(58 days)
The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.
Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the bleed. Each device contains approximately 20g of powder.
This document is a 510(k) Premarket Notification for a medical device called the Hemospray Endoscopic Hemostat. The submission primarily addresses a minor design change to an existing predicate device to correct a failure mode related to the activation knob. Because the changes are focused on a revised manufacturing process and an improved safety feature (the activation knob's tensile strength) rather than a change in the therapeutic mechanism or intended use, many of the typical acceptance criteria for AI/ML-based devices, such as those related to diagnostic performance or multi-reader studies, are not applicable here.
Therefore, I cannot populate the table and sections as requested for an AI/ML device's acceptance criteria and study proving performance. This document concerns a physical medical device and primarily focuses on mechanical performance and safety, not on the performance of a software algorithm.
However, I can extract information related to the device's functional acceptance criteria as demonstrated through bench testing for the design modification.
Here's how I can interpret and present the available information in the context of your request, focusing on the specific modification made to the physical device:
1. A table of acceptance criteria and the reported device performance
Note: The acceptance criteria and performance data provided relate to the mechanical integrity of the modified activation knob, not to an AI/ML algorithm's diagnostic or therapeutic performance.
| Acceptance Criteria (for the modified activation knob) | Reported Device Performance |
|---|---|
| Tensile strength of the red activation knob > Established Design Specification | All tested samples had tensile strength greater than the established design specification. |
| Functionality as intended (post-modification) | Bench testing demonstrated the subject device met the established performance requirement to fulfill the intended use, and performs as intended. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a number of units, but "All tested samples" implies a complete test of the sample set prepared.
- Data Provenance: The testing was "bench testing" conducted by the manufacturer, Wilson-Cook Medical, Inc., located in Winston-Salem, North Carolina. This is prospective testing performed for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This study is not evaluating a diagnostic or AI/ML device requiring clinical expert ground truth for image interpretation or diagnosis. It focuses on the mechanical performance of a device component. The "ground truth" for the new design specification was established based on a human factors study evaluating the maximum force a user could apply.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described, as the evaluation is based on objective physical measurements (tensile strength) against a defined design specification, rather than subjective interpretations.
5. 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
- Not applicable. This study is not an MRMC study and does not involve AI assistance. It evaluates a mechanical design change to a physical hemostatic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This study does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the new tensile strength design specification was established based on a human factors study that evaluated the maximum force a user could apply to the red activation knob during use. The success of the device was then determined by objective mechanical testing to confirm that the component met this established design specification.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; therefore, there is no "training set." The human factors study provided data to establish the design specification.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML algorithm. The design specification (which could be considered a form of "ground truth" for the mechanical test) was established through a "human factors study that evaluated the maximum force a user could apply to the red activation knob during use."
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 10, 2020
Wilson-Cook Medical, Inc Marge Walls-Walker Sr, Regulatory Specialist 4900 Bethania Station Road Winston-Salem, North Carolina 27105
Re: K200972
Trade/Device Name: Hemospray Endoscopic Hemostat Regulation Number: 21 CFR 878.4456 Regulation Name: Hemostatic Device For Intraluminal Gastrointestinal Use Regulatory Class: Class II Product Code: QAU Dated: April 10, 2020 Received: April 13, 2020
Dear Ms. Walls-Walker:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Hemospray Endoscopic Hemostat
Indications for Use (Describe)
The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.
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
In accordance with 21 CFR § 807.92, Wilson-Cook Medical, Inc submits the following 510(k) Summary. Wilson-Cook Medical, Inc. /Cook Endoscopy Name: Address: 4900 Bethania Station Road Winston-Salem, North Carolina 27105
| Contacts: | Marge Walls-Walker, MS |
|---|---|
| Senior Regulatory Specialist | |
| (336) 744-0157 x396290 | |
| Marge.walls-walker@cookmedical.com | |
| Ram Iyer, Ph.D. | |
| Director, Global Regulatory Science - MedSurg | |
| (812) 339-2235 ext. 5238 | |
| Ram.Iyer@cookmedical.com | |
| Date: | April 10, 2020 |
| Trade Names: | Hemospray® Endoscopic Hemostat |
| Common Name: | Hemospray |
| Classification Name: | Hemostasis Device for intraluminal gastrointestinal use |
| 21 CFR 878.4456, QAU, Class II | |
| Predicate Device: | Hemospray Endoscopic Hemostat, DEN 170015 |
| Intended Use: | The COOK Hemospray device is intended for hemostasis of non-variceal bleeds inthe GI (gastrointestinal) tract. It is for prescription use only. |
Device Description:
Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the bleed. Each device contains approximately 20g of powder.
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Substantial Equivalence:
A minor design change was made to the predicate Hemospray device to correct an observed failure mode of the introducer activation knob. It has been reported that the activation knob could separate or break during rotation to activate the CO2 cartridge. This failure mode led to the initiation of a recall. The changes proposed in this submission creates a tensile strength design specification for the red activation knob component of the Hemospray Endoscopic Hemostat handle and add a new manufacturing inspection step that involves 100% proof loading every red activation knob to the established design specification prior to final device assembly. The following table compares the subject device to the predicate.
| Hemospray Endoscopic Hemostat | Hemospray Endoscopic Hemostat | |
|---|---|---|
| Parameter | (subject device) | (DEN 170015) |
| Intended Use | This device is used for hemostasis ofnonvariceal gastrointestinal bleeding. | Same |
| Supplied Sterile | Yes (Gamma) | Same |
| Disposable/Reusable | Disposable, Single Use | Same |
| Hemostatic agent | Bentonite powder ~ 20 g | Same |
| Delivery method | Powder propelled by CO2 | Same |
| CO2 Pressure RegulatorSetting | 37 psi | Same |
| Catheter material | Polyethylene ( PE) | Same |
| Catheter length | 220 cm | Same |
| Catheter Diameter | 7 FR or 10 FR | Same |
| Laser Markings | Yes, "Cook" on distal end of catheter | Same |
Table 1 : Predicate Device Comparison
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| Parameter | Hemospray Endoscopic Hemostat(subject device) | Hemospray Endoscopic Hemostat(DEN 170015) |
|---|---|---|
| Endoscope AccessoryChannel (EAC)compatibility | 7 FR=2.8 mm EAC10 FR=3.7 mm EAC | Same |
| Handle material | Polycarbonate | Same |
| Target Population | Adult with non-variceal GI bleeding(NVGIB) | Same |
| Max number of devicesused /day/adult | 3 devices, ~ 60 gm of powder | Same |
Device Modification:
A modification is being made to address the root cause associated with the voluntary recall (RES84822 (temp)) initiated by Cook on 1/16/2020; specifically, the modification is intended to address the potential for the activation knob component of the Hemospray introducer system to separate or break and potentially eject the CO2 cartridge under pressure toward the physician or patient. The changes proposed in this submission creates a tensile strength design specification for the red activation knob component of the Hemospray Endoscopic Hemostat handle, thereby establishing pass/fail limits of the component and add a new manufacturing inspection step that involves 100% proof loading every red activation knob to the established design specification prior to final device assembly.
Bench testing demonstrated the subject device met the established performance requirement to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended. The modification to the subject device does not raise new questions of safety or effectiveness as compared to the predicate device.
Summary of non-clinical evaluation:
A new tensile strength design specification for the red activation knob was developed based on a human factors study that evaluated the maximum force a user could apply to the red activation knob during use. The sample preparation for bench testing involved proof loading the red activation knobs to the established design specification followed by 2X gamma sterilization prior to tensile testing to failure. All
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tested samples had tensile strength greater than the established design specification thereby confirming that the subject device performs as intended.
Conclusion:
The subject Hemospray device is substantially equivalent to the predicate Hemospray device subject of DEN 170015 with respect to intended use, key operating principles, materials of construction, and technological characteristics. The risks associated with the modification of the design by addition of a design requirement to the subject device have been adequately addressed through our Design Control Processes.
§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.
(a)
Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance data must support the sterility and pyrogenicity of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:
(i) The ability to deliver the hemostatic material to the bleeding site;
(ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
(iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.
(ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
(6) Labeling must include:
(i) Information identifying and explaining how to use the device and its components; and
(ii) A shelf life.