K Number
K133465
Device Name
CONSURE STOOL MANAGEMENT SYSTEM
Date Cleared
2014-06-26

(226 days)

Product Code
Regulation Number
876.5980
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
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.
More Information

Not Found

No
The device description focuses on mechanical components and physical properties. There is no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is for fecal management, diverting and collecting stool to minimize skin contact, not for treating a disease or condition.

No

The device is indicated for fecal management by diverting and collecting liquid or semi-formed stool, not for diagnosing a medical condition.

No

The device description clearly outlines physical components such as an applicator, indwelling diverter, transit sheath, and collection bags, indicating it is a hardware-based medical device.

Based on the provided information, the Consure 120 SMS is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for "fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients." This is a physical management system for bodily waste.
  • Device Description: The description details a physical device with components like an applicator, diverter, transit sheath, and collection bags. These are all mechanical components designed to manage stool externally or within the rectum for collection.
  • Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like stool) to diagnose a disease, condition, or state of health. IVDs are specifically designed for such analysis.
  • No Mention of Laboratory Use: The intended use and care setting (hospitals, nursing homes) are consistent with a device used for patient care and management, not laboratory testing.

In summary, the Consure 120 SMS is a medical device for managing fecal output, not for performing diagnostic tests on biological samples.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KNT

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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

rectal

Indicated Patient Age Range

Adults only

Intended User / Care Setting

Hospitals, nursing homes

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)

  1. In addition to 100% receiving and in-process inspection, the following test are performed on each lot prior to release. These tests 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.
  3. Biocompatibility testing per ISO 10993 for all components that has mucosa contact (for more than 60 seconds).

Key results: The product meets specifications for functional performance and structural integrity, dimensional parameters, radial force, fatigue testing, bonding strength, and withdrawal force. The comparative analysis against the predicate device for features such as insertion mechanism, insertion diameter, indwelling diverter characteristics (lattice vs. inflatable cuff, position, OD, radial pressure), interference in physiological functioning, transit sheath properties (material, profile diameter, wall thickness, length), withdrawal mechanism, collapsed diameter, odor proofing, and gas release valve shows the Consure 120 SMS has similar or improved characteristics.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K102391

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.

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.
    1. 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.
    1. 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/FeatureDimensionTest Method
Assembled crown OD50 – 56 mmIPI by GLU-0155 Rev 01
Applicator OD15 ± 0.5 mmICI 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
IPI by AC-0276 Rev 01 and
AC-0278 Rev 01 |
|-------------------------------------------|--------------|---------------------------------------------------------------------|
| Radial force *1 | $8 \pm 3$ N | Per TST-037 Rev 01 and
ECO - 02006-001 |
| Fatigue Testing | 50 cycles | Per TST-037 Rev 01 and
ECO - 02006-001 |
| Bonding Strength - Crown foil to sheath | 35 N minimum | Per TST-037 Rev 01 and
ECO - 02006-001 |
| Bonding Strength - Sheath to connector | 35 N minimum | Per TST-037 Rev 01 and
ECO - 02006-001 |
| Bonding Strength - Y-adapter to extrusion | 35 N minimum | Per TST-037 Rev 01 and
ECO - 02006-001 |
| Bonding Strength - Bag to connector | 35 N minimum | Per TST-037 Rev 01 and
ECO - 02006-001 |
| Withdrawal force *2 | 45 N maximum | Per TST-037 Rev 01 and
ECO - 02006-001 |

Table II: Comparative Analysis - bench top.

| S/N | Features and
Specifications | Consure 120 SMS | In-dwelling Catheters | Comments |
|-----|-------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 1 | Insertion
Mechanism | Safe and hygienic
applicator available | Unavailable.
Device inserted when
index finger traverses
anatomy | |
| 2 | Insertion diameter | Applicator OD: 14 mm | Index Finger + Device:
23 to 30 mm | |
| 3 | Indwelling
Diverter | Lattice | Inflatable cuff | |
| | Diverter position | Transverse rectal valve | Anorectal junction | 1 - No pain sensation
above the rectal valve.
2 - Anchoring at
anorectal causing
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,
the body will try to |
| | | | | expel the in-dwelling
diverter thinking its
fecal material |
| | Interference in
physiological
functioning | No.
Lattice is pliable 3 axis | Yes.
Applies constant radial
pressure | Constant radial
pressure manifest
pressure necrosis |
| | Transit Sheath | Polyurethane 80A | Silicone & TPE | |
| | Profile Diameter | Less than 7 mm | 10 - 15 mm | Large profile diameter
causes foreign body
sensation to the patient
and could lead to
sphincter dysfunction |
| 4 | Wall thickness | 0.050 mm | 2 mm | Large wall leads to
large profile diameter |
| | Length | 370 mm | 1500 mm | Long sheath does not
enable transfer of
formed stool |
| | Withdrawal
Mechanism | Integrated collapsing
system | Deflated using inflation
device | |
| 5 | Collapsed
Diameter | 17 mm | 20 - 30 mm | |
| 6 | Odor proof | Yes | Not during bag
exchange | |
| 7 | Gas release valve | Yes
Charcoal Filter | No | Lack of flatus release
valve can cause the
collection bags to
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
Management System |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Fecal management | Fecal management |
| Intended Users | Bedridden patients | Bedridden patients |
| Indications for Use | The Consure 120 SMS is
indicated for fecal management
by diverting and collecting liquid
or semi-formed stool to minimize
skin contact in bedridden patients | The Bard® DigniShield™
Stool Management System is
intended for fecal
management by diverting
and collecting liquid or
semi-liquid stool to minimize
skin contact in bedridden
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
removal? | Yes | Yes |
| Detachable
collection device? | Yes | Yes |
| Irrigation port | Yes | Yes |
| Retrieval by | Collapse of crown | Deflation |
| Closed waste bag
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
cushions SS 304 wire form lattice | Styrene-based TPE |
| Collection bag | Urethane based TPU | Styrene-based TPE |
| Sterility | Supplied non-sterile, disposable,
single patient use. | Supplied non-sterile,
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.

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