(282 days)
No
The summary describes a simple mechanical tubeset for delivering CO2 and monitoring pressure during endoscopy. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The document states that the device is used to "supply CO2 to an endoscope" and "insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure," which are supportive functions for the procedure rather than direct treatment or diagnosis.
No
The device is a tubeset used to supply CO2 for insufflation during endoscopic procedures and monitor pressure. It does not perform any diagnostic functions by identifying, detecting, or measuring a disease or medical condition.
No
The device description clearly states it is a "dual lumen tube with clips" and is a physical, disposable component used to deliver CO2. It is not software.
Based on the provided information, the END-200 Tubeset is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to supply CO2 to an endoscope during gastrointestinal endoscopic procedures. This is a therapeutic or procedural support function, not a diagnostic one.
- Device Description: The device is a tube for delivering gas and monitoring pressure within a body cavity. It does not analyze samples taken from the body (in vitro).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is used directly within the gastrointestinal tract, which is an in vivo application.
In summary, the END-200 Tubeset is a medical device used to facilitate an endoscopic procedure by providing insufflation and pressure monitoring. It does not perform any diagnostic testing on samples outside of the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.
Product codes
FCX
Device Description
The END-200 Tubeset is a dual lumen tube with clips that attach to the outside of an endoscope. It connects to a CO2 gas source and is used to insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure. It is single use, disposable and provided non-sterile similar to the predicate. The ENDO-200 Tubeset is offered in Small and Medium sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal Tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room or endoscopy suite.
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
Performance testing was conducted to ensure that the tubing does not affect the delivery pressure accuracy of the insufflator. The subject device was tested and met its performance acceptance criteria.
Animal testing demonstrated that the tubeset device is compatible with the endoscope system, the tubeset remained attached to the endoscope during use, the device could be maneuvered as intended and did not cause any tissue injury during use.
Biocompatibility testing of the patient contacting materials included ISO 10993-5 - Cytotoxicity and ISO 10993-10 - Sensitization and Irritation as a Surface Contacting, Mucosal, Limited Duration of Use device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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July 8, 2021
Palliare Ltd. % Paul Dryden Consultant Palliare Ltd. c/o ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704
Re: K202922
Trade/Device Name: END 200 Tubeset Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCX Dated: June 6, 2021 Received: June 8, 2021
Dear Paul Dryden:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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
Shanil P. Haugen, Ph.D. 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)
K202922
Device Name
END-200 Tubeset
Indications for Use (Describe)
The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
Page 1 of 1
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| Page 1 of 4 | |
|---|---|
| -- | ------------- |
| Date Prepared: | 7-Jul-2021 |
|---|---|
| ---------------- | ------------ |
Palliare Ltd.
Galway Business Park, Dangan
Galway H91 P2DK, Ireland
| Official Contact: | John O'Dea, Ph.D., Director |
|---|---|
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Device Name: | END-200 Tubeset |
| Common Name: | Endoscope and accessories |
| Regulation Number: | 21CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Product Code: | FCX |
| Regulatory Class: | II |
| Device Panel: | Gastroenterology/Urology |
| Predicate Device: | K053008 – E-Z-EM, Inc. – E-Z-EM Endoscopic CO2 regulator |
| Reference Device: | K163614 - Pentax Medical - PENTAX Medical ED34-i10T, Video Duodenoscope |
510(k) Summary
Device Description:
The END-200 Tubeset is a dual lumen tube with clips that attach to the outside of an endoscope. It connects to a CO2 gas source and is used to insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure. It is single use, disposable and provided non-sterile similar to the predicate. The ENDO-200 Tubeset is offered in Small and Medium sizes.
Principle of Operation:
The device is a simple dual lumen conduit from an insufflator to an anatomical cavity being insufflated. One lumen is used when monitoring pressure in the cavity and the other lumen is used to delivered CO2 from the insufflator.
Indications for Use:
The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.
Patient Population:
Patients undergoing endoscopic procedures in which insufflation may be helpful.
Environments of use:
Operating room or endoscopy suite.
Table 1 is a comparison - Subject Device vs. the Predicate, K053008 and includes a discussion of the reference device, K163614.
4
510(k) Summary Page 2 of 4
Table 1 – Comparison – Subject vs. Predicate / Reference
| | Predicate:
EZ-EM, Inc. – E-Z-EM
Endoscopic CO2 regulator
K053008 | Reference
PENTAX Medical ED34-i10T,
Video Duodenoscope accessory
K163614 | Proposed Device:
END-200 Tubeset | Comparison |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | E-ZEM, Inc. (now Bracco
Diagnostics, Inc) | Pentax Medical | Palliare | |
| Classification | 21 C.F.R. § 876.1500
Product Code - FCX | 21 C.F.R. § 876.1500
Product Code - FDT | 21 C.F.R. § 876.1500
Product Code - FCX | Similar.
The reference is for
the external accessory
reference only. |
| Fundamental scientific
technology | Tube that connects to the
endoscope and delivers CO2 during
endoscopic procedures | Detachable Distal Cap | Tube that connects to the
endoscope and delivers CO2 during
endoscopic procedures | Same |
| Indications for Use | The CO2 endoscopic Insufflator In-
line tubing set is intended to
connect a CO2 source (insufflator),
and a sterile water source (water
bottle), to an endoscope to supply
CO2 during gastrointestinal
endoscopic procedures. | The PENTAX Duodenoscope
ED34-i10T is intended to provide
optical visualization of (via a
video monitor), and
therapeutic access to, Biliary
Tract via the Upper
Gastrointestinal Tract. This
anatomy includes, but is not
restricted to, the
organs; tissues; and subsystems:
Esophagus, Stomach,
Duodenum, Common Bile,
Hepatic and Cystic Ducts.
These instruments are introduced
via the mouth when indications
consistent with the need for the
procedure are observed in adult
and pediatric patient populations. | The END-200 tubeset is intended
to be used with the EVA15
insufflator, to supply CO2 to an
endoscope during gastrointestinal
endoscopic procedures. | Similar except
subject device is not
connected to water
source
With regards to the
reference we are only
referring to the
external cap which
has a similar design
as an external
accessory to the
endoscope. |
| Compatibility | Connects to OEM Endoscope
systems that are equipped with an
external luer connector | Connects to endoscope systems | Connects to OEM Endoscope
systems | Same |
| Sterile | Non-sterile | Sterilized prior to use | Non-sterile | Same |
| Disposable | Single patient use, disposable | Single patient use, disposable | Single patient use, disposable | Same |
| Shelf-life | 6 years | Not stated | 1 year | Similar |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Similar |
| | Surface Contact, mucosa, limited
duration | Surface Contact, mucosa, limited
duration | Surface Contact, mucosa, limited
duration | |
5
510(k) Summary Page 3 of 4
Substantial Equivalence Discussion
The END-200 Tubeset has the same general indications, technological characteristics, and principles of operation as the predicate.
Intended Use/ Indications for Use
The proposed indications for use are similar to the predicate.
Technological Characteristics
The technology of a set of tubing with connectors that can endoscope and deliver CO2 as desired for insufflation is similar to the predicate.
6
Principles of Operation
The principle of operation of providing a conduit to delivery gas for insufflation is similar to the predicate.
Non-clinical Testing Bench Testing
Performance testing was conducted to ensure that the tubing does not affect the delivery pressure accuracy of the insufflator. The subject device was tested and met its performance acceptance criteria.
Animal Testing
Animal testing demonstrated that the tubeset device is compatible with the endoscope system, the tubeset remained attached to the endoscope during use, the device could be maneuvered as intended and did not cause any tissue injury during use.
Biocompatibility
Biocompatibility testing of the patient contacting materials included ISO 10993-5 - Cytotoxicity and ISO 10993-10 - Sensitization and Irritation as a Surface Contacting, Mucosal, Limited Duration of Use device.
Substantial Equivalence Conclusion
The comparison and testing demonstrate that the subject device is substantially equivalent to the predicate and that there are no new questions of safety or effectiveness raised when compared to the predicate.