent | |||
| Packaging | Each model packed separately | ||
| in a seal pouched | Each model packed separately in | ||
| a seal pouched | Identical | ||
| Manufacturing | |||
| method | Injection moulding | Injection moulding | Substantial |
| Equivalent | |||
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |
9. Non-Clinical Performance Data
Smartdata performed bench testing to support substantial equivalence. The following testing were performed on Smartdata samples from initial production lots, including sterilization.
9.1 Performance Test
9.1.1 Vacutore® Air/Water Bottle Tubing (GAR025, GAR072 and GAR076)
- Assembling Integrity 9.1.1.1
- 9.1.1.2 Endoscope Compatibility
- 9.1.1.3 Compatibility with Bottle
- 9.1.1.4 Two-Way Valve Integrity
- 9.1.1.5 Flow Clamp Test
- 9.1.1.6 Water Flow Test
- 9.1.1.7 Back Flow Performance Test
6
510(k) Premarket Notification: Traditional Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd. CONFIDENTIAL
9.2 Sterilization
Vacutore® Air/Water Bottle Tubing is sold in sterile package, like the Medivators predicate devices. The subject device has been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 106 EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The Vacutore® Air/Water Bottle Tubing, and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact.
9.3 Shelf Life
The Vacutore® Air/Water Bottle Tubing has a three (3) year expiration date, based on the design and material equivalence to the predicate devices and existing sterile barrier data from Smartdata existing packaging. The Vacutore® Air/Water Bottle Tubing is packaged in a paper/film pouch respectively like other sterile products Smartdata currently manufactures. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University .which is an CNAS accredited laboratory. The tests conducted including accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and the sterility test. Smartdata conducted the performance test after the accelerated aging process. The test result can imply that the air/water bottle tubing can provide and maintain a sterile barrier and its intended performance for at least three (3) years.
9.4 Biocompatibilitv
The biocompatibility of the Vacutore® Air/Water Bottle Tubing was conducted in accordance with the FDA quideline "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"". It included the following tests.
- Acute Systemic Toxicity Test -
- In Vitro Cytotoxicity -
- । Skin sensitization
- Irritation -
The air/water bottle tubing is classified as surface device with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the air/water bottle tubing is biocompatible.
0.5 Barrier Integrity and Simulated Use Testing
The barrier integrity and simulated use testing of Vacutore® Air/Water Bottle Tubing was conducted. The test result can imply that the air/water valve in the endoscope provide sufficient back-backflow prevention to the Vacutore® Air/Water Bottle Tubing and verified 24-hour multi-patient use
10. Clinical Testing
Similar devices have been on the market for many years with proven safety and efficacy for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports safety and efficacy of the devices and provides data to show substantial equivalence to the predicate device.
7
11. Conclusion
Vacutore® Air/Water Bottle Tubing has the same intended use as the predicate devices.
Based on the technological characteristics and overall performance of the devices in bench testing, Smartdata believes that no significant differences exist between the proposed air/water bottle tubing and the predicate devices.
The Vacutore® Air/Water Bottle Tubing does not raise any new issues of safety and effectiveness.
From a clinical perspective and comparing design specifications, the Vacutore® Air/Water Bottle Tubing, and the predicate device are substantially equivalent.