(126 days)
Not Found
No
The device description focuses on mechanical properties and function, with no mention of software, algorithms, or data processing.
No
The device is designed to facilitate endoscopic therapy by improving visualization and ease of endoscope insertion and withdrawal, but it does not directly perform a therapeutic action itself.
No
Explanation: The device is described as facilitating endoscopic therapy and improving visualization during examination by opening up the intestinal lumen, but it does not perform any diagnostic function itself. Its purpose is to aid the endoscope, not to make a diagnosis.
No
The device is a physical, all-polymer product designed to be attached to an endoscope, clearly indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an accessory attached to an endoscope. Its function is to facilitate endoscopic procedures by:
- Keeping the suitable depth of the endoscope's view field.
- Helping the endoscope with being inserted into the gastrointestinal tract.
- Stabilizing the endoscope tip.
- Improving visualization during withdrawal by everting mucosal folds.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It is a mechanical aid used during a medical procedure.
Therefore, the Arc EndoCuff and Arc Endocuff Vision are medical devices used in vivo (within the body) during an endoscopic procedure, not in vitro (in a lab) for diagnostic testing of samples.
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 (comma separated list FDA assigned to the subject device)
FED
Device Description
The Arc EndoCuff and Arc Endocuff Vision have short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy. The Arc EndoCuff and Arc Endocuff Vision are designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only. The Arc EndoCuff and Arc Endocuff Vision are cylindrical shaped all polymer products. They utilise the combined properties of two polymer materials to self-retain to the designated endoscope(s). The products feature a number of flexible "hairs" 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. Both the Arc EndoCuff and Arc Endocuff Vision devices are manually pushed onto the tip of the endoscope. It is designed to grip the endoscope sufficiently so as to prevent dislodgment during the procedure but without causing damage to the endoscope. At the end of the procedure, the device is removed either manually or with a purpose designed disposable tool before the endoscope is reprocessed. The endoscope fitted with the Arc EndoCuff or Arc Endocuff Vision is inserted into the intestine either through the anus or a stoma and is used in the standard manner. The EndoCuff stabilizes the tip of the instrument in the bowel lumen enabling the shaft of the Arc endoscope to be more easily straightened on pulling back so avoiding excessive looping. This is because the cuff maintains the position of the tip without having to angle it acutely against the bowel wall to gain purchase. The device does not hinder forward motion or cause trauma. During extubation, the device enables tip withdrawal in a more controlled fashion and provides improved visualisation by opening up the intestinal lumen for careful examination. Mucosal folds are everted and flattened enabling a more complete view of the areas of the bowel wall that were hidden behind mucosal folds.
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)
The expanded marketing claims are substantially equivalent and do not change fundamental scientific technology and intended use of the market cleared device. A Meta-Analysis of the Clinical literature supports the improvement of Adenoma Detection Rate claims.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked one behind the other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2017
Boddingtons Plastics Ltd Sarah Gibson Regulatory Compliance Manager Unit 6 Pattenden Lane, Marden Tonbridge, Kent TN12 9QJ United Kingdom
Re: K162205
Trade/Device Name: Arc EndoCuff and Arc Endocuff Vision Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated (Date on orig SE ltr): November 10, 2016 Received (Date on orig SE ltr): November 14, 2016
Dear Sarah Gibson:
This letter corrects our substantially equivalent letter of December 9, 2016
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K162205
Device Name
Arc EndoCuff and Arc Endocuff Vision
Indications for Use (Describe)
- 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
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
510(k) Summary
Summary of Safety and Effectiveness
510(k) number _K162205
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: | Sarah Gibson |
| Telephone: | +44 1622 833700 |
| Fax: | +44 1622 833701 |
| Email: | Sarah.gibson@boddingtons.co.uk |
| Date of Summary: | 01st August 2016 |
| Device Name: | Arc EndoCuff and Arc Endocuff Vision |
| Proprietary Name: | Arc Endocuff Vision ARV110; ARV120; ARV130
and ARV140
Arc EndoCuff AEC110, AEC120, AEC130 and
AEC140 |
| 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 |
Boddingtons Plastics Limited | Arc EndoCuff | AEC110, AEC120, | |
AEC130, AEC140 | K122565 | ||
Boddingtons Plastics Limited | Arc Endocuff Vision | ARV110, ARV120, | |
ARV130, ARV140 | K151801 |
Description
Description of Device
The Arc EndoCuff and Arc Endocuff Vision have short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.
4
Arc EndoCuff Vision
The Arc EndoCuff and Arc Endocuff Vision are designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.
The Arc EndoCuff and Arc Endocuff Vision are cylindrical shaped all polymer products. They utilise the combined properties of two polymer materials to self-retain to the designated endoscope(s). The products feature a number of flexible "hairs" 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.
Both the Arc EndoCuff and Arc Endocuff Vision devices are manually pushed onto the tip of the endoscope. It is designed to grip the endoscope sufficiently so as to prevent dislodgment during the procedure but without causing damage to the endoscope. At the end of the procedure, the device is removed either manually or with a purpose designed disposable tool before the endoscope is reprocessed.
The endoscope fitted with the Arc EndoCuff or Arc Endocuff Vision is inserted into the intestine either through the anus or a stoma and is used in the standard manner. The EndoCuff stabilizes the tip of the instrument in the bowel lumen enabling the shaft of the Arc endoscope to be more easily straightened on pulling back so avoiding excessive looping. This is because the cuff maintains the position of the tip without having to angle it acutely against the bowel wall to gain purchase. The device does not hinder forward motion or cause trauma.
During extubation, the device enables tip withdrawal in a more controlled fashion and provides improved visualisation by opening up the intestinal lumen for careful examination. Mucosal folds are everted and flattened enabling a more complete view of the areas of the bowel wall that were hidden behind mucosal folds.
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
Technological Characteristics
The purpose of this notification is to add additional marketing claims to the Arc EndoCuff and Arc Endocuff Vision, there are no new technological features incorporated in the devices.
5
Conclusion
lt is concluded that the Arc EndoCuff and Arc Endocuff Vision remain safe and effective as the product design, materials and sterilisation methods remain unchanged from the original Premarket Notifications.
The expanded marketing claims are substantially equivalent and do not change fundamental scientific technology and intended use of the market cleared device. A Meta-Analysis of the Clinical literature supports the improvement of Adenoma Detection Rate claims.
Marketing Claims
The marketing claims were supported via non-clinical performance testing, clinical data, or were based on the device design, will be included within the advertising and promotional materials for Arc EndoCuff and Arc Endocuff Vision, and are as follows;
No. | Marketing Claims | Supporting Documentation |
---|---|---|
1 | Arc EndoCuff assisted colonoscopy results | |
in a statistically significant and clinically | ||
relevant improvement in adenoma | ||
detection rate in screening, surveillance, | ||
and diagnostic populations, as compared | ||
with unassisted colonoscopy. | Based on Clinical Data | |
2 | Arc EndoCuff and Arc Endocuff Vision are | |
designed to increase ADR by manipulating | ||
folds to maximize the viewable mucosa. | Based on Device Design | |
In addition, based on Clinical Data | ||
3 | The Arc EndoCuff and Arc Endocuff Vision | |
allows for controlled withdrawal. | Based on Device Design | |
4 | The Arc EndoCuff and Arc Endocuff Vision | |
have been designed to minimize the | ||
difficulties in loop reduction. | Based on Device Design | |
5 | The Arc EndoCuff and Arc Endocuff Vision | |
are designed with an outer diameter to | ||
provide increase wall apposition in the | ||
colon. | Based on Device Design |
6
boddingtons Arc EndoCuff Vision
No. | Marketing Claims | Supporting Documentation |
---|---|---|
6 | The hinged arms of the Arc EndoCuff and | |
Arc Endocuff Vision collapse into the body | ||
to minimize intubation force and insertion | ||
resistance. | Based on Device Design and In-vitro | |
testing. | ||
7 | The internal ridges provide a tight grip on | |
the distal end of the colonoscope and | ||
minimize risk of dislodgement. | Based on Device Design and Clinical | |
Data. | ||
8 | The design is intended to minimize the risk | |
of mucosal trauma. | Based on Device Design and In-vitro | |
testing. | ||
9 | The Arc Endocuff Vision reduces the | |
likelihood of red-out. | Based on Device Design |