(174 days)
Not Found
No
The device description focuses on mechanical components and their function in preventing backflow, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's intended use is to resist the backflow of fluid, which is a supportive function during endoscopic procedures, not a direct treatment or diagnosis of a disease or condition.
No
The device's intended use and description focus on managing fluid backflow and providing access for instruments during endoscopic procedures, which are functional aspects rather than diagnostic ones. The performance studies also relate to the device's functional integrity (e.g., leakage, flow rate) rather than diagnostic accuracy.
No
The device description details physical components made of materials like silicone, acetal, vinyl, polycarbonate, and polyethylene, and the performance studies focus on physical characteristics like leakage, flow rate, and biocompatibility. There is no mention of software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope, cystoscope, or other endoscope." This describes a mechanical function related to fluid management during endoscopic procedures.
- Device Description: The description details physical components like caps, adapters, valves, and tubing, all designed for connection and fluid control within an endoscopic system.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays.
- Performing tests on samples outside of the body.
The device is clearly intended for use during an endoscopic procedure to manage fluid flow, which is a clinical function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
This device is intended to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope, cystoscope, or other endoscope.
Product codes
ODC
Device Description
The Endoscopic Cap covers female Luer locks and bulb-type endoscopic fittings. The Endoscopic Cap is constructed from silicone. The proximal end is manufactured in three ways: without a hole, with a small hole, and with a large hole. The small hole is compatible with instruments that are 0.025 - 0.038 inches in diameter. The large hole is compatible with devices that are 7.0-12.0 Fr.
The Check-Flo Adapters have a linear, cylindrical shape and attach to female Luer locks and bulb-type endoscopic fittings. The Check-Flo Adapter is constructed from four components: male Luer lock, body, valve, and cap. The distal side of the Check-Flo Adapter is an acetal male Luer lock. The body is constructed from acetal and connects all the components. The valve is a silicone disc and is seated in the cap. The cap is constructed from acetal and is located at the distal end of the Check-Flo Adapter. The Check-Flo Adapters are compatible with devices that are less than or equal to 9.0 Fr.
The Check-Flo Adapter design has two variations: a side-arm assembly and universal tubing. The side-arm assembly is a 10 cm length of vinyl tubing with a female Luer lock made from polycarbonate. The side-arm assembly comes with an additional one-way or three-way stopcock constructed from polycarbonate and polyethylene. The Check-Flo Adapter with universal tubing includes a segment of white silicone tubing. It protrudes 2.5 cm from the distal end of the male Luer lock and is 4.0 French in diameter.
The Side-Arm Adapter is shaped like the letter "y" and attaches to female Luer locks. It is constructed from four components: the body, male Luer lock, o-ring, and cap. The body is constructed from acetal. The protruding side-arm of the body has a female Luer lock. A one-way stopcock is provided and is constructed from polycarbonate and polyethylene. The male Luer lock is constructed from acetal and is located on the distal end of the body. The o-ring is seated inside the cap located on the proximal end of the body. The Side-Arm Adapter is compatible with instruments that are 3.0 - 6.0 Fr.
The Tuohy-Borst Adapter has a linear, cylindrical shape and attaches to female Luer locks. The Tuohy-Borst Adapter is constructed from four components: tightening knob, body, sealing ring, and rotator. The tightening knob is located on the proximal side of the Tuohy-Borst Adapter. The body is constructed from polycarbonate and connects all the components. The sealing ring is seated inside the rotator located on the distal end of the body. The Touhy-Borst is compatible with instruments that are 6.0 Fr and smaller.
The Tuohy-Borst has an alternate design where the body has an additional side-arm with female Luer lock. This design has the same four basic components.
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)
The following testing was performed in order to demonstrate that the proposed Endoscopic Cap, Side-Arm Adapter, Check-Flo Adapter, and Tuohy-Borst Adapter met applicable design and performance requirements.
- Biocompatibility
- Sterilization
- Leakage
- Device Compatibility and Integrity
- Flow Rate
- Accelerated Age
The results of these tests support a conclusion that the Endoscopic Cap, Side-Arm Adapter, Check-Flo Adapter, and Tuohy-Borst Adapter will perform as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
March 22, 2018
Cook Incorporated Samuel Engelman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K173105
Trade/Device Name: Endoscopic Cap, Check-Flo® Adapter, Side-Arm Adapter, Tuohy-Borst Adapter Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: February 20, 2018 Received: February 21, 2018
Dear Samuel Engelman:
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,
Joyce M. Whang -S
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) K173105
Device Name
Endoscopic Cap, Check-Flo® Adapter, Side-Arm Adapter, Tuohy-Borst Adapter
Indications for Use (Describe)
This device is intended to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope, cystoscope, or other endoscope.
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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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo is white text on a red background. The word "COOK" is in a large, bold font, and the word "MEDICAL" is in a smaller font below it.
6
COOK INCORPORATE
750 DANIELS WA
BLOOMINGTON, IN 47404 US
PHONE: 812.339.2235 TOLL FREE: 800.457.450
WWW.COOKMEDICAL.CO
K173105 Page 1 of 3
2.0 510(k) Summary
Endoscopic Cap, Side-Arm Adapter, Check-Flo Adapter, and Tuohy-Borst Adapter 21 CFR §807.92 Date Prepared: September 28, 2017
| Submitted By: | |
|---|---|
| Submission: | Traditional 510(k) Premarket Notification |
| Applicant: | Cook Incorporated |
| Contact: | Samuel Engelman |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone: | (812) 339-2235 x104340 |
| Contact Fax: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Endoscopic Cap |
| Check-Flo® Adapter | |
| Side-Arm Adapter | |
| Tuohy-Borst Adapter | |
| Common Name: | Endoscope Channel Accessory |
| Classification Name: | Endoscope and accessories |
| Classification Regulation: | 21 CFR §876.1500, Product Code ODC |
| Device Class/Classification Panel: | Class II, Gastroenterology/Urology |
Predicate Device:
- Primary predicate device: OBP Self Sealing Endoscopic Seal (K091838). ■
- Secondary predicate device: Gateway™ Advantage Y-Adapter (K130909) ■
Device Description:
The Endoscopic Cap covers female Luer locks and bulb-type endoscopic fittings. The Endoscopic Cap is constructed from silicone. The proximal end is manufactured in three ways: without a hole, with a small hole, and with a large hole. The small hole is compatible with instruments that are 0.025 - 0.038 inches in diameter. The large hole is compatible with devices that are 7.0-12.0 Fr.
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a dark red background. The dark red background is shaped like a banner.
OK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA NE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
K173105 Page 2 of 3
The Check-Flo Adapters have a linear, cylindrical shape and attach to female Luer locks and bulb-type endoscopic fittings. The Check-Flo Adapter is constructed from four components: male Luer lock, body, valve, and cap. The distal side of the Check-Flo Adapter is an acetal male Luer lock. The body is constructed from acetal and connects all the components. The valve is a silicone disc and is seated in the cap. The cap is constructed from acetal and is located at the distal end of the Check-Flo Adapter. The Check-Flo Adapters are compatible with devices that are less than or equal to 9.0 Fr.
The Check-Flo Adapter design has two variations: a side-arm assembly and universal tubing. The side-arm assembly is a 10 cm length of vinyl tubing with a female Luer lock made from polycarbonate. The side-arm assembly comes with an additional one-way or three-way stopcock constructed from polycarbonate and polyethylene. The Check-Flo Adapter with universal tubing includes a segment of white silicone tubing. It protrudes 2.5 cm from the distal end of the male Luer lock and is 4.0 French in diameter.
The Side-Arm Adapter is shaped like the letter "y" and attaches to female Luer locks. It is constructed from four components: the body, male Luer lock, o-ring, and cap. The body is constructed from acetal. The protruding side-arm of the body has a female Luer lock. A one-way stopcock is provided and is constructed from polycarbonate and polyethylene. The male Luer lock is constructed from acetal and is located on the distal end of the body. The o-ring is seated inside the cap located on the proximal end of the body. The Side-Arm Adapter is compatible with instruments that are 3.0 - 6.0 Fr.
The Tuohy-Borst Adapter has a linear, cylindrical shape and attaches to female Luer locks. The Tuohy-Borst Adapter is constructed from four components: tightening knob, body, sealing ring, and rotator. The tightening knob is located on the proximal side of the Tuohy-Borst Adapter. The body is constructed from polycarbonate and connects all the components. The sealing ring is seated inside the rotator located on the distal end of the body. The Touhy-Borst is compatible with instruments that are 6.0 Fr and smaller.
The Tuohy-Borst has an alternate design where the body has an additional side-arm with female Luer lock. This design has the same four basic components.
5
Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background with a diagonal cut on the lower left side.
8
COOK INCORPORATE
750 DANIELS WA
BLOOMINGTON, IN 47404 US
PHONE: 812.339.2235 TOLL FREE: 800.457.450
WWW.COOKMEDICAL.COM
Page 3 of 3
Indications for Use:
This device is intended to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope, cystoscope, or other endoscope.
Comparison to Predicate Device:
The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate devices. Differences between the subject devices and the predicate devices include a difference in product code, indications for use, components, design, and material. Characteristics of the subject devices that differ from the predicate devices are supported by testing and analysis.
Performance Data:
The following testing was performed in order to demonstrate that the proposed Endoscopic Cap, Side-Arm Adapter, Check-Flo Adapter, and Tuohy-Borst Adapter met applicable design and performance requirements.
- Biocompatibility
- 트 Sterilization
- Leakage
- Device Compatibility and Integrity
- Flow Rate
- Accelerated Age
Conclusion:
The results of these tests support a conclusion that the Endoscopic Cap, Side-Arm Adapter, Check-Flo Adapter, and Tuohy-Borst Adapter will perform as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices.