(55 days)
Not Found
Not Found
No
The summary describes an electro-pneumatic device for volume/pressure measurement and does not mention any AI or ML capabilities.
No
The device is described as an "adjunct to other diagnostic methods" for evaluating gastrointestinal motility disorders, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders." This indicates its role in the diagnostic process.
No
The device description explicitly states it is an "electro-pnuematic device," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description states the device is an "electro-pnuematic device used for volume/pressure measurement in the alimentary tract." This involves direct measurement within the body, not analysis of samples taken from the body.
- Intended Use: The intended use describes it as an "adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders." This further reinforces its role in direct physiological measurement within the body.
Therefore, the G&J Electronics Distender Series II Dual Drive Barostat device is a medical device used for in-vivo measurement, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of pationts with symptoms consistent with gastrointestinal motility disorders.
Product codes
78 FFX
Device Description
electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentrary tract (gastrointestinal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 1999
Mr. Sam Jundler President G & J Electronics Inc. 6 Dornfell Street Willowdale, Ontario CANADA M2R 2Y6
Re: K991288 Distender Series II Barostat Dated: April 8, 1999 Received: April 14, 1999 Regulatory Class: II 21 CFR §876.1725/Procode: 78 FFX
Dear Mr. Jundler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally asternment and is cabstantean, oquitantean, oquitante commerce prior to May 28, 1976, the enactment date of the manical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
00/01/00 - 17:15 FAX 301 604 2330
TDA/CDRH/ODE/DRAERD
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5 | =
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|---------|--------|---------------|
| | 1 | Sa- binnes-a- |
| 510(k) Number (if known): | k9912188 |
|---|---|
| Device Name: | Distender Series II Dual Drive Barostat: |
Indications For Use:
The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of pationts with symptoms consistent with gastrointestinal motility disorders.
(PLEASE DO NOT WRITE DELOW THIS LINE - CONTINUE ON ANOTHER PAGE II NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ra-Ralph
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
scription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Funnul 1-2-96)