(227 days)
Not Found
No
The description focuses on a physical attachment (a cap) to the colonoscope and mentions only mechanical and biocompatibility testing, with no indication of software, image processing, or AI/ML components.
No
The device is intended to facilitate the scope's view during colonoscopy procedures by maintaining a suitable depth of the field of view, rather than directly treating a disease or condition.
No
Explanation: The device is intended to facilitate the colonoscope's view by maintaining a suitable depth of field, which is an enhancement to the visualization process, but it does not analyze or interpret medical images or physiological data to diagnose a condition.
No
The device description clearly states it is a "short transparent tube which is attached to the distal end of the colonoscope," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "keep the suitable depth of the colonoscope's field of view" during a colonoscopy procedure. This is a mechanical function related to the visualization during an in-vivo procedure, not an in-vitro test performed on samples outside the body.
- Device Description: The device is a physical attachment for a colonoscope, designed to facilitate the scope's view. This aligns with a medical device used during a procedure, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and related to the visualization aspect of an endoscopic procedure.
N/A
Intended Use / Indications for Use
The Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following: For use in keeping the suitable depth of the colonoscope's field of view.
Product codes (comma separated list FDA assigned to the subject device)
FDF
Device Description
The GCE Focus Cap has the shape of a short transparent tube which is attached to the distal end of the colonoscope. The Focus Cap is designed to facilitate the scope's view during colonoscopy procedures.
The Focus Cap will be offered in two sizes:
- 11mm (Catalog #11 FC 1701)
- 13.5mm (Catalog #13 FC 1702)
The 11mm Focus Cap will fit 11.6mm and 12.8mm scopes. The 13.5mm Focus Cap will fit 13.2mm and 13.9mm scopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing has been completed for the GCE Focus Cap to demonstrate substantial equivalence to the predicate Olympus Distal Attachment (K984358). The Focus Cap has been subjected to the following verification and validation testing: Mechanical and biocompatibility. All test requirements were met as specified by test protocols and pre-determined acceptance criteria.
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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January 19, 2018
GCE Medical Corporation % Stephen M. Page President MedReg Associates Inc. 228 Hull Cove Farm Road Jamestown, Rhode Island 02835
Re: K171673 Trade/Device Name: Focus Cap Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: January 10, 2018 Received: January 16, 2018
Dear Stephen M. Page:
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. 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.
1
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); 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
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For 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
2
Indications for Use
510(k) Number (if known)
Device Name Focus Cap
Indications for Use (Describe)
The Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following:
- For use in keeping the suitable depth of the colonoscope's field of view.
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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510(k) Summary
Submitter Information
- A. Company Name: GCE Medical Corporation
- B. Company Address: 2723 West Tenaya, Fresno CA 93711
- Company Phone: 559-439-5757 C.
- Contact Person: Dr. Stanley Chang D.
- E. Summary Prepared on: January 10, 2018
Device Identification
- Device Trade Name: Focus Cap A.
- B. Device Common Name: Transparent Cap
- Classification Name: Endoscope and accessories C.
- Classification Number: 21 CFR Part 876.1500 D.
- Product Code: FDF D.
- E. Device Class: II
Identification of Predicate Device
| Trade Name | Manufacturer | 510(k) |
|---|---|---|
| Distal Distal Attachment | Olympus | K984358 |
Indications for Use
The GCE Medical Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following:
- For use in keeping the suitable depth of the colonoscope's field of view.
Device Description
The GCE Focus Cap has the shape of a short transparent tube which is attached to the distal end of the colonoscope. The Focus Cap is designed to facilitate the scope's view during colonoscopy procedures.
4
The Focus Cap will be offered in two sizes:
- 11mm (Catalog #11 FC 1701)
- 13.5mm (Catalog #13 FC 1702)
The 11mm Focus Cap will fit 11.6mm and 12.8mm scopes. The 13.5mm Focus Cap will fit 13.2mm and 13.9mm scopes.
Comparison to Predicate Device:
| Characteristic | Comparison to Predicate
Olympus Distal
Attachment (K984358) | Differences |
|-----------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Identical | N/A |
| Indications for Use | Identical | N/A |
| Fundamental
scientific
technology | Identical | N/A |
| Operating
principles | Similar | The operating principle for both
devices is that they attach to a scope
by compression. Although there are
slight differences in their relative
adhesion strengths, those differences
are minimal and have no impact on
safety or effectivenss. |
| Mechanism of
action | Similar | Both the predicate and proposed
devices act as simple spacers. They
establish a space between the end of
the scope and patient's anatomy,
thereby preventing the camera image
from being blocked. Although the two
devices have slightly different
dimensional characteristics, those
differences are minimal and have no
impact on safety or effectiveness. |
| Technological
aspects | Similar | The Olympus Distal Attachment
incorporates a side hole which is not
present on the Focus Cap. In addition,
the Focus Cap incorporates a slant
design while the Olympus design is
flat The slant design of the Focus |
5
| Cap, which essentially takes the place |
|---|
| of the side hole, allows for a wide |
| open surface for the exit of fluid which |
| is many times larger than the side hole |
| on the predicate device. Therefore. |
| these differences have no impact on |
| safety or effectiveness. |
Performance Testing
Performance testing has been completed for the GCE Focus Cap to demonstrate substantial equivalence to the predicate Olympus Distal Attachment (K984358). The Focus Cap has been subjected to the following verification and validation testing: Mechanical and biocompatibility. All test requirements were met as specified by test protocols and pre-determined acceptance criteria.
Conclusions
The subject Focus Cap and predicate Olympus Distal Attachment (K984358) share the same intended use and indications for use. Furthermore, the subject and predicate devices share the same fundamental technology and key device characteristics. Differences in design and technological characteristics between the subject and predicate devices do not raise any new questions of safety and effectiveness. The results of verification and validation support the safety and effectiveness of the Focus Cap for its intended use and provide reasonable assurance of the substantial equivalence of the subject device to the predicate Olympus Distal Attachment (K984358).