The EndoFLIP® system and catheter are identical to the predicate K092850, except the addition of the new software which permits a programmed series of inflations of the balloon in steps of volume. This feature is equivalent to a modality offered by the predicate Barostat (K991288).

The device is not intended to perform a diagnostic test.

AI/ML Overview

The provided text is a 510(k) summary for the EndoFLIP® Barostat Mode device. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, nor any performance data resulting from such a study.

The document states:

"No comparative bench testing was required as the change is a software change only."
"The proposed software modification does not change the performance specification of the EndoFLIP®, which remains identical to the predicate K092850."

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, environment of use, patient population, technology/design, and materials, asserting that the software change does not alter performance specifications.

Summary

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510(k) Summary Page I of 4 20-Aug-12

AUG 27 2012

Company	Crospon Ltd.Galway Business ParkDanganGalway, Ireland
Official Contact:	John O'Dea PhD
Proprietary or Trade Name:	EndoFLIP® Barostat Mode
Common/Usual Name:	Gastrointestinal motility monitoring system
Classification Name:	FFX - system, gastrointestinal motility (electrical)CFR 876.1725Class 2
Device:	EndoFLIP System and Catheter
Predicate Devices:	K991288 - G&J Electronics, Distender Series IIBarostatK092850 - EndoFLIP® systems - Crospon Ltd.

Device Description:

The device is not intended to perform a diagnostic test.

Indications for Use:

Patient Population:

Patients with esophageal disorders.

Environment of Use:

Hospitals, Physician offices.

Contraindications:

The EndoFLIP® System is contraindicated where endoscopy is contraindicated.

The EndoFLIP System is contraindicated in patients with an increased risk of esophageal perforation or bleeding.

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0(k) Summa Page 2 of 4 20-Aug-12lS
------------------------------------------------

FLAVOR PROFILE

COMPLEX, INTENSE, PRONOUNCED
DARK CHOCOLATE, BROWN SUGAR
FULL BODIED, SMOOTH
DEVICA IS STANDARD

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ntraindicati	Not stated		he EndoFLIP® System is ontraindicated where endosed ontraindicated.



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	ecords volume and pressure charing the protocol.

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510(k) Summary

	Distender Series II Barostat(G&J Electronics) K991288	EndoFLIP®Crospon (K092850)	EndoFLIP®Barostat Mode
Principle of Operation	Pressure sensor in the device is connected tothe balloon via a measurement line.	Pressure sensor in the catheterballoon. Dest electrodes are located at16 points along the catheter inside aballoon. The balloon is placed suchthat its midpoint is located in a stomawithin a stomach fitted with a gastricband	Pressure sensor in the catheterballoon. Dest electrodes are located at16 points along the catheter inside aballoon. The balloon is placed suchthat its midpoint is located in theesophagus.
Data Recording	4 channels of data can be recorded on a chartrecorder	Data is saved internally and can beexported to a USB mass storagedevice or printed to an attached USBprinter	Data is saved internally and can beexported to a USB mass storagedevice or printed to an attached USBprinter
Electrical SafetyBiocompatibility	Not stated	IEC60601-1 2nd Ed. + Am.1 + Am.2All materials have passedbiocompatibility tests in accordancewith ISO 10993-1	IEC60601-1 2nd Ed. + Am.1 + Am.2Identical to K092850
Compatibility With TheEnvironment And OtherDevices	User sources balloons and tubing.	User sources balloons and tubing.	EndoFLIP operates with customcatheters only.
Performance	Volume range and resolution is dependent onthe cylinder size used. Range available is 25mlto 1200ml. Resolution ranges from a pistonstep size of 0.181ml to 0.804ml	EndoFLIP operates with customcatheters only.	Balloon volume is controlled andvolume is displayed:Range: 0 to 50 ml.Resolution: 1 mL
			Balloon volume is controlled andvolume is displayed:Range: 0 to 50 ml.Resolution: 1 mL

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510(k) Summarv Page 4 of 4 20-Aug-12

Substantial Equivalence

The EndoFLIP® system in Barostat.mode is viewed as substantially equivalent to the predicate devices presented above. In summary we have found that the following key elements support a determination of substantially equivalent:

Indications -

The proposed indications for use are nearly identical to the predicate, Barostat K991288.

The EndoFLIP system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity vs. the predicate Distender Series II Dual Drive Barostat device which is used for volume/pressure measurement in the alimentary tract as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test.

Environment of Use -

The proposed environments of use are identical to the predicates. EndoFLIP® K092850 and Barostat (K991288), which are for Hospitals and Physician offices.

Patient Population -

The proposed patient population is patients with esophageal disorders whereas the predicate Barostat (K991288) lists patients with symptoms consistent with gastrointestinal motility disorders, which are equivalent.

Technology / Design / Features -

The technology is identical to the predicate EndoFLIP® systems (K092850) and we have only added a new software feature which is the Barostat mode, which allows programmed volume distentions, each volume distention being identical in nature to the single volume distention permitted using the existing software.

Materials -

The materials are identical to the predicate EndoFLIP® K092850 and thus not applicable as the modification is software only.

Performance Specifications -

The proposed software modification does not change the performance specification of the EndoFLIP®, which remains identical to the predicate K092850.

Performance Testing - Bench.

No comparative bench testing was required as the change is a software change only.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and progress.

Public Health Service

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

Crospon, Ltd. % Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134

AUG 27 2012

Re: K120997

Trade/Device Name: EndoFLIP® Barostat Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: August 20, 2012 Received: August 21, 2012

Dear Mr. Dryden:

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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rior thator and to 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part now are 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 Tou may 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/Resourcesfor You/Industry/default.htm.

Sincerély yours,

Sincerely yours,
Benjamin K. Fisher

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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Indications for Use Statement

Page 1 of 1

510(k) Number: K120997

Device Name:

EndoFLIP® Barostat

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Halur Rem

ision Sign-Off) of Reproductive, Gastro-Renal, xical De (k) Numbe

Regulation Number and Section

§ 876.1725 Gastrointestinal motility monitoring system.

(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).