(158 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a catheter used for spraying fluid, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device sprays fluid to clean tissue or apply dye for disease detection, which are diagnostic or procedural functions, not therapeutic.
No
The device is used to spray the gastrointestinal mucosa with fluid for cleaning or dye for chromoendoscopy, which aids in disease detection, but the device itself does not perform the diagnosis.
No
The device description clearly outlines physical components like a PTFE tube, stylet, and mentions sterilization, shelf life, and biocompatibility testing, indicating it is a hardware device.
Based on the provided information, the Glo-Tip® Spray Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to spray the gastrointestinal mucosa with fluid (like water, saline, or dye) for cleaning or aiding in disease detection during an endoscopic procedure. This is a direct interaction with the patient's body for a procedural purpose.
- Device Description: The device is a catheter designed to be inserted through an endoscope to deliver fluid to the tissue. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The Glo-Tip® Spray Catheter does not perform any analysis or testing of bodily specimens.
The device is clearly intended for use within the patient's body during an endoscopic procedure, which is characteristic of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip® Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa, GI tract
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 consisted of sterilization, shelf life, biocompatibility, and nonclinical bench testing.
Sterilization validation demonstrates that the device has a sterility assurance level of 10° with acceptable sterilization residuals.
Biocompatibility testing results:
- ISO 1X MEM Elution Method: Test article considered not cytotoxic.
- ISO Intracutaneous Irritation Study in Rabbits: two extracts: Test article considered a non-irritant.
- ISO Guinea Pig Maximization: two extracts: Test article considered not a sensitizer.
Shelf-life and non-clinical bench testing results:
- Packaging shall maintain functional integrity of the device following EO sterilization and shipping: Packages met acceptance criteria.
- Product must perform intended use over labeled shelf life: Product performed as intended over labeled shelf life.
- Sterile product must be adequately packaged to maintain sterile barrier during expected shipping conditions: No signs of functional damage.
- Package maintains sterile barrier over labeled shelf life: Package has acceptable sterile barrier.
- Device must be a Glo-tip device: Tip is fluoroscopically visible.
- The product label shall contain accurate dimensional/compatibility information: Device dimensions are in accordance with labeling.
- In accordance with ISO 8600-1:2013, Clause 4.3: The maximum insertion portion width shall not be larger than that stated in the instruction manual.
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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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
February 1, 2019
Wilson-Cook Medical, Inc. % Daniel Dillon Senior Regulatory Scientist MED Institute 1330 Win Hentschel Boulevard West Lafayette, Indiana 47906
Re: K182319/S001 Trade/Device Name: Glo-Tip® Spray Catheter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: January 24, 2019 Received: January 24, 2019
Dear Daniel Dillon:
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Daniel G. Walter Jr -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)
Device Name Glo-Tip® Spray Catheter
Indications for Use (Describe)
The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.
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 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. The red background is shaped like a rectangle with a diagonal cut on the bottom left corner.
510(k) Summary 001.
Glo-Tip® Spray Catheter
Traditional 510(k) Premarket Notification October 1, 2018
Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy
4900 Bethania Station Road
Winston-Salem, North Carolina 27105 |
|------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Paula Joyce, Vice President, Regulatory Affairs\Corporate
Compliance Officer |
| Phone: | (336) 744-0157 ext. 396245 |
| Fax: | (336) 201-5994 |
Device Information
| Trade Name: | Glo-Tip® Spray Catheter |
|---|---|
| Common Names: | Spray catheter |
| Classification Name: | Endoscope and accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | OCX |
| Device Class: | Class II |
| Review Panel: | Gastroenterology-Urology |
Predicate Device
| Name: | Hobbs Mistifier Medical Endoscopic Spray Catheter |
|---|---|
| 510(k) Number: | K030765 |
| Date: | Cleared June 9, 2003 |
Device Description
The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip®
4
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Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).
Indications for Use
The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.
Comparison to Predicate Device
The subject device and predicate device have the same intended use and different technological characteristics, as follows:
| Characteristic | Hobbs Mistifier Medical
Endoscopic Spray Catheter
(K030765) | Glo-Tip® Spray Catheter
(Subject of This 510(k)) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Intended Use | Used as a flexible endoscopic
accessory to apply legally marketed
solutions for washing or staining
mucosal tissue. | Used in conjunction with an
endoscope to spray the
gastrointestinal mucosa. |
| Design | | |
| Catheter working length | 165 cm or 260 cm | 235 cm |
| Catheter diameter | 2.6 mm | 6.9 Fr (2.3 mm) |
| Compatible scope channel | Unknown | 2.8 mm |
| Spray tip | Forward-facing, 360° | Same |
| Materials | | |
| Catheter | PTFE | PTFE |
| Proximal-fitting | Unknown | Polycarbonate |
| Radiopaque crimping band | Unknown | Tantalum |
| Spray tip | "Metal" | 303 Stainless Steel and Brass |
| Packaging | Unknown | Tyvek/Mylar Pouch |
| Other | | |
| Injection Port? | Yes | Same |
| Sterile? | Yes | Same |
| Single Use? | Yes | Same |
None of the differences in technological characteristics raise different questions of safety and effectiveness. Furthermore, performance data from acceptable scientific methods provide evidence that the subject device is substantially equivalent to the predicate device.
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K182319 page 3 of 4
Image /page/5/Picture/1 description: The image is a logo for Cook Medical. The logo consists of the word "COOK" in white, bold, sans-serif font, with the registered trademark symbol next to it. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font. The background is a solid red color.
COOK ENDOSCOPY 0 BETHANIA STAT ON-SALEM, NC 27 TOLL FREE: 800 WWW.COOKMEDICAL
Performance Data
Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrates that the Glo-Tip® Spray Catheter meets the performance requirements to fulfill the intended use of the device.
Sterilization validation demonstrates that the device has a sterility assurance level of 10° with acceptable sterilization residuals. Biocompatibility testing is summarized as follows:
| Test method | Results |
|---|---|
| ISO 1X MEM Elution Method | Test article considered |
| not cytotoxic. | |
| ISO Intracutaneous Irritation Study in Rabbits: two extracts | Test article considered |
| a non-irritant. | |
| ISO Guinea Pig Maximization: two extracts | Test article considered |
| not a sensitizer. |
| Requirement | Acceptance Criteria (summary) | Results |
|---|---|---|
| Packaging shall maintain | ||
| functional integrity of the device | ||
| following EO sterilization and | ||
| shipping. | Meet user requirements and have | |
| acceptable visual appearance | ||
| following two sterilization cycles | ||
| and simulated shipping conditions. | Packages met acceptance | |
| criteria. | ||
| Product must perform intended | ||
| use over labeled shelf life. | Same requirements as above, | |
| except following two sterilization | ||
| cycles and aging. | Product performed as intended | |
| over labeled shelf life | ||
| Sterile product must be | ||
| adequately packaged to maintain | ||
| sterile barrier during expected | ||
| shipping conditions. | Non-opened sterile packaging | |
| shall not show any signs of | ||
| functional damage, such as holes | ||
| in the pouch and/or voids in the | ||
| seal area after simulated shipping | ||
| conditions. | No signs of functional | |
| damage. | ||
| Package maintains sterile barrier | ||
| over labeled shelf life. | Same requirements as above | |
| previous, except following aging. | Package has acceptable sterile | |
| barrier. | ||
| Device must be a Glo-tip device. | Distal tip of device must be | |
| fluoroscopically visible. | Tip is fluoroscopically visible. |
Shelf-life and non-clinical bench testing is summarized as follows:
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cook endoscopy 4900 bethania station road WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
| Requirement | Acceptance Criteria (summary) | Results |
|---|---|---|
| The product label shall contain | ||
| accurate dimensional/ | ||
| compatibility information | Catheter outer diameter: 6.9 Fr | |
| with acceptable tolerance. | Device dimensions are in | |
| accordance with labeling. | ||
| Working length: 235 with | ||
| acceptable tolerance. | ||
| In accordance with ISO | ||
| 8600-1:2013, Clause 4.3: The | ||
| maximum insertion portion | ||
| width shall not be larger than | ||
| that stated in the instruction | ||
| manual | Maximum insertion portion width |