(267 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a simple introducer sheath and dilator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to facilitate the passage of instruments during urological procedures, rather than directly treating a disease or condition.
No
Explanation: The device is an introducer sheath and dilator, described as establishing a conduit and facilitating the passage of instruments during urological procedures. Its function is to aid in access for other medical instruments, not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like PTFE, polyethylene, and EVA, and the performance studies detail physical testing (tensile, peel force, rollback, etc.) and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to establish a conduit during endoscopic urological procedures to facilitate the passage of instruments into the urinary tract. This is a direct intervention on the patient's body.
- Device Description: The description details a physical device (dilator and sheath) designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, and instruments used to analyze biological samples like blood, urine, or tissue.
This device is a surgical instrument used for access during a medical procedure, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Peel-Away Introducer is intended to be used to establish a conduit during endoscopic urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) facilitating the passage of endoscopes and other instruments into the urinary tract.
Product codes
FED
Device Description
The subject device, Peel-Away Introducer, consists of an inner dilator and outer peel-away sheath. The outer sheath fits over the inner dilator and has dual knobs allowing the sheath, manufactured from radiopaque polytetrafluoroethylene (PTFE), to be peeled back and removed. The sheath is manufactured with a length of 32 centimeters. The dilator has an outside diameter of 9, 10, or 12 French, and has a length of 37 centimeters. The 10 French dilator is manufactured from radiopaque polyethylene, while the 9 and 12 French dilators are manufactured from ethylene-vinyl acetate (EVA). The dilator is also tapered 1.2 to 1.5 centimeters from the distal end, depending on its outer diameter, and has a proximal hub composed of polyethylene. The Peel-Away Introducer is supplied sterile and intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary 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)
The Peel-Away Introducer was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
- Tensile (Time-Zero and Aged) .
- Dilator Shaft .
- Dilator Shaft-to-Hub .
- Peel-Away Sheath .
- Peel Force (Time-Zero and Aged) ●
- Peel-Away Sheath .
- Rollback (Time-Zero and Aged) ●
- Compatibility (Time-Zero and Aged) .
- . Radiopacity
- Packaging ●
- Sterility ●
Biocompatibility Testing:
- Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous . irritation, acute systemic toxicity, and hemocompatibility were performed to ensure the biocompatibility of the subject device set.
The results of these tests confirm that the Peel-Away Introducer meets the design input requirements based on the intended use and support the conclusion that this device does not raise different questions of safety and/or effectiveness as compared to the predicate device.
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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May 29, 2019
Cook Incorporated Johnathan Liu Regulatory Affairs Manager 750 Daniels Way Bloomington, IN 47404
Re: K182403
Trade/Device Name: Peel-Away® Introducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Dated: April 15, 2019 Received: April 16, 2019
Dear Johnathan Liu:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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.
for
Glenn B. Bell, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology 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
Indications for Use
510(k) Number (if known) K182403
Device Name Peel-Away Introducer
Indications for Use (Describe)
The Peel-Away Introducer is intended to be used to establish a conduit during endoscopic urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) facilitating the passage of endoscopes and other instruments into the urinary tract.
| 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) |
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510(k) SUMMARY
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 LOOMINGTON, IN 47402-0489 U.S.A. 812 339 2235 TOLLERE: 800 457 4500 WWW.COOKMEDICAL.COM
K182403 page 1 of 3
Peel-Away® Introducer 21 CFR §807.92 Date Prepared: April 15, 2019
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Primary Contact: | Carly Powell |
| Secondary Contact: | Paul Meyer |
| Email: | regsubmissions@cookmedical.com |
| Contact Phone Number: | (812) 335-3575 x104509 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Peel-Away® Introducer |
|---|---|
| Common or Usual Name: | Endoscopic Access Overtube, Gastroenterology-Urology |
| Classification Name: | Endoscope and accessories |
| Regulation Number: | 21 CFR §876.1500 |
| Product Code: | FED |
| Regulatory Class: | II |
| Classification Panel: | Gastroenterology/Urology |
Predicate Devices:
The Cook Peel-Away® Introducer is substantially equivalent to the following devices:
- Flexor® Ureteral Access Sheath (K172217, Cook Inc.) cleared on Dec. 13, 2017. -
- Vari-Pass™ Adjustable Length Access Sheath (K123170, Olympus Surgical Technologies -America) cleared on Feb. 4, 2013.
4
Device Description:
The subject device, Peel-Away Introducer, consists of an inner dilator and outer peel-away sheath. The outer sheath fits over the inner dilator and has dual knobs allowing the sheath, manufactured from radiopaque polytetrafluoroethylene (PTFE), to be peeled back and removed. The sheath is manufactured with a length of 32 centimeters. The dilator has an outside diameter of 9, 10, or 12 French, and has a length of 37 centimeters. The 10 French dilator is manufactured from radiopaque polyethylene, while the 9 and 12 French dilators are manufactured from ethylene-vinyl acetate (EVA). The dilator is also tapered 1.2 to 1.5 centimeters from the distal end, depending on its outer diameter, and has a proximal hub composed of polyethylene. The Peel-Away Introducer is supplied sterile and intended for one-time use.
Indications for Use:
The Peel-Away Introducer is intended to be used to establish a conduit during endoscopic urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) facilitating the passage of endoscopes and other instruments into the urinary tract.
Comparison to Predicate Device:
The Peel-Away® Introducer is substantially equivalent to the primary predicate device, Flexor Ureteral Access Sheath (K172217), and the secondary predicate device, Gyrus ACMI Vari-Pass Adjustable Length Access Sheath (K123170). The subject device has the same general intended use and principles of operation as the predicate devices. The differences in indications for use, sheath technology, materials, and dimensions between the subject device and the predicate devices do not raise different questions of safety and/or effectiveness.
Technological Characteristics:
The subject device Peel-Away Introducer was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
5
Performance:
- Tensile (Time-Zero and Aged) .
- Dilator Shaft .
- Dilator Shaft-to-Hub .
- Peel-Away Sheath .
- Peel Force (Time-Zero and Aged) ●
- Peel-Away Sheath .
- Rollback (Time-Zero and Aged) ●
- Compatibility (Time-Zero and Aged) .
- . Radiopacity
- Packaging ●
- Sterility ●
Biocompatibility Testing:
- Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous . irritation, acute systemic toxicity, and hemocompatibility were performed to ensure the biocompatibility of the subject device set.
Conclusion:
The results of these tests confirm that the Peel-Away Introducer meets the design input requirements based on the intended use and support the conclusion that this device does not raise different questions of safety and/or effectiveness as compared to the predicate device. The submitted information supports the determination that the subject device is substantially equivalent to the predicate devices. Flexor Ureteral Access Sheath (K172217) and Vari-Pass Variable Length Access Sheath (K123170).