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.

AI/ML Overview

The Consure 120 SMS™ device underwent several tests to confirm functional performance and structural integrity, as well as a comparative analysis against predicate devices.

1. Acceptance Criteria and Reported Device Performance

Product Components/Feature	Acceptance Criteria	Reported Device Performance (No specific separate performance data provided, implies compliance with criteria)
Assembled Crown OD	50 – 56 mm	-
Applicator OD	15 ± 0.5 mm	-
Visual inspection	N/A (Method provided)	-
Radial force	8 ± 3 N	-
Fatigue Testing	50 cycles	-
Bonding Strength - Crown foil to sheath	35 N minimum	-
Bonding Strength - Sheath to connector	35 N minimum	-
Bonding Strength - Y-adapter to extrusion	35 N minimum	-
Bonding Strength - Bag to connector	35 N minimum	-
Withdrawal force	45 N maximum	-

2. Sample Size and Data Provenance

The document states that "100% receiving and in-process inspection" is performed, and the listed tests are conducted "on each lot prior to release." This suggests a continuous sampling or full inspection approach for manufacturing quality control, rather than a single large-scale test set.
The "Comparative analysis of Consure 120 SMS vs predicate devices" was performed "in-house." The document does not specify the sample size for this comparative analysis.
The data provenance is internal ("in-house") and appears to be from manufacturing and bench-top testing. There is no information regarding country of origin of data or whether it's retrospective or prospective in the context of clinical studies.

3. Number of Experts and Qualifications for Ground Truth

The provided document does not mention any ground truth established by experts for a test set. The testing described is primarily focused on engineering specifications, functional performance, and comparative bench-top analysis against predicate devices, not clinical performance or expert-adjudicated outcomes.

4. Adjudication Method for the Test Set

Not applicable, as no expert-adjudicated test set is described in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided text. The comparative analysis described is a bench-top comparison of device features and specifications, not a study involving human readers or clinical outcomes.

6. Standalone (Algorithm Only) Performance Study

Not applicable, as the Consure 120 SMS is a physical medical device (rectal catheter) and not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the device testing appears to be based on:

Engineering Specifications: Defined dimensional and force thresholds for manufacturing and functional performance.
Predicate Device Specifications: Published functional parameters and characteristics of the Bard® DigniShield™ Stool Management System, used for bench-top comparison.

8. Sample Size for the Training Set

Not applicable, as the Consure 120 SMS is a physical medical device and not an AI or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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.

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-- 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/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

Page 5-2

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Consure 120 SMS™

Visual inspection		CMP-01975-002 Rev 00IPI by AC-0276 Rev 01 andAC-0278 Rev 01
Radial force *1	$8 \pm 3$ N	Per TST-037 Rev 01 andECO - 02006-001
Fatigue Testing	50 cycles	Per TST-037 Rev 01 andECO - 02006-001
Bonding Strength - Crown foil to sheath	35 N minimum	Per TST-037 Rev 01 andECO - 02006-001
Bonding Strength - Sheath to connector	35 N minimum	Per TST-037 Rev 01 andECO - 02006-001
Bonding Strength - Y-adapter to extrusion	35 N minimum	Per TST-037 Rev 01 andECO - 02006-001
Bonding Strength - Bag to connector	35 N minimum	Per TST-037 Rev 01 andECO - 02006-001
Withdrawal force *2	45 N maximum	Per TST-037 Rev 01 andECO - 02006-001

Table II: Comparative Analysis - bench top.

S/N	Features andSpecifications	Consure 120 SMS	In-dwelling Catheters	Comments
1	InsertionMechanism	Safe and hygienicapplicator available	Unavailable.Device inserted whenindex finger traversesanatomy
2	Insertion diameter	Applicator OD: 14 mm	Index Finger + Device:23 to 30 mm
3	IndwellingDiverter	Lattice	Inflatable cuff
	Diverter position	Transverse rectal valve	Anorectal junction	1 - No pain sensationabove the rectal valve.2 - Anchoring atanorectal causingsphincter 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-dwellingdiverter thinking itsfecal material
	Interference inphysiologicalfunctioning	No.Lattice is pliable 3 axis	Yes.Applies constant radialpressure	Constant radialpressure manifestpressure necrosis
	Transit Sheath	Polyurethane 80A	Silicone & TPE
	Profile Diameter	Less than 7 mm	10 - 15 mm	Large profile diametercauses foreign bodysensation to the patientand could lead tosphincter dysfunction
4	Wall thickness	0.050 mm	2 mm	Large wall leads tolarge profile diameter
	Length	370 mm	1500 mm	Long sheath does notenable transfer offormed stool
	WithdrawalMechanism	Integrated collapsingsystem	Deflated using inflationdevice
5	CollapsedDiameter	17 mm	20 - 30 mm
6	Odor proof	Yes	Not during bagexchange
7	Gas release valve	YesCharcoal Filter	No	Lack of flatus releasevalve can cause thecollection bags tobulge

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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.

Page 5-4

: .

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Comparison Table of New and Predicate Device

Parameter	Consure 120 SMS	DigniShield™ StoolManagement System
Intended Use	Fecal management	Fecal management
Intended Users	Bedridden patients	Bedridden patients
Indications for Use	The Consure 120 SMS isindicated for fecal managementby diverting and collecting liquidor semi-formed stool to minimizeskin contact in bedridden patients	The Bard® DigniShield™Stool Management System isintended for fecalmanagement by divertingand collecting liquid orsemi-liquid stool to minimizeskin contact in bedriddenpatients."
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 uponremoval?	Yes	Yes
Detachablecollection device?	Yes	Yes
Irrigation port	Yes	Yes
Retrieval by	Collapse of crown	Deflation
Closed waste bagvolume	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 thatcushions 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.

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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.

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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

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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)

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Page 4-1

Regulation Number and Section

§ 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.