CONSURE STOOL MANAGEMENT SYSTEM

{0}------------------------------------------------ K133465 Page 1 of 5 #### 510(k) Summary of Safety and Effectiveness 5 Consure 120 SMSTM Device / trade name: Device type / Common Name: \ Rectal Catheter 510(k) submitter: Consure Medical, Pvt., Ltd. 86/1 Shahpur Jat Village, Building No.1, 1st Floor, New Delhi, Delhi - 110 049 INDIA Contact: Mr. Nishith Chasmawala, CEO Establishment registration number: Not obtained yet. Note: The product is manufactured and packaged by Contract Medical International GmbH, a contract manufacturer. Address of manufacturing/packaging facility: Contract Medical International GmbH. Lauensteiner Strasse 37 Dresden 01277 Germany Telephone: +42 494 949 564 Contact: Mr. Jan Kloboucnik Alan Donald, President Authorized Contact Person: Matrix Medical Consulting, Inc. 11440 West Bernardo Court, Suite 300 San Diego, California 92127-1644 Phone: 858 485 8584 Fax: 858 753 1801 Recommended regulation: 21 CFR 876.5980 Device classification name: Gastrointestinal tube and accessories Device class: Class II device Panel: Gastroenterology-Urology Devices Product code: KNT Bard® DigniShield™ Stool Management System Predicate device: Predicate Device Pro Code/K#: KNT, 510(k) K102391 ### Date Summary Prepared: November 6, 2013 ### Device Description: Fecal incontinence (FI) is the inability to control bowel movements resulting in involuntary leakage or soiling. The condition is believed to affect 8-15 percent of the general population, with the highest prevalence among the elderly and in acute and ICU care settings. C Copyright 2013 Consure Medical Pvt., Ltd. {1}------------------------------------------------ The Consure 120 Stool Management System is a non-sterile device packaged in individual SteriClin (medical grade paper with peel-away PE lamination) pouches. Ten such individual pouches are packed in corrugated boxes for shipping. Each Consure 120 SMS pouch contains: -- I soft and hygienic applicator that houses a soft in-dwelling diverter and -- 3 collection bags. The primary component of the device is the fecal diverter. It consists of an indwelling, pliable, self-expanding lattice structure 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 can reduce abrasion and subsequent clinical complications originating from the mucosal damage. The transit sheath is a thin, biocompatible conduit that facilitates the transfer fecal material from the indwelling diverter to the collection bag. The use of thin sheath reduces the foreign body sensation and risk of anal sphincter dysfunction. The applicator is used to hygienically insert and deploy the indwelling diverter at the intended location inside the rectum. Whereas the bag connection interface allows the prevention of accidental soiling of bed sheets, garments, etc. during exchange of collection bag or other regular maneuvers during patient handling. ### Indications for Use: Consure 120 SMS is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. ## Testing - 1) In addition to 100% receiving and in-process inspection, the following tests are performed on each lot prior to release. These tests (Table I below) confirm the functional performance and structural integrity of the product. - 2) Comparative analysis of Consure 120 SMS vs predicate devices for dimensional and functional parameters. The comparison was performed in-house with the aid of published functional parameters of predicate devices. Refer to Table II. - 3) Biocompatibility testing per ISO 10993 for all components that has mucosa contact (for more than 60 seconds). Refer to Table III | | | unctional Performance and Structural Integrity . | OCTIVET | |--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|---------| | | . A series and the control and the submit of the comments of the production of the commend of the commend of the commend of the commend of the commend of the commend of the c | . | | | Product Components/Feature | Dimension | Test Method | |----------------------------|-------------|---------------------------| | Assembled crown OD | 50 – 56 mm | IPI by GLU-0155 Rev 01 | | Applicator OD | 15 ± 0.5 mm | ICI by IC-0587 Rev 01 and | © Copyright 2013 Consure Medical Pvt., Ltd. Page 5-2 \$\cdot\$ {2}------------------------------------------------ Consure 120 SMS™ | Visual inspection | | CMP-01975-002 Rev 00<br>IPI by AC-0276 Rev 01 and<br>AC-0278 Rev 01 | |-------------------------------------------|--------------|---------------------------------------------------------------------| | Radial force *1 | $8 \pm 3$ N | Per TST-037 Rev 01 and<br>ECO - 02006-001 | | Fatigue Testing | 50 cycles | Per TST-037 Rev 01 and<br>ECO - 02006-001 | | Bonding Strength - Crown foil to sheath | 35 N minimum | Per TST-037 Rev 01 and<br>ECO - 02006-001 | | Bonding Strength - Sheath to connector | 35 N minimum | Per TST-037 Rev 01 and<br>ECO - 02006-001 | | Bonding Strength - Y-adapter to extrusion | 35 N minimum | Per TST-037 Rev 01 and<br>ECO - 02006-001 | | Bonding Strength - Bag to connector | 35 N minimum | Per TST-037 Rev 01 and<br>ECO - 02006-001 | | Withdrawal force *2 | 45 N maximum | Per TST-037 Rev 01 and<br>ECO - 02006-001 | # Table II: Comparative Analysis - bench top. | S/N | Features and<br>Specifications | Consure 120 SMS | In-dwelling Catheters | Comments | |-----|-------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | 1 | Insertion<br>Mechanism | Safe and hygienic<br>applicator available | Unavailable.<br>Device inserted when<br>index finger traverses<br>anatomy | | | 2 | Insertion diameter | Applicator OD: 14 mm | Index Finger + Device:<br>23 to 30 mm | | | 3 | Indwelling<br>Diverter | Lattice | Inflatable cuff | | | | Diverter position | Transverse rectal valve | Anorectal junction | 1 - No pain sensation<br>above the rectal valve.<br>2 - Anchoring at<br>anorectal causing<br>sphincter dysfunction | | | Diverter OD | 55 mm | 53 - 58 mm | | | | Radial pressure | 4 - 9 cm of H2O | 30 - 40 cm of H2O | Above 35 cm of H2O,<br>the body will try to | | | | | | expel the in-dwelling<br>diverter thinking its<br>fecal material | | | Interference in<br>physiological<br>functioning | No.<br>Lattice is pliable 3 axis | Yes.<br>Applies constant radial<br>pressure | Constant radial<br>pressure manifest<br>pressure necrosis | | | Transit Sheath | Polyurethane 80A | Silicone & TPE | | | | Profile Diameter | Less than 7 mm | 10 - 15 mm | Large profile diameter<br>causes foreign body<br>sensation to the patient<br>and could lead to<br>sphincter dysfunction | | 4 | Wall thickness | 0.050 mm | 2 mm | Large wall leads to<br>large profile diameter | | | Length | 370 mm | 1500 mm | Long sheath does not<br>enable transfer of<br>formed stool | | | Withdrawal<br>Mechanism | Integrated collapsing<br>system | Deflated using inflation<br>device | | | 5 | Collapsed<br>Diameter | 17 mm | 20 - 30 mm | | | 6 | Odor proof | Yes | Not during bag<br>exchange | | | 7 | Gas release valve | Yes<br>Charcoal Filter | No | Lack of flatus release<br>valve can cause the<br>collection bags to<br>bulge | © Copyright 2013 Consure Medical Pvt., Ltd. · ・´ . ー・ ・ {3}------------------------------------------------ # Consure 120 SMS™ ## Consure Medical, Inc. ## Substantial Equivalency A summary of the equivalence between the Consure 120 SMS and the predicate device is given in the following table. © Copyright 2013 Consure Medical Pvt., Ltd. f Page 5-4 : . {4}------------------------------------------------ 1 | Comparison Table of New and Predicate Device | | | | |----------------------------------------------|--|--|--| | | | | | | Parameter | Consure 120 SMS | DigniShield™ Stool<br>Management System | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Fecal management | Fecal management | | Intended Users | Bedridden patients | Bedridden patients | | Indications for Use | The Consure 120 SMS is<br>indicated for fecal management<br>by diverting and collecting liquid<br>or semi-formed stool to minimize<br>skin contact in bedridden patients | The Bard® DigniShield™<br>Stool Management System is<br>intended for fecal<br>management by diverting<br>and collecting liquid or<br>semi-liquid stool to minimize<br>skin contact in bedridden<br>patients." | | Patient Population | Adults only | Adults only | | Environment of Use | Hospitals, nursing homes | Hospitals, nursing homes | | Condition of Use | Single Use | Single Use | | Period of Usage | 5 days | 29 days | | Expanded OD | 55 mm | 55 mm | | Self-sealing upon<br>removal? | Yes | Yes | | Detachable<br>collection device? | Yes | Yes | | Irrigation port | Yes | Yes | | Retrieval by | Collapse of crown | Deflation | | Closed waste bag<br>volume | Approximate = 1 liter | Approximate = 1 liter | | Port | Side catheter connector port | Top catheter connector port | | Filter | Charcoal filter | Charcoal filter | | Materials | | | | Catheter | Urethane based TPU that<br>cushions SS 304 wire form lattice | Styrene-based TPE | | Collection bag | Urethane based TPU | Styrene-based TPE | | Sterility | Supplied non-sterile, disposable,<br>single patient use. | Supplied non-sterile,<br>disposable, single patient use. | Based on the comparison of intended use, indications for use, and technological characteristics, the Consure SMS 120 is substantially equivalent to the Bard DigniShield (K102391), with respect to intended use, indications for use, performance and technological characteristics. The Consure SMS 120 raises no new safety or effectiveness issues. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three curved lines that resemble a stylized human figure or a flowing ribbon. #### Public I lealth Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 June 26, 2014 Consure Medical Pvt., Ltd. % Alan Donald, MS, MBA, FRAPS President Matrix Medical Consulting, Inc. 11440 West Bernardo Court, Suite 300 San Diego, CA 92127 K133465 Re: Trade/Device Name: Consure 120 SMSTM Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 26, 2014 Received: May 29, 2014 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. {6}------------------------------------------------ ## Page 2 - Alan Donald, MS, MBA, FRAPS 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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/6/Picture/8 description: The image shows the name "Benjamin Fisher-S" with a logo in the middle. The logo is a stylized FDA logo. The text is in black and the background is white. 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 {7}------------------------------------------------ ## Consure 120 SMSTM #### Indications for Use Statement 4 510(k) Number: K133465 Device Name: Consure 120 SMS TM Indications For Use: Consure 120 SMS is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. X Prescription Use AND/OR Over-The-Counter Use (21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/7/Picture/16 description: The image contains the name "Benjamin R. Fisher -S" in bold font. Below the name is the date "2014.06.26 16:14:31 -04'00'" also in bold font. The text appears to be extracted from a document or image. The text is black and the background is white. © Copyright 2013 Consure Medical Pvt., Ltd. Page 4-1