(147 days)
No
The summary explicitly states that the software change is equivalent to a modality offered by a predicate device and does not mention AI, ML, or related terms.
No
The device is described as a "pressure and dimension measurement device" and explicitly states it is "not intended to perform a diagnostic test." Its use is as an "adjunct to other methods in the comprehensive evaluation," indicating a diagnostic or investigative role, not a therapeutic one.
No
The Device Description explicitly states: "The device is not intended to perform a diagnostic test."
No
The device description explicitly states that the system includes both the "EndoFLIP® system and catheter," indicating a hardware component (the catheter) in addition to the software change. The performance studies section also mentions the change is "a software change only," implying the existing system (with hardware) remains.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section explicitly states: "The device is not intended to perform a diagnostic test."
- Intended Use: The intended use describes the device as a "pressure and dimension measurement device" and an "adjunct to other methods in the comprehensive evaluation." While it contributes to evaluation, it doesn't perform a diagnostic test on a sample taken from the body.
- Lack of IVD Characteristics: The description doesn't mention analyzing biological samples (blood, tissue, etc.) or performing a test in vitro (outside the body).
Therefore, the EndoFLIP system, as described here, does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FFX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, Physician offices.
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)
No comparative bench testing was required as the change is a software change only.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991288 - G&J Electronics, Distender Series II Barostat, K092850 - EndoFLIP® systems - Crospon Ltd.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary Page I of 4 20-Aug-12
AUG 27 2012
| Company | Crospon Ltd.
Galway Business Park
Dangan
Galway, 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 876.1725
Class 2 |
| Device: | EndoFLIP System and Catheter |
| Predicate Devices: | K991288 - G&J Electronics, Distender Series II
Barostat
K092850 - EndoFLIP® systems - Crospon Ltd. |
Device Description:
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.
Indications for Use:
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.
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.
1
| 0(k) Summa Page 2 of 4 20-Aug-12
l
| S |
|---|
| ------------------------------------------------ |
FLAVOR PROFILE
- COMPLEX, INTENSE, PRONOUNCED
- DARK CHOCOLATE, BROWN SUGAR
- FULL BODIED, SMOOTH
- DEVICA IS STANDARD
| dications for | |||
|---|---|---|---|
| ក្រសួរសង្គម ស្រុក ស្រុក ស្រុក និង ភូមិ | inders III MBAA The Times March As a Previous and Caroles Andresses Marchiller March Asia Previous and Career Andress Normalians West National Provinces Supersions Sons | ||
| natomical Si | Stomac | Esophagi | |
| ospitals. Physician offices tients with esophageal disord | |||
| wironments of tient Populatio | |||
| spitals. Physician offices Reflection Resolução Brand Lista em Rossing Brasilia Band Leathernia Single System Band Norther Threat System Transmille Hurai | |||
| ntraindicati | Not stated | he EndoFLIP® System is ontraindicated where endosed ontraindicated. | |
| EndoFLIP System is contraindi tients with an increased risk of | |||
| escriptio | scription use | ||
| inciple of Operat | Presseription use Pressure or isovolumetric volume within pressure or isovolumetric volume within balloon. | catheter is positioned in the economics for any within and within are within are and with bearling the bearling the best and the best and the best and the bested to be set to | |
| ecords volume and pressure charing the protocol. | |||
2
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 to
the balloon via a measurement line. | Pressure sensor in the catheter
balloon. Dest electrodes are located at
16 points along the catheter inside a
balloon. The balloon is placed such
that its midpoint is located in a stoma
within a stomach fitted with a gastric
band | Pressure sensor in the catheter
balloon. Dest electrodes are located at
16 points along the catheter inside a
balloon. The balloon is placed such
that its midpoint is located in the
esophagus. |
| Data Recording | 4 channels of data can be recorded on a chart
recorder | Data is saved internally and can be
exported to a USB mass storage
device or printed to an attached USB
printer | Data is saved internally and can be
exported to a USB mass storage
device or printed to an attached USB
printer |
| Electrical Safety
Biocompatibility | Not stated | IEC60601-1 2nd Ed. + Am.1 + Am.2
All materials have passed
biocompatibility tests in accordance
with ISO 10993-1 | IEC60601-1 2nd Ed. + Am.1 + Am.2
Identical to K092850 |
| Compatibility With The
Environment And Other
Devices | User sources balloons and tubing. | User sources balloons and tubing. | EndoFLIP operates with custom
catheters only. |
| Performance | Volume range and resolution is dependent on
the cylinder size used. Range available is 25ml
to 1200ml. Resolution ranges from a piston
step size of 0.181ml to 0.804ml | EndoFLIP operates with custom
catheters only. | Balloon volume is controlled and
volume is displayed:
Range: 0 to 50 ml.
Resolution: 1 mL |
| | | | Balloon volume is controlled and
volume is displayed:
Range: 0 to 50 ml.
Resolution: 1 mL |
3
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.
4
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
5
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
6
Indications for Use Statement
Page 1 of 1
510(k) Number: K120997
Device Name:
EndoFLIP® Barostat
Indications for Use:
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.
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