Qora Stool Management Kit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. November 17, 2021 CM Technologies, Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108 Re: K212444 > Trade/Device Name: Qora® Stool Management Kit Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: October 11, 2021 Received: October 19, 2021 Dear Alan Donald: 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. {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 and Part 809); 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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). Sincerely, Je Hi An, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212444 Device Name Qora® Stool Management Kit # Indications for Use (Describe) The Qora® Stool Management Kit is indicated for fecal management by diverting liquid or semi-formed stool to minimize skin contact with bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use of this device, including replacement with other same devices, should not exceed 29 days. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # SECTION 5 Special 510(k) Summary This summary of safety and effectiveness for the Qora® Stool Management Kit is being submitted in accordance with the requirements of 21 CFR 807.92. 510(k) Number: Name: CM Technologies, Inc. Address: 2165 San Diego Avenue, San Diego, CA 92110 Owner Operator Number: 10049590 Establishment Registration: 3013524793 Phone: (858) 243-3582 Contact: Alan Donald Date Prepared: July 20, 2021 Trade Name: Qora® Stool Management Kit Common Name: Rectal Catheter Classification: 21 CFR 876.5980; Gastrointestinal Tube and Accessories Product Code: KNT Regulatory Class: Class II # Identification of the legally marketed predicate device The modifications described herein relate to the Oora AIM™ Stool Management Kit, the legally marketed predicate device, with further details below. Table 1: Legally Marketed Predicate Device | 510(K) Identifier: | K153506 | Regulation Name: | Gastrointestinal Tube<br>and Accessories | |--------------------------|--------------------------------|-------------------|------------------------------------------| | Trade/Device Name: | Qora AIM™ Stool Management Kit | Regulatory Class: | Class II | | Device Type/Common Name: | Rectal Catheter | Product Code: | KNT | | Regulation Number: | 21 CFR 876.5980 | Clearance Date: | May 6, 2016 | For this submission, the modified device, the Qora® Stool Management Kit, is compared with the Qora AIM™ Stool Management Kit, which was cleared in the company's 510(k) (ref. K153506). #### Description of the modified device Similar to the predicate device, the modified device is a non-sterile, single-use device intended to use for the management of fecal incontinence in bedridden patients. The device consists of an indwelling diverter, an external transit sheath, and an external collection bag. The kit also includes a collection bag hanger and a transit sheath clamp. The self-conforming indwelling fecal diverter, which is provided pre-loaded into a hygienic applicator used to deploy inside the rectum, remains in place by apposition to the rectal wall when deployed. The transit sheath acts as a conduit to facilitate the transfer of fecal matter from the indwelling diverter to the collection bag. The device includes three ports attached to the transit sheath, to facilitate irrigating of the indwelling divery, sample collection, and to allow withdrawal in a trauma-free manner. # Indications for Use The Oora" Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi formed stool to mimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days. Note: There has been no modifications for Use statement other than the product name which has been changed from Qora AIM™ Stool Management Kit to Qora® Stool Management Kit. {4}------------------------------------------------ # Substantial Equivalence | Description | Modified Qora® SMK | Predicate Device (K153506) | Result | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------| | Intended Use | Fecal management | Fecal management | Identical | | Intended Users | Bedridden patients | Bedridden patients | Identical | | Indications for Use | The Qora® Stool Management Kit is<br>indicated for fecal management by<br>diverting and collecting liquid or<br>semi-formed stool to minimize skin<br>contact with bedridden patients. The<br>device is for use in patients 18 years<br>and older only. The uninterrupted<br>use of this device, including<br>replacement with other same<br>devices, should not exceed 29 days. | The Qora® AIM Stool Management<br>Kit is indicated for fecal<br>management by diverting and<br>collecting liquid or semi-formed<br>stool to minimize skin contact in<br>bedridden patients. The device is for<br>use in patients 18 years and older<br>only. The uninterrupted use for this<br>device, including replacement with<br>other same devices, should not<br>exceed 29 days. | Identical | | Patient Population | 18 years and older | 18 years and older | Identical | | Environment of Use | Hospitals and Nursing Homes | Hospitals and Nursing Homes | Identical | | Condition of Use | Single-use | Single-use | Identical | | Period of Usage | 29 days | 29 days | Identical | | Insertion Method | Hygienic Applicator | Hygienic Applicator | Identical | | Diverter OD | 55mm ± 10mm | 55mm ± 10mm | Identical | | Detachable | Yes | Yes | Identical | | Collection Bag | Yes | Yes | Identical | | Irrigation Port | Yes | Yes | Identical | | Sampling Port | Yes | Yes | Identical | | Retrieval By | Collapsing Diameter | Collapsing Diameter | Identical | | Interface Port | Side catheter connector port | Side catheter connector port | Identical | | Odor Protection | Yes | Yes | Identical | | Sterility | Supplied non-sterile, disposable,<br>single patient use | Supplied non-sterile, disposable,<br>single patient use | Identical | | Shelf Life | 12 months | 12 months | Identical | | MR Safety | Non-clinical testing demonstrated<br>that the Qora® SMK is MR<br>Conditional.<br>Conditions for MRI Testing were<br>revised based on the updates to the<br>indwelling diverter | Non-clinical testing demonstrated<br>that the Qora AIMTM SMK is MR<br>Conditional. | Reconfirmed<br>/Identical<br>See Note 1 | Table 2: A summary of equivalence between the modified and the predicate device is given below: Note 1: MR testing of the modified device was performed by the same independent laboratory, following the same applicable ASTM standards and US FDA guidance document, (Testing and Labeling Medical Devices for Safety in the MR environment, May 2021), as those for the predicate device. The test results of the modified device were found to be within the same acceptable range for Conditional usage as those cleared for Qora AIM™ SMK under K153506. # Description of Change No design change has been made that would alter the technology used in the modified device. However, to improve manufacturability, and due to raw material availability, the stainless-steel wire in the indwelling diverter has been modified. This new wire allows the diameter to be increased by a small amount (0.09mm) without impacting the patient safety or device functionality, as demonstrated from the non-clinical tests performed. The name of the product has been changed to Qora Stool Management Kit for marketing purposes. Corresponding label changes have been made to the Instructions For Use to reflect the name change and updated MR conditions. The labeling is in compliance with the US FDA guidance document, Testing and Labeling Medical Devices for Safety in the MR environment, May 2021. {5}------------------------------------------------ # Summary of Non-clinical Testing Validation and verification testing, primarily dimensional force testing, identical to that performed on the original device, were performed on the modified device/components to ensure that the performance of the modified device is equivalent to the performance of the predicate device met all previous device specifications for the predicate device. No additional biocompatibility testing was required by the modification of the diverter wire. Other minor changes did not involve patient contact materials. ### Conclusions from Nonclinical Testing The Qora® Stool Management Kit is fundamentally equivalent in design and function to the predicate device, the Qora AIM™ Stool Management Kit. Qora® Stool Management Kit incorporates the similarities with the predicate device, the Qora AIM™ Stool Management Kit as shown in the above comparison table. The few differences, including this described modification, do not new issues of safety or effectiveness. In summary, Qora® Stool Management Kit described in this substantially equivalent to the predicate Qora AIMTM Stool Management Kit.