(117 days)
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No
The summary describes a perfusion pump for pressure measurement and does not mention any AI/ML terms or functionalities.
No
The device is described as an "accessory device" used to measure pressures during intraluminal studies, not to treat a condition.
Yes
The device is used to measure pressures within the gastrointestinal tract, which indicates an diagnostic function to assess the physiological state.
No
The device is described as a "Perfusion Pump," which is a hardware device used to deliver fluids. The description also mentions "designated catheters and accessories," which are also hardware components. There is no mention of software being the primary or sole component of this device.
Based on the provided information, the Solar Perfusion Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for intraluminal studies of the gastro-intestinal tract to perfuse water and measure pressures. This is a physiological measurement performed in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information about a patient's health.
The Solar Perfusion Pump is a medical device used for a diagnostic procedure performed directly on the patient, not on a sample taken from the patient.
N/A
Intended Use / Indications for Use
The Solar Perfusion Pump is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures. Designated catheters and accessories are required for measurement in each specific area.
Product codes
FFX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines representing the human services aspect of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 3 2007
Ms. Karin Ogink-Somhorst Quality Assurance and Regulatory Affairs Manager Medical Measurement Systems, B.V. Colosseum 25 7521 PV Enschede THE NETHERLANDS
Re: K071094
Trade/Device Name: Solar Perfusion Pump Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: June 25, 2007 Received: June 27, 2007
Dear Ms. Ogink-Somhorst:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/0/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the circle, and the word "Centennial" is at the bottom. The letters "FDA" are prominently displayed in the center of the circle. There are stars around the perimeter of the circle.
Protecting and Promoting Public Health
1
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876.xxxx 21 CFR 884 xxxx 21 CFR 892 xxxxx Other
(Gastroenterology/Renal/Urology) 240-276-0115 240-276-0115 (Obstetrics/Gynecology) 240-276-0120 (Radiology); 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K071094 510(k) Number (if known):
Solar Perfusion Pump Device Name:
Indications For Use:
The Solar Perfusion Pump is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures.
Designated catheters and accessories are required for measurement in each specific area.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Chroglon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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