(163 days)
No
The device description and performance studies focus on the physical characteristics, biocompatibility, and compatibility with endoscopes. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is intended for "Gastrointestinal mucosal resection (endoscopic mucosal resection)", which is a therapeutic procedure.
No
The device is described as an attachment for an endoscope designed to facilitate endoscopic therapy and maintain a clear view during surgical procedures, specifically for gastrointestinal mucosal resection. It does not perform any diagnostic function.
No
The device description clearly states it is a physical attachment made of three main sections (attaching portion, distal portion, draining holes) and is supplied sterile for single-patient use. This indicates a hardware component, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be attached to an endoscope to facilitate endoscopic therapy, specifically gastrointestinal mucosal resection and maintaining the view field. This is a therapeutic and procedural aid, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical structure and function of the attachment in relation to the endoscope and the procedure. It doesn't mention analyzing biological samples (blood, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing information for diagnosis, monitoring, or screening.
- Reagents, calibrators, or controls.
- Analytical or clinical performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.).
The device is clearly described as a surgical accessory used during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The ClearCap Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.
The ClearCap Distal Attachment is intended for the following:
- · Gastrointestinal mucosal resection (endoscopic mucosal resection)
- · Keeping the suitable depth of the endoscope's view field
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures.
The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter.
Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-EC0001, FM-EC0005, FM-EC0006 and FM-EC0007 are for lower GI Tract, and FM-EC0002, EC0003 and EC0004 are for upper GI tract.
It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal (GI) tract, lower digestive tract, upper GI tract.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993- 10:2010, ISO 10993-11:2017.
- Performance testing such as appearance, dimension, extractable substance and Endoscope Compatibility and Suction testing
- EO Sterilization residuals testing according to ISO 10993-7:2008
- Shelf Life Testing according to ASTM F1980
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
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.
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
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February 19, 2021
Finemedix Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, CA 92620
Re: K202616
Trade/Device Name: ClearCap Distal Attachment Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: December 22, 2020 Received: January 8, 2021
Dear April Lee:
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202616
Device Name ClearCap Distal Attachment
Indications for Use (Describe)
The ClearCap Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.
The ClearCap Distal Attachment is intended for the following:
- · Gastrointestinal mucosal resection (endoscopic mucosal resection)
- · Keeping the suitable depth of the endoscope's view field
Type of Use (Select one or both, as applicable) | |
---|---|
------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
Submitter
FINEMEDIX CO., LTD. Seok-Jun Ma 60, Maeyeo-ro, Dong-gu, Daegu 41065 South Korea Email: msj1003@finemedix.com Tel. +82-53-741-8388 Fax. +82-53-741-8168
Official Correspondent
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: ClearCap Distal Attachment ●
- Regulation Name: Endoscope and accessories
- Product Code: OCX
- Panel: Gastroenterology/Urology ●
- Regulation Number: 21 CFR 876.1500
- . Device Class: Class II
- Date Prepared: 02/18/2020
Predicate Devices:
Primary Predicate
K140315, US ENDOSCOPY DISTAL ATTACHMENT CAP by UNITED STATES ENDOSCOPY GROUP, INC
Reference Device K162749, FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR by FUJIFILM Medical System U.S.A., Inc.
Indication for Use:
The ClearCap Distal Attachment has been designed to the distal end of the endoscope to facilitate endoscopic therapy.
The ClearCap Distal Attachment is intended for the following:
- Gastrointestinal mucosal resection (endoscopic mucosal resection)
- . Keeping the suitable depth of the endoscope's view field
4
Device Description:
ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures.
The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter.
Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-EC0001, FM-EC0005, FM-EC0006 and FM-EC0007 are for lower GI Tract, and FM-EC0002, EC0003 and EC0004 are for upper GI tract.
It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
Summary of Technological Characteristics:
A Comparison of the technological characteristics between the subject and predicate devices is provided in the table below:
Subject Device | Primary Predicate | Reference Device | |
---|---|---|---|
Company | Finemedix Co., Ltd. | United States Endoscopy | |
Group Inc. | FUJIFILM Medical Systems | ||
U.S.A., Inc. | |||
Device Name | ClearCap Distal Attachment | US Endoscopy Distal | |
Attachment Cap | FUJIFILM Hood Models DH- | ||
28GR, DH-29CR and DH- | |||
30CR | |||
510(k) Number | NA | K140315 | K162749 |
Device | |||
Classification Name | Endoscope and accessories. | Endoscope and accessories. | Endoscope and accessories. |
Product Code | OCX | OCX | FDS, FDF |
Regulation Number | 876.1500 | 876.1500 | 876.1500 |
Indications for Use | The ClearCap Distal | ||
Attachment has been designed | |||
to be attached to the distal end | |||
of the endoscope to facilitate | |||
endoscopic therapy. | |||
The ClearCap Distal | |||
Attachment is intended for the | |||
following: | |||
● Gastrointestinal mucosal | |||
resection (endoscopic | |||
mucosal resection) | |||
● Keeping the suitable | |||
depth of the endoscope's | |||
view field | The US Endoscopy Distal | ||
Attachment Cap has been | |||
designed to be attached to the | |||
distal end of the endoscope to | |||
facilitate endoscopic therapy. | |||
The US Endoscopy Distal | |||
Attachment Cap is intended | |||
for the following: | |||
● Gastrointestinal mucosal | |||
resection (endoscopic | |||
mucosal resection) | |||
● Keeping the suitable | |||
depth of the endoscope's | |||
view field | The FUJIFILM Hood Models | ||
DH-28GR, DH-29CR and | |||
DH-30CR are intended to be | |||
used in combination with | |||
compatible endoscopes to | |||
maintain the field of view | |||
during endoscopic procedures | |||
such as mucosal resection. | |||
It is attached to the end of the | |||
endoscope device to maintain | |||
proper distance from the | |||
tissue and to ensure visibility | |||
by discharging bleeding and | |||
some foreign substances | |||
through two holes on the side. | It is attached to the end of the | ||
endoscope device to maintain | |||
proper distance from the | |||
tissue and to ensure visibility | |||
by discharging bleeding and | |||
some foreign substances | |||
through one hole on the side. | It is attached to the end of the | ||
endoscope device to maintain | |||
proper distance from the | |||
tissue and to ensure visibility | |||
by discharging bleeding and | |||
some foreign substances | |||
through two holes on the side. | |||
Appearance | |||
Materials | Thermoplastic Polyurethane | ||
(TPU) | Unknown | Silicone | |
Outer Diameter | 11.35mm, 11.8mm, 12.4mm, | ||
13.4mm, 14.0mm, 15.0mm, | |||
15.7mm | Unknown | 11.8mm, 13.0mm, 14.8mm | |
Maximum Diameter | |||
of attaching | |||
endoscope | 9.4mm, 9.8mm, 10.5mm, | ||
11.7mm, 12.2mm, 13.7mm, | |||
13.9mm | Unknown | 15.5mm, 16.5mm, 18.4mm | |
Total Length | 11mm | Unknown | 17mm |
Inner Diameter of | |||
distal end | 8.9mm, 9.4mm,10mm, | ||
11mm,11.6mm,12.6mm, | |||
13.3mm | Unknown | 8.0mm | |
Size and number of | |||
the drain | Round hole | ||
Ø3mm, 2 piece | Round hole | ||
Unknown, 1 piece | Square hole | ||
5.0mm X 1.25mm, 2 piece | |||
Sterility | Sterilized by | ||
Ethylene Oxide | Sterilized by | ||
Ethylene Oxide | Unknown | ||
Reuse or not re-use | Single Use | Single Use | Single Use |
Similarities | The subject device is substantially equivalent to the predicate devices in Indications for Use, | ||
materials, dimensions, hole shape, sterilization methods and principle of operation. | |||
Differences | The differences between the subject and primary predicate are below: |
- Materials: While the material of the subject device is TPU, the material of the primary
predicate is unknown, and material of the reference device is silicone. The subject material,
TPU is a thermoplastic Polyurethane and has gained wide acceptance as an alternative to
silicone. By performing the biocompatibility testing on the subject device, it is demonstrated
that the subject device is biocompatible and substantially equivalent. - Number of the drain hole: The number of the drain hole is different; subject device has two
drain hole pieces and the primary predicate has one drain hole piece. The two drain holes have
only improved the discharge of bleeding and some foreign matter, and there are not directly
connected part to the endoscope, so no other effects will occur.
These differences do not raise any questions of substantial equivalence to the declared
predicates. | | |
5
6
Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993-● 10:2010, ISO 10993-11:2017.
- Performance testing such as appearance, dimension, extractable substance and Endoscope Compatibility and Suction testing
- . EO Sterilization residuals testing according to ISO 10993-7:2008
- Shelf Life Testing according to ASTM F1980
Below tests were performed on our own device and they can be leveraged for the subject device:
- EO Sterilization Validation Testing according to ISO 11737-1:2006 and ISO 11737-2:2009 . referenced in K180363
The biocompatibility evaluation for ClearCap Distal Attachment was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (May 1, 1995). The following tests were completed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity and Pyrogen Test.
Performance testing such as appearance and dimensions were performed as per Finemedix's design control system.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion:
The Clear Cap Distal Attachment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, the ClearCap Distal Attachment and its predicates are substantially equivalent.