Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

K153506 · Consure Medical Pvt , Ltd. · KNT · May 6, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153506
• Device Name: Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
• Applicant: Consure Medical Pvt , Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: May 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

The Qora AIM Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize 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. The Qora Aeon Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize 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. The Qora Arida Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device is intended to be until the collection pouch is filled or until it has been utilized for 72 hours, whichever comes first. The replacement with other same devices should not exceed 29 days.

Device Story

Non-sterile, single-use fecal management kits; includes hygienic applicator and soft, self-expanding indwelling fecal diverter. Diverter remains apposed to rectal wall; collapses/expands with peristaltic contractions to reduce abrasion. Transit sheath or pouch facilitates fecal transfer to collection bag. Qora AIM/Aeon include transit sheath with irrigation, sampling, and retrieval ports; Qora Arida uses pouch with retrieval port. Used in hospitals/nursing homes by clinicians. Reduces skin contact with stool; minimizes foreign body sensation/risk of anal sphincter trauma. Retrieval via collapsing diverter mechanism.

Clinical Evidence

Bench testing only. Evaluated structural/functional characteristics (lumen size, dimensions, functional strength, simulated use) and biocompatibility per ISO 10993-1. Results demonstrate non-sensitizing, non-cytotoxic, and non-irritating properties.

Technological Characteristics

Materials: Urethane-based TPU, stainless steel wire form lattice (MRI safe), EVA/PVDC odor barrier film. Form factor: Indwelling diverter (55mm diameter) with transit sheath or collection pouch. Single-use, non-sterile. No energy source. Mechanical operation.

Indications for Use

Indicated for fecal management by diverting/collecting liquid or semi-formed stool to minimize skin contact in bedridden patients 18 years and older.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Consure 120 SMS (K133465)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2016

Consure Medical Pvt Ltd. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108

Re: K153506

> Trade/Device Name: Qora AIM™ Stool Management Kit, Qora Aeon™ Stool Management Kit, Qora Arida™ Stool Management Kit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KNT Dated: March 23, 2016 Received: April 4, 2016

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. 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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours.

**Herbert P. Lerner -S**

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}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

| 510(k) Number (if known) | K153506 | | |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Device Name | Qora AIM Stool Management Kit<br>Qora Aeon Stool Management Kit<br>Qora Arida Stool Management Kit | | |
| Indications for Use ( <i>Describe</i> ) | | | |
| | The Qora AIM Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize 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. | | |
| | The Qora Aeon Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize 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. | | |
| | The Qora Arida Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device is intended to be until the collection pouch is filled or until it has been utilized for 72 hours, whichever comes first. The replacement with other same devices should not exceed 29 days. | | |
| Type of Use (Select one or both, as applicable) | | | |
| | <table><tr><td><div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div></td><td><div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div></td></tr></table> | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |
| <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </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

[e-mail]

"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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Consure Medical. The word "consure" is written in teal, with a red curved line running vertically through the middle of the word. Below the word "consure" is the word "MEDICAL" in gray.

#### SECTION 5 510(k) Summary

| Device/Trade Name(s): | Qora AIMTM Stool Management Kit<br>Qora AeonTM Stool Management Kit<br>Qora AridaTM Stool Management Kit |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type/Common Name: | Rectal Tube |
| 510(k) Submitter: | Consure Medical Pvt. Ltd<br>5L, Third Floor<br>Shahpur Jat<br>New Delhi, Delhi 110049<br>INDIA<br>Contact: Mr.Nishith Chasmawala, CEO<br>Phone: [phone] |
| Establishment Registration<br>Number: | 3011802696 |
| Address Of<br>Manufacturing/Packaging<br>Facility: | Contract Medical International GmbH.<br>Lauensteiner Strasse 37<br>Dresden 01277<br>Germany<br>Contact: Mr. Jan Kloboucnik, QA/RA Director<br>Telephone: [phone] |
| Authorized Contact Person: | Alan Donald, President<br>Matrix Medical Consulting, Inc.<br>8880 Rio San Diego Drive, Suite 800<br>San Diego, California 92108<br>Phone: [phone]<br>Fax: [phone] |
| Recommended Regulation: | 21 CFR 876.5980 |
| Device Classification Name: | Gastrointestinal Tube and Accessories |
| Device Class: | Class II |
| Panel: | Gastroenterology-Urology Devices |
| Product Code: | KNT |
| Predicate Device: | Consure 120 SMS |
| Predicate Device Product Code: | KNT, 510(k) K133465 |
| Date Summary Prepared | May 4, 2016 |

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Consure Medical. The word "consure" is written in teal, with the "s" being a red, curved line. Below the "ure" in "consure" is the word "MEDICAL" in gray, in a smaller font size than the rest of the logo.

#### Device Descriptions

Fecal incontinence (FI) is the inability to control bowel movements resulting in the involuntary and untimely release of feces or flatus. Although FI is a benign condition, its clinical sequelae are often devastating to both the patient and the health system. The condition is believed to affect 8-15 percent of the general population, with the highest prevalence among the elderly and in acute care settings.

The Qora AIM™, Qora Aeon™, and Qora Arida™ Stool Management Kits are non-sterile, single-use devices packaged in a product box. Each kit contains one hygienic device applicator that houses a soft indwelling fecal diverter. The Qora AIM™ and Qora Aeon™ kits contain an additional two odor-proof collection bags.

The primary component of the device is the fecal diverter. It consists of soft, pliable, and self-expanding indwelling diverter that remains apposed to the rectal wall and the transit sheath. The indwelling diverter is sufficiently compliant to collapse and expand with the adjacent anatomy during peristaltic contractions of the rectum. This pliancy within the rectum is designed to help reduce abrasion and subsequent clinical complicator is used to hygienically insert and deploy the indwelling diverter at the intended location inside the rectum.

The Qora Arida™ collection pouch is a thin, biocompatible conduit that facilitates the transfer and collection of fecal material from the indwelling diverter. The use of thin material is engineered to reduce the foreign body sensation and risk of anal sphinction. Furthermore, the Qora Arida™ kit offers a single port attached to the side of the collection pouch. The port is used to withdraw the device in a trauma-free way from the patient.

The Qora AIM™ and Qora Aeon™ kits utilize a transit sheath that is a thin, biocompatible conduit that facilitates the transfer fecal material from the indwelling diverter to the collection bag. The use of thin sheath is designed to reduce the foreign body sensation and risk of anal sphinction. The bag connection interface at the end of the transit sheath prevents accidental soiling of bed sheets, garments, etc. during the exchange of a collection bag or other regular maneuvers during patient handling. Furthermore, the Qora AlM™ and Qora Aeon™ kits offer three ports attached to the side of the transit sheath. One port is used to irrigate the indwelling diverter if needed. The second port is used to collect samples from within the transit sheath if desired. The third and final port is used to withdraw the device in a trauma-free way from the patient.

## Indications for Use

The Indications for Use for the three products are as below:

The Qora AIM" Stool Manaqement Kit is indicated for fecal manaqement by diverting and collecting liquid or semiformed stool to minimize 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.

The Qora Aeon™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize 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.

The Qora Arida'" Stool Management Kit is indicated for fecal management by diverting and collecting liguid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device is intended to be until the collection pouch is filled or until it has been utilized for 72 hours, whichever comes first. The replacement with other same devices should not exceed 29 days.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Consure Medical. The word "consure" is written in teal, with a red curved line in the middle of the word. Below the word "ure" is the word "MEDICAL" in gray. The logo is simple and modern.

# Substantial Equivalence

A summary of the equivalence between the Qora AIM™ Stool Management Kit, Qora Aeon™ Stool Management Kit, and Qora Arida™ Stool Management Kit and the predicate device is given in the following table.

| | MODIFIED DEVICES | | | PREDICATE |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | Qora AIMTM SMK | Qora AeonTM SMK | Qora AridaTM SMK | Consure 120 SMS<br>(K133465) |
| Intended Use | Fecal management | Fecal management | Fecal management | Fecal management |
| Intended Users | Bedridden patients | Bedridden patients | Bedridden patients | Bedridden patients |
| Indications For<br>Use | The Qora AIMTM Stool<br>Management Kit is<br>indicated for fecal<br>management by<br>diverting and<br>collecting liquid or<br>semi-formed stool to<br>minimize skin contact<br>in bedridden<br>patients. The device<br>is for use in patients<br>18 years and older<br>only. The<br>uninterrupted use for<br>this device, including<br>replacement with<br>other same devices,<br>should not exceed 29<br>days. | The Qora AeonTM<br>Stool Management<br>Kit is indicated for<br>fecal management by<br>diverting and<br>collecting liquid or<br>semi-formed stool to<br>minimize skin contact<br>in bedridden<br>patients. The device<br>is for use in patients<br>18 years and older<br>only. The<br>uninterrupted use for<br>this device, including<br>replacement with<br>other same devices,<br>should not exceed 29<br>days. | The Qora AridaTM<br>Stool Management<br>Kit is indicated for<br>fecal management by<br>diverting and<br>collecting liquid or<br>semi-formed stool to<br>minimize skin contact<br>in bedridden<br>patients. The device<br>is for use in patients<br>18 years and older<br>only. The<br>uninterrupted use for<br>this device is<br>intended to be until<br>the collection pouch<br>is filled or until it has<br>been utilized for 72<br>hours, whichever<br>comes first. The<br>replacement with<br>other same devices<br>should not exceed 29<br>days. | The Consure 120 SMS<br>is indicated for fecal<br>management by<br>diverting and<br>collecting liquid or<br>semi-formed stool to<br>minimize skin contact<br>in bedridden<br>patients. |
| Patient<br>Population | 18 years and older | 18 years and older | 18 years and older | 18 years and older |
| Environment Of<br>Use | Hospitals and nursing<br>homes | Hospitals and nursing<br>homes | Hospitals and nursing<br>homes | Hospitals and nursing<br>homes |
| Condition Of Use | Single use | Single use | Single use | Single use |
| Period Of Usage | 29 days | 29 days | 29 days | 5 days |
| Insertion Method | Hygienic Applicator | Hygienic Applicator | Hygienic Applicator | Hygienic Applicator |
| Diverter Outer<br>Diameter | 55mm | 55mm | 55mm | 55mm |
| Detachable<br>Collection Bag | Yes | Yes | No | Yes |
| Irrigation Port | Yes | Yes | No | Yes |
| Sampling Port | Yes | Yes | No | No |
| Retrieval By | Collapsing diverter | Collapsing diverter | Collapsing diverter | Collapsing diverter |
| Closed Waste Bag<br>Volume | Approximately 1 liter | Approximately 1 liter | Approximately 1.5<br>liter | Approximately 1 liter |
| Interface Port | Side catheter<br>connector port | Side catheter<br>connector port | Side catheter<br>connector port | Side catheter<br>connector port |
| Odor Protection | Yes | Yes | No | No |
| Materials | Diverter: Urethane<br>based TPU that<br>cushions stainless<br>steel wire form<br>lattice that is MRI<br>Safe. Urethane base<br>TPU film to divert<br>fecal matter into<br>collection bag.<br>Collection Bag:<br>Hypoallergenic<br>EVA/PVDC odor<br>barrier film. | Diverter: Urethane<br>based TPU that<br>cushions stainless<br>steel wire form<br>lattice. Urethane<br>base TPU film to<br>divert fecal matter<br>into collection bag.<br>Collection Bag:<br>Hypoallergenic<br>EVA/PVDC odor<br>barrier film. | Diverter: Urethane<br>based TPU that<br>cushions stainless<br>steel wire form<br>lattice. Urethane<br>base TPU film to<br>divert fecal matter<br>into collection bag.<br>Collection Bag:<br>Urethane based TPU<br>film | Diverter: Urethane<br>based TPU that<br>cushions stainless<br>steel wire form<br>lattice. Urethane<br>base TPU film to<br>divert fecal matter<br>into collection bag.<br>Collection Bag:<br>Urethane based TPU. |
| Sterility | Supplied non-sterile,<br>disposable, single<br>patient use. | Supplied non-sterile,<br>disposable, single<br>patient use | Supplied non-sterile,<br>disposable, single<br>patient use | Supplied non-sterile,<br>disposable, single<br>patient use. |
| Packaging | Device tray in tamper<br>proof duplex box. | Device tray in tamper<br>proof duplex box. | Device in tamper<br>proof duplex box. | Cardboard tray in<br>Tyvek Pouch. |

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Consure Medical. The word "consure" is written in teal, with a red curved line in place of the "s". Below the word "ure" is the word "MEDICAL" in gray. The logo is simple and modern, and the colors are eye-catching.

## Summary of Performance Data (Non-Clinical Testing):

Non-clinical testing of the subject devices for structural and functional use characteristics has been performed (lumen size, device dimensions, functional strength, simulated use, etc.). In this testing, the subject devices were found to be substantially equivalent to the predicate device for dimensional, functional, and structural integrity testing.

The components of the Qora AIM™, Qora Aeon™, and Qora Arida™ Stool Management Kits have been evaluated for biocompatibility in accordance with the U.S. Food and Drug Administration's guidance entitled Use of International Standard 180 -10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', issued May 1, 1995. The results of this testing demonstrate that the Qora AIM™, and Qora Arida™ Stool Management Kits are considered to be non-sensitizing, non-cytotoxic, and non-irritating, and has been found safe in such respect for its intended use.

This 510(k) submission for the Qora AlM™ Stool Management Kit, Qora Aeon" Stool Management Kit, and the Qora Arida"" Stool Management Kit is intended to address line extensions to the previously FDA cleared Consure 120 SMS (K133465). Based on the comparison of intended use, indications for use, and technological characteristics, the three line extensions are substantially equivalent to the Consure 120 SMS (K133465), with respect to intended use, indications for use, performance, and technological characteristics. The line extensions do not raise any new issues of safety or effectiveness.