(163 days)
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
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.
The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a medical device called the "ClearCap Distal Attachment." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Based on the provided text, the device is not an AI/Software as a Medical Device (SaMD). It is a physical accessory designed to be attached to the distal end of an endoscope. Therefore, the questions related to AI/SaMD acceptance criteria, test sets, ground truth establishment, expert consensus, MRMC studies, and training sets are not applicable to this document.
The document focuses on demonstrating the physical device's safety and effectiveness through non-clinical testing, primarily biocompatibility and performance testing, to show its substantial equivalence to already marketed predicate devices.
Here's a breakdown of the relevant information provided:
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Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of "acceptance criteria" in the way one might see for an AI model (e.g., specific thresholds for sensitivity, specificity, or F1-score). Instead, substantial equivalence for this physical device is demonstrated through:
- Indications for Use (IFU) comparability: The ClearCap Distal Attachment has the same IFU as its primary predicate device (US Endoscopy Distal Attachment Cap).
- Technological Characteristics Comparability: A table compares the subject device to its primary predicate and a reference device across various characteristics like company, device name, classification, product code, regulation number, IFU, appearance, materials, outer diameter, maximum diameter of attaching endoscope, total length, inner diameter of distal end, size and number of the drain, sterility, and reuse.
- Non-Clinical Testing Results: The device underwent specific tests to ensure it met relevant standards and performed comparably to expectations for such devices. The "performance" is reported as meeting these standards, rather than numerical metrics for AI performance.
Table of Non-Clinical Testing and Outcome (interpreted as meeting "acceptance"):
Acceptance Criterion (Testing Standard) Reported Device Performance (Outcome) Biocompatibility (ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017) Completed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, and Pyrogen Test (Demonstrated biocompatibility and substantial equivalence) Performance Testing (Finemedix's design control system) Appearance, Dimension, Extractable Substance, Endoscope Compatibility, and Suction testing (Performed as per system) EO Sterilization Residuals (ISO 10993-7:2008) Tested (No specific pass/fail values given, but implies acceptance) Shelf Life Testing (ASTM F1980) Tested (No specific duration or pass/fail values given, but implies acceptance) EO Sterilization Validation (ISO 11737-1:2006, ISO 11737-2:2009) Tested (Leveraged from K180363, implies acceptance) The conclusion explicitly states: "The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device."
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Sample size used for the test set and the data provenance:
- Not applicable (N/A) for AI/SaMD test set. This document describes a physical medical device.
- For the non-clinical tests (biocompatibility, performance, sterilization, shelf-life), specific sample sizes for tests on the physical device are not detailed in the provided summary, but standard practices for these types of tests would have been followed. The provenance would be the manufacturing site where the device prototypes were produced for testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A for AI/SaMD. Ground truth as understood in AI (e.g., image annotations by radiologists) is not relevant for this physical device. The "ground truth" for this device's performance would be the physical properties and material characteristics verified by laboratory testing professionals.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A for AI/SaMD. Adjudication methods are typically used for establishing consensus ground truth for complex interpretations (like medical images), which is not relevant here.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A for AI/SaMD. This device is an accessory for an endoscopy procedure, not an AI system. No human reader studies (MRMC) would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A for AI/SaMD. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this physical device, the "ground truth" is established through objective laboratory measurements and tests against established international standards (e.g., ISO, ASTM) for biocompatibility, sterility, dimensions, material properties, and functional performance. It's not based on expert consensus on diagnostic interpretations or patient outcomes data in an AI sense.
-
The sample size for the training set:
- N/A for AI/SaMD. There is no training set for a physical medical device.
-
How the ground truth for the training set was established:
- N/A for AI/SaMD.
In summary, the provided document pertains to the FDA 510(k) clearance of a physical medical device accessory, not an AI or software product. Therefore, most of the requested information regarding AI model validation and performance is not present or applicable. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through comparability of indications for use, technological characteristics, and successful completion of standard non-clinical safety (biocompatibility, sterility) and performance tests.
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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
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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
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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)
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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
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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 EndoscopyGroup Inc. | FUJIFILM Medical SystemsU.S.A., Inc. |
| Device Name | ClearCap Distal Attachment | US Endoscopy DistalAttachment Cap | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR |
| 510(k) Number | NA | K140315 | K162749 |
| DeviceClassification 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 DistalAttachment has been designedto be attached to the distal endof the endoscope to facilitateendoscopic therapy.The ClearCap DistalAttachment is intended for thefollowing:● Gastrointestinal mucosalresection (endoscopicmucosal resection)● Keeping the suitabledepth of the endoscope'sview field | The US Endoscopy DistalAttachment Cap has beendesigned to be attached to thedistal end of the endoscope tofacilitate endoscopic therapy.The US Endoscopy DistalAttachment Cap is intendedfor the following:● Gastrointestinal mucosalresection (endoscopicmucosal resection)● Keeping the suitabledepth of the endoscope'sview field | The FUJIFILM Hood ModelsDH-28GR, DH-29CR andDH-30CR are intended to beused in combination withcompatible endoscopes tomaintain the field of viewduring endoscopic proceduressuch as mucosal resection. |
| It is attached to the end of theendoscope device to maintainproper distance from thetissue and to ensure visibilityby discharging bleeding andsome foreign substancesthrough two holes on the side. | It is attached to the end of theendoscope device to maintainproper distance from thetissue and to ensure visibilityby discharging bleeding andsome foreign substancesthrough one hole on the side. | It is attached to the end of theendoscope device to maintainproper distance from thetissue and to ensure visibilityby discharging bleeding andsome foreign substancesthrough 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 Diameterof attachingendoscope | 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 ofdistal end | 8.9mm, 9.4mm,10mm,11mm,11.6mm,12.6mm,13.3mm | Unknown | 8.0mm |
| Size and number ofthe drain | Round holeØ3mm, 2 piece | Round holeUnknown, 1 piece | Square hole5.0mm X 1.25mm, 2 piece |
| Sterility | Sterilized byEthylene Oxide | Sterilized byEthylene 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 primarypredicate 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 tosilicone. By performing the biocompatibility testing on the subject device, it is demonstratedthat the subject device is biocompatible and substantially equivalent.- Number of the drain hole: The number of the drain hole is different; subject device has twodrain hole pieces and the primary predicate has one drain hole piece. The two drain holes haveonly improved the discharge of bleeding and some foreign matter, and there are not directlyconnected part to the endoscope, so no other effects will occur.These differences do not raise any questions of substantial equivalence to the declaredpredicates. |
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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.
§ 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.