(29 days)
Not Found
No
The device description and intended use focus on a mechanical attachment for endoscopes, with no mention of AI or ML capabilities for image analysis, diagnosis, or any other function.
No.
The "ClearCap Distal Attachment" is an accessory for endoscopes designed to facilitate endoscopic therapy by improving control and maintaining a clear view during procedures like gastrointestinal mucosal resection. It is not directly therapeutic itself but enables a therapeutic procedure.
No
The device is described as a "distal attachment" to an endoscope to "facilitate endoscopic therapy" and "improve endoscopic control and to help maintain the clear view" during "endoscopic surgical procedures." Its intended uses are "Gastrointestinal mucosal resection (endoscopic mucosal resection)" and "Keeping the suitable depth of the endoscope's view field." These functions are therapeutic and supportive of therapy, not diagnostic.
No
The device description clearly states it is a physical attachment comprised of three main sections (attaching portion, distal portion, draining holes) intended to be attached to an endoscope. It is a sterile, single-use hardware component.
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 ClearCap Distal Attachment is a physical accessory attached to an endoscope. Its function is to facilitate endoscopic procedures by improving control, maintaining a clear view, and assisting with procedures like mucosal resection. It does not analyze biological samples.
- Intended Use: The intended use clearly describes its role in endoscopic therapy and maintaining the view field during these procedures. It does not mention any diagnostic testing of biological samples.
- Device Description: The description focuses on the physical components and how it attaches to the endoscope to aid in the procedure. There is no mention of analyzing samples.
Therefore, the ClearCap Distal Attachment is a medical device used during an endoscopic procedure, not an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications 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
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The 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-CC01, FM-CC05, FM-CC06 and FM-CC07 are for lower GI Tract, and FM-CC02, FM-CC03 and FM-CC04 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 resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal (GI) tract (lower and upper)
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)
Non-clinical Tests: Direct comparison testing between the subject device models and predicate device models for gap, endoscope compatibility and viewing, and suction function were performed. The test results support that the differences do not raise any questions of substantial equivalence to the declared predicates. The nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as 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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 20, 2024
FINEMEDIX Co., Ltd. Seok-Jun Ma Official Correspondent 140-9, Yuram-Ro, Dong-Gu Daegu, 41059 South Korea
Re: K242134
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: July 18, 2024 Received: July 22, 2024
Dear Seok-Jun Ma:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Shanil P. Haugen -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
ClearCap Distal Attachment
Indications for Use (Describe)
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
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(K) SUMMARY
July 18, 2024
1. Submitted by:
FINEMEDIX Co., Ltd. 140-9, Yuram-ro, Dong-gu, Daegu, 41059 Republic of Korea Tel : 82-53-741-8388, Fax : 82-53-741-8168
2. US Agent/ Official Correspondent:
Priscilla Chung
LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com
3. Device Name:
- Trade Name : ClearCap Distal Attachment - Classification Class II : - Classification Name Endoscopy Distal Attachment Cap :
- Product Code OCX :
- Regulation Number ・・ 21 CFR 876.1500
- Review Panel Gastroenterology/Urology :
4. Predicate Device:
ClearCap Distal Attachment (K202616) by FINEMEDIX Co., Ltd.
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റ Device Description:
The 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-CC01, FM-CC05, FM-CC06 and FM-CC07 are for lower GI Tract, and FM-CC02, FM-CC03 and FM-CC04 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 resterilized.
Indications for Use Statement ર
The Clear Cap 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
7 Substantial Equivalence Discussion:
7.1. Comparison Chart
A comparison of the technological characteristics between the subject and predicate devices is provided in the table below:
| Subject Device | Predicate Device | |
|---|---|---|
| Company | Finemedix Co., Ltd. | Finemedix Co., Ltd. |
| Device Name | ClearCap Distal Attachment | ClearCap Distal Attachment |
| 510(k) Number | K242134 | K202616 |
| Device Classification Name | Endoscope and accessories. | Endoscope and accessories. |
| Product Code | OCX | OCX |
| Regulation Number | 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 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 | ||
| Principle of Operation | 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 two holes on the side. | ||
| Materials | Thermoplastic Polyurethane (TPU) | Thermoplastic Polyurethane (TPU) |
| Outer Diameter | 11.35mm, 11.8mm, 12.4mm, 13.4mm, | |
| 14.0mm, 15.0mm, 15.7mm | 11.35mm, 11.8mm, 12.4mm, 13.4mm, | |
| 14.0mm, 15.0mm, 15.7mm | ||
| Inner Diameter for | ||
| Connection to Endoscopy | 13.2mm, 10.0mm, 9.5mm, 10.6mm, | |
| 11.6mm, 12.2mm, 13.9mm | 13.2mm, 10.0mm, 9.5mm, 10.6mm, | |
| 11.6mm, 12.2mm, 13.9mm | ||
| Total Length | 14.0mm | 11.0mm |
| Inner Diameter of distal | ||
| end | 8.0mm | 8.9mm, 9.4mm,10mm, |
| 11mm,11.6mm,12.6mm, | ||
| 13.3mm | ||
| Shape, Size and number | ||
| of the draining hole | Oval Hole | |
| Ø3.55x2mm, 2 pieces | Round Hole | |
| Ø3mm, 2 pieces | ||
| Sterility | Sterilized by | |
| Ethylene Oxide | Sterilized by | |
| Ethylene Oxide | ||
| Reuse or not re-use | Single Use | Single Use |
| Similarities | The subject device is substantially equivalent to the predicate devices in Indications | |
| for Use, materials, dimensions, sterilization methods and principle of operation. | ||
| Substantial Equivalence | ||
| Discussion | The differences between the subject and the predicate devices are below: |
- Overall Length: The overall length is 14.00mm, which is 3.0mm longer than the
predicate device. This additional length allows for better maintenance of a consistent
distance between the mucosal layers. - Inner Diameter of distal end: The smaller distal end in conical shape makes it easier
to access the dissected submucosal layer. - Shape of the drain: The number of draining holes is the same, but the draining holes
have been modified to oval shape to facilitate suction function.
We have conducted risk analysis and the verification and validation activities for the
modifications, and the test results support that the differences do not raise any
questions of substantial equivalence to the declared predicates. | |
6
7
8. Non-clinical Tests
The ClearCap Distal Attachment and the predicate devices in the market have the substantially equivalent technological characteristics. Risks associated with the changes were identified and appropriate design controls implemented to mitigate the risks.
To validate the control of the risks, direct comparison testing between the subject device models and predicate device models for gap, endoscope compatibility and viewing, and suction function were performed.
9. Conclusion:
Based on the information provided herein and the test results, we conclude that the subject device is substantially equivalent to its predicate device.The nonclincal tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.