(13 days)
No
The device description and performance studies focus on the mechanical function and material properties of the device, with no mention of AI or ML.
No
The device facilitates endoscopic therapy by improving visualization and insertion, but it does not directly treat or diagnose a disease or condition itself. Its function is to aid the endoscope during a therapeutic procedure.
No
The device is described as an accessory attached to an endoscope to facilitate endoscopic therapy by keeping the view field depth and helping insertion, not for diagnostic purposes.
No
The device description clearly states it is a physical attachment ("short tube like shape with flexible hairs") that is attached to the distal end of an endoscope. It is also supplied sterile and is single-use, indicating a physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate endoscopic therapy by keeping a suitable depth of view and helping with insertion into the gastrointestinal tract. This is a therapeutic and procedural aid, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical attachment for an endoscope, designed to interact with the gastrointestinal tract directly during a procedure. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract .
Product codes
FED
Device Description
The Arc EndoCuff has a short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.
The Arc EndoCuff is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.
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
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)
Bench testing demonstrates that the EndoCuff design combines some of the benefits of both being a slim cylindrical device (like the Olympus product) and being able to stabilise and view the mucosa effectively on a greater diameter (as does the Fujinon balloon) but within the one product.
The performance data showed that the sterilisation method selected (Arc EndoCuff is irradiated and the D-201 Series is Ethylene Oxide sterilised K984358) has not introduced any additional risks and the patient contacting materials have been tested for biocompatibility with reports demonstrating no negatives in safety or effectiveness.
The bench testing has demonstrated that the device does not introduce any additional risks when undertaking endoscopic therapy and meeting the intended use.
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.
0
SEP 4 2012
510(k) Summary
Summary of Safety and Effectiveness
510(k) number_ كا2256) 510
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Summary
| Submitter's Identification: | Boddingtons Plastics Ltd | |
|---|---|---|
| Unit 6 Wheelbarrow Park Estate | ||
| Pattenden Lane | ||
| Tonbridge | ||
| Kent | ||
| TN12 9QJ | ||
| United Kingdom | ||
| Contact: | John Bovis | |
| Telephone: | +44 1622 833700 | |
| Fax: | +44 1622 833701 | |
| Email: | John.bovis@boddingtons.co.uk | |
| Date of Summary: | 11th May 2012 | |
| Device Name: | EndoCuff | |
| Proprietary Name: | Arc EndoCuff AEC 110; AEC 120; AEC 140 | |
| Classification: | Endoscope and/or accessories | |
| Product Code: | FED | |
| Product Class: | II | |
| Code of Federal Regulation: | 21 CFR 876.1500 | |
| Panel | Gastroenterology and Urology |
| Substantial Equivalence: | ||||
|---|---|---|---|---|
| Manufacturer | Trade Name | Model | 510(k) Number | |
| Olympus Optical Co. | ||||
| Ltd | Olympus Distal | |||
| Attachment | MH & D-201 Series | K984358 | ||
| Fujinon Corporation | Fujinon EC-450815 | |||
| (BS-2 Balloon only) | BS-2 Balloon | K090116 |
| Device Cross-Reference | ||||
|---|---|---|---|---|
| Arc EndoCuff | MH-Series | |||
| (K984358) | D-201 | |||
| (K984358) | BS-2 Balloon | |||
| (K090116) | ||||
| Model No. AEC 110 | MH-463 | D-201-13404 | BS-2 Balloon | |
| Model No. AEC 120 | MH-466 | D-201-14304 | BS-2 Balloon | |
| Model No. AEC 140 | MH-466 | D-201-15004 | BS-2 Balloon |
lssue 2
1
Description
Description of Device
The Arc EndoCuff has a short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.
The Arc EndoCuff is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.
Indications for Use:
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract �
Summary of the Technological Characteristics of the Device compared to the Predicate Device
Design
The EndoCuff are a cylindrical shaped all polymer products. It utilises the combined properties of two polymer materials to self-retain to the designated endoscope(s). The product features a number of flexible "hair" features that fold within the structure of the product during intubation and forward movement when in use, and open out when drawn backward to control field of view.
Materials
EndoCuff raw materials have been purpose chosen as conforming to USP class VI and tested for biocompatibility (See Section 15).
Size:
The product is similar in bodily size and cylindrical shape to the products seen in both the Olympus Reusable (MH Series K984358) and Single-use (D-201 Series K984358) Distal Attachment model ranges.
The flexible hair features work at a similar diameter to the size of the 200 predicate Fujinon BS-2 balloon (when inflated).
2
Summary of the Determination of Substantial Equivalence & Performance Data
The EndoCuff is used to maintain and maximise the endoscopes field of view during endoscopic therapy by manipulating colonic folds, maintaining a central position in the lumen and avoiding sudden slippage. The nominated predicate devices maximise the field of view in the same way, in particular:
- . The Olympus Distal Attachment (MH Series and D-201 series K984358), is used to manipulate colonic folds; and
- . The Fujinon BS-2 balloon (K090116) maintains central position in the lumen and avoids slippage by exerting circumferential pressure.
The bench testing demonstrates that the Endocuff design combines some of the benefits of both being a slim cylindrical device (like the Olympus product) and being able to stabilise and view the mucosa effectively on a greater diameter (as does the Fujinon balloon) but within the one product.
The design of the device is similar in length and is cylindrical in shape. Like both types of predicate devices, flexible polymers are the means for attachment/retention to the distal end of an endoscope.
The device contacts the patient in the same way and for the same period of time however they are made from different materials and are sterilised (where appropriate) using different methods.
The performance data showed that the sterilisation method selected (Arc EndoCuff is irradiated and the D-201 Series is Ethylene Oxide sterilised K984358) has not introduced any additional risks and the patient contacting materials have been tested for biocompatibility with reports demonstrating no negatives in safety or effectiveness
The bench testing has demonstrated that the device does not introduce any additional risks when undertaking endoscopic therapy and meeting the intended use.
Conclusion
After a review of the bench testing, it is concluded that the Arc EndoCuff is as safe and effective as the predicate devices for facilitating endoscopic therapy.
There are a few minor technological differences, in both materials used and the design. However the bio-compatibility testing shows that no additional risks are introduced from the materials used, and the performance testing demonstrates that there are no design weaknesses that could affect safety or effectiveness. There are no new indications for use and therefore by following the FDA 510(k) "Substantial Equivalence" decision making process,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourD evice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm
it is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 4 2012
Mr. Satish Champaneri Technical Reviewer BSI Healthcare Kitemark Court, Davy Avenue, Knowlhill MILTON KEYNES MK5 8PP UNITED KINGDOM
Re: K122565
Trade/Device Name: Arc EndoCuff AEC110; AEC120; AEC140 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: August 22, 2012 Received: August 22, 2012
Dear Mr. Champaneri:
We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve a rowe 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 10 abs been and 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 (Act that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may), ate of novisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviseration. 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 r source a view a determination that your device complies with other requirements of the Act that I Dr Hab Intacted and regulations administered by other Federal agencies. You must or ury reachard the Act's requirements, including, but not limited to: registration and listing Configry with an the Pre-Brequirence) at 801); medical device reporting (reporting of medical
4
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rico-related daverse ovenas) (21 CFR Part 820); and if applicable, the electronic for in the quality by belies (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire operatio ad 110 coutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mep., www.radiological Health's (CDRH's) Office of Compliance. Also, please the Conton Do 1000 and Radiovanding by reference to premarket notification" (21CFR Part note the regalation onlines and ing 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the rou may ocain outsi generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerély yours,
Sincerely yours,
Benjamin K. Kirk
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Arc EndoCuff
510(k) number_K 122565
Indications for Use
510(k) Number (if known):
Device Name:
Arc EndoCuff AEC110; AEC120; AEC140
Indications for Use:
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field .
- Helping the endoscope with being inserted into the gastrointestinal tract .
No Over the Counter Use And/Or Prescription Use Yes
(21 CFR Part 801 Subpart D)
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-off) currence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and
Urological Devices
| 510(k) Number | K122565 |
|---|---|
| --------------- | --------- |